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Committee 15 Surgery for Pelvic Organ Prolapse Chairman L. BRUBAKER (USA) Members C. GLAZENER (U.K), B. JACQUETIN (France), C. MAHER (Australia), A. MELGREM (USA), P. NORTON (USA), N. RAJAMAHESWARI (India), P. VON THEOBALD 1273 (France) CONTENTS INTRODUCTION IV. CONCOMITANT SURGERY 1. EFFECT OF COMBINATION PROCEDURES I. OUTCOME ASSESSMENT 2. HYSTERECTOMY - The Role of Hysterectomy in Surgical Treatment of Prolapse 1. OUTCOME ASSESSMENT: ANATOMY 2. OUTCOME ASSESSMENT: SYMPTOMS 3. CONTINENCE TREATMENT (Treatment and Prophylaxis) 3. OUTCOME EVALUATION: QUALITY OF LIFE 4. CONCOMITANT PERIOPERATIVE PELVIC PHYSICAL THERAPY II. SELECTION OF SURGICAL ROUTE FOR RECONSTRUCTIVE POP PROCEDURES V. THE ROLE OF AUGMENTING MATERIALS IN POP SURGERY 1. COMPARISON OF OPEN ABDOMINAL TO VAGINAL 1. AUGMENTATION FOR ANTERIOR WALL SURGERY 2. SAFETY ISSUES RELATED TO THE CHOICE OF SURGICAL ROUTE VI. RECTAL PROLAPSE 3. LAPAROSCOPIC AND ROBOTIC SURGERY 1. PERINEAL PROCEDURES III. EFFICACY OF SPECIFIC PROCEDURES 2. TRANSABDOMINAL PROCEDURES VII. RECOMMENDATIONS 1. RECONSTRUCTIVE PROCEDURES 2. OBLITERATIVE PROCEDURES: LeFort colpocleisis, Colpectomy and colpocleisis REFERENCES 1274 Surgery for Pelvic Organ Prolapse L. BRUBAKER, C. GLAZENER, B. JACQUETIN, C. MAHER, A. MELGREM, P. NORTON, N. RAJAMAHESWARI, P. VON THEOBALD INTRODUCTION Surgery for pelvic organ prolapse (POP) is common with increasing high-quality evidence to guide surgical practice. Yet many important basic questions remain, including the optimal timing for POP surgery, the optimal pre-operative evaluation of urinary tract function and the post-operative outcome assessment. Olsen [1] and Fialkow [2] have separately documented high rates of surgery for POP and/or urinary incontinence (UI) in US women. In Fiakow’s study, 169 women who underwent a primary prolapse surgery (+ concomitant UI procedure) were identified (Table 1). In addition, there remains uncertainty about the longevity of prolapse repairs, with some experts stating that recurrences may be inevitable in at least a subgroup of women. Olsens’ recurrence rate estimate was based on 384 women in the Kasier Permanente Northwest population who underwent at least one POP/UI procedure. In that study, only 13 sacrocolpopexies were performed, reflecting the surgical practice in 1995. Until women at higher risk for recurrence are reliably identified prior to surgery, reoperation rates of up to 30% may persist. Despite the need for additional studies to guide many aspects of POP surgical care, this chapter can be used to facilitate evidence-based management of POP. This committee has deliberated, graded evidence and provided recommended areas of high priority for current surgical care as well as further POP research. Readers of this chapter are also encouraged to periodically review continuously updated evidence from reviews including the Cochrane and NICE reports [3, 4]. This chapter also includes scientific contributions with lower levels of evidence than these reviews so that we can highlight the areas for future research. I. OUTCOME ASSESSMENT One of the most glaring limitations in recommending evidence-based POP surgery is the lack of an optimal method for determining outcome. While anatomic correction is usually reported, there is good evidence that POP and POP repairs have significant impact on urinary, sexual, and anorectal function; these aspects should be taken into account when assessing the outcome of POP surgeries. Therefore, recognizing that pelvic organ prolapse is a multidimensional disorder, outcomes of treatments should be evaluated in multiple domains. Group consensus statements Table 1. Age-specific incidence of surgically-managed POP and UI (per 1,000 women years) Age group (yrs) At risk women POP only UI only POP and UI All cases 20-29 23,560 0.17 0.00 0.04 0.21 30-39 34,893 0.31 0.34 0.11 0.77 40-49 36,120 0.72 0.72 0.30 1.74 50-59 18,976 0.94 1.05 0.47 2.48 60-69 15,368 2.10 0.78 0.26 3.12 70-79 12,958 2.54 0.85 0.31 3.70 80+ 5,844 1.71 0.17 0.34 2.22 Total 147,719 0.91 0.56 0.24 1.70 Adapted from Fialkow et al. Int Urogynecol J (2008) 19:437-440 (2) 1275 agree with this philosophy, although there is no evidence-based recommendation for optimal outcome assessment at this time [5]. In addition, it is imperative that future research address the patient’s global perspective as an outcome in order to understand the contributions of various anatomical and functional sub-outcomes on the overall patient experience. 1. OUTCOME ASSESSMENT: ANATOMY There is no consensus on several critical areas of outcomes. There are significant difficulties in creating dichotomous anatomical outcome criteria for success and failure, especially in the absence of symptoms. This difficulty is exacerbated in the situation where support loss is evident in an unoperated portion of the vagina and there is no consensus regarding coding of “de novo” POP. Finally, it is likely incorrect to strive for “perfect” support of the vagina (Stage 0) as this is inconsistent with the demographic profile of asymptomatic vaginally parous women [6]. In addition, the five-level staging system of the current POP-Q (Stages 0-IV) may be insufficient to discriminate among clinically important groups of women with POP, placing virtually all such women into Stage II or III. While the staging may facilitate comparisons, it may not describe sufficient detail as the individual POP-Q measurements provide. While most surgeons believe that prolapse beyond the hymen following POP surgery is not an optimal anatomic outcome, the required level of support above the hymen is not known and the relationship with symptoms remains poorly understood. 2. OUTCOME ASSESSMENT: SYMPTOMS It is well recognized that symptoms and anatomy do not necessarily correlate in women with pelvic organ prolapse. Burrows et al reported that while women with more advanced prolapse are less likely to experience stress urinary incontinence, bothersome sexual or ano-rectal symptoms do not correlate with prolapse severity [7]. The symptom of feeling or seeing a bulge is reliably associated with the anatomic finding of prolapse [8]. However, other symptoms may impact the perception or bother of the anatomic finding. FitzGerald et al reported that women planning sacrocolpexy with Stage II POP and prior pelvic surgery reported more symptoms and quality of life impact than those with more advance prolapse [9]. Symptoms of urinary incontinence, fecael incontinence, sexual dysfunction, voiding dysfunction and defecatory dysfunction are common in women with prolapse, but are not well correlated with anatomic findings [10]. Nonetheless, most patients expect resolution of pelvic symptoms following surgery. a) Urinary Symptoms Urinary Incontinence: There is a risk of de novo stress incontinence following POP repair by any route. This risk is approximately 44% following sacrocolpopexy in stress continent women [11] and can be reduced by concomitant Burch colposuspension. It is not known if other continence procedures are protective in this surgical setting. Estimates for de novo stress incontinence following vaginal repair range between 15 to 80% [12]. An ongoing trial (Clinicaltrials.gov NCT 00460434) is assessing the utility of concomitant TVT at the time of vaginal prolapse repair in stress continent women. The risk of urge incontinence is also present, although there is growing evidence that prolapse repair improves this risk [13, 14]. Improvement of urge incontinence may be a welcome side effect of the surgery, but it is not an indication for surgery per se. Voiding dysfunction: Voiding function is expected to improve after surgical correction of prolapse. Fitzgerald and co-workers found significant improvement in bladder emptying in patients after surgery for advanced POP [15]. Before surgery, the average post-void residual in 35 patients was 226 mL, and this was reduced to less than 100 mL in 89% of the women after surgery for POP. b) Sexual function The effect of POP on sexual function is variable, but repair of POP may improve sexual function. In the Colpopexy and Urinary Reduction Efforts (CARE) trial, more women were sexually active one year after abdominal sacrocolpopexy (171, 76.3%) compared to before surgery (148, 66.1%), and significantly fewer women reported sexual interference from pelvic and vaginal symptoms [16]. Pauls and colleagues [17]reported no change in sexual function and sexual frequency using the Female Sexual Function Index (FISI) and other standardized questionnaires in prospectively surveyed women undergoing POP surgery with and without continence procedures. In those women, the most bothersome barrier to sexual activity before repair was vaginal bulging; postoperatively, it was vaginal pain. De novo dyspareunia is a risk of many transvaginal prolapse repairs. c) Ano-Rectal Symptoms Ano-rectal symptoms are common in women with POP [18]. Fifteen to 20% of women with POP or SUI also report fecal incontinence [19]. Meschia evaluated 881 women with UI or POP, of whom 178 also had anal incontinence. Two-thirds reported constipation, with other common complaints of incomplete evacuation, and splinting in the vaginal or perineal body to effect evacuation [20]. Although such symptoms are common, they do not correlate well with prolapse stage. Bradley et al [18] described the prevalence of pre-operative bowel symptoms and Colorectal-Anal Distress Inventory symptom scores in 322 women planning sacrocolpopexy. Correlations between symptoms and 1276 prolapse were negative and weak, indicating that bowel symptoms do not increase with increasing prolapse stage [18]. Although there is no level 1 evidence regarding the impact of POP surgery on these symptoms, ano-rectal symptoms were assessed in the CARE trial. Surgeons were allowed to include posterior colporrhaphy (in addition to sacrocolpopexy) at their discretion. The sacrocolpopexy with posterior colporrhaphy group (n= 87) had more baseline obstructive colorectal symptoms (higher Colo-Rectal-And Distress Inventory(CRADI) and CRADI-obstructive scores: P =.04 and .01, respectively) than the sacrocolpopexy alone group (n =211). However CRADI total, obstructive, and pain/irritation scores significantly improved in both groups (all P =.01) [21]. 3. OUTCOME EVALUATION: QUALITY OF LIFE It is recommended that investigators describe the impact of POP surgical treatment on quality of life. Maher et al reported significant improvements in condition-specific and generic QOL after SSLF, similar to that after abdominal sacrocolpopexy [22]. The CARE trial also reported significant improvements in quality of life following sacrocolpopexy at three months and two years [11, 14]. In that trial, Nygaard et al reported pre-surgical physical activity levels [23]. Most participants were physically active preoperatively, but reported that prolapse substantially interfered with exercise or recreation (27%), household work or yard work (19%) and work outside the home (8%) The interference was not associated with the stage of prolapse. In the first study of its kind, Jelovsek et al assessed body image using a modified body image scale [10]. These investigators reported that women seeking treatment for advanced pelvic organ prolapse had measurable decreases in body image and overall quality of life. The idea that distortion of body image is a factor that impacts quality of life is novel and a fruitful area for further research. II. SELECTION OF SURGICAL ROUTE FOR RECONSTRUCTIVE POP PROCEDURES The individual woman’s surgical history and goals, as well as her individual risks for surgical complications, prolapse recurrence and de novo symptoms impact surgical planning. In addition, the route and method of access for reconstruction may include laparoscopic and robotic techniques. In the U.S., 80-90% of prolapse surgeries are completed vaginally [24]. 1. COMPARISON OF OPEN ABDOMINAL TO VAGINAL Level one evidence supports a higher anatomic efficacy with abdominal route of surgery. There are three randomized controlled trials designed with the specific aim to compare vaginal and abdominal routes for the surgical correction of POP [22, 25-27] as well as a Cohrane review [27] and the major outcomes are summarized in Table 14. Although these studies had relatively small numbers for comparison (approximately 40 women in each comparison group), the effect sizes were large. In the first trial designed to compare route of POP repair, Benson et al reported that the abdominal route had better anatomic results 1 to 5.5 years (mean 2.5 years) after surgery compared with the vaginal route, OR for optimal cure (no symptoms of POP, no anatomic defect beyond the hymeneal ring) 3.44, 985%CI 1.24-9.69). The Benson study was stopped when the planned interim analysis revealed the superiority of the abdominal approach. Of the 101 women randomized, ten decided against surgery after randomization, 3 refused their abdominal route randomization assignment, and 8 were not available for long term evaluation, leaving a sample size of 80 women. A significant proportion of participants who were randomized to the abdominal group also had vaginal procedures performed (30% anterior colporrhaphy and 50% posterior colporrhaphy.) Needle urethropexy, a widely used procedure at the time of the trial that has since been abandoned, was used as the primary incontinence procedure in the vaginal repairs. Since that time, the combination of needle urethropexy and sacrospinous ligament suspension has been abandoned because it predisposes to upper vaginal wall prolapse [28]. Given that this was the first such trial, the optimal vaginal approach was not known. Experts have expressed concern that the specific primary prolapse procedures performed may have been responsible for differences in outcome rather than the surgical route: these include (vaginal route) bilateral sacrospinous suspension, vaginal paravaginal repair, Pereyra needle urethropexy; and (abdominal route) sacrocolpopexy, retropubic paravaginal repair, and Burch colposuspension. In addition, the results for women with concomitant hysterectomy were not reported separately. The abdominal route was associated with higher costs, longer operating times, and increased complications, although the numbers did not reach statistical significance due ot small numbers. Of note is that post-operative dyspareunia was seen only in the vaginal group (15/26, 58%). Lo and Wang (1998) randomized 138 women with Stage III-IV uterine prolapse or vaginal vault prolapse; 20 were excluded after randomization for inability to follow-up. Of the remaining 118, 52 underwent sacrocolpopexy with mersilene mesh and 66 underwent sacrospinous ligament fixation with polypropylene suture. The definition of cure was POP no greater than Stage II (no greater than 1 cm beyond the hymeneal ring), and at a median of 2.1 years after 1277 the index surgery, 49/52 (94%) of women undergoing SC were cured, while 53/66 (80%) of women undergoing SSLF met the definition of cure. Complications were higher in the vaginal group with increased blood loss and longer hospital stays, with some serious complications of rectovaginal fistula and ureteric injury. While there are several methodologic problems with this RCT, there was a higher rate of dyspareunia due to vaginal narrowing in the SSLF group (7/66, 39%, 4 of whom were sexually inactive due to the complication) compared to the SC group (1/52, 9%.) Maher and colleagues (2004) performed an RCT randomizing 95 women to sacrocolpopexy (n=47) and sacrospinous ligament fixation (n=48) with follow up at two years (6-60 months). This study differs from that of Benson in that all subjects had already undergone hysterectomy, no patients in the vaginal group had either a needle urethropexy or vaginal paravaginal repair, and the minimum allowed duration of follow-up was six months (mean 22-24 months) rather than Benson’s 12 months (mean 30 months.) Although this group reported comparable subjective and objective outcomes between the two surgical groups, a subanalysis showed anatomic superiority of the abdominal group (OR18, 95% CI .05, .55) with a significantly higher rate of combined recurrent anterior and apical prolapse. However, the abdominal route had longer operating times, longer hospitalization, more complications, and higher medical costs compared with the vaginal route. The Cochrane review on the surgical management of prolapse by Maher et al summarizes these studies and concludes that these trials provide level 1 evidence that the overall outcome (including quality of life) is similar between abdominal and vaginal approaches, but that sacrospinous-based vaginal procedures have a higher anterior and apical anatomical recurrence rate and higher rates of dyspareunia than sacrocolpopexy-based abdominal repairs. This is somewhat offset by the higher short term morbidity of open abdominal sacrocolpopexy [22]. 2. SAFETY ISSUES RELATED TO THE CHOICE OF SURGICAL ROUTE In these trials, serious perioperative injuries are more common with abdominal than vaginal surgery. While it is known that the number of complications increases as the number of procedures increases, the number of procedures is less related to the route of surgery and more to the severity and number of pelvic floor defects requiring surgical correction. Safety associated with mesh will be considered separately later in the chapter. Boyles [24] found that pre-existing comorbidities did not increase the risk of complications in a review of discharge diagnoses after surgery for POP, but this finding seems counter-intuitive and points out the limitation of this kind of review: it is unknown how the route of surgery nor preventative measures in individual cases affects these findings, and a prospective comparison is needed. Boyles examined mortality risk in some detail. Although the mortality rate was low (.53 per 1000 women), women who died were significantly older than those who survived (69.1 versus 52.1). Details on the route of surgery were often incomplete. In summary, what little is known about safety agrees with the commonly held opinion that vaginal surgery for POP is safer than abdominal surgery, and this may be an important consideration when deciding on the route of surgery for individual patients. 3. LAPAROSCOPIC AND ROBOTIC SURGERY There are multiple reports of the feasibility of various abdominal prolapse repairs being performed using laparoscopic (with or without robotic assistance) surgical techniques, most reporting good short- and intermediate-term results. As of March 2008, no randomized controlled trials have been reported comparing laparoscopic to conventional abdominal POP procedures. There is no reason to believe that the same procedure performed in precisely the same manner using the same materials would have any different outcome using the laparoscopic abdominal technique compared to the open abdominal technique. However, there is likely to be different adverse events depending on the technique of access. In addition, procedures are sometimes modified to allow them to be performed more easily with laparoscopy, and so it is essential to establish independently the effectiveness and safey of the modified procedures in a well-designed RCT. Similarly the learning curves and number of procedures together with the frequency of performing these technically challenging operations have yet to be established for prolapse surgery by all routes and techniques. III. EFFICACY OF SPECIFIC PROCEDURES There are a variety of procedures suitable for surgical correction of prolapse. Table 2 briefly summarized the main concepts of the broad surgical categories. 1. RECONSTRUCTIVE PROCEDURES a) Apical support procedures The apex is the keystone of pelvic organ support. Support of the apex must be assessed regardless of the presence or absence of the uterus. Without good suspension of the uterus or post-hysterectomy vaginal cuff, the anterior and posterior walls are exposed to intra-abdominal forces that drive these tissues toward the introitus. Because of the significant contribution of the apex to anterior vaginal support, the best surgical 1278 Table 2. RCTs comparing abdominal versus vaginal approaches to POP surgery n Mean f/umos) Outcomes abd v vaginal Major complications Reoperation rate abd v vag Benson 1996 [25] 80* 29 mos (12-78 mos) Optimal a 22/38 (58%) v 12/42 (29%) Dyspareunia 0/15 v 15/26 (58%) 6/38(16%) v 14/42 (33%) Lo 1998 [26] 118** 25 mos (12-74 mos) 49/52 (94%) v 53/66 (80%) Dyspareunia 1/52 (9%) v 7/66 (39%) Not stated Maher 2004 [22] 95 24 (6-60 mos) Subjective b 43/46 Dyspareunia 1/52 (9%) (94%) v 39/43 (91%) v 7/66 (58%), UI 23% Objective c 35/46 (76%) v 44% v 29/42 (69%) 6/47(13%) v 7/43 (16%) *recruitment halted after first interim analysis showed superiority of abdominal route. **138 randomized, but 20 excluded after randomization for inability to follow-up. aoptimal cure defined as no prolpase symptoms, no anatomic defect beyond the hymeneal ring bsubjective cure defined as no symptoms of POP csubjective cure defined as no symptoms of POP , anatomic defect less than Baden-Walker grade 2 (prolapse to the hymeneal ring.) correction of the anterior and posterior walls may fail unless the apex is adequately supported [30, 31]. While recognition of apical defects is one of the biggest problems in the evaluation of pelvic support defects, surgical correction of the apex has several good options with relatively high success rates. 1. SACROCOLPOPEXY Sacrocolpopexy has proven to be a durable technique for apical support with an acceptable risk/benefit ratio (Tables 3 and 4). While level 1 evidence supports the usefulness of this procedure in POP, investigators are just beginning to test the hypothesis that will refine this technique, optimize concomitant procedures and urinary tract function. Because concomitant hysterectomy increases the risk of mesh erosion [32], alternative techniques including sacrohysteropexy or supracervical hysterectomy are being used based on clinical judgment. Sacrocolpopexy requires an intervening material, typically a synthetic mesh. Level 1 evidence supports the superiority of polypropylene mesh to fascia lata for objective anatomic support following sacrocolpopexy [97]. There is no evidence for the equivalence or superiority of any material other than permanent synthetic mesh for this procedure. Expert opinion strongly warns against simple suturing of the apical skin as this is insufficient fixation and likely to result in recurrent prolapse. Mesh erosion is a known complication of sacrocolpopexy regardless of performance of concomitant hysterectomy. A recent review [33] noted the rates of erosion to be 2-11% from institution to institution. Visco and colleagues [98]reported on 155 women and found an erosion rate of 3.2% with abdominal sacrocolpopexy, 4.5% when combined with colpoperineopexy, 20% when a combined abdominal/ vaginal approach was used (sutures passed vaginally to abdominally) and 40% when mesh was introduced vaginally. Cundiff et al presented suture/mesh complications from the CARE trial (32) The predominant graft used was synthetic mesh; Mersilene (42%) or Polypropylene (48%). Twenty subjects (6%) experienced mesh/suture erosion. Unadjusted risk factors for mesh/suture erosion were expanded polytrafluroethylene (ePTFE) mesh (ePTFE 4/21 (19%) versus non-ePFTE 16/301 (5%): OR 4.2), concurrent hysterectomy (OR 4.9) and current smoking (OR 5.2). Of those with mesh erosion, most affected women (13/17) underwent at least one surgery for partial or total mesh removal. Two were completely resolved, 6 had persistent problems and 5 were lost to follow-up. No resolution was documented in the 4 women who elected observation. These investigators concluded that expanded PTFE mesh should not be used for sacrocolpopexy and documented that concurrent hysterectomy and smoking are modifiable risks for mesh/suture erosion. These data is corroborated by the majority of other evidence from Level 3 reports [84, 99, 100], although there is conflicting level 2 data from [91]. While uterine preservation (or supracervical hysterectomy) is an alternative, the utility and safety of these techniques are not known. In a level 2 RCT, Roovers et al reported poor outcomes for sacral hysteropexy as compared to vaginal repair [90]. Allograft fascia lata has been described variably as an alternative to mesh: the biologic graft avoids the risk of mesh erosion, but resulted in unexpected failures in which no mesh could be seen during reoperation [101-104]. Similarly, Flynn et al [105] reported on 24 colpopexies using allograft fascia lata in a retrospective design, and found unacceptable rates of anatomic improvement at one year follow-up. 1279 Table 3. Table of Main Categories of Operations: Operation Description FOR APICAL SUPPORT (UTERINE OR VAULT PROLAPSE) Sacrocolpopexy Fixation of vagina through suspension material (preferably anterior and posterior vaginal arms of synthetic mesh to bridge to the anterior longitudinal ligament of sacrum. Sacrocolpoperineopexy Same technique as above, except that the posterior arm of mesh extends to t he perineal body. Iliococcygeus fascia fixation An extraperitoneal vaginal procedure that attaches the vaginal apex to the fascial coverings of the iliococcygeus muscles bilaterally, often with a suture-passing device. Levator myorrhaphy with apical plication Wide midline plication of the levator with fixation of the vaginal cuff. Mayo culdoplasty A modification of the McCall’s culdoplasty attaches the apex to plicated uterosacral ligaments. Sacrospinous ligament This procedure suspends the vaginal apex to the sacrospinous ligament either suspension procedures unilaterally or bilaterally, typically using an extraperitoneal approach. The enterocele, anterior and posterior walls are repaired as needed. Traditional version: attaches one edge of the apex to the ligament using permanent suture Michigan modification [29] avoids a suture bridge and draws the entire vaginal apex into direct contact with the coccygeus muscle and underlying ligament, using delayed absorbable sutures across the entire vaginal cuff. Uterosacral ligament suspension This intraperitoneal vaginal procedure traditionally uses permanent suture to suspend the vaginal apex to the remnants of the uterosacral ligaments at the level of the ischial spines and cephalad, with incorporation of the (often reconstructed) fibromuscular walls of the anterior and posterior vagina. FOR ANTERIOR VAGINAL WALL PROLAPSE Anterior colporrhaphy Midline plication of endopelvic fascia of anterior vagina Paravaginal repair Attachment of lateral vaginal to arcus tendineous fascia pelvis (either abdominally or vaginally) FOR POSTERIOR VAGINAL WALL PROLAPSE Posterior colporrhaphy Midline plication of endopelvic fascia of posterior vagina Posterior site-specific repair Identification and repair of specific defects in recto-vaginal fascia. Trans-anal repair Rectal mucosa separated and the rectovaginal septum is plicated from rectal side. FOR ANY PROLAPSE Colpocleisis Closure of vagina following removal of most (partial) or all (complete) vaginal skin. 1280 Table 4. Sacrocolpopexy outcomes. Author Year Follow –up (months) Success rate (%) Criteria for success Comments 1949 Number of patients, (number lost to follow-up, if known) 50 (2) Arthure [34] NS 90 Falk [35] 1961 3 (0) ≤ 36 100 No recurrence of uterine prolapse or enterocele Cured Lane [36] 1962 24 NS 92 No recurrence of prolapse Uterus, cervical stump or cuff directly affixed to sacrum Uterus, cervical stump or cuff directly affixed to sacrum 20 patients had the synthetic material stapled to the sacrum, 2 of whom had prolapse recurrence due to staples becoming dislodged from the sacrum Birnbaum [37] Rust [38] 1973 1976 9 (0) 12 (0) 33 24 100 100 Feldman [39] 1979 21 (0) 16 95 Cowan [40] 1980 39 30 97 Good support No vaginal vault prolapse Adequate vaginal support, sufficient vaginal depth and appropriate vaginal axis Good vaginal support, no pelvic complaints Symmonds [41] 1981 17 (1) NS 94 Lansman [42] 1984 8 (0) 5.5 100 Grundsell [43] 1984 9 (0) 46.8 100 Addison [43] 1985 56 (2) 39 96 Good vaginal vault suspension in a normal axis 1985 14 (0) 30 71 Adequate vaginal support on exam Kauppila [46] 1986 9 (0) 50 100 Excellent vaginal support on exam Drutz [47] 1987 15 (0) 28 93 Well-supported vault Angulo [48] 1989 18 (0) 13 100 Baker [49] 1990 59 (6) 6 100 Free of symptoms that caused consultation and no degree of prolapse found on vaginal exam No complaint of protrusion from the vagin Kauppila [45] 1 1281 The patient with the failure had apparent detachment of the graft from the apex based upon exam Surgical failure involved distal detachment of mesh from vagina Good vaginal support and function No recurrence of an enterocele or vault prolapse No recurrences of vault prolapse Fascia lata was graft material used for patient with early recurrence 1 patient unimproved as a presacral hemorrhage prevented successful completion of the procedure 6 of 14 patients had direct attachment of the vaginal apex to presacral fascia, and 4 of these recurred. None of 8 patients in whom graft was used recurred. Fascial grafts used to suspend the cuff in all patients 1 patient with recurrent vault prolapse was the only with direct attachment of the vagina to the promontory 51/59 patients had postoperative records available, at which time all patients had a wellsupported vagina Table 4. Sacrocolpopexy outcomes (continued) Author Year Follow –up (months) Success rate (%) Criteria for success 26 90 Complete relief of symptoms No vault prolapse on exam and no complaints of prolapse Lack of major longterm postoperative complications, restoration of functional vagina in the proper axis, and no recurrence of presenting symptoms with at least 6 months of follow-up Excellent, wellsuspended vault on exam Good vault suspension, but asymptomatic vaginal “relaxation” Good vaginal vault support Good results on exam Maloney [50] 1990 Number of patients, (number lost to follow-up, if known) 10 (0) Creighton [51] 1991 23 17 91 Snyder [52] 1991 147 (15) 43 93 (108/116) Imparato [53] 1992 71 (8) NS 78 16 Timmons [54] 1992 163 33 99 Traiman [55] 1992 9 (0) 36.5 91 Iosif [56] 1993 40 (0) 36 97 van Lindert [57] 1993 61 32 97 Grunberger [58] 1994 62 (14) 75.6 94 Lecuru [59]** 1994 203 32.5 86.7-100 53.3-80.5 Nezhat [60] 1994 15 (0) 3 – 40 100 Valaitis [61] 1994 41 (2) 21 88 Virtanen [62] 1994 30 (3) 36 85 85 1282 Complete symptom relief, no vault prolapse No recurrent vaginal prolapse No moderate vaginal vault prolapse on exam Anatomically good results Functionally good results Complete relief of symptoms, excellent vaginal vault support No third degree enterocele on exam, no symptomatic enterocele Good vaginal vault support on exam Patient “satisfied” with the procedure Comments Graft attached to the entire length of the vagina in the rectovaginal septum 50 had direct attachment of the vaginal apex to the anterior sacrum 1/2 patients with direct attachment of the vagina to the sacral promontory failed Patient with failure had detached graft from apex 8 patients had preservation of the uterus 42 patients had direct attachment of the vagina to the sacral promontory 12 had permanent “suture bridges” 8 had lyodura loops The range of success is due to 4 different techniques which were compared All cases done laparoscopically; 1 converted to laparotomy One failure had direct attachment of the vagina to the sacrum 2 patients with recurrences had failure at the vaginal apex (absorbable sutures) Table 4. Sacrocolpopexy outcomes (continued) Author Year Brubaker [63] 1995 Number of patients, (number lost to follow-up, if known) 65 (0) de Vries [64] 1995 101 (29) Follow –up (months) Success rate (%) Criteria for success Comments 3 71 No anterior or apical prolapse 48 32 Fully cured (patient satisfaction based upon questionnaire) 39 Considerable improvement No improvement 63/65 patients had abdominal anterior compartment repair at the time of the sacrocolpopexy Questionnaires sent to patients to evaluate pain, prolapse-related complaints and functional disorders. Patients indicated symptoms before surgery, >1 year after surgery, and >1 year after surgery 29 Benson [25] 1996 40 60 58 (another 26% of patients had “satisfactory” outcomes) Patient asymptomatic, vaginal apex supported above the levator plate, no protrusion beyond the hymen Hardiman [65] 1996 80 47 99 Cundiff [66] 1997 19 (0) 11 weeks 100 No recurrent vault prolapse No prolapse > stage II (63% stage 0, 21% stage I, 16% stage II) Ross [67] 1997 19 (2) 12 100 No recurrent vault prolapse at 6 weeks or 1 year postoperatively Costantini [68] 1998 21 (0) 31.6 90 Occelli [69]** Patsner [70] Pilsgaard [71] 1999 1999 1999 271 (54) 175 (0) 35 (4) 66 ≥ 12 24 97.7 97 97 Overall satisfaction per postoperative questionnaire; in all patients prolapse was reduced on exam postoperatively Cured for prolapse No “mesh failures” No recurrent vault prolapse Schettini [72] 1999 15 (0) 15 100 Sze [73] 1999 56 (9) 23 81 Diana [74] 2000 15 20 100 1283 High position of the vaginal apex No recurrent prolapse to or beyond the hymen No relapse of the treated prolapses All patients had sacrocolpopexy and paravaginal repair. Results are from a RCT comparing sacrocolpopexy to sacrospinous suspension. Abdominal sacral colpoperineopexy performed in all patients due to posterior compartment defects and perineal descent associated with vaginal vault prolapse All patients underwent laparoscopic sacral colpopexy, Burch colposuspension and modified culpoplasty, with paravaginal defect repairs and posterior colporrhaphy added as indicated 7 patients underwent hysterosacropexy The 1 patient with recurrent vault prolapse was noted to have the mesh detached from the promontory All 9 patients with recurrent prolapse were symptomatic Table 4. Sacrocolpopexy outcomes (continued) Author Year Follow –up (months) Success rate (%) Criteria for success Comments 14 100 > Stage I prolapse at any site Any symptomatic prolapse, or asymptomatic stage II-IV prolapse No recurrent enterocele or vault prolapse No recurrence of vaginal vault prolapse enterocele or anterior rectal wall prolapse No vault prolapse Procedure involved sacrocolpopexy and mesh interposition for the correction of both vault prolapse and rectocele Direct attachment of the vagina to the sacrum in 4 patients Fox [75] 2000 Number of patients, (number lost to follow-up, if known) 29 Nieminen [76] 2000 26 (6) 105 64 Winters [77] 2000 20 (0) 11 100 Baessler [78] 2001 33 (2) 26 100 Geomini [79] 2001 45 (5) 38 93 Scarpero [80] 2001 20 11 100 No recurrent enterocele or vault prolapse Sullivan [81] 2001 236 (31) 64 100 No recurrence of vaginal or rectal prolapse 34% Very satisfied 38% Satisfied No recurrence of rectal or vaginal vault prolapse No evidence of clinical prolapse Attempted to correnct rectoceles abdominally with extension of the graft Culdoplasty done only selectively; 2/3 failures were noted to be a result of graft detachment from the vagina (staples and a tacker used for attachment) All patients underwent sacrocolpopexy, Halban’s culdoplasty and paravaginal repair Total pelvic mesh repair involved attachment mesh strip between the perineal body and the sacrum, and then attaching two additional strips laterally to the pubis to support the vagina and bladder Collopy [82] 2002 89 (0) 56.7 100 Cosson [83] 2002 77 (12) 12 94 Culligan [84] Lefranc [85] 2002 2002 245 85 (0) 61.2 126 (median) 85 90.6 Any POP-Q point ≥ 2 No relapse of any prolapse Leonardo [86] 2002 25 (0) 48 100 No recurrent prolapse Lindeque [87] 2002 262 (0) ≥ 16 99 No vaginal vault prolapse 1/3 failures due to graft detachment from vagina Medina [88] 2002 97 (1) 19 90 < Grade I prolapse Etiology of 1 failure was graft detachment from the vagina (etiology of other 4 unknown) 1284 All had concomitant culdoplasty All patients had a laparoscopic sacropexy with other procedures as indicated; 6 other patients had attempted laparoscopic surgery, but required conversion to a laparotomy No apical failures observed All patients without preoperative SUI had a prophylactic Burch procedure done Table 4. Sacrocolpopexy outcomes (continued) Author Year Follow –up (months) Success rate (%) Criteria for success Comments 61.2 126 (median) 85 90.6 Any POP-Q point ≥ 2 No relapse of any prolapse No apical failures observed All patients without preoperative SUI had a prophylactic Burch procedure done Culligan [84] Lefranc [85] 2002 2002 Number of patients, (number lost to follow-up, if known) 245 85 (0) Leonardo [86] 2002 25 (0) 48 100 No recurrent prolapse Lindeque [87] 2002 262 (0) ≥ 16 99 No vaginal vault prolapse 1/3 failures due to graft detachment from vagina Medina [88] 2002 97 (1) 19 90 < Grade I prolapse Etiology of 1 failure was graft detachment from the vagina (etiology of other 4 unknown) Reddy [89] 2002 11 (0) 60 100 No prolapse symptoms or vault prolapse based upon patient questionnaire Satisfied 64 Roovers [90] 2002 12 18 36 Considerable improvement 92 No symptomatic genital prolapse Satisfied with the result of surgery No recurrent vault prolapse No recurrent prolapse (anterior, posterior, or vault) Excellent vaginal support, no recurrence of prolapse Asymptomatic (including no incontinence) and durable repair by exam Subsequent POP operation or a positive response to question 5 on the PFDI*** No prolapse > Stage II 55 Brizzolara [91] 2003 124 36 98 Marinkovic [92] 2003 12 (0) 39 83 Sanz [93] 2003 11 12-24 100 Podratz [94] 1995 50(6) 70 70 Hilger [95] 2003 69(31) 164 74 Lo [96] 1998 52 (not clear) 25 94 Maher [22] 2004 47 (1) 24 76% objective 94% subjective Objective: No POP beyond halfway point Subjective: No symptoms of POP All patients had sacrocolpopexy and RPU A suture anchor system was used for placement of the suture in the mesh at the sacrum Results are from a RCT comparing sacrocolpopexy to sacrospinous ligament suspension. Results are from a RCT comparing sacrocolpopexy to sacrospinous ligament suspension. NS = not stated SUI = stress urinary incontinence RPU = retropubic urethropexy RCT=randomized clinical trial *Some patients also included in Addison’s series **Only abstract reviewed (paper not in English) ***Question 5 on the Pelvic Floor Distress Inventory – “Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?” 1285 Gastrointestinal problems may occur following open sacrocolpopexy. One in 20 women in CARE trial experienced significant gastrointestinal morbidity after sacrocolpopexy. Of 322 women in the study, 19 had symptoms of possible ileus or small bowel obstruction; of these, 4 had reoperation for small bowel obstruction, 11 were readmitted for medical management, and 4 had a prolonged initial hospitalization for gastrointestional symptoms [106]. Abdominal sacrocolpopoexy has greater morbidity, higher cost and less dypareunia than vaginal sacrospinous ligament suspension [22, 25]. These disadvantages have prompted surgeons to seek alternatives that maintain the advantages and reduce procedure-associated morbidity. Laparoscopic sacrocolpopexy is performed in some centres, with and without robotic assistance. Only case series are available for evaluation. Von Theobald et al reported a series of 100 patients with 8 year followup [107]. Higgs reported on 140 consecutive women undergoing laparoscopic sacrocolpopexy with mesh [108]. At a median follow up of 66 months, 66 women were examined and a further 37 had questionnaire data available only. Subjects lost to follow-up were not included in the analysis, and could be failures or successes. Symptomatic improvement was good with 79% subjects reporting prolapse symptoms as “cured” or “improved”, but 39/103 (38%) had persistent symptoms of POP. Anatomic prolapse was seen on exam in 21/66 women examined. 2.TRANSVAGINAL APICAL SUSPENSION TECHNIQUES Support of the vaginal cuff following hysterectomy is recommended by most authorities, and may be achieved by sacrospinous ligament suspension or reattachment of the uterosacral ligaments to the vaginal cuff, McCall culdoplasty, and Mayo culdoplasty. A single study compared these three methods of transvaginal apical suspension at the time of hysterectomy to determine th efficacy of prevention of posterior enterocele as a proxy for apical support [109]. • Iliococcygeus fascia fixation There are no randomized trials that support the use of this procedure. Several case series have provided some information. Shull reported that apical support was optimal in 39/42 (83%) of patients, but eight others had apical or other defects [110]. Meeks and colleagues reported a 96% objective cure in 110 women followed up to 13 years [111]. In a retrospective case-control study, Maher and colleagues reported similar subjective (91% v 94%) and objective (53% v 67%) cure rates with iliococcygeus fixation (n=50) compared to sacrospinous fixation (n=78) [112]. • Levator myorrhaphy with apical plication Francis and Jeffcoate [113] described their retrospective series using levator myorrhaphy with vaginal vault suspension to the plication. A large sponge pack in the rectum is used to avoid overplication and bowel dysfunction. Five of 35 wowen responding to the questionnaire had transient ureteral complications, one requiring re-operation. Seventeen women were quite satisfied, while six were dissatisfied. • Mayo culdoplasty A large retrospective series from the Mayo clinic described an 82% satisfaction rate on subjective follow-up with few complications [114]. It may achieve its suspension in a mechanism similar to the uterosacral ligament suspension, but no direct comparisons have been reported. A retrospective case series of 411 women undergoing Mayo culdoplasty in two other institutions found that a more dorsal “deep” placement of sutures through the uterosacral ligaments reduced the incidence of ureteral obstruction compared to other published series [115]. • Sacrospinous ligament suspension (SSLS) The sacrospinous ligament suspension was first described in 1958 [116]. The traditional procedure as described by Nichols has been associated with high rates of anterior wall recurrences in some studies [117]. Table 5 contains outcomes from studies that have included SSLS. Uncontrolled retrospective case series and clinical trials in which SSLS was used in one arm suggest that anterior recurrence is more common (6% to 28.5%) than apical recurrence (2.4% to 19%). Reoperation rates after SSLF range from 1.3% to 37%, with all but two series reporting rates less than 7%. Case series provide the majority of evidence regarding the SSLS complications which include buttock pain and sacral/pudendal neurovascular injury. Sze et al reviewed 22 studies that included 1229 SSLS procedures and reported that 3 patients (0.2%) had life-threatening hemorrhage from sacral or pudendal vascular injury with a 2% transfusion rate [118]. Buttock pain occurred in 3% of patients, with resolution within 6 weeks for most affected women. • Uterosacral ligament suspention First described by Miller [126] in 1927 and popularized by Shull [127], this procedure maintains the vaginal axis in the midline and allows adjustment of the vaginal length. A weakness of the procedure is the risk of ureteral injury; therefore intraoperative cystoscopy after the sutures are tied down is an essential part of this procedure. The current evidence supporting the use of ULS is limited to seven uncontrolled retrospective case-series (Table 6). In these studies, ULS is associated with low overall recurrence (4% 18%), anterior vaginal prolapse recurrence of 3.5% 11%, and reoperation of less than 7%. These promising results are balanced by ureteral injury with this procedure. 1286 Table 5. Anatomic Outcomes from CARE cohort at 3 and 24 months. POP-Q (mean± SD or N(%)) Burch N=149 3 mo No Burch N=164 Test Burch N=117 24 mo No Burch N=133 Test Point C -8.3±1.8 -8.5±1.6 0.07 -8.0±1.5 -8.2±1.3 0.46 Point Ba -2.6±0.7 -2.0±0.9 <0.001 -2.2±0.9 -1.8±1.1 <0.001 Point Bp -2.4±0.9 -2.4±0.9 0.70 <0.001 -2.0±1.3 -2.3±0.8 0.006 0.55 0 55 (37.7%) 29 (17.8%) 24 (20.5%) 23 (17.4%) 1 70 (47.9%) 80 (49.1%) 43 (36.8%) 51(38.6%) 2 19 (13.0%) 53 (32.5%) 46 (39.3%) 57 (43.2%) 3 2 (1.4%) 1 (0.6%) 4 (3.4%) 1 (0.8%) Stage Table 6. Sacrospinous Ligament Suspension Procedures First Author Year No. of Pts. Mean Follow-up Months (range) Definition of anatomic success* Anatomic success –all segments Morley [29] 1988 92 51.6 (1-132) Not defined 90% Imparato [53] 1992 155 Not stated Not defined 90.3% Shull [119] 1992 81 (24 – 60) Grade 0-1 82% Pasley [120] 1995 144 35 (6-83) Asymptom-atic and above hymen 85.4% Benson [25] 1996 42 30 (12-66) Vaginal walls above hymen or apical descent less than # 50% length 67% Paraiso [121] 1996 243 76. (1-190) Grade 0 or asymptomatic grade 1 79.7% at 5 years Penalver [122] 1998 160 40 (18-78) ‘any symptomatic descent’ 85% Colombo [123] 1998 62 83 (48-108) Grade 0-1 74% Meschia [124] 1999 91 43 (12-86) Grade 0-1 85% Sze [73] 1997 75 24 (3-72) above hymen 71% Lantzsch [125] Maher [22] 2001 2004 123 48 58 (6 – 108) 22 (6-58) Not defined Grade 0-1 1287 87% 69% Anatomic recurrence by segment Apex 4% Anterior 6% Not reported Apex 4% Anterior 12% Posterior 1% Apex 5.6% Anterior 7.6% Posterior 1.4% Apex 12% Anterior 28.5% Posterior 2.3% Apex 4.9% Anterior 15.9% Posterior 4.9% Apex 6% Anterior 6% Posterior 2.5% Apex 8% Anterior 14% Posterior 3% Reoperation for prolapse 4 (5%) None reported 4 (5%) 2 (1.3%) 14 (37%) 11 (4.5%) 11 (6.8%) 0 (0%) Apex 4% Anterior 13% Posterior 9% None reported Anterior 21% Other 8% 7 (12.9%) Apex 3.5% Anterior 8% Posterior 1.6% Apex 19% Anterior 14% Posterior 7% 2 (1.6%) 3 (6.3%) Young [147] reported a 21 major complications and a 16% transfusion rate. b) Anterior vaginal wall prolapse 1. ANTERIOR COLPORRHAPHY 3. OPTIMAL ROUTE OF SURGERY Since the first description in 1913 by Kelly [134], the success rates of anterior colporrhaphy in the management of cystoceles ranges from 80-100% in retrospective series [135-138] (Table 7). Experts agree that there is a great deal of variation in the clinical performance of anterior colporrhaphy. In two separate randomized control trials, Weber et al [139] and Sand et al [140] reported less favorable outcomes with the anterior colporraphy, 42% and 57% respectively. Athough colposuspension is not used as a treatment for anterior vaginal support defects, Colombo et al reported long-term follow-up randomized trial results suggesting that the anterior colporraphy (97% success rate) was superior to the colposuspension (66%) in the management of the cystocele in women with cystocele and stress urinary incontinence [141]. Surgical correction of pelvic organ prolapse can be divided into two main categories: reconstructive procedures to correct anterior and posterior wall defects and resuspend the vaginal apex or obliterative procedures to close off the vagina. Reconstructive surgery may use the vaginal route or the abdominal route. In planning surgery, the individual patient’s risk for surgery, risk of recurrence, previous treatments, and surgical goals are all considered in deciding on obliterative versus reconstructive procedures, and in deciding whether the vaginal or the abdominal approach will be used for reconstructive repairs. The goal of this section is to examine the evidence for selecting the surgical route in prolapse repairs. • Selection of Paravaginal Defect Repair Route (vaginal v abdominal): 2. PARAVAGINAL REPAIR No randomized control studies have evaluated the abdominal or vaginal paravaginal repair in isolation. As discussed in the apical section of this chapter, Benson et al [25] and Maher et al [22] have reported RCT’s on upper vaginal prolapse comparing abdominal sacral colpopexy and vaginal sacrospinous colpopexy. Abdominal paravaginal repair was performed in the abdominal group if required and an anterior colporrhaphy without or without vaginal paravaginal laterally. Both authors reported the abdominal group to have a statistically lower rate of postoperative anterior vaginal prolapse than the vaginal group. In 1976, Richardson [149] popularized the paravaginal repair originally described by White [142] as early as 1912. Several case series have reported that the range of success rate for the abdominal paravaginal repair is 75-97% [149-153] (Table 8). While this technique can be duplicated laparoscopically, no efficacy information is available. Since Shull’s [143] initial report on the safety and efficacy of the vaginal paravaginal repair in 1994, several case series have reported success rates between 67 –100% [142-147]. The high success rates have been tempered by complications such as those reported by Mallipeddi [146] in her case series of 45 patients including: 1 bilateral ureteric obstruction, one retropubic haematoma requiring surgery, two vaginal abscesses; two transfusions. In a series of 100 women Raz et al [154] popularized the needle suspension type procedure for cystoceles and success rates in case series vary from 90-98% [154, 155, 156]. The addition of polyglactin mesh to the repair appears to Table 7. Uterosacral Vault Suspension Procedures First Author Jenkins [128] Comiter [129] Year No. of Pts. Mean Follow-up Months (range) Definition of anatomic success* Anatomic success –all segments Anatomic recurrence by segment Reoperation for prolapse 1997 50 (6-48) Not defined 96% Anterior 4% None reported 1999 100 17 (6.5-35) Grade 0-1 96% 90% Barber [130] 2001 46 15.5 (3.5-40) Stage 0/1 or Stage 2 without symptoms Karram [131] 2001 168 21.6 (6 -36) Grade 0-1 88% Shull [127] 2001 289 Not stated Grade 0-1 95% Amundsen [132] 2003 33 28 (6-43) Stage 0 or 1 82% Silva [133] 2006 72 61.2 (42-90) Symptomatic Stage 2 or greater 85% 133 1288 Apex 4% Apex 5% Anterior 5% Posterior 5% Apex 1% Anterior or posterior 11% Apex 1% Anterior 3.5% Posterior 1.4% Apex 6% Posterior 12% Apex 3% Anterior 7% Posterior 14% 4 (4%) 3 (6.5%) 11 (5.5%) None reported None reported 2 (3%) Table 8. Anterior Vaginal Wall Prolapse Procedures Author Year No. Follow-up Success Rate Anterior Colporrhaphy Stanton [137] 1982 54 up to 2 yrs 85% Macer [135] 1978 109 5-20yrs 80% Walter [138] 1982 76 1.2yrs 100% Porges [136] 1994 388 2.6yrs 97% Colombo [141] 2000 33 AC 35 colposupension 8-17yrs 8-17 yrs 97% 66% Sand [140] 2001 70 AC 73 AC& mesh 1yr 1yr 57% 75% No mesh complications Weber [139] 2001 57 AC 26 AC+mesh 23month 23 month 37% 42% No mesh complications 100% Vaginal Paravaginal Repair White [142] 1912 19 up to 3 yrs Shull [143] 1994 62 .6 yrs Grody [144] 1995 72 0.5-3yrs 67% 99% Elkins [145] 2000 25 0.5-3yrs 92% Mallipeddi [146] 2001 45 .6yrs 97% Young [147] 2001 100 11 months 78% Morse [148] 2007 27 VPVR 86 AC 13 24 54% 45% Abdominal Paravaginal Repair Richardson [149] 1976 60 1.7yrs 97% Richardson [150] 1981 213 0.5-6yrs 95% Shull [151] 1989 149 0.5-4yrs 95% Bruce [152] 1999 27 APR& sling 25 APR 17 months 17 months 93% 76% Scotti [153] 1998 40 39 months 97% Raz [154] 1989 107 AC & needle 2yrs 98% Raz [155] 1991 50 2.8yrs 90% Sling type support Gardy [156] 1991 58 AC & needle 2yrs 95% Benirzi [157] 1996 36 AC & vaginal wall sling 17months 95% Dmochowski [158] 1997 47 Raz type 47months 43% Cross [159] 1997 36 AC & sling 20months 92% Safir [160] 1999 112 Raz + polyglactin mesh 21months 92% Goldberg [161] 2001 53 AC& sling 1 yr 81% 90 AC 1yr 58% APR Abdominal paravaginal repair AC Anterior colporrhaphy Definition varies between authors 1289 With the site specific defect repair, following posterior vaginotomy, the defects in the rectovaginal fascia are identified with a rectal finger bringing the rectal wall forward. The connective tissues are pulled across over the defects and sutured with absorbable sutures to close the defect. have little impact on the success [160]. Dmochowski et al [158] reported a lower success rate using a stricter outcome definition of success. Goldberg et al [161] reported results from a case control study of women with cystocele and stress urinary incontinence. He suggests that the addition of the pubovaginal sling to the anterior colporrhaphy significantly reduced the recurrence rate of cystocele from 42% in the control group to 19% in the anterior colporrhaphy and sling group (P<0.05). 1. MIDLINE PLICATION (traditional posterior colporrhaphy) In five studies, where traditional posterior colporraphy was evaluated, the success rate ranged from 76% to 97% (Table 8), while postoperative dyspareunia rates range from 11 to 27% (Table 8) with denovo dyspareunia rates of 4% to 16% [137, 162-164]. This has been attributed to levator ani plication forming a rigid band across the vagina. Midline fascial plication of rectovaginal fascia without levator plication is believed to reduce this high rate of dyspareunia. The surgical management of anterior vaginal prolapse remains controversial. In reconstructive gynaecology surgery Level 1 [22, 25] evidence suggest the combined use of abdominal sacral colpopexy with or without retropubic colposuspension or paravaginal repair is superior to the vaginal approach including sacrospinous colpopexy and anterior colporrhaphy with or without vaginal paravaginal repair in the management of anterior vaginal prolapse (Grade B recommendation). 2. SITE SPECIFIC DEFECT REPAIR Richardson identified discrete defects in rectovaginal fascia and directed repair at the specific sites of defect to produce a more anatomical repair [169]. Both prospective and retrospective case series on the site specific defect repair, have reported success rates in the range of 67-92% with good functional outcomes (Table 9) [167, 170-172]. Table 9 contains a summary of reports using site specific defect repair for posterior vaginal support defects. One uncontrolled comparison of posterior colporrhaphy with site-specific defect repair [173] reported that the recurrence risk was higher in the site specific group at the end of 1 year follow-up (33% vs. 14%) and the postoperative Bp point was (-2.2 SSDR vs. - 2.7 PCR) P=0.001. The functional outcomes of difficult evacuation, fecal incontinence and post-operative dyspareunia were similar in both groups. Level 2 evidence suggests that in women with stress urinary incontinence and anterior vaginal support defects, the addition of a sling at the time of anterior colporrhaphy enhances anatomical outcome as compared to anterior colporrhaphy alone or in combination with other continence surgery [140, 161]. This evidence arises from one institution and one sample of women is reported twice. c) Posterior vaginal wall prolapse In standard posterior colporraphy, the posterior vaginal wall is incised in the midline and rectovaginal fascia identified. The fascia is then approximated in the midline either with continuous or interrupted absorbable suture. In the traditional technique described by Jeffcote [113], this was supplemented with levator ani muscle approximation in the midline. Posterior vaginal wall prolapse repair has traditionally used the vaginal approach, although several studies Table 9. Midline Fascial Plication (traditional posterior colporrhaphy) Author N Kahn M (164) 171 Lopez A* (163) 24 Follow-up Success Dyspareunia Pre-op Post-op 43 months 76% 5 years 91% 6% 20% Arnold W (162) 29 4 years 77% - 23% Mellgren A* (165) 25 12 months 96% 6% 19% Maher C** (166) 38 12 months 97 % 52% 11% Singh (167) 42 18 month 92% 31% 12% Robinson (168) 34 41 mos (mean) NR 33% 10% *includes levatorplasty **without levatorplasty 1290 address the transanal / transperineal approaches. The threshold for surgical intervention in the posterior wall has been poorly studied and the relationship between symptoms and anatomy is particularly poorly understood. There is insufficient evidence to recommend a surgical threshold based on anatomical support loss. Symptoms that have been associated with posterior wall prolapse include difficult defecation and splinting. Constipation is recognized as a colonic motility disorder that is not treated by posterior vaginal surgery. The transvaginal approach appears to be superior to the transanal approach for repair of posterior wall prolapse. Two prospective randomized controlled trials compared the transvaginal and transanal techniques. Nieminen et al reported one-year outcomes for 30 women with symptomatic rectocele who were randomly assigned to vaginal vs. transanal surgery [175]. Despite the small sample size of this group, they reported superiority of the transvaginal route with significant differences in recurrence rate (7% vs. 40%, p=0.04) and symptom improvement (93% vs. 73%, p=0.08) in the transvaginal and transanal groups respectively. No differences were reported in post-operative splinting or sexual function, perhaps due to the small sample size. Improved posterior support was reported with the transvaginal point (POP-Q Ap point -2.8 vs. -1.36). Kahn et al reported the superiority of the 2 year anatomic outcomes transvaginal route in 57 women randomly allocated to transvaginal (N=24) vs. transanal repair (N=33) with 13 % vs. 30%, (p=0.01) respectively [164]. Puigdollers et al reported results from a prospective cohort of women with rectocele and constipation who underwent surgery via endorectal or transperineal route, according to preference of the surgeon). At the end of one year the subjective improvement in constipation was reported in 43% (p < 0.001) and the need to splint decreased in 52%.(p=0.001) [176]. A single non-randomized study reports outcomes for a cohort of women with symptomatic rectocele who were treated laparoscopically (N=40) vs. transanally (n=40). Level 2B evidence from this study supports the superiority of the transanal approach for symptomatic relief (55% vs. 28%, p < 0.02), but lower post-operative dysparenuia rates (22% vs. 36%) with laparoscopic approach [177]. Paraiso et al compared three techniques of vaginal repair – posterior colporrhaphy (PCR), site specific repair (SSDR) and graft augmentation with site specific repair by prospective RCT [174]. Women randomly assigned to the posterior colporrhaphy (n= 37) and the site-specific repair group (n= 37) were reviewed at 17 months. The anatomical success rates were 86% and 78% respectively in the PCR vs. SSDR group. The functional outcomes of difficult evacuation and vaginal digitations were similar in both groups, and there was improvement in the PISQ –12 scores in all the treatment groups. The dyspareunia rates were 20% in the PCR compared to 14% in the SSDR. The anatomical and functional outcomes between SSDR and PCR were similar in this study. These studies do not provide evidence to support use of augmenting materials for posterior prolapse repair. 3. MODIFICATIONS TO TRADITIONAL REPAIRS In the case series by Van Dam J H et al combined transvaginal and transanal repair was done in 89 women and evaluated at a follow-up of 52 months. The anatomical success rate was 71% with no persistent or recurrent rectocele on defecography at 6 months. However, denovo dyspareunia was reported in 41% of women and there was deterioration of fecal incontinence in 7 patients [178]. The abdominal route has been employed in the correction of posterior vaginal wall prolapse when a co-existing apical defect required surgery. The technique is a modification of sacrocolpopexy with extension of the posterior mesh to the rectovaginal septum or upto the perineal body. The procedure has been performed completely abdominally or as a combined abdominal and vaginal approach. Table 10 summarizes a series of studies using extended posterior fixation of sacrocolopexy mesh. Table 10. Site specific defect repair (SSDR) Author Abramov Y [173] N 124 (SSDR) Follow-up 14 months 183 (PCR) Success Dyspareunia Pre-op Post-op 67% 8% 16% 86% 8% 17% Cundiff G [170] 69 12 months 82% 29% 19% Kenton K [171] 66 12 months 77% 26% 8% Porter [172] 89 18 months 82% 67% 46% Paraiso [174] 37 (SSDR) 17 months 78% 9% 14% 86% 30% 20% 27 (PCR) 1291 2. OBLITERATIVE PROCEDURES: LeFort colpocleisis, Colpectomy and colpocleisis obliterative procedures have an important role to play in the management of POP: in many women, the loss of coital function is offset by the positive impact on their daily activities. These procedures are performed on an outpatient basis with an immediate return to normal activities, and success rates have been described as high as 100%. High rates of patient satisfaction have been reported [182, 183] with low rates of regret for loss of sexual function. Barber et al reported results from a multicenter study followed by a prospective cohort design with a concurrent control group (184). Despite permanent alterations in sexual function and potential alterations in self-image, iImprovements in quality of life for the thirty women aged 65 or older who selected obliterative prolapse surgery were similar to the concurrent cohort of forth women who selected reconstructive surgery. These procedures are offered to women with Stage II-IV POP seeking a relatively non-invasive surgical procedure with cure rates as high as 100% [181] and who no longer wish to preserve coital function per vaginam (Table 11). With partial colpocleisis (for vaginal vault prolapse) or LeFort colpocleisis (for uterine prolapse), rectangles of vaginal epithelium are excised from the dorsal and ventral surfaces of the prolapsed vagina. The vagina is inverted and closed with the two raw surfaces in direct contact and reinforced with sutured skin edges. A small amount of skin is usually preserved on each side of the vagina, speeding the excision and allowing drainage of any secretions. The enterocele need not be addressed because there is no longer room in the vagina to permit descent, and the uterus can be left in situ unless there is separate pathology. In total colpectomy, all vaginal skin is removed, often including a high levator myorrphaphy. The Pelvic Floor Disorders Network recently completed a large series of women undergoing colpocleisis with one year follow-up [185]. All pelvic symptom scores and related bother significantly improved at 3 and 12 months, and 125 (95%) patients said they were either ‘very satisfied’ or ‘satisfied’ with the outcome of their surgery. These investigators concluded that colpocleisis was associated with high patient satisfaction.and was effective in resolving prolapse and pelvic symptoms. In the U.S., the number of colpocleises has declined from a high of 17, 200 procedures in 1992 to a low of 900 procedures in 1997 [24], while the number of total colpectomies decreased from a high of 3229 in 1989 to a low of 32 procedures in 1995. Nevertheless, Table 11. Abdominal Repair (Posterior Extension of Colpopexy Mesh) Author N Follow-up Success Dyspareunia Pre-op Post-op Baessler K [78] 33 26 months 45% 39% 13% Fox S [75] 29 14 months 90% 38% 17% Su K [179] 122 12 months 90% - - Lyons [180] 20 12 months 80% - - Marinkovic [92] 12 39 months 91% 29% none *Laparoscopic approach Table 12. Post-Colpocleisis Anatomic Measures. (Data available for 146 patients at baseline, 110 at 3 months and 103 12 months after surgery) Baseline 3 Mos Post-op 12 Mos Post-op 0 (0%) 90/110 (82%) 75/103 (73%) 0 (0%) 107/110 (97%) 96/103 (93%) 146/146 (100%) 3/110 (3%) 7/103 (7%) Most distal vaginal point (leading edge) ≤ 1cm inside hymen ≤ 1cm beyond hymen > 1cm beyond hymen 1292 IV. CONCOMITANT SURGERY 1. EFFECT OF COMBINATION PROCEDURES With apical suspensions: The success of anterior wall support procedures seems to interact with concomitant vaginal apical suspension procedures. Paraiso et al [121] reported a 37% cystocele rate after 243 women had undergone sacrospinous colpopexy and suggested the rate of cystocele may decrease with the iliococcygeous fixation as there was less posterior displacement of the vault. Subsequently, Maher et al [112] reported high rates of cystoceles after both sacrospinous and iliococcygeous fixation. With bladder neck suspension, Kohli et al [186] found the concomitant use of transvaginal bladder neck suspension used in conjunction with the anterior colporrhaphy was also problematic. Women undergoing anterior colporrhaphy alone had a 7 % recurrence rate as compared to a 33% recurrence rate after combined anterior colporrhaphy. 2. HYSTERECTOMY - The Role of Hysterectomy in Surgical Treatment of Prolapse Hysterectomy at the time of POP repairs is the standard practice in most parts of the world despite the fact that descent of the uterus may be a consequence, not a cause of POP. Surprisingly, given its widespread use, concomitant hysterectomy is not an evidence-based practice. Increasingly, women may wish to avoid hysterectomy at the time of POP repairs because of factors such as desire for further childbearing, the belief that the uterus is important for sexual satisfaction, and the success of recent conservative procedures for uterine bleeding and fibroids. While there are no prospective comparative trials, a few smaller studies suggest that there may be no disadvantage in outcome with conservation of the uterus, and operating time is shorter. Well-designed RCT studies comparing the repair of POP with and without hysterectomy should be prioritized. Several studies report results of preservation of the uterus with sacrohysteropexy. Banu 1997 [187] reported 100% success in a case series of 19 women with following sacrohysteropexy using mersilene mesh at 3-5 year follow-up. Leron 2001 [188] reported 92% success with the same procedure using teflon mesh in 13 subjects at a mean 15.6 months. Maher 2001 used a laparoscopic-assisted high McCall procedure for hysteropexy in 43 patients, with a reported 79% success rate at a mean 12 months follow-up [189]. Jeon, et al [190] reported outcomes after a median follow-up of 36 months in their retrospective comparison of 168 patients in 3 groups: sacrocolpopexy with synthetic mesh and hysterectomy (N=63); abdominosacral uteropexy with mesh (N=35), and abdominal uterosacrocardinal colpopexy and hysterectomy (N=70). Recurrence in the latter group III was 6.2 times higher than in the sacrocolpopexy/ hysterectomy group, however due to the design and group size, specific hypothesis testing was not possible. Dietz [191] and co-workers observed 133 Dutch women undergoing a sacrospinous hysteropexy, and examined 60 of these women with mean followup of 22.5 months. Eight-four percent of women were highly satisfied about the outcome of the procedure, and the rate of reoperation for uterine descent was 2.3%. The recurrence of anterior wall defects in this study was 35%. Three studies describe uterine preservation at the time of vaginal reconstruction. Uterine preservation or removal did not appear to affect the risk of POP recurrence, although these studies are significantly underpowered. Maher et al [189] reported a retrospective comparison of 34 sacrospinous hysteropexies and 36 vaginal hysterectomies with sacrospinous fixation. Uterine conservation was associated with significantly less blood loss (198 vs 402 ml) and decreased operating time (59 vs. 91 minutes). At a 36 month mean followup in the hysterectomy group and a slightly shorter follow-up of 26 months in the hysteropexy group, the investigators did not detect differences in subjective success (86% vs. 78%, p=0.70), objective success 72% vs. 74%, p=1.00) or patient-determined satisfaction (86% vs. 85%, p=0.10). Hefni [192] et al reported a nonrandomized prospective controlled study of 109 women who underwent sacrospinous cervicocolpopexy with uterine conservation [61 (56%)] and sacrospinous colpopexy + vaginal hysterectomy [48 (44%)]. Uterine conservation was associated with significantly less blood loss, decreased operating time and complication rate. At approximately 34 months, anatomic success was similar for the upper vaginal support (93.5% vs. 95%), anterior wall (11.4% vs. 10.4%, p=0.9) and re-operation (5% vs. 4.2%) for the uterine conserving vs. hysterectomy groups respectively. Van Brummen [193] performed a retrospective comparison of the same two procedures (n=30 with hyst, 44 with hysteropexy) and recurrence of prolapse defined as > grade 2 was similar in hysterectomy (2/30, 6.7%) and women with uterine preservation (5/44, 11.4%) Neuman at al [194] reported their prospective nonrandomised series in an abstract comparing 44 patients undergoing Posterior Intravaginal Sling (PIVS) with (N=44) and without (N=35) hysterectomy according to the patient’s preference. The women who selected uterine conservation were younger (51 vs. 63 yrs). With mean follow-up of 30 months, the 1293 investigators did not detect a significant difference in anatomical results (98.7), patient satisfaction (89.9%), or perioperative morbidity. • Risks of concomitant hysterectomy diagnosed when leaking occurs with Valsalva maneuvers after reduction of the prolapse in the absence of detrusor contractions. Using these criteria, incidence of occult stress incontinence has been shown to range between 36% and 80% [12]. There is growing evidence that concomitant hysterectomy increases the risk of suture or mesh erosion at the time of sacrocolpopexy. Cundiff et al, [32] in a prospectively planned analysis of the randomized CARE trial, reported that hysterectomy increases the risk of suture/mesh erosion. There are no comparative studies of complete vs. supracervical hysterectomy at the time of sacrocolpopexy to address the appropriate clinical treatment, given this finding. Many case series have documented the risk of de novo SUI following POP repair with the incidence of de novo postoperative stress incontinence in patients with a negative preoperative reduction cough stress test has been showed to be 1.9% [199] in a recent retrospective chart review study. Concomitantly, a 67.9% prevalence of occult SUI has been reported in a population of 78 women with POP[200]. Several case series have addressed specific risks that concomitant hysterectomy may confer at the time of prolapse repair, especially with regard to concomitant synthetic mesh use. Federow [195] did not detect significant differences in short-term post-op febrile morbidity, haemoglobin change or duration of hospital stay in a series of 235 sacrocolpopexy patients, 36.6% of whom had concomitant total abdominal hysterectomy. The pre-operative lack of symptoms in some women who experience de novo SUI following POP surgery is due to anatomic obstruction of the kinked urethra [201], and may have voiding difficulties due to similar urethral mechanics [202]. Techniques for prolapse reduction to optimally predict the risk of post-operative SUI has not been evidence-based. Visco et al (203) reported that certain techniques have poor predictive values for predicting de novo SUI following sacrocolpopexy . Belot et al reported that an inverted T-colopotomy and concomitant hysterectomy increased the risk of mesh erosions fourfold [196]. Gauruden -Burmester reported on 120 women, 12 months following armed monofilament polypropylene mesh with a mesh erosion rate of 3% which was not affected by performance of inverted T-colpotomy in over 50% (197). Collinet et al (198) reported that concomitant hysterectomy at the time of mesh-augmented vaginal reconstructive surgery increases the risk of mesh erosion [OR = 5.17 (p = 0.003] in his retrospective series of 277 patients. One non-randomized comparative study of 124 women reported by Brizzolara et al suggests that concomitant hysterectomy (n=60) is not a risk factor for mesh erosion [91]. Concomitant culdoplasty. There is insufficient evidence to comment on the utility of concomitant culdoplasty at the time of prolapse repair by any method. 3. CONTINENCE TREATMENT (Treatment and Prophylaxis) Although many women with anterior vaginal wall prolapse also experience stress urinary incontinence, women with advanced prolapse may not have incontinence symptoms. There is no standardized nomenclature to describe clinical or urodynamic findings for stress continent women who exhibit urine loss during prolapse reduction testing. In published papers, the terms “occult”, “potential”, “masked”, “latent”, “hidden” and “iatrogenic” are used interchangeably to describe SUI, which occurs following POP surgery in symptom-free patients before surgery. Conventionally, occult stress incontinence is Level 1 evidence exists from the CARE study which randomized 322 stress-continent women with Stage II-IV POP to a Burch colposuspension or no continence procedure at the time of concomitant open abdominal sacrocolpopexy [11]. The trial ended when the first planned interim analysis demonstrated the significant reduction of de novo SUI three months after surgery in women who were assigned to the Burch colposuspension compared to the group without a continence procedure. This benefit was not offset by any untoward intra-operative or post-operative side effects such as worsening urge incontinence or voiding dysfunction. These benefits were maintained at one year [13] and two years [14]. In the trial reported by Costantini, et al, [204] 66 patients with a negative stress test before and after prolapse reduction and no preoperative history of SUI symptoms were randomized to colposuspension or no colposuspension with a mean follow-up of 39.5 months. The pre- and post-operative definitions are not consistently defined or standardized. Although this paper does not support the routine use of colposuspension at the time of sacrocolpopexy in patients with negative preoperative stress test, the study was significantly underpowered and concluded the concomitant colposuspension increases the rate of post-operative stress incontinence. The contradictory results between these two studies may be due to different inclusion criteria or differences in sacrocolpopexy technique. Participants in the CARE study were randomized without regard to results of urodynamic testing with prolapse reduction, in order to determine the pre-operative utility of such testing. 1294 Given the overall benefit of the Burch colposuspension, the recommendations did not change based on reduction testing results; however, women who demonstrated preoperative urodynamic stress incontinence during prolapse reduction were more likely to report postoperative SUI, regardless of concomitant colposuspension (in the control group 58% versus 38% (p=0.04) and in the Burch group 32% versus 21% (p=0.19)) and experience a higher risk of postoperative SUI [203]. Tables 12 and 13 summarize studies of prophylactic continence procedures. Several randomized trials have reported lack of effect when a prophylactic bladder neck procedure is performed among continent women. Bump et al randomized 29 women with stage III-IV prolapse but without stress incontinence to either a needle suspension or endopelvic fascial placation without detecting a difference in urinary continence [28]. Similarly Colombo et. al. did not find differences in continence outcomes following randomization of 102 women with stage 2-4 prolapse without stress incontinence to cystopexy with or without pubourethral ligament plication [141]. Meschia et al reported results from their single small randomized clinical trial that addressed the surgical stress incontinence prophylaxis with TVT® at the time of vaginal prolapse surgery [205]. Although this was a positive trial, only women who were incontinent with prolapse reduction were included and any de novo incontinence, regardless of bother, was used as an endpoint. Thus, the use of prophylactic TVT® (or other prophylaxis) among women who are continent with prolapse reduction remains an unanswered but important clinical question. A recent prospective randomized trial has shown that anterior mesh repairs are more likely to lead to postoperative SUI than colporrhaphy alone (23% to 10% respectively) [206] (Tables 13, 14). The Effect of Concomitant Continence Surgery on Prolapse Outcome: a) Concomitant Sling Goldberg et al reported that a suburethral sling is protective in the anterior wall [161]. In a randomized trial designed to evaluate the efficacy of cadaveric fascia patch for augmentation of anterior colporrhaphy, Gandhi et al reported that concomitant sling placement reduces anterior wall recurrence [221]. b) Concomitant Colposuspension In a secondary analysis of a randomized controlled trial of the utility of Burch colposuspension for prevention of post-operative stress incontinence, Brubaker et al reported that Burch colposuspension at the time of open sacrocolpopexy results in anatomical changes that improve anterior support and decrease posterior vaginal wall support (Table 4) [14]. 4. CONCOMITANT PERIOPERATIVE PELVIC PHYSICAL THERAPY Jarvis et al reported the only study to date that has evaluated perioperative pelvic muscle training in women undergoing prolapse surgery [222]. Three months after surgery, subjects in the intervention group had significantly greater reduction in urinary symptoms, including reduction in daytime urinary frequency, and greater improvement in quality of life compared to the control group. Subjects were not followed beyond 3 months postoperatively, however, and only urinary symptoms were assessed. The role of perioperative pelvic muscle training for reducing the recurrence of prolapse or its symptoms in the long-term is unknown. a) Risk factors for POP and their relationship to the choice of surgical route Experts believe that it is important to understand the specific risk factors for an individual patient in planning her surgical correction POP results from a continuum of predisposing, inciting, promoting, and decompensating factors [223]. There are limited data regarding risk factors for POP recurrence after surgery, but expert opinion supports the concept that there are certain women who are at high risk for primary and/or recurrent POP. Some established risk factors for primary POP include vaginal delivery, age, obesity, and family history.Most experts recommend that, whenever feasible, POP repair be delayed until after childbearing is complete. As older women may have increased surgical risks compared to younger women [224] some surgeons may advocate the vaginal approach avoiding an incision. Obesity may be viewed as a separate risk for abdominal surgery, with the vaginal approach avoiding the risk associated with an abdominal wall incision [225]. There is no evidence to guide clinical decision making for the woman who develops POP without evident risk factors, such as the young woman or the nulliparous woman. In fact, one study of nulliparous nuns and their multiparous sisters reveals similar rates of POP in siblings after menopause, regardless of parity [226]. Younger women needing repair of POP often choose the most durable procedure allowing coital function. Expert opinion is supported by level 2 evidence that there are certain women who are at high risk for primary and/or recurrent POP). Dietz-Itza and coworkers [191] found that women with increased body weight (>65 kg) and women under 60 years of age had increase in both anatomical and functional recurrence of prolapse. Women with more severe prolapse are more likely to recur than those with milder support abnormalities. Other factors are not considered to be risk factors for POP but influence surgery itself. Obviously 1295 Table 13. SUI prevention at the time of vaginal surgery biologic grafts (continued) Author / year type of trial level of evidence Bump [28] prospective randomized Level 2 Colombo [207] randomized Level 1 1296 Colombo [208] randomized Level 1 Year 1996 1996 1997 Surgery + Follow up SUI type Follow-up Needle urethropexy group: urge incontinence 58% at 6 weeks - (36% de novo) 14% at 6 mos. Plication group: Urge incontinence 0% at 6 weeks 7% at 6 mos. 2.6 +/- 1.7 y. Fascia plication group SUI 21% at 6 weeks 7% at 6 mos. SUI : 8% 2.9 +/- 1.8 y. SUI : 8% > 5 y. SUI : 40% ‘’ SUI : 29% ‘’ SUI : 15% ‘’ SUI : 0% 25,5 m. 1 (7%) de novo urge incontinence Needle urethropexy (Muzsnaï) n = 10 Fascia plication n = 10 Needle colposusp. n=4 fascia plication n=5 6 weeks and 6 months Negative stress test with prolapse reduction Cystopecy n = 52 Cystopexy + pubourethral ligaments plication n = 50 post pubourethral ligt plication n = 15 Pereyra procedure n = 21 post pubourethral ligt plication n = 40 Pereyra procedure n = 33 Kelly plication occult SUI Comments Needle urethropexy group: SUI = 7% at 6 weeks 14 % at 6 mos. Occult USI (Pressure transmission ratio < 90% or positive stress test during barrier testing) n = 20 Without occult SUI n=9 Overt SUI SUI outcome 1 reoperation 0 long term micturition disorders 2% symptomatic OAB 1 reoperation 10% long term micturition disorders 2% symptomatic OAB 4% symptomatic OAB after pubourethral plication 2% symptomatic OAB after Pereyra procedure non effective to prevent postoperative SUI in patients undergoing POP repair Gordon [209] prospective case series Level 3 1999 Occult SUI n = 30 Chaikin [210] prospective cohort study Level 2 2000 Occult SUI n = 14 Pubovaginal sling 47 mos. (12-108) Subjective and objective SUI: 50% objective SUI with no subjective complaints: 37% SUI : 14% No additional procedure 44 mos. (12-96) SUI : 0% 0 de novo urge incontinence Klutke [211] retrospective. (charts review) Level 4 2000 Negative stress testat reduction n = 10 Occult SUI n = 55 Burch n = 52 3.5 y (1-7) ‘’ SUI : 4% 30% de novo detrusor instability ‘’ SUI : 0% 5% de novo detrusor instability negative stress test with reduction N = 70 Needle colposusp. N=3 No additional procedure 36 Table 13. SUI prevention at the time of vaginal surgery biologic grafts (continued) Author / year type of trial level of evidence Groutz [212] Prospective Level 3 Year Surgery + Follow up SUI type Follow-up SUI outcome Comments 1297 2000 occult SUI n = 30 Stamey 8 mos. (3-19) Symptomatic urodynamically confirmed SUI 23.3% asymptomatic patients with positive postop stress test 36.7% Yamada [213] Retrospective case control Level 4 2001 suburethral sling 51.2 (24-72) 57.6 (27-70) subjective SUI : 10% De novo urge symptom: 10% subjective SUI: 0 De novo urge symptom: 0 Gordon [214] Prospective Level 3 Barnes [215] retrospect. (charts review) Level 4 De Tayrac [216] retrospective case control Level 4 2001 occult SUI n = 10 negative stress test with reduction n = 10 Occult SUI TVT 14,25 +/-3.08 m. (12-24) Subjective SUI : 0% objective SUI : 10% De novo detrusor instability (without obstruction): 13,33% 2002 Occult SUI n= 38 Pubovaginal sling 15 m. (6-39) SUI : 5% De novo urge incontinence : 9,5% 0 permanent retention 2004 Overt SUI n = 29 TVT n = 15 No additional incontinence procedure n = 14 TVT n = 11 no additional anti-incontinence procedure n=8 17.3 +/-11.4 (7-36) 24.1+/-6.7 (13-41) SUI: 6.7% NB: POP repair included ant mesh repair in all patients 17.3 +/-11.4 (7-36) 24.1+/-6.7 (13-41) SUI : 0%* Occult SUI n= 19 Groutz [217] Prospective cohorte study Level 3 Meschia [205] prospective randomized Level 1 no anti-incontinence procedure 2004 Occult SUI n= 100 TVT 27 m. (12-52) 2004 Occult SUI TVT 26 m. plicature 24 m SUI : 35.7% SUI : 12.5%* * NS Symptomatic SUI urodynamically confirmed 1 year follow-up : 2% Subjective SUI: 4% objective SUI: 8% subjective SUI: 36% objective SUI: 44% De novo urge incontinence : 8% De novo urge incontinence 12% De novo urge incontinence 4% Table 13. SUI prevention at the time of vaginal surgery biologic grafts (continued) Author / year type of trial level of evidence Liang [218] Prospective case_control Level 2 Clemons [219] retrospective Level 4 1298 Reena [200] prospective cohorte study Level 3 Brubaker [14] Year 2004 2005 2007 2008 Surgery + Follow up SUI type Occult SUI (positive pessary test) n = 49 No masked SUI (negative pessary test n= 30) occult SUI n = 64 Occult SUI (pessary during provocative exercises) n = 53 Multicenter prospective randomized Level 1 322 patients enrolled all initially screened-negative for SUI Follow-up TVT n = 32 SUI outcome objective SUI : 0% Comments Idiopathic detrusor overactivity 16% subjective SUI: 9,4% No TVT n = 17 objective SUI : 52,9% subjective SUI: 64,7% Idiopathic detrusor overactivity 5,9% No TVT n= 30 Suburethral sling grade 3-4 anterior prolapse n = 39 Suburethral sling grade 3-4 posterior/apical prolapse n = 25 no post-op SUI Idiopathic detrusor overactivity 0% 22.5 m SUI: 13%* De novo or worsening urge incontinence: 8% 13.6 SUI : 0%* De novo or worsening urge incontinence: 4% * NS No procedure 6w Objective SUI: 34 (64.2%) 19 patients remained continent after surgery Burch group N = 157 Symptoms SUI: 19.7% (30) Positive stress test without reduction: 2% (3) with POP reduction: 35.7% (55) Detrusor overactivity: 12.1% (19) 2 yrs Composite SUI outcome: 32.0% (Symptoms: 25.9% Stress test: 9.5%) Control group N = 165 Subjective SUI: 18.8% (30) Positive stress test without reduction: 5.7% (9) With reduction: 35.8% (58) Detrusor overactivity: 10.4% (17) 2 years Composite SUI outcome: 45.2% (Symptoms: 40.6% Stress test: 6.7%) Table 13. SUI prevention at the time of vaginal surgery biologic grafts (continued) Author / year type of trial Year level of evidence Costantini [204] 2007 Misraï [220] Laparoscopic sacral colpopexy 2008 w = week m= month Surgery + Follow up SUI type Single site, prospective randomized Level 2 Retrospective case series Level 4 SUI outcome ( ) Negative stress test before and after reduction No symptoms of UI (history, questionnaire) No leakage during UDS Burch group N = 34 Control group N = 32 No SUI procedure y= year SUI= stress urinary incontinence Follow-up Negative stress test Comments 42+/- 18 mos (12-74) De novo SUI: 26.4% 38+/-19 mos (15-71) 20.4 mos. De novo SUI: 3.1% De novo SUI: 13% colposusp= colposuspension TVT= tension free vaginal tape ranscut= transcutaneous 1299 Table 14. Concomitant Continence Procedure at Time of Colpocleisis Bothersome SUI three months after surgery (n=68) Underwent concomitant incontinence surgery Yes No Yes 8 (21%) 8 (28%) No 31 (79%) 21 (72%) Bothersome SUI 1 year after surgery (n=64) Yes 6 (17%) 6 (21%) No 30 (83%) 22 (79%) concomitant clinical consideration, such as a pelvic mass or extensive abdominal mesh from prior hernia repair alters the risk/benefit for certain surgical routes. There is insufficient evidence to guide the route of prolapse surgery for women with known intraabdominal adhesions. Some surgeons may seek to avoid adhesions using an extraperitoneal approach from the vagina, while others may prefer to manage the adhesions through an incision. A shortened vagina with dyspareunia may dictate procedures that have the potential to improve vaginal depth. In one retrospective cohort study, Hilger found that almost 50% of elderly women who underwent successful abdominal repair of POP did not resume sexual activities, despite the fact that the abdominal repair was selected to preserve coital function [95]. In summary, individual risks factors should be weighed against the perceived risk of recurrence in any one individual woman in order to select the most favorable risk/benefit ratio for their specific support defects. V. THE ROLE OF AUGMENTING MATERIALS IN POP SURGERY The use of material is inherent in the performance of abdominal sacrocolpopexy. However, there is increasing interest in the potential role of augmenting materials to enhance POP surgery outcomes with other POP procedures, including vaginal surgery. The Cochrane review of surgically managed POP in 2007 concluded that there were insufficient data about mesh and biological graft augmentation of vaginal repairs, and stressed the need for adequately powered randomized controlled clinical trials [27]. Despite recent results from three recent RCTs [227] addressing the anterior wall and demonstrating the utility of mesh augmentation for that indication, the committee considered the current levels of uncertainty about clinical care scenarios, especially in primary prolapse repairs completed with mesh. Although a prolapse persistence or recurrence is an undesirable outcome, a secondary prolapse procedure has a good likelihood of success, especially when sacrocolpopexy is used. The clinical scenarios for subsequent procedures following failed mesh procedures are highly anecdotal. There is insufficient information about risks and efficacy of secondary procedures following primary mesh repairs. 1. AUGMENTATION FOR ANTERIOR WALL SURGERY • Synthetic material In line with our surgical colleagues there has been a move towards the use of prosthesis to augment the native tissue repair in reconstructive gynaecology. Given the relatively high failure rate of the anterior vaginal compartment at prolapse surgery it is likely that anterior vaginal wall repair would benefit most from the use of prosthesis. The majority of Level 1 and 2 evidence [140, 228] suggest that the use of absorbable synthetic mesh overlay offers a superior anatomical outcome for anterior wall prolapse as compared to anterior colporrhaphy alone, although the evidence is divided based on relatively few women [139]. Synthetic mesh was used by Julian et al who described his prospective case control study in women who had undergone at least 2 previous vaginal repair [228]. These women had an overlay of Marlex mesh to the anterior colporrhaphy reduced the recurrence rate of cystocele from 33% to 0%, but the mesh erosion rate was 25%. Flood et al in a retrospective review of 142 women with Marlex mesh augmentation of anterior colporrhaphy demonstrated a 100 % success rate for cystoceles at 3.2 years and a mesh erosion rate of 2% [229]. Weber et al [139] in a randomized control trial compared the anterior colporrhaphy [33], ultra-wide anterior colporrhaphy [24] or anterior colporrhaphy with absorbable polyglactin (Vicryl) 910 mesh [26] in the management of cystoceles. The study size was too small to detect small differences (or no differences) in efficacy or adverse events. However, at a mean follow-up of nearly 2 years the groups had similar proportions of women experiencing satisfactory or optimal anatomic results, 30%, 46% and 42% respectively. Sand et al [140] in a larger RCT randomonly allocated cystoceles to anterior colporraphy alone (n=70) and to anterior colporraphy plus polyglactin mesh underlay (n=73). At I year the success rate in the mesh group was 75% and significantly greater than the 57% success rate in the anterior repair group alone (P=0.02). Concurrent paravaginal defect were present in 11 women and concomitant paravaginal repair was significantly associated with a lower recurrence of cystocele overall (P=0.02). In a separate study multivariate logistic regression demonstrated concurrent pubovaginal slings for stress urinary incontinence, to be associated with significantly fewer recurrent cystoceles (odds ratio, 0.32; p=0.005) [221]. A variety of polypropylene mesh overlays have been evaluated in case series for the management of anterior wall prolapse. The anatomical success rate varies from 76 to 100% [230-235]. Salvatore et al reported worrying functional outcomes after a prolene mesh overlay including a mesh erosion rate of 13%, overactive bladder increasing from 28 to 56% and dyspareunia increasing from 18 to 38% postoperatively [236]. Visco et al suggested that the mesh erosion or infection rate was increased four-fold when mesh was 1300 introduced vaginally as compared to the abdominal route [98]. More recently three year follow-up after the polypropylene mesh overlay in the anterior compartment has been reported. Cervigni reported on 218 women at over 3 year review with a 76% objective success rate. Mesh erosions were identified in 12.3% and vaginal stenosis in 7.7% [230]. De Tayrac reported on 55 women at 3-year review with a 89% success rate, 9.1% mesh erosions, 5.5% mesh shrinkage and 16.7% dyspareunia [237] He concluded that lower weight and coated meshes were required to limit the rate of complications and duly reported on 132 women, 12 months following low weight coated polypropylene mesh with a 92% success rate [238]. Unfortunately local problems remained with mesh erosions in 6.3% and de novo dyspareunia in 12.8%. Two randomised control trials have been published comparing overlaying polyprolene mesh and traditional anterior colporrhaphy. Hiltunen et al compared 104 women undergoing anterior compartment prolapse repair with 6x11cm low weight monofilament polypropylene (Parietene light, Sofradim Co, Trevoux, France) with 97 undergoing traditional anterior colporrhaphy [206]. At 12 months the objective success (stage 0 or 1 Aa and Ba) rate was 93 in the mesh group and 61% in no mesh group (P<.001). Symptomatic anterior compartment prolapse was significantly lower at 4% in the mesh group as compared to 15% in the no mesh group (p<0.05). Mesh erosions were seen in 17.3%. Sivaslioglu et al reported on 43 undergoing low weight polyprolpylene mesh as compared to 42 undergoing site-specific vicryl repair and at 12 months found the objective success rate (leading edge of cystocoele was <?1 cm in relation to hymen (stage 1) was significantly higher at 91% in the mesh group and 72% in the non-mesh group [239]. The mesh erosion rate was 6.9% and de novo dyspareunia was reported in 4.6% in the mesh group and none in the non-mesh group. Quality of life assessment demonstrated no difference in outcomes between the groups and no patient in either group underwent further surgery for anterior compartment prolapse. Since 2004, a variety of kit transobturator armed polypropylene meshes have been available. A recent RCT compared anterior polypropylene mesh (n=38) with anterior colporrhaphy. At 1 year the objective success rate (defined as less than POP-q stage II anterior vaginal prolapse) was higher in the mesh group (89% vs. 55%). Functional outcomes including quality of life, sexual activity and dyspareunia were similar in both groups with a 5% mesh erosion and 2% unilateral leg pain that settled by 8 weeks after the surgery in the mesh group [240]. Fatton et al reported on 106 women three months following vaginal mesh polypropylene mesh (anterior, posterior or total) with a 95% success rate and 4.7% mesh erosion rate in short term followup [241]. Concomitant hysterectomy was not performed and the authors felt surgeon experience was important in minimizing mesh erosion, a view that was supported by Dwyer and Orielly who reported a decreasing rate of mesh complications with increasing surgeon experience [242]. Gauruden –Burmester reported on mesh contracture rate by performing postoperative introital ultrasound measurements and revealed the vaginal polypropylene anterior mesh contracted from 7.5cm to 3.5cm (54%) and 11.5cm to 6.4cm (46%). While the mesh contracture was significant the authors found the mesh contraction was not associated with postoperative vaginal length measurements [197]. Majority Level 1 evidence suggests that polyprolene mesh overlay has a superior anatomical outcome as compared to traditional anterior colporrhaphy. These findings need to be tempered with Level 2 and 3 evidence suggesting that significant functional complications are associated with the employment of non-absorbable meshes at the time vaginal reconstructive surgery [98, 228, 236]. The consequences of these complications are not insignificant and may result in multiple subsequent surgical procedures and residual symptoms. There is a lack of evidence on the optimal management of such mesh-provoked complications. A single RCT demonstrated an armed polypropylene mesh kit had a superior anatomical outcome at one year compared to anterior colporrhaphy. This study is significantly underpowered to adequately assess functional outcomes [240]. There remains a significant paucity of data available on efficacy of the commercially available kit armed polypropelene meshes for anterior compartment prolapse. A single well designed RCT and level 2 evidence suggest the porcine dermis graft overlay to be more effective than Anterior colporrhaphy alone. A significant body of Level 2 and 3 evidence has not been able to reproduce these results. A single RCT and level 3 evidence suggest little benefit is be derived from cadaveric fascia lata or dermis as a graft material. 2. BIOLOGIC GRAFTS Alternatively to synthetic prosthetic grafts autologous material may have a lower risk of host rejection or infection. Cosson [243] described an autologous 6-8cm long and 4 cm wide vaginal patch suspended from the tendinous archs of the pelvic fascia and tucked under the anterior repair. The success rate (<grade 1 POP) was 93% at a mean follow-up of 16 months. Allografts from postmortem tissue banks have been used for many years in orthopedic surgery and decrease the risk associated with harvesting autologous rectus sheath or fascia lata. Cadaveric fascia lata with or without pubovaginal sling has been utilised to correct anterior compartment prolapse with a success rate varying from 81-100% with acceptable 1301 complication rates [244-247]. Gandhi et al have reported preliminary results of a randomized control trial comparing anterior colporrhaphy alone and augmented with fascia lata graft for cystoceles [221]. At 1 year they were not able to demonstrate that the addition of the fascial lata graft improved outcomes with the success rate after anterior colporrhaphy alone being 71% as compared to 82% in those augmented with the fascia lata graft (P=0.07). No complications were reported. Cadaveric dermis has been employed as a graft material in the anterior compartment with success rates varying from 42-84% at 2 years [248250]. Concerns regarding prion transmission causing infectious diseases [251] or residual antigenicity [252] that may cause host graft reactions have encouraged the use of porcine or bovine xenografts. Leboeuf et al retrospectively reviewed 24 women with native tissue four corner defect repair (FDR) and 19 FDR [253]. At 15 months the success rate was 100% in the FDR group and reduced to 84% if Pelvicol overlay was utilized. Wheeler et al reported on 36 women who all underwent high uterosacral vault suspension with anterior repair augmented with porcine dermis and at 17 months found a 50% recurrence rate [254]. The authors highlighted that despite the high objective failure rate greater that 90% of the women were satisfied or somewhat satisfied with the repair and 83% would undergo the surgery again. Handel et al retrospectively compared anterior colporrhaphy (n=18), porcine dermis (n=56) and polypropelene graft (n=24) in those with cystocele [255]. The success rate at 13 months was 94%, 64% and 96% respectively with a 21% rate of vaginal extrusion of the porcine dermis graft. Alternatively to these relatively disappointing results, a number of groups have reported satisfactory objective results utilizing the porcine dermis. Gomelsky et al found in 70 women after 2 years, an 87% success rate with no complications [256]. Simsiman et al also after 2-year review of 89 women reported a 78% success rate with a 17% rate of graft erosions [257]. Meschia et al in a multicentre randomised clinical trial comparing the anterior colporrhaphy (n=103) and anterior colporrhaphy-augmented with 4x7cm piece of porcine dermis [258]. The success rate at 1 year was 93% in the anterior colporrhaphy with porcine graft overlay group as compared to 81% in anterior colporrhaphy alone group (P<0.001) with a 1% rate of graft erosion. Tables 15, 16 and 17 summarize studies using augmenting materials for various transvaginal procedures. In 83 women who underwent transperineal rectocele repair using polyglycolic acid mesh, Leventoglu et al reported an 89% anatomical cure rate at 14 months as well as improvement in functional outcomes for splinting, straining, and incomplete evacuation of bowel (p value =0.0001) [274]. Biological grafts do not appear to enhance to results of traditional posterior colporrhaphy. Pariaso, et al reported the results of a randomized trial in which 3 groups of women were allocated to posterior colporraphy, site-specific defect repair or biograft augmentation with xenograft and followed over 17 months [174]. Women with graft augmentation had the highest anatomic failure rate (46%) compared to PCR and SSDR group (14% and 22% respectively). The functional outcomes in all the 3 groups were similar. Similarly, in the prospective cohort study by Altman, et al, augmentation with the porcine collagen in 23 patients resulted in a recurrence rate of 41% at 38 months [271] without major materials-related complications. Several case series demonstrate that the surgical therapeutic ratio of augmentation with synthetic material is not favourable. Case series report that synthetic grafts are associated with high anatomical success rates at the cost of complications and sequelae. De Tayrac and colleagues reported an anatomical cure rate of 92% at two-years following a combined sacrospinous suspension with polypropylene mesh posterior repair. In this case series of 26 women, one patient developed denovo dyspareunia and 3 developed vaginal erosion [237]. In the French multicenter case series reported by de Tayrac et al, investigators evaluated 76 women who underwent posterior repair using low-weight polypropylene mesh coated with absorbable hydrophilic film [238]. At a median follow-up of 10 months, they reported a 2.6% recurrence rate, 12% denovo dyspareunia rate and 6.3% vaginal mesh erosion rate. A retrospective case series of 50 women with mesh placement in the posterior compartment (with or without anterior placement) was reported by Dwyer et al. [242]. Despite no recurrences, at a mean followup of 29 months, he reported 6 mesh erosions (12%), 1 denovo dyspareunia and one rectovaginal fistula. Similarly, Lim et al reported a 30% rate of vaginal erosion, 27% denovo dyspareunia rate as well as a 22% recurrence rate 35 months after posterior repair augmented with composite polyglactin 910polypropylene mesh [268]. Milani et al augmented the midline fascial plication for rectocele repair with polypropylene mesh in 31 women. After the median follow-up of 17 months the anatomical success rate was 94% but the rate of dyspareunia in this group increased from 6% to 69% (p= <0.05) and the mesh erosion rate was 6.5% with one pelvic abscess [269]. Gauruder-Burmester et al evaluated 48 subjects with posterior wall defects in their study with a polypropylene mesh kit. At the end of one year followup reported good outcomes with an anatomical success at posterior vaginal wall as 100%, cure of dyspareunia postoperatively and no mesh erosions in the posterior compartment [197]. In the case series by Fatton et al, evaluating a polypropylene mesh kit, 1302 Table 15. Augmenting Materials for Anterior Vaginal (continued) Author SYNTHETIC MESH Julian (228) Nicita (234) 1303 Type No Review Months Success Rate Complications 12 12 44 24 14 100% 66% 100% 25% mesh erosion, infection 1998 Marlex Control Prolene Flood (229) Migliari (232) Migliari(231) 1998 1999 2000 Marlex Mixed fiber Polypropylene 142 15 12 38 23 20 100% 93% 75% 3 mesh erosions Natale 2000 Polypropylene 138 19 97% Sand (140) 2001 2001 Salvatore (236) O’Reilly (235) 2002 2003 73 70 26 57 32 81 12 Weber (139) 23 23 17 28 75% 57% 42% 37% 87% 88% Cervigini (230) 2007 Polyglactin No mesh Polyglactin No mesh Prolene Polypropylene Atrium Polypropylene 13 mesh erosions, 9 dyspareunia, 1 haematoma no mesh complications 218 38 76% Jo(259) 2007 Polypropylene Gynemesh 38 18 94% 12.3% erosions 7% Vaginal stenosis 0 erosions Rodriguez (260) Amrute (261) 2005 2007 Polypropylene Polypropylene 98 76 30 85% 95% 0 erosions 3% erosions de Tayrac(262) 2005 Polypropylene 84 24 92% 8.3% de Tayrac(263) 2006 Polypropylene 55 37 89.1% de Tayrac(237) 2006 Polypropylene 48 18 98% 9.1% mesh erosion 5.5% mesh shrinkage 16.7% dyspareunia 10% dyspareunia 8.3% erosions de Tayrac(238) 2007 32 13 93% 6.3% erosion 12.8% de novo dyspareunia Hiltunen (206) 2007 104 12 93% 17.3% erosions 4 TVT 1 vault prolapse 5 TVT 1 ant mesh Sivaslioglu (239) 2007 low weight Polypropylene coated RCT low weight Polypropylene AC RCT low weight Polypropylene Site specific vicryl AC 42 97 43 12 12 62% 91% 42 12 72% (233) Year 1996 3 uterine prolapse no mesh complications 13% mesh erosions no mesh erosions 6.9% mesh erosions 4.6% de novo dyspareunia dyspareunia Table 15. Augmenting Materials for Anterior Vaginal (continued) Author Nguyen (240) Altman (264) Year 2008 2007 Type RCT Armed Polypropylene Perigee AC Polypropylene No 38 Review Months 12 Success Rate 89% 38 123 12 2 55% 87% 47 16 months 93% none 19 20 100% none Prolift Biological Grafts Allographs: Cosson (243) 2001 Complications 5% Erosion 9%dyspareunia 16% dysparuenia 1.5% mesh Erosions 3.2% organ perforation 1304 Groutz (245) 2001 Kobashi (265) 2002 Chung (248) 2002 Autologous Vaginal patch cadaveric & pubovaginal sling cadaveric fascia lata & sling cadaveric dermis Clemons(249) 2003 cadaveric dermis 33 18 59% 1 incision breakdown Powell (247) 2004 cadaveric fascia lata 58 24 81% Frederick (244) 2005 251 6 93% Gandhi(221) 2005 76 13 82% no graft comlications Ward (250) 2007 cadaveric fascia lata & sling RCT AC & fascia lata (Tutoplasta) AC no graft cadaveric dermis 10% graft erosion 2 transfusions, 1 cystotomy 3 ureteral kinking 1 osteitis pubis 78 39 13 24 71% 42% Xenographs Lebouf (253) 2004 Salomon (266) 2004 9 24 27 15 15 14 84% 100% 81% None None 1 graft r/o vaginal pain Gomelsky (256) 2004 70 24 87% none Wheeler (254) 2006 28 18 50% 2% granulation tissue Meschia (258)RCT 2007 2007 Simsiman (256) Robles (267) 2006 2007 12 12 13 13 13 24 8 93% 81% 64% 96% 94% 78% 85% 1% vaginal extrusion Handel (255) 98 103 56 25 18 89 90 Variable definitions of success used. FDR & Pelvicol PDR porcine dermis transobturator porcine dermis porcine dermis Uterosacral repair Porcine AC Porcine dermis Polypropylene AC Porcine graft Porcine dermis Polypropylene arm 132 12 87% 1 osteitis pubis 19 24 84% 1 infection removal 1 de novo dyspareunia No graft erosions 21% vaginal extrusions 4% mesh erosion 17% erosions no complications Table 16. Augmenting Materials for the Posterior Vagina SYNTHETIC MESH Author Graft N Follow-up Succes % Complications Polypropylene 91 6 months 91% Rectal perforation N=4 Permanent Altman D [264] Wound infection N=1 De Tayrac [237] Polypropylene 26 22 months 92% Vaginal erosion N=3 De Tayrac [238] Polypropylene 76 10 months 72% Vaginal erosion 6.3% De novo dyspareunia 13% Dwyer P [242] Poypropylene 50 29 months 100% Fatton B [241] Polypropylene 28 (isolated) 58 ant and posterior 25 weeks 86.2% 98.3% GauruderBurmester A [197] Polypropylene 48 12 months 100% Rectovaginal fistula N=1 Lim Y [268] Prolene-vicryl 37 35 months 78% Mesh erosion N=11 Milani [269] Polypropylene 31 17 months 94% Mesh erosion 6.5% Parker MC [270] Polypropylene 4 14 months 75% Polyglycolic acid No mesh 67 65 ?One yr. 90% 91% No mesh erosion Author Graft N Follow-up Succes % Complications Altman D [271] Porcine Dermis 23 3 years 69& None Absorbable Sand P [140] BIOLOGIC GRAFTS Ghoniem G [272] Allograft 91 2.6 years 97.6% Vaginal hematoma N=1 Kobashi K [246] Cadaveric Fascia 73 13 months 90% Dyspareunia 23% Kohli N [273] Porcine Dermis 30 12 months 93% None Paraiso M [174] Porcine Dermis Site Specific 31 37 37 17 months 54% 78% 86% None Granulation tissue 11% Posterior Colpo. 1305 Table 17. Mesh kits used for apical repairs Author Year Type No. Followup weeks Success rate complications Abdel Fattah [275] 2008 Apogee American Medical Systems 38 12 95% (36/38) Gaurder-Burmester [197] 2007 Apogee American Medical Systems 48 52 100% Fatton [241] 2007 Prolift, Johnson & Johnson, Ethicon 88 25 93% 2 haematoma Belot F [196] 2005 Prolift Johnson & Johnson, Ethicon 277 Not stated Not stated Erosion 34/277 Abdel Fattah [275] 2008 Prolift Johnson & Johnson, Ethicon 143 12 94% 1rectal injury 1 bladder injury 1 Transfusion 14 buttock pain 7 dyspareunia 16Vag.erosion 1 bladder erosion Biertho [276] 2007 PIVS Tyco Helathcare, USA 34 12 91 1erosion 1 haemorrhage Foote [277] 2007 PIVS Tyco Helathcare, USA 52 20 83% Erosion 11/52 Matox [278] 2006 PIVS Tyco Helathcare, USA 21 7 37% 1 proctotomy 1 hemotoma Vardy [279] [280] 2006 2005 PIVS Tyco Helathcare, USA 98 3 99% 2 erosion Neuman [194] 2007 PIVS Tyco Helathcare, USA 140 120 99% 12 erosions de Tayrac [238] 2007 PIVS Tyco Helathcare, USA 21 42 95% 2 hemotoma Amrute [261] 2007 Polypropelene H shaped 76 123 95% 2 erosion 2 dyspareunia 1306 Blood loss>400mls 1 UTI 1 Dyspareunia 1 Rectal injury 1 Vag erosion 4 58 women with rectocele underwent posterior mesh repir. At the short-term follow-up at 3 months, there were two cases of Stage 2 prolapse of the posterior vaginal wall and there were five patients with mesh exposure [241]. Altman, et al, reported a 91% posterior anatomical cure rate in their interim analysis at 2 months following polypropylene mesh repair. The same authors evaluating the perioperative morbidity with this technique at the 6-month follow-up reported four cases of rectal perforation and one wound infection [264]. A variety of kits have been proposed for repair of prolapse that includes apical support loss. Routine use of these kits should be regarded cautiously based on the complications reported in the series in Table 17. VI. RECTAL PROLAPSE External rectal prolapse is a circumferential, fullthickness protrusion of the rectum through the anus. This section is limited to a discussion of surgically treatment for external rectal prolapse and does not discuss internal rectal prolapse or various forms of intrasuccesption. More than 90% of patients with rectal prolapse are women [281] and the incidence peaks in women older than 70 years old [282] Pelvic organ prolapse and rectal prolapse may occur concurrently. In a recent study, 48% of patients treated for rectal prolapse developed genital prolapse at some point of time [283]. Patients with rectal prolapse have debilitating symptoms and they usually therefore require surgical intervention. There are some 100 different surgical methods described for surgical correction of rectal prolapse, but there are no randomized, well powered, studies to base clinical decision making on. Available randomized studies have major methodological limitations. Surgical treatment of complete rectal prolapse includes has traditionally been divided into perineal and transabdominal approaches. Perineal procedures include complete (the “Altemeier procedure”), or partial resection (the “Delorme procedure”) of the prolapse. Transabdominal procedures can be performed either with open or laparoscopic techniques and include different types of suspension and sometimes concomitant bowel resection. Mobilization of the rectum down is an integral part of correction of the prolapse. The extent of mobilization varies and there are some data suggesting that the lateral ligaments should be preserved. A recently introduced surgical technique, laparoscopic ventral rectopexy, avoids posterior rectal mobilization and has been found to have low rate of postoperative constipation in initial studies. These results need to be confirmed in larger trials, with longer follow-up, at other institutions. Concomitant sigmoid resection is frequently used in patients with preoperative constipation symptoms and there are some data that this addition may slightly decrease the risk for postoperative constipation. There are few randomized studies evaluating surgical treatment for rectal prolapse. In 2000, Bachoo et al. performed a review for the Cochrane collaboration evaluating all randomized or quasi-randomized trials of surgery for rectal prolapse [284]. Ten trials were included with a total of 324 participants and the studies had varying aims. The small sample size of included trials, together with methodological weaknesses, limited the review and the authors suggested larger and better designed trials to define the optimal treatment for rectal prolapse. The Association of Coloproctology of Great Britain and Ireland initiated a randomized multicenter trial, the PROSPER (Prolapse Surgery: Perineal or Rectopexy) trial, in 2000 which is currently recruiting. 1. PERINEAL PROCEDURES Perineal procedures offer less surgical trauma, but are associated with higher recurrence rates and therefore usually reserved to old or frail patients. The two most common perineal procedures for rectal prolapse are the Delorme procedure and the Altemeier procedure. In several studies the recurrence rate is stated to be approximately 20% for both these procedures. However, recurrence rates tend to increase with the follow-up time in the studies and it is conceivable that the recurrence rate is significantly higher in fit patients. There are no prospective randomized studies comparing the recurrence rates between these procedures. The Delorme procedure has been the more popular in Western Europe, while the Altemeier procedure has been the dominating perineal procedure in North America. Agachan et al. compared the outcome after the Delorme procedureand the Altemeir procedure with or without concomitant levatorplasty [285]. The recurrence rate was highest after the Delorme procedure (38%) and lowest after the Altemier procedure including a concomitant levatorpalsty (5%). a) The Delorme procedure The Delorme procedure was first described in 1900 by the French military surgeon Edmond Delorme [286]. The procedure includes stripping of the mucosa of the prolapsed rectum and suture plication of the remnant rectal wall. There are several studies on the outcome after the Delorme procedure and results vary between studies [287-291]. The vast majority of studies are retrospective and there are no prospective randomized studies published comparing the results with other surgical techniques. In a recent retrospective study, Marchal et al. [288] reported a complication rate of 15% 1307 and a recurrence rate of 23% in 60 patients undergoing the Delorme procedure. The authors compared the Delorme group of patients with a group of patients undergoing the Orr-Loygue rectopexy and found that the Delorme procedure had a higher recurrence rate. After the Delorme procedure, patients with preoperative constipation had this symptom improved or completely resolved in 54% and worsened in 12% postoperatively. 42% of patients with preoperative incontinence were continent or had continence improvement postoperatively. b) The Altemeier procedure Perineal rectosigmoidectomy for rectal prolapse was tried in a few patients in the late 19th century, but it was not until 1952 the procedure was popularized by Altemeier [292]. The prolapsed bowel is transected 24cm proximal to the dentate line and the level should not include the internal or external anal sphincters. The inner tube of the rectum is then mobilized until there is some resistance to achieve more mobilization. The vessels to the rectal mesentery are ligated or transected using the ultracision equipment. The inner tube of the rectum is transected and sutured to the outer tube with an anastomosis. Some surgeons add a levatorplasty, to decrease the size of the levator hiatus, before suturing the anastomosis. Some surgeons use a stapled technique to achieve the anastomosis. There are several studies on the outcome after the Delorme procedure and results vary between studies [282, 293-296]. The vast majority of studies are retrospective. There is one randomized study comparing perineal rectosigmoidectomy with pelvic floor repair with abdominal resection rectopexy and pelvic floor repair [297]. The study included ten patients in each group and only one patient had a recurrence. There were no significant differences in functional outcomes. In a recent retrospective study, Kim et al. reported a complication rate of 14% and a recurrence rate of 16% in 60 patients undergoing the Delorme procedure [294]. Functional improvement was not significantly different, and most patients were satisfied with treatment and outcome. 2. TRANSABDOMINAL PROCEDURES Transabdominal procedures can be performed either with open or laparoscopic techniques and they include different types of suspension and sometimes concomitant bowel resection. Laparoscopic rectopexy is reported to offer the same or better outcome as after open rectopexy [298-305]. There are two small (21 and 40 patients respectively) randomized studies, with 21 and 40 patients respectively in the literature comparing laparoscopic mesh rectopexy with open mesh rectopex [299, 306]. Recurrence rates were quite small after both types of procedures and there were no significant differences in functional outcome. Transabdominal procedures result in general in low recurrence rates [307-309] and the discussion regarding outcomes is therefore focused on functional outcome. As discussed above, some patients may develop worsened constipation postoperatively and not all patients regain normal continence. The mobilization of the rectum at transabdominal procedures can be of varying degrees. The effect of lateral ligament division was assessed in one small randomized study involving 26 patients [310]. The study demonstrated a trend for higher recurrence rate after preservation of the lateral ligaments, while this preservation seemed to decrease the risk for postoperative constipation. A recently introduced technique (laparoscopic ventral rectopexy) provides rectal prolapse repair without any significant rectal mobilization [311]. In the first initial reports, the authors have reported excellent postoperative outcome [311, 312]; however there is no high-quality evidence to recommend this procedure. a) Rectopexy The dominating transabdominal technique for the treatment of rectal prolapse in recent decades has been rectopexy. The surgical procedure, open or laparoscopic, begins with mobilization of the rectum. The extent of dissection varies in different series, but most surgeons tend to mobilize the rectum down to the coccyx posteriorly, preserve the lateral ligaments laterally. The extent of anterior dissection varies, from none to mobilization of 2-4 centimeters of the rectovaginal septum. The choice of fixation method varies in different reports [172, 294, 309, 313, 314]. The fixation can be achieved with different mesh materials fixated usually posteriorly, but sometimes laterally or anteriorly. Suture rectopexy is frequently used and the mesorectum is then fixated to the sacrum with a few sutures. There are few studies comparing different fixation methods or materials in the same report. Novell et al compared the use of Ivalon sponge with suture rectopexy in one randomized trial involving 63 patients [315]. The recurrence rates were the same (one in each group) and functional outcome was not significantly different. Two other randomized trials compared the outcome after different types of mesh. Galili et al. [316] compared polyglycolic acid mesh with polypropylene mesh and Winde et al [317] compared polyglycolic acid mesh with polyglactin mesh. Sample sizes were limited (37 and 49 patients respectively) and no significant differences in recurrence rates or functional outcome were detected. As there has not been possible to detect any difference in outcomes between different fixations methods, some authors argue that suture rectopexy may be preferable as this method does not carry an associated risk for mesh complications [309]. The combination of rectopexy and concomitant sigmoid resection (the “Frykman-Goldberg operation”) is frequently used to decrease the risk for postoperative 1308 constipation problems. Several studies have evaluated postoperative constipation symptoms after resection rectopexy [318, 319]. Benoist et al. compared results after laparoscopic suture rectopexy with (n = 18) or without sigmoid resection (n = 16) (298). Postoperative constipation was observed in 2 patients (11%) after resection rectopexy and in 10 (62%) after suture rectopexy (P < 0.01). Two small randomized studies have evaluated the effect of concomitant sigmoid resection on constipation after rectopexy. McKee et al. prospectively randomized 18 patients to rectopexy alone or rectopexy combined with concomitant sigmoid resection [320]. Three months postoperatively, 7 patients after rectopexy alone and 2 patients after concomitant sigmoid resection complained of severe constipation. Luukkonen et al. prospectively randomized 15 patients to rectopexy and sigmoid resection or rectopexy without resection [321]. The authors found a lower risk for postoperative constipation in the patients who underwent concomitant sigmoid resection. Orr-Loygue rectopexy includes mobilization of the rectum and fixing the rectum with two strips of synthetic mesh from the anterolateral sides of the distal rectum to the sacral promontory [322]. In a recent prospective study, Douard et al. evaluated 31 consecutive patients operated with this technique [323]. They reported no recurrences after a mean follow-up of 28 months. Patients with incontinence decreased from 81% preoperatively to 55% postoperatively and continence improved in 96% of patients. Evacuation difficulties increased significantly after surgery, from 23% to 61% of patients. In another recent study, Marchal et al. [288] reported similar results, with a recurrence rate of 4% in 49 patients with a mean follow-up time of 88 months (Marchal, 2005). In patients with preoperative constipation, this symptom was improved or completely resolved in 33% and worsened in 58% postoperatively. In patients with preoperative incontinence, 73% were continent or had continence improvement postoperatively. b) Laparoscopic ventral rectopexy Laparoscopic ventral rectopexy provides rectal prolapse repair without any significant posterior rectal mobilization, which therefore decreases the risk for autonomic nerve damage [311]. The rectovaginal septum is opened and dissected. A Marlex mesh is thereafter sutured to the anterior aspect of the distal rectum and fixated proximally to the sacral promontory. No posterior mobilization of the rectum is performed. The authors have reported recurrence rate of less than 5% after a mean follow up of 61 months and constipation resolved in 16 of 19 patients with preoperative constipation [311]. VII. RECOMMENDATIONS The committee makes the following graded recommendations: • GRADE A (usually depends on consistent level 1 evidence and often means that the recommendation is effectively mandatory and placed within a clinical care pathway. Sacrocolpopexy is a highly recommended apical prolapse procedure. Synthetic material is superior to biological material for sacrocolpopexy. The use of polypropylene mesh for trans-vaginal anterior wall repair improves 1 year anatomic outcomes; this advantage should be weighed against the risk of mesh-related complications and uncertainty regarding long-term functional outcomes. Transvaginal route is preferable to transanal route for posterior vaginal prolapse repair. • GRADE B usually depends on consistent level 2 and/or 3 studies, or “majority evidence from RCTs: A single RCT provides level 1 evidence that concomitant Burch colposuspension is recommended in women without symptoms of stress incontinence at the time of open sacrocolpopexy. There is conflicting Level 2 evidence. Concomitant total hysterectomy at the time of meshaugmented repairs increases mesh erosion; therefore, alternative surgical plans with reduced risks should be considered. When hysterectomy is indicated, concomitant anterior repair without augmenting materials is reasonable. There is no evidence to support the use of synthetic mesh for trans-vaginal repair (or augmentation of repair) in the posterior wall. Levator ani plication during posterior colporrhaphy should rarely be used in sexually active women because of the increased risk of dyspareunia. A single RCT provides level 1 evidence that porcine dermis without fascial repair is inferior to posterior vaginal fascial plication or site specific defect repair. This is consistent with a Level 2 cohort study. • GRADE C usually depends on level 4 studies or “majority evidence’ from level 2/3 studies or Dephi processed expert opinion. Suspension of the apex by an appropriate method should be considered at the time of each vaginal prolapse repair. 1309 There is no evidence for the superiority of any specific technique for transvaginal apical suspension using native tissue. Traditional fascial plication of the posterior vaginal wall has a lower anatomic failure rate than site-specific fascial defect repair. A single level 1 study provides evidence that the use of porcine dermis as an overlay for anterior vaginal repair is superior to traditional vaginal fascial plication, although there is conflicting Level 2 and 3 data. Trans-vaginal placement of mesh after intraoperative procotomy is discourgaged. The committee recommends that the following areas be prioritized for future research: • It is essential to standardized mal method for determining outcome for POP surgery. The lack of consensus significantly impacts the ability to conduct, compare and contrast clinical research in this area. - Patient-reported and functional status before and after prolapse surgery. - Anatomic resolution (in operated and unoperated compartments) and relationship with symptoms. • Well-designed RCT studies are needed to: Trialists should report sufficient detail regarding anatomic and symptomatic outcomes so that subsequent outcome definitions can be tested in a wide variety of datasets. Primary and recurrent cases should be reported separately. Outcomes of treatments should be evaluated in multiple domains. - determine the role of hysterectomy (total or subtotal) during repair of POP with in situ uterus, - determine the optimal procedure for repair of post-hysterectomy POP, - compare native tissue vs. mesh-based apical repair techniques, Laparoscopic sacrocolpopexy is used as an alternative to open sacrocolpopexy, although no comparative studies report outcomes. - compare various trans-vaginal techniques for apical support, Anatomic support defects without accompanying, relevant symptoms are rarely an indication for prolalpse surgery. - compare the role of peri-operative physical therapy, - compare native tissue vs. mesh-based apical repair techniques, Evidence-based surgical alternatives should be offered to all women planning prolapse surgery. - determine the optimal management of stress continent women at the time of prolapse repair, by any technique, and The safety and feasibility of reoperation in the event of recurrent prolapse should be considered when performing the primary repair. • GRADE D = “no recommendation possible” to be used where the evidence is inadequate or conflicting and where expert opinion is delivered without a formal analystical process, such as by Dephi. - determine the optimal technique for repair of recurrence after primary mesh repair in any compartment. • Well-designed comparative studies are needed to study There is insufficient information to provide evidencebased recommendations for the route of primary prolapse repair. There is level I evidence that sacrocolpopexy is more effective and durable in correcting anatomical defects, while the native tissue vaginal route is faster and less expensive to perform with a quicker return to activities of daily living. In addition, the vaginal route has fewer serious perioperative complications. - the utility of self-prepared mesh vs. kit-prepared mesh for apical and/or anterior prolapse repairs, There is insufficient information to provide evidencebased recommendations for the optimal vaginal repair approach, including technique and materials. - management of recurrent anterior compartment prolapse following unsuccessful permanent mesh. There is insufficient information to provide an evidencebased recommendation for trans-vaginal mesh placement following intraoperative cystotomy. • Registeries are strongly recommended with the introduction of new devices to ensure safety and inform clinical trial planning. - the safety and efficacy of prolapse-repair meshes that include arms that traverse non-vaginal spaces, - management of mesh complications especially mesh contracture and complications associated with armed meshes, and 1310 There is sufficient evidence to support recommendations for some, but not all, decisions regarding the route of POP surgery. Textbooks of pelvic surgery often describe both abdominal and vaginal routes for POP procedures without commenting on the basis for selection of the route of surgery. When mentioned, most authorities state that pelvic surgeons should be proficient at procedures using both routes, and should tailor the procedure to the patient and her specific defects, decrying the “one procedure fits all” concept. However, some procedures for POP require special skills or experience, and not all surgeons will feel comfortable with all procedures. Relative indications cited for abdominal surgery include other reasons that mandate an abdominal approach, such as pelvic masses, the likelihood of dense pelvic adhesions, or the need for other extrapelvic abdominal procedures. Additional factors must include risk factors for failure, medical condition of the patient, risk of abdominal surgery in obesity or the frail elderly, and prior failed procedures for POP. The emergence of mesh-based procedures poses a dilemma as there is significant uncertainty about the safety and efficacy of secondary prolapse procedures for prolapse recurrence following a primary mesh procedure. 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