REVIEW URRENT C OPINION
Role of apical support defect: correction in women undergoing vaginal prolapse surgery Alexandriah N. Alas a and Jennifer T. Anger b
Purpose of review The aim was to review most recent literature and provide updates in clinical management and surgical treatment of apical pelvic organ prolapse. Recent findings In patients who decline surgical intervention, formal referral to pelvic floor muscle training is beneficial over self-directed Kegel exercises. Systematic reviews revealed that sacrocolpopexy has better long-term outcomes than vaginal approaches. Uterosacral ligament suspension and sacrospinous ligament suspension have equal efficacy at 1 year. These procedures should be considered as acceptable alternatives to sacrocolpopexy. Two randomized controlled trials have demonstrated equal efficacy between robotic and laparoscopic sacrocolpopexy. Summary Minimally invasive sacrocolpopexy should be considered the gold standard for apical prolapse, but these techniques are associated with longer operating times and higher complication rates and longer convalescence than nonmesh vaginal surgery. Surgeons must individualize surgical technique for each patient and should consider a vaginal approach in patients who do not desire laparotomy and are not candidates for minimally invasive surgery. Keywords apical support, apical suspension, pelvic organ prolapse, sacrocolpopexy
INTRODUCTION Apical prolapse is the descent of the uterus, cervix, or vaginal vault after hysterectomy to approximately the hymenal plane [1]. Although some women have only anterior or posterior prolapse, loss of apical support is common among women whose anterior wall prolapse extends beyond the hymen [2,3]. In fact, women with high stage cystocele almost invariably have significant loss of apical support, and it is apical support loss that is the cause of the cystocele defect [2]. Surgeons are now recommending concomitant procedures for patients with evidence of apical descent [4–6]. Eilber et al. [7 ] recently analyzed claims data on female Medicare beneficiaries, and found that, at 10-year follow-up, women who underwent an anterior repair with concomitant apical suspension had significantly less pelvic organ prolapse (POP) recurrence than women who underwent an isolated anterior repair (11.6 vs. 20.2%, P < 0.01).
(PFPT), and pessaries. Depending on symptom severity and impact on quality of life (QOL), women may opt for observation alone. A recent randomized control trial (RCT) by Hagen et al. [8 ] evaluated patient reported symptoms of POP after 12 months of therapy, either with formal PFPT or lifestyle modification with advice pamphlets (control group). They found a significant reduction in patient reported prolapse symptoms at 12 months, as evaluated by the Pelvic Organ Prolapse Symptom Score (POP-SS), in the intervention group compared with control (P ¼ 0.0053). This suggests that formal PFPT &
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NONSURGICAL TREATMENT Conservative therapy for symptomatic prolapse includes observation, pelvic floor physical therapy www.co-obgyn.com
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Department of Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Cleveland Clinic Florida, Weston, FL and b Department of Surgery, Division of Urology, Cedars-Sinai Medical Center, Los Angeles, CA, United States Correspondence to Jennifer T. Anger, MD, MPH, Associate Professor of Surgery, Associate Director of Urological Research, Department of Surgery, Division of Urology, Cedars-Sinai Medical Center, Adjunct Assistant Professor of Urology, UCLA, 99N. La Cienega Blvd., #307, Beverly Hills, CA 90211, United States. Tel: +1 310 385 2992; fax: +1 310 385 2973; e-mail: [email protected] Curr Opin Obstet Gynecol 2014, 26:386–392 DOI:10.1097/GCO.0000000000000105 Volume 26 Number 5 October 2014
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Management of apical prolapse support defects Alas and Anger
KEY POINTS Apical support procedures include vaginal, abdominal, and minimally invasive techniques. Robotic and laparoscopic sacrocolpopexy have similar outcomes at 1 year, and these minimally invasive techniques should be considered the gold standard for treatment. Vaginal procedures are acceptable alternatives to sacrocolpopexies with shorter operating times but higher reoperation rates. Colpocleisis is a well tolerated procedure among older populations and should be considered if sexual function is no longer desired.
is more beneficial than lifestyle modification or selfdirected Kegels [8 ]. Pessaries are considered first-line conservative therapy. Despite large numbers of pelvic floor physicians using these devices, there remains paucity of data regarding their effectiveness and recommended maintenance [9,10]. An expert panel recommended vaginal examination by a provider at least every 6 months, although in practice there is extreme variability in pessary maintenance by providers [11 ,12]. Currently, there is an ongoing, parallel, open-label RCT, POP in primary care: effects of Pelvic floor muscle training and Pessary treatment Study (POPPS), which includes two trials. POPPS trial 1 compares PFPT vs. watchful waiting among women with mild POP, and POPPS trial 2 compares PFPT to pessary use [13 ]. Although pessaries are an excellent nonsurgical option, some women do not wish to use them, and others are unable to maintain them in the vaginal canal because of significant introital laxity. &
time of hysterectomy in 1957, with others adopting their own modifications [14–16]. The modified McCall procedure involves lateral placement of one to three permanent sutures through the uterosacral ligament, followed by cul-de-sac peritoneum and full thickness posterior vaginal wall with final suture placement through the opposite uterosacral ligament to plicate the midline and suspend the vaginal apex (Fig. 1) [17]. This has the benefit of elevating the vaginal apex as well as preventing future enteroceles from developing after hysterectomy [14]. A retrospective study (n ¼ 62 per group) comparing McCall’s culdoplasty to sacrospinous ligament suspension (SSLS) showed no significant difference in recurrence rates between the procedures (15%) at 4–9 years [16]. A larger retrospective group of 693 patients from the Mayo Clinic found patient satisfaction to be 82% and a low reoperation rate of 5.2% [15]. Risks of this surgery include ureteral injury or obstruction from suture placement and ureteral patency should be confirmed after the procedure [18]. No recent RCTs have been performed. However, in 2011 a prospective study (n ¼ 70), evaluating patients who underwent
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SURGICAL TREATMENT Apical support procedures can be categorized as reconstructive or obliterative and can be performed either vaginally or abdominally, with or without a concomitant hysterectomy. Additionally, abdominal procedures can be performed by conventional laparotomy or by minimally invasive techniques, including laparoscopy and robotic-assisted laparoscopy. The technique used depends on surgeon preference and training, but individualizing the surgery to the specific patient is important because each technique carries its own unique success and complication rates.
MCCALL CULDOPLASTY McCall first described the surgical technique of closing the deep cul-de-sac and enterocele at the
FIGURE 1. McCall culdoplasty. Internal and external McCall sutures are placed. The distal suture (external McCall) incorporates the uterosacral ligament and posterior vaginal wall, providing apical support. Reprinted with permission, Cleveland Clinic Center for Medical Art & Photography 2012–2014. All Rights Reserved.
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vaginal hysterectomy with McCall culdoplasty, found the only risk factor for failure at 2 years, defined as Pelvic Organ Prolapse Quantification (POPQ) at least stage 3 of the apical portion, was fetal macrosomia compared to those with birth weights less than 4000 g (44.4 vs. 6.9%, P ¼ 0.000) [19]. Although, McCall culdoplasty can be performed for apical suspension, failure rates are reported as 5.2–44.4%, and caution should be used when choosing this procedure alone for apical suspension [15,16,19]. To prevent future enteroceles from occurring, a Moskowitz or a Halban’s procedure can be done during intra-abdominal surgery by performing a series of purse string sutures in the cul-de-sac. However, these procedures only obliterate the cul-de-sac space and should not be considered apical suspension procedures.
follow-up, demonstrated significant anatomical success (91 vs. 94%) and improvement in QOL in both groups, and a reoperation rate for apical prolapse of 19% for SSLS [21]. A meta-analysis of 17 observational studies and RCTs demonstrated failure to relieve symptoms in 10.3% and failure to provide patient satisfaction in 13% [22]. Complications include hemorrhage, buttocks pain, nerve or rectal injury, occult stress urinary incontinence (SUI), vaginal stricture, and future recurrences. A review of 22 studies that included 1229 patients who underwent SSLS found 27 patients (2%) required transfusion, and 32 patients (3%) had buttock pain on the side of SSLS that resolved by 6 weeks without intervention [23]. Of note, the SSLS is the basis of the majority of transvaginal mesh kits, which attach proximal mesh straps to the SSL.
SACROSPINOUS LIGAMENT SUSPENSION
HIGH UTEROSACRAL LIGAMENT SUSPENSION
Sederel first described the SSLS in 1958, which involves a transvaginal extraperitoneal approach of attaching the sacrospinous ligament (SSL) to the vaginal apex, either bilaterally or unilaterally, with either permanent or dissolvable sutures (Fig. 2) [17,20]. An RCT (n ¼ 95) comparing SSLS to abdominal sacrocolpopexy (ASC) with mesh, at 2-year
(a)
Uterosacral ligament suspension (USLS) was described in 1927 by Miller [24] but was not popularized until Shull [5] reported high success rates requiring only two reoperations in 298 patients. In women with a previous hysterectomy, identification of the remnant uterosacral ligament (USL) is
(c)
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FIGURE 2. Sacrospinous ligament suspension. (a) Passage of transvaginal suture-capturing device with suture through the coccygeus-sacrospinous ligament. (b) Three sutures are placed through the coccygeus-sacrospinous ligament. (c) Final attachment of the vagina to the coccygeus-sacrospinous ligament. Reprinted with permission, Cleveland Clinic Center for Medical Art & Photography 2012–2014. All Rights Reserved. 388
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Management of apical prolapse support defects Alas and Anger
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FIGURE 3. Uterosacral ligament suspension. (a) The uterosacral ligament at about the level of the ischial spine is grasped with an Allis clamp. (b) Three sutures are placed through the ipsilateral uterosacral ligament and then through the vaginal apex. (c) Sutures are placed bilaterally and tied, suspending the apex. Reprinted with permission, Cleveland Clinic Center for Medical Art & Photography 2012–2014. All Rights Reserved.
possible by transperitoneal palpation of the ischial spines, with USL location posterior and medial. The USLs are then plicated together as close to the ischial spines using one to three permanent sutures (Fig. 3) [17]. Karram et al. [25] found 89% of patients were satisfied with USLS and only 5.5% required reoperation (n ¼ 168). Margulies et al. [26] performed a meta-analysis of 32 studies and found success, defined as POPQ or less 1, of 81.2, 98.3, and 87.4% for anterior, apical, and posterior prolapse, respectively. Despite a high success rate, the complications of ureteral injury or obstruction were 1–11% [26]. The Pelvic Floor Disorders Network (PFDN) published this year the OPTIMAL Trial, the Operations and Pelvic Muscle Training in the Management of Apical Loss trial, a multicenter, 2 2 factorial RCT. Complications included ureteral obstruction in the USLS group (3.2%) and neurologic pain requiring intervention, 6.9 USLS vs. 12.4% SSLS (P ¼ 0.049). At 4–6 weeks, SSLS patients had persistent neurologic pain, 4.3 vs. 0.5%. The lower success rates for both procedures in this study were attributed to the stringent success criteria applied [27 ]. &&
Administration (FDA) warnings of transvaginal mesh. It was recommended that physicians monitor patients more carefully, and disclose serious complications, including those that could affect QOL, result in pain, scarring, and narrowing of the vagina [28]. In 2011, the FDA reported an additional 2784 complications and stated that these serious complications are not rare. They concluded that most cases of POP do not require mesh and should only be used when alternatives are not available and risks and benefits have been discussed with the patient [28,29]. In addition, specialized training for mesh devices was recommended, which will likely significantly reduce mesh-related complications. Additionally, American Urogynecologic Society (AUGS) and Society for Urodynamics, Female pelvic medicine and Urogenital reconstruction reported their position statement on mesh after the FDA warnings. In summary, the FDA did not recommend removal of these devices from the market, and because these devices may be the only surgical option for some patients, the decision to use such devices should be made by both the surgeon and patient. It was also stated that the FDA warning did not apply to slings for SUI or abdominal mesh, only to transvaginal mesh [30 ]. In 2011, a multicenter RCT reported trocarguided transvaginal mesh kits having higher objective and subjective cure rates compared with anterior vaginal repair, at 12 months. However, there were higher complications in the transvaginal mesh group, including intraoperative hemorrhage, bladder perforation, and reoperation for mesh &&
TRANSVAGINAL MESH Multiple vaginal mesh kits have been manufactured to assist in apical suspension with the goal of improving success and longevity when using a minimally invasive transvaginal extraperitoneal approach. Unfortunately, over 1000 reported complications in 2008 led to the US Food and Drug
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removal [31]. Su et al. [32 ] reported cohort data comparing traditional native tissue repair to the elevate transvaginal mesh system (American Medical Systems, Minnetonka, MN, USA) in 2014. Although there was a significantly higher success with mesh at 1 year in the anterior compartment (98 vs. 87%), there was no difference in the apical (99 vs. 96%), or posterior compartments (100 vs. 97%) [32 ]. Currently, the PFDN is recruiting for the SUPeR trial, the Study of Uterine Prolapse procedure – Randomized trial. This is an RCT comparing vaginal hysterectomy with USLS to hysteropexy using the UPHOLD sacrospinous mesh system (Boston Scientific, MA, USA). Aims of the study include evaluation of both subjective and objective data at 3 years [33 ].
0.24 for symptomatic failure. The conclusions of the study suggested higher treatment failure over time than other studies had previously reported [36 ]. Complications included mesh erosion (10.5%) as well as small bowel obstruction and postoperative ileus in 0.31%. In 2013, a Cochrane review [37 ] comparing three RCTs, reported that ASC had lower reoccurrence rates and less dyspareunia but longer operating and recovery times than SSLS. A recent retrospective cohort evaluated 292 patients who underwent ASC and found that the greatest risk for mesh complications was in those with stage 3 to 4 POP (P ¼ 0.04), previous hysterectomy (P ¼ 0.03), concomitant hysterectomy (P ¼ 0.03), and more than three procedures being performed concomitantly (P ¼ 0.02) [38 ].
ABDOMINAL SACROCOLPOPEXY
LAPAROSCOPIC SACROCOLPOPEXY
Lane described the ASC in 1962, which is considered the gold standard in treatment of apical prolapse (Fig. 4) [17,34]. In 2004, Nygaard et al. [35] performed a systematic review of ASC and reported success rates, defined as lack of apical prolapse, ranging from 78 to 100%, with a median reoperation rate of 4.4% for recurrent prolapse and 4.9% for postoperative SUI. In 2013, results from the extended CARE trial, Colpopexy and Urinary Reduction Efforts trial, which evaluated the longterm success of ASC with Burch urethropexy and ASC alone. At 7 years, the ASC only group treatment failure probability was 0.22 for anatomic failure and
Given the long recovery time associated with the laparotomy involved with the ASC, minimally invasive techniques have evolved. A recent retrospective cohort compared ASC (n ¼ 58) with minimally invasive assisted sacrocolpopexy [273 laparoscopic assisted sacrocolpopexy (LASC), 262 robotic assisted sacrocolpopexy (RASC)] and found no difference in anatomical failure rates, but an increase in complications in the ASC group (20 vs. 12.7%, P ¼ 0.001). The minimally invasive group had shorter hospitalizations, smaller blood loss, but longer operating times [39 ]. A multicenter prospective two-sided equivalence trial compared ASC to LASC. At 1 year, POPQ point C was 6.63 and 6.65 and patients reported being ‘very much better’ in 66.7 and 54.2% of patients, for LASC and ASC, respectively [40 ]. Although this study was statistically powered, it excluded women who required concomitant SUI surgery. Surgeons should be aware that including additional surgical procedures for SUI might affect success rates.
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ROBOTIC SACROCOLPOPEXY
FIGURE 4. Sacrocolpopexy. Lateral view of completed sacrocolpopexy with graft attaching the anterior and posterior vagina to the sacral promontory. Reprinted with permission, Cleveland Clinic Center for Medical Art & Photography 2012–2014. All Rights Reserved. 390
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Surgeons have begun to utilize robotic technology to assist them with a minimally invasive approach to the ASC as it allows many pelvic surgeons, not exclusively expert laparoscopists, to perform minimally invasive ASCs. A study in 2009 reported a short learning curve, with a 25% reduction in operating time after 10 cases for the RASC [41]. To date, two RCTs have compared RASC to LASC. Paraiso et al. [42] completed a single center, blinded, RCT and found no difference in functional outcomes at 1 year between RASC (n ¼ 40) and LASC (n ¼ 38). However, the RASC group experienced significantly longer operating times, higher pain scores Volume 26 Number 5 October 2014
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Management of apical prolapse support defects Alas and Anger
between weeks 3–5 of recovery, and higher surgical costs [42]. Similar results were reported in 2014 in a multicenter RCT that compared RASC (n ¼ 40) and LASC (n ¼ 38). There was no difference in POP stage, Pelvic Floor Distress Inventory (PFDI) score or adverse events at 6 months. However, the RASC group had longer operating times and increased pain the first week after surgery. Additionally, the RASC was associated with higher hospital costs both initially and at 6 weeks, but when initial costs and maintenance of the robot were excluded, there was no difference in surgical costs among the groups [43 ]. Although RASC is associated with higher pain scores and operating costs, it does have equal efficacy compared with LASC. This technique should be considered as an acceptable alternative to ASC for those surgeons who do not have the surgical skills for LASC but want to provide a minimally invasive approach for their patients.
durability but have increased complications and pain. Acceptable minimally invasive techniques include RASC and LASC, which are as effective as ASC [40 ]. Additionally, RASC and LASC have equal subjective and objective outcomes at 1 year [42,43 ]. Alternatively, patients could be offered a vaginal approach to apical suspension, either SSLS or USLS, which have demonstrated equal efficacy [27 ]. The use of transvaginal mesh cannot be recommended given limited data, as further studies are recommended to evaluate cure rates and mesh complications. &
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OBLITERATIVE PROCEDURE Both LeFort colpocleisis and total colpocleisis are considered obliterative procedures in which the vaginal opening is closed to prevent uterine or visceral prolapse from recurring. These procedures are typically performed on older women with no desire for sexual activity, as vaginal sexual function is lost after the procedure. Barber et al. [44] performed a multicenter prospective study comparing vaginal reconstructive surgery to obliterative procedures and reported significant improvement in the Short Form 36, PFDI, and Pelvic Floor Impact Questionnaire. To date, the largest study evaluating LeFort colpocleisis was in 2013. This was a retrospective, single center study (n ¼ 325) that reported anatomic success as 98.1% and patient satisfaction of ‘cured’ or ‘greatly improved’ as 92.9% with a mean follow-up of 45 (2–392) weeks. Mean age was 81.3, with 74.1% of patients having at least one comorbidity. Complication rate was 15.2% and included urinary tract infection, pulmonary embolism, anemia, hematoma, delirium, cardiovascular events, and mortality (1.3%) [45 ]. Although colpocleisis alters sexual function, it is a well tolerated procedure with excellent patient satisfaction and long-term results. This procedure should be considered an option for older women who no longer desire sexual function. &
CONCLUSION For women who decline surgery, pessaries and formal PFPT are more beneficial than observation or Kegels [8 ]. ASCs are associated with excellent &
Acknowledgements We would like to thank Dr Mark Walters, Dr Beri Ridgeway, and Ross Papalardo at the Cleveland Clinic Center for their illustrations. Conflicts of interest There are no conflicts of interest.
REFERENCES AND RECOMMENDED READING Papers of particular interest, published within the annual period of review, have been highlighted as: & of special interest && of outstanding interest 1. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 2002; 21:167– 178. 2. Rooney K, Kenton K, Mueller ER, et al. Advanced anterior vaginal wall prolapse is highly correlated with apical prolapse. Am J Obstet Gynecol 2006; 195:1837–1840. 3. Hsu Y, Chen L, Summers A, Ashton-Miller JA. Anterior vaginal wall length and degree of anterior compartment prolapse seen on dynamic MRI. Int Urogynecol J 2008; 19:137–142. 4. Chen L, Ashton-Miller JA, Hsu Y, Delancey JOL. Interaction among apical support, levator ani impairment, and anterior vaginal wall prolapse. Obstet Gynecol 2006; 108:324–332. 5. Shull BL. Pelvic organ prolapse: anterior, superior, and posterior vaginal segment defects. Am J Obstet Gynecol 1999; 181:6–11. 6. Toozs-Hobson P, Boos K, Cardozo L. Management of vaginal vault prolapse. Br J Obstet Gynaecol 1998; 105:13–17. 7. Eilber KS, Alperin M, Khan A, et al. Outcomes of vaginal prolapse surgery & among female Medicare beneficiaries: the role of apical support. Obstet Gynecol 2013; 122:981–987. Among female Medicare beneficiaries, women who underwent an anterior repair with concomitant apical suspension had significantly less POP recurrence than women who underwent an isolated anterior repair, at 10-year follow-up. 8. Hagen S, Stark D, Glazener C, et al. Individualised pelvic floor muscle training & in women with pelvic organ prolapse (POPPY): a multicentre randomised controlled trial. Lancet 2014; 383:796–806. In an RCT, formal PFPT was demonstrated to be more beneficial than lifestyle modification or Kegels. 9. Cundiff GW, Weidner AC, Visco AG, et al. A survey of pessary use by members of the American Urogynecologic Society. Obstet Gynecol 2000; 95:931–935. 10. Pott-Grinstein E, Newcomer JR. Gynecologists’ patterns of prescribing pessaries. J Reprod Med 2001; 46:205–208. 11. Anger JT, Scott VCS, Kiyosaki K, et al. Quality-of-care indicators for pelvic & organ prolapse: development of an infrastructure for quality assessment. Int Urogynecol J 2013; 24:2039–2047. There is limited data on recommended practices for pessary use, but an expert panel recommended pessary visits every 6 months. 12. Alperin M, Khan A, Dubina E, et al. Patterns of pessary care and outcomes for Medicare beneficiaries with pelvic organ prolapse. Female Pelvic Med Reconstr Surg 2013; 19:142–147.
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Urogynecology 13. Wiegersma M, Panman CMCR, Kollen BJ, et al. Pelvic floor muscle training versus watchful waiting or pessary treatment for pelvic organ prolapse (POPPS): design and participant baseline characteristics of two parallel pragmatic randomized controlled trials in primary care. Maturitas 2014; 77:168– 173. This is an ongoing RCT comparing pessary treatment and formal PFPT to observation. 14. McCALL ML. Posterior culdeplasty; surgical correction of enterocele during vaginal hysterectomy; a preliminary report. Obstet Gynecol 1957; 10:595– 602. 15. Webb MJ, Aronson MP, Ferguson LK, Lee RA. Posthysterectomy vaginal vault prolapse: primary repair in 693 patients. Obstet Gynecol 1998; 92:281–285. 16. Colombo M, Milani R. Sacrospinous ligament fixation and modified McCall culdoplasty during vaginal hysterectomy for advanced uterovaginal prolapse. Am J Obstet Gynecol 1998; 179:13–20. 17. Walters M, Ridgeway B. Surgical treatment of vaginal apex prolapse. Obstet Gynecol 2013; 121:354–374. 18. Stanhope CR, Wilson TO, Utz WJ, et al. Suture entrapment and secondary ureteral obstruction. Am J Obstet Gynecol 1991; J164 (6 Pt 1):1513–1517. 19. Cam C, Karateke A, Asoglu MR, et al. Possible cause of failure after McCall culdoplasty. Arch Gynecol Obstet 2011; 283:791–794. 20. Sederel J. Surgery in prolapse of a blind-end vagina. Geburtshilfe Frauenheilkd 1958; 18:824–828. 21. Maher CF, Qatawneh AM, Dwyer PL, et al. Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal vault prolapse: a prospective randomized study. Am J Obstet Gynecol 2004; 190:20–26. 22. Morgan DM, Rogers MAM, Huebner M, et al. Heterogeneity in anatomic outcome of sacrospinous ligament fixation for prolapse: a systematic review. Obstet Gynecol 2007; 109:1424–1433. 23. Sze EH, Karram MM. Transvaginal repair of vault prolapse: a review. Obstet Gynecol 1997; 89:466–475. 24. Miller NF. A new method of correcting complete inversion of the vagina. Surg Gynecol Obstet 1927; 44:550–554. 25. Karram M, Goldwasser S, Kleeman S, et al. High uterosacral vaginal vault suspension with fascial reconstruction for vaginal repair of enterocele and vaginal vault prolapse. Am J Obstet Gynecol 2001; 185:1339–1342. 26. Margulies RU, Rogers MAM, Morgan DM. Outcomes of transvaginal uterosacral ligament suspension: systematic review and metaanalysis. Am J Obstet Gynecol 2010; 202:124–134. 27. Barber MD, Brubaker L, Burgio KL, Richter HE. Comparison of 2 transvaginal && surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA 2014; 311:1023–1034. This was a 2 2, multicenter, RCT that first randomized to formal PFPT or control and then secondary randomization to uterosacral ligament suspension or SSLS in women requiring pelvic prolapse and SUI surgery. There was no difference in success, with perioperative physical therapy or between surgical intervention groups at 2 years. 28. US Food and Drug Administration. Administration UFAD. FDA public health notification: serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence [internet] 2008. Available from: http://www.fda.gov/medical devices/safety/alertsandnotices/publichealthnotifications/ucm061976.htm. [Accessed 30 April 2014] 29. US Food and Drug Administration. Administration UFAD. FDA safety communication: update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse [internet] 2011. Available from: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ ucm262435.htm. 30. The American Urogynecologic Society. AUGS position statement on the && restriction of surgical options for pelvic floor disorders [internet] 2013. Available from: http://www.augs.org/guidelines-statements. [Accessed 30 April 2014] The AUGS addressed the FDA mesh warnings and stated that the decision to use such devices should be made by both the surgeon and patient and reiterated that the warning only applied to transvaginal mesh and not slings for incontinence or abdominal mesh. &
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31. Altman D, Va¨yrynen T, Engh ME, et al. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N Engl J Med 2011; 364:1826– 1836. 32. Su T-H, Lau H-H, Huang W-C, et al. Single-incision mesh repair versus & traditional native tissue repair for pelvic organ prolapse: results of a cohort study. Int Urogynecol J 2014; 25:901–908. The use of a single incision transvaginal mesh kit improved 1-year outcome in the anterior compartment, but not in the apical or posterior compartment. 33. Charles Nager MD. Study of Uterine Prolapse Procedures - Randomized & Trial (SUPeR) [internet]. clinicaltrials.gov. Available at: https://pfdn.rti.org/ ResearchStudies/ActiveStudies/SUPeR.aspx. [Accessed 30 April 2014] This is an ongoing RCT, which will evaluate success at 3-year follow-up, comparing vaginal hysterectomy with uterosacral ligament suspension to hysteropexy using a sacrospinous mesh system. 34. Lane FE. Repair of posthysterectomy vaginal-vault prolapse. Obstet Gynecol 1962; 20:72–77. 35. Nygaard IE, McCreery R, Brubaker L, et al. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol 2004; 104:805–823. 36. Nygaard I, Brubaker L, Zyczynski HM, et al. Long-term outcomes following && abdominal sacrocolpopexy for pelvic organ prolapse. JAMA 2013; 309: 2016–2024. A multicenter RCT showed higher treatment failure of ASC both with and without urethropexy, at 7 years, than previously reported. 37. Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic & organ prolapse in women. Cochrane Database Syst Rev 2013; 4:CD004014. In this Cochrane review, ASC was shown to have lower reoccurrence rates and less dyspareunia but longer operating and recovery times than SSLS. 38. Akyol A, Akca A, Ulker V, et al. Additional surgical risk factors and patient & characteristics for mesh erosion after abdominal sacrocolpopexy. J Obstet Gynaecol Res 2014; 40:1368–1374. This was retrospective cohort that reported that the greatest risk for mesh complications in ASC was in those with stage 3 to 4 prolapse, previous hysterectomy, concomitant hysterectomy, and more than three procedures being performed concomitantly. 39. Nosti PA, Umoh Andy U, Kane S, et al. Outcomes of abdominal and minimally & invasive sacrocolpopexy: a retrospective cohort study. Female Pelvic Med Reconstr Surg 2014; 20:33–37. This retrospective cohort found that there was no difference in outcomes between ASC and minimally invasive assisted sacrocolpopexy. 40. Freeman RM, Pantazis K, Thomson A. A randomised controlled trial of & abdominal versus laparoscopic sacrocolpopexy for the treatment of posthysterectomy vaginal vault prolapse: LAS study. International 2013. This multicenter, prospective, two-sided equivalence trial demonstrated no difference in patient reported satisfaction or apical prolapse at 1 year when comparing ASC to laparoscopic sacrocolpopexy. 41. Akl MN, Long JB, Giles DL, et al. Robotic-assisted sacrocolpopexy: technique and learning curve. Surg Endosc 2009; 23:2390–2394. 42. Paraiso MFR, Jelovsek JE, Frick A, et al. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. Obstet Gynecol 2011; 118:1005–1013. 43. Anger JT, Mueller ER, Tarnay C, et al. Robotic compared with laparoscopic & sacrocolpopexy: a randomized controlled trial. Obstet Gynecol 2014; 123:5–12. This was a multicenter, randomized trial comparing robotic to laparoscopic sacrocolpopexy, which found equal subjective and objective outcomes at 6 months. 44. Barber MD, Amundsen CL, Paraiso MFR, et al. Quality of life after surgery for genital prolapse in elderly women: obliterative and reconstructive surgery. Int Urogynecol J 2006; 18:799–806. 45. Zebede S, Smith AL, Plowright LN, et al. Obliterative LeFort colpocleisis in a & large group of elderly women. Obstet Gynecol 2013; 121 (2 Pt 1):279– 284. To date; this was the largest retrospective, single center study evaluating LeFort colpocleisis, which reported very high anatomic success and patient satisfaction, with minimal complications.
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Role of apical support defect: correction in women undergoing vaginal prolapse surgery Alexandriah N. Alas a and Jennifer T. Anger b
Purpose of review The aim was to review most recent literature and provide updates in clinical management and surgical treatment of apical pelvic organ prolapse. Recent findings In patients who decline surgical intervention, formal referral to pelvic floor muscle training is beneficial over self-directed Kegel exercises. Systematic reviews revealed that sacrocolpopexy has better long-term outcomes than vaginal approaches. Uterosacral ligament suspension and sacrospinous ligament suspension have equal efficacy at 1 year. These procedures should be considered as acceptable alternatives to sacrocolpopexy. Two randomized controlled trials have demonstrated equal efficacy between robotic and laparoscopic sacrocolpopexy. Summary Minimally invasive sacrocolpopexy should be considered the gold standard for apical prolapse, but these techniques are associated with longer operating times and higher complication rates and longer convalescence than nonmesh vaginal surgery. Surgeons must individualize surgical technique for each patient and should consider a vaginal approach in patients who do not desire laparotomy and are not candidates for minimally invasive surgery. Keywords apical support, apical suspension, pelvic organ prolapse, sacrocolpopexy
INTRODUCTION Apical prolapse is the descent of the uterus, cervix, or vaginal vault after hysterectomy to approximately the hymenal plane [1]. Although some women have only anterior or posterior prolapse, loss of apical support is common among women whose anterior wall prolapse extends beyond the hymen [2,3]. In fact, women with high stage cystocele almost invariably have significant loss of apical support, and it is apical support loss that is the cause of the cystocele defect [2]. Surgeons are now recommending concomitant procedures for patients with evidence of apical descent [4–6]. Eilber et al. [7 ] recently analyzed claims data on female Medicare beneficiaries, and found that, at 10-year follow-up, women who underwent an anterior repair with concomitant apical suspension had significantly less pelvic organ prolapse (POP) recurrence than women who underwent an isolated anterior repair (11.6 vs. 20.2%, P < 0.01).
(PFPT), and pessaries. Depending on symptom severity and impact on quality of life (QOL), women may opt for observation alone. A recent randomized control trial (RCT) by Hagen et al. [8 ] evaluated patient reported symptoms of POP after 12 months of therapy, either with formal PFPT or lifestyle modification with advice pamphlets (control group). They found a significant reduction in patient reported prolapse symptoms at 12 months, as evaluated by the Pelvic Organ Prolapse Symptom Score (POP-SS), in the intervention group compared with control (P ¼ 0.0053). This suggests that formal PFPT &
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NONSURGICAL TREATMENT Conservative therapy for symptomatic prolapse includes observation, pelvic floor physical therapy www.co-obgyn.com
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Department of Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Cleveland Clinic Florida, Weston, FL and b Department of Surgery, Division of Urology, Cedars-Sinai Medical Center, Los Angeles, CA, United States Correspondence to Jennifer T. Anger, MD, MPH, Associate Professor of Surgery, Associate Director of Urological Research, Department of Surgery, Division of Urology, Cedars-Sinai Medical Center, Adjunct Assistant Professor of Urology, UCLA, 99N. La Cienega Blvd., #307, Beverly Hills, CA 90211, United States. Tel: +1 310 385 2992; fax: +1 310 385 2973; e-mail: [email protected] Curr Opin Obstet Gynecol 2014, 26:386–392 DOI:10.1097/GCO.0000000000000105 Volume 26 Number 5 October 2014
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Management of apical prolapse support defects Alas and Anger
KEY POINTS Apical support procedures include vaginal, abdominal, and minimally invasive techniques. Robotic and laparoscopic sacrocolpopexy have similar outcomes at 1 year, and these minimally invasive techniques should be considered the gold standard for treatment. Vaginal procedures are acceptable alternatives to sacrocolpopexies with shorter operating times but higher reoperation rates. Colpocleisis is a well tolerated procedure among older populations and should be considered if sexual function is no longer desired.
is more beneficial than lifestyle modification or selfdirected Kegels [8 ]. Pessaries are considered first-line conservative therapy. Despite large numbers of pelvic floor physicians using these devices, there remains paucity of data regarding their effectiveness and recommended maintenance [9,10]. An expert panel recommended vaginal examination by a provider at least every 6 months, although in practice there is extreme variability in pessary maintenance by providers [11 ,12]. Currently, there is an ongoing, parallel, open-label RCT, POP in primary care: effects of Pelvic floor muscle training and Pessary treatment Study (POPPS), which includes two trials. POPPS trial 1 compares PFPT vs. watchful waiting among women with mild POP, and POPPS trial 2 compares PFPT to pessary use [13 ]. Although pessaries are an excellent nonsurgical option, some women do not wish to use them, and others are unable to maintain them in the vaginal canal because of significant introital laxity. &
time of hysterectomy in 1957, with others adopting their own modifications [14–16]. The modified McCall procedure involves lateral placement of one to three permanent sutures through the uterosacral ligament, followed by cul-de-sac peritoneum and full thickness posterior vaginal wall with final suture placement through the opposite uterosacral ligament to plicate the midline and suspend the vaginal apex (Fig. 1) [17]. This has the benefit of elevating the vaginal apex as well as preventing future enteroceles from developing after hysterectomy [14]. A retrospective study (n ¼ 62 per group) comparing McCall’s culdoplasty to sacrospinous ligament suspension (SSLS) showed no significant difference in recurrence rates between the procedures (15%) at 4–9 years [16]. A larger retrospective group of 693 patients from the Mayo Clinic found patient satisfaction to be 82% and a low reoperation rate of 5.2% [15]. Risks of this surgery include ureteral injury or obstruction from suture placement and ureteral patency should be confirmed after the procedure [18]. No recent RCTs have been performed. However, in 2011 a prospective study (n ¼ 70), evaluating patients who underwent
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SURGICAL TREATMENT Apical support procedures can be categorized as reconstructive or obliterative and can be performed either vaginally or abdominally, with or without a concomitant hysterectomy. Additionally, abdominal procedures can be performed by conventional laparotomy or by minimally invasive techniques, including laparoscopy and robotic-assisted laparoscopy. The technique used depends on surgeon preference and training, but individualizing the surgery to the specific patient is important because each technique carries its own unique success and complication rates.
MCCALL CULDOPLASTY McCall first described the surgical technique of closing the deep cul-de-sac and enterocele at the
FIGURE 1. McCall culdoplasty. Internal and external McCall sutures are placed. The distal suture (external McCall) incorporates the uterosacral ligament and posterior vaginal wall, providing apical support. Reprinted with permission, Cleveland Clinic Center for Medical Art & Photography 2012–2014. All Rights Reserved.
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vaginal hysterectomy with McCall culdoplasty, found the only risk factor for failure at 2 years, defined as Pelvic Organ Prolapse Quantification (POPQ) at least stage 3 of the apical portion, was fetal macrosomia compared to those with birth weights less than 4000 g (44.4 vs. 6.9%, P ¼ 0.000) [19]. Although, McCall culdoplasty can be performed for apical suspension, failure rates are reported as 5.2–44.4%, and caution should be used when choosing this procedure alone for apical suspension [15,16,19]. To prevent future enteroceles from occurring, a Moskowitz or a Halban’s procedure can be done during intra-abdominal surgery by performing a series of purse string sutures in the cul-de-sac. However, these procedures only obliterate the cul-de-sac space and should not be considered apical suspension procedures.
follow-up, demonstrated significant anatomical success (91 vs. 94%) and improvement in QOL in both groups, and a reoperation rate for apical prolapse of 19% for SSLS [21]. A meta-analysis of 17 observational studies and RCTs demonstrated failure to relieve symptoms in 10.3% and failure to provide patient satisfaction in 13% [22]. Complications include hemorrhage, buttocks pain, nerve or rectal injury, occult stress urinary incontinence (SUI), vaginal stricture, and future recurrences. A review of 22 studies that included 1229 patients who underwent SSLS found 27 patients (2%) required transfusion, and 32 patients (3%) had buttock pain on the side of SSLS that resolved by 6 weeks without intervention [23]. Of note, the SSLS is the basis of the majority of transvaginal mesh kits, which attach proximal mesh straps to the SSL.
SACROSPINOUS LIGAMENT SUSPENSION
HIGH UTEROSACRAL LIGAMENT SUSPENSION
Sederel first described the SSLS in 1958, which involves a transvaginal extraperitoneal approach of attaching the sacrospinous ligament (SSL) to the vaginal apex, either bilaterally or unilaterally, with either permanent or dissolvable sutures (Fig. 2) [17,20]. An RCT (n ¼ 95) comparing SSLS to abdominal sacrocolpopexy (ASC) with mesh, at 2-year
(a)
Uterosacral ligament suspension (USLS) was described in 1927 by Miller [24] but was not popularized until Shull [5] reported high success rates requiring only two reoperations in 298 patients. In women with a previous hysterectomy, identification of the remnant uterosacral ligament (USL) is
(c)
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FIGURE 2. Sacrospinous ligament suspension. (a) Passage of transvaginal suture-capturing device with suture through the coccygeus-sacrospinous ligament. (b) Three sutures are placed through the coccygeus-sacrospinous ligament. (c) Final attachment of the vagina to the coccygeus-sacrospinous ligament. Reprinted with permission, Cleveland Clinic Center for Medical Art & Photography 2012–2014. All Rights Reserved. 388
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Management of apical prolapse support defects Alas and Anger
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FIGURE 3. Uterosacral ligament suspension. (a) The uterosacral ligament at about the level of the ischial spine is grasped with an Allis clamp. (b) Three sutures are placed through the ipsilateral uterosacral ligament and then through the vaginal apex. (c) Sutures are placed bilaterally and tied, suspending the apex. Reprinted with permission, Cleveland Clinic Center for Medical Art & Photography 2012–2014. All Rights Reserved.
possible by transperitoneal palpation of the ischial spines, with USL location posterior and medial. The USLs are then plicated together as close to the ischial spines using one to three permanent sutures (Fig. 3) [17]. Karram et al. [25] found 89% of patients were satisfied with USLS and only 5.5% required reoperation (n ¼ 168). Margulies et al. [26] performed a meta-analysis of 32 studies and found success, defined as POPQ or less 1, of 81.2, 98.3, and 87.4% for anterior, apical, and posterior prolapse, respectively. Despite a high success rate, the complications of ureteral injury or obstruction were 1–11% [26]. The Pelvic Floor Disorders Network (PFDN) published this year the OPTIMAL Trial, the Operations and Pelvic Muscle Training in the Management of Apical Loss trial, a multicenter, 2 2 factorial RCT. Complications included ureteral obstruction in the USLS group (3.2%) and neurologic pain requiring intervention, 6.9 USLS vs. 12.4% SSLS (P ¼ 0.049). At 4–6 weeks, SSLS patients had persistent neurologic pain, 4.3 vs. 0.5%. The lower success rates for both procedures in this study were attributed to the stringent success criteria applied [27 ]. &&
Administration (FDA) warnings of transvaginal mesh. It was recommended that physicians monitor patients more carefully, and disclose serious complications, including those that could affect QOL, result in pain, scarring, and narrowing of the vagina [28]. In 2011, the FDA reported an additional 2784 complications and stated that these serious complications are not rare. They concluded that most cases of POP do not require mesh and should only be used when alternatives are not available and risks and benefits have been discussed with the patient [28,29]. In addition, specialized training for mesh devices was recommended, which will likely significantly reduce mesh-related complications. Additionally, American Urogynecologic Society (AUGS) and Society for Urodynamics, Female pelvic medicine and Urogenital reconstruction reported their position statement on mesh after the FDA warnings. In summary, the FDA did not recommend removal of these devices from the market, and because these devices may be the only surgical option for some patients, the decision to use such devices should be made by both the surgeon and patient. It was also stated that the FDA warning did not apply to slings for SUI or abdominal mesh, only to transvaginal mesh [30 ]. In 2011, a multicenter RCT reported trocarguided transvaginal mesh kits having higher objective and subjective cure rates compared with anterior vaginal repair, at 12 months. However, there were higher complications in the transvaginal mesh group, including intraoperative hemorrhage, bladder perforation, and reoperation for mesh &&
TRANSVAGINAL MESH Multiple vaginal mesh kits have been manufactured to assist in apical suspension with the goal of improving success and longevity when using a minimally invasive transvaginal extraperitoneal approach. Unfortunately, over 1000 reported complications in 2008 led to the US Food and Drug
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removal [31]. Su et al. [32 ] reported cohort data comparing traditional native tissue repair to the elevate transvaginal mesh system (American Medical Systems, Minnetonka, MN, USA) in 2014. Although there was a significantly higher success with mesh at 1 year in the anterior compartment (98 vs. 87%), there was no difference in the apical (99 vs. 96%), or posterior compartments (100 vs. 97%) [32 ]. Currently, the PFDN is recruiting for the SUPeR trial, the Study of Uterine Prolapse procedure – Randomized trial. This is an RCT comparing vaginal hysterectomy with USLS to hysteropexy using the UPHOLD sacrospinous mesh system (Boston Scientific, MA, USA). Aims of the study include evaluation of both subjective and objective data at 3 years [33 ].
0.24 for symptomatic failure. The conclusions of the study suggested higher treatment failure over time than other studies had previously reported [36 ]. Complications included mesh erosion (10.5%) as well as small bowel obstruction and postoperative ileus in 0.31%. In 2013, a Cochrane review [37 ] comparing three RCTs, reported that ASC had lower reoccurrence rates and less dyspareunia but longer operating and recovery times than SSLS. A recent retrospective cohort evaluated 292 patients who underwent ASC and found that the greatest risk for mesh complications was in those with stage 3 to 4 POP (P ¼ 0.04), previous hysterectomy (P ¼ 0.03), concomitant hysterectomy (P ¼ 0.03), and more than three procedures being performed concomitantly (P ¼ 0.02) [38 ].
ABDOMINAL SACROCOLPOPEXY
LAPAROSCOPIC SACROCOLPOPEXY
Lane described the ASC in 1962, which is considered the gold standard in treatment of apical prolapse (Fig. 4) [17,34]. In 2004, Nygaard et al. [35] performed a systematic review of ASC and reported success rates, defined as lack of apical prolapse, ranging from 78 to 100%, with a median reoperation rate of 4.4% for recurrent prolapse and 4.9% for postoperative SUI. In 2013, results from the extended CARE trial, Colpopexy and Urinary Reduction Efforts trial, which evaluated the longterm success of ASC with Burch urethropexy and ASC alone. At 7 years, the ASC only group treatment failure probability was 0.22 for anatomic failure and
Given the long recovery time associated with the laparotomy involved with the ASC, minimally invasive techniques have evolved. A recent retrospective cohort compared ASC (n ¼ 58) with minimally invasive assisted sacrocolpopexy [273 laparoscopic assisted sacrocolpopexy (LASC), 262 robotic assisted sacrocolpopexy (RASC)] and found no difference in anatomical failure rates, but an increase in complications in the ASC group (20 vs. 12.7%, P ¼ 0.001). The minimally invasive group had shorter hospitalizations, smaller blood loss, but longer operating times [39 ]. A multicenter prospective two-sided equivalence trial compared ASC to LASC. At 1 year, POPQ point C was 6.63 and 6.65 and patients reported being ‘very much better’ in 66.7 and 54.2% of patients, for LASC and ASC, respectively [40 ]. Although this study was statistically powered, it excluded women who required concomitant SUI surgery. Surgeons should be aware that including additional surgical procedures for SUI might affect success rates.
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ROBOTIC SACROCOLPOPEXY
FIGURE 4. Sacrocolpopexy. Lateral view of completed sacrocolpopexy with graft attaching the anterior and posterior vagina to the sacral promontory. Reprinted with permission, Cleveland Clinic Center for Medical Art & Photography 2012–2014. All Rights Reserved. 390
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Surgeons have begun to utilize robotic technology to assist them with a minimally invasive approach to the ASC as it allows many pelvic surgeons, not exclusively expert laparoscopists, to perform minimally invasive ASCs. A study in 2009 reported a short learning curve, with a 25% reduction in operating time after 10 cases for the RASC [41]. To date, two RCTs have compared RASC to LASC. Paraiso et al. [42] completed a single center, blinded, RCT and found no difference in functional outcomes at 1 year between RASC (n ¼ 40) and LASC (n ¼ 38). However, the RASC group experienced significantly longer operating times, higher pain scores Volume 26 Number 5 October 2014
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Management of apical prolapse support defects Alas and Anger
between weeks 3–5 of recovery, and higher surgical costs [42]. Similar results were reported in 2014 in a multicenter RCT that compared RASC (n ¼ 40) and LASC (n ¼ 38). There was no difference in POP stage, Pelvic Floor Distress Inventory (PFDI) score or adverse events at 6 months. However, the RASC group had longer operating times and increased pain the first week after surgery. Additionally, the RASC was associated with higher hospital costs both initially and at 6 weeks, but when initial costs and maintenance of the robot were excluded, there was no difference in surgical costs among the groups [43 ]. Although RASC is associated with higher pain scores and operating costs, it does have equal efficacy compared with LASC. This technique should be considered as an acceptable alternative to ASC for those surgeons who do not have the surgical skills for LASC but want to provide a minimally invasive approach for their patients.
durability but have increased complications and pain. Acceptable minimally invasive techniques include RASC and LASC, which are as effective as ASC [40 ]. Additionally, RASC and LASC have equal subjective and objective outcomes at 1 year [42,43 ]. Alternatively, patients could be offered a vaginal approach to apical suspension, either SSLS or USLS, which have demonstrated equal efficacy [27 ]. The use of transvaginal mesh cannot be recommended given limited data, as further studies are recommended to evaluate cure rates and mesh complications. &
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OBLITERATIVE PROCEDURE Both LeFort colpocleisis and total colpocleisis are considered obliterative procedures in which the vaginal opening is closed to prevent uterine or visceral prolapse from recurring. These procedures are typically performed on older women with no desire for sexual activity, as vaginal sexual function is lost after the procedure. Barber et al. [44] performed a multicenter prospective study comparing vaginal reconstructive surgery to obliterative procedures and reported significant improvement in the Short Form 36, PFDI, and Pelvic Floor Impact Questionnaire. To date, the largest study evaluating LeFort colpocleisis was in 2013. This was a retrospective, single center study (n ¼ 325) that reported anatomic success as 98.1% and patient satisfaction of ‘cured’ or ‘greatly improved’ as 92.9% with a mean follow-up of 45 (2–392) weeks. Mean age was 81.3, with 74.1% of patients having at least one comorbidity. Complication rate was 15.2% and included urinary tract infection, pulmonary embolism, anemia, hematoma, delirium, cardiovascular events, and mortality (1.3%) [45 ]. Although colpocleisis alters sexual function, it is a well tolerated procedure with excellent patient satisfaction and long-term results. This procedure should be considered an option for older women who no longer desire sexual function. &
CONCLUSION For women who decline surgery, pessaries and formal PFPT are more beneficial than observation or Kegels [8 ]. ASCs are associated with excellent &
Acknowledgements We would like to thank Dr Mark Walters, Dr Beri Ridgeway, and Ross Papalardo at the Cleveland Clinic Center for their illustrations. Conflicts of interest There are no conflicts of interest.
REFERENCES AND RECOMMENDED READING Papers of particular interest, published within the annual period of review, have been highlighted as: & of special interest && of outstanding interest 1. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 2002; 21:167– 178. 2. Rooney K, Kenton K, Mueller ER, et al. Advanced anterior vaginal wall prolapse is highly correlated with apical prolapse. Am J Obstet Gynecol 2006; 195:1837–1840. 3. Hsu Y, Chen L, Summers A, Ashton-Miller JA. Anterior vaginal wall length and degree of anterior compartment prolapse seen on dynamic MRI. Int Urogynecol J 2008; 19:137–142. 4. Chen L, Ashton-Miller JA, Hsu Y, Delancey JOL. Interaction among apical support, levator ani impairment, and anterior vaginal wall prolapse. Obstet Gynecol 2006; 108:324–332. 5. Shull BL. Pelvic organ prolapse: anterior, superior, and posterior vaginal segment defects. Am J Obstet Gynecol 1999; 181:6–11. 6. Toozs-Hobson P, Boos K, Cardozo L. Management of vaginal vault prolapse. Br J Obstet Gynaecol 1998; 105:13–17. 7. Eilber KS, Alperin M, Khan A, et al. Outcomes of vaginal prolapse surgery & among female Medicare beneficiaries: the role of apical support. Obstet Gynecol 2013; 122:981–987. Among female Medicare beneficiaries, women who underwent an anterior repair with concomitant apical suspension had significantly less POP recurrence than women who underwent an isolated anterior repair, at 10-year follow-up. 8. Hagen S, Stark D, Glazener C, et al. Individualised pelvic floor muscle training & in women with pelvic organ prolapse (POPPY): a multicentre randomised controlled trial. Lancet 2014; 383:796–806. In an RCT, formal PFPT was demonstrated to be more beneficial than lifestyle modification or Kegels. 9. Cundiff GW, Weidner AC, Visco AG, et al. A survey of pessary use by members of the American Urogynecologic Society. Obstet Gynecol 2000; 95:931–935. 10. Pott-Grinstein E, Newcomer JR. Gynecologists’ patterns of prescribing pessaries. J Reprod Med 2001; 46:205–208. 11. Anger JT, Scott VCS, Kiyosaki K, et al. Quality-of-care indicators for pelvic & organ prolapse: development of an infrastructure for quality assessment. Int Urogynecol J 2013; 24:2039–2047. There is limited data on recommended practices for pessary use, but an expert panel recommended pessary visits every 6 months. 12. Alperin M, Khan A, Dubina E, et al. Patterns of pessary care and outcomes for Medicare beneficiaries with pelvic organ prolapse. Female Pelvic Med Reconstr Surg 2013; 19:142–147.
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Urogynecology 13. Wiegersma M, Panman CMCR, Kollen BJ, et al. Pelvic floor muscle training versus watchful waiting or pessary treatment for pelvic organ prolapse (POPPS): design and participant baseline characteristics of two parallel pragmatic randomized controlled trials in primary care. Maturitas 2014; 77:168– 173. This is an ongoing RCT comparing pessary treatment and formal PFPT to observation. 14. McCALL ML. Posterior culdeplasty; surgical correction of enterocele during vaginal hysterectomy; a preliminary report. Obstet Gynecol 1957; 10:595– 602. 15. Webb MJ, Aronson MP, Ferguson LK, Lee RA. Posthysterectomy vaginal vault prolapse: primary repair in 693 patients. Obstet Gynecol 1998; 92:281–285. 16. Colombo M, Milani R. Sacrospinous ligament fixation and modified McCall culdoplasty during vaginal hysterectomy for advanced uterovaginal prolapse. Am J Obstet Gynecol 1998; 179:13–20. 17. Walters M, Ridgeway B. Surgical treatment of vaginal apex prolapse. Obstet Gynecol 2013; 121:354–374. 18. Stanhope CR, Wilson TO, Utz WJ, et al. Suture entrapment and secondary ureteral obstruction. Am J Obstet Gynecol 1991; J164 (6 Pt 1):1513–1517. 19. Cam C, Karateke A, Asoglu MR, et al. Possible cause of failure after McCall culdoplasty. Arch Gynecol Obstet 2011; 283:791–794. 20. Sederel J. Surgery in prolapse of a blind-end vagina. Geburtshilfe Frauenheilkd 1958; 18:824–828. 21. Maher CF, Qatawneh AM, Dwyer PL, et al. Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal vault prolapse: a prospective randomized study. Am J Obstet Gynecol 2004; 190:20–26. 22. Morgan DM, Rogers MAM, Huebner M, et al. Heterogeneity in anatomic outcome of sacrospinous ligament fixation for prolapse: a systematic review. Obstet Gynecol 2007; 109:1424–1433. 23. Sze EH, Karram MM. Transvaginal repair of vault prolapse: a review. Obstet Gynecol 1997; 89:466–475. 24. Miller NF. A new method of correcting complete inversion of the vagina. Surg Gynecol Obstet 1927; 44:550–554. 25. Karram M, Goldwasser S, Kleeman S, et al. High uterosacral vaginal vault suspension with fascial reconstruction for vaginal repair of enterocele and vaginal vault prolapse. Am J Obstet Gynecol 2001; 185:1339–1342. 26. Margulies RU, Rogers MAM, Morgan DM. Outcomes of transvaginal uterosacral ligament suspension: systematic review and metaanalysis. Am J Obstet Gynecol 2010; 202:124–134. 27. Barber MD, Brubaker L, Burgio KL, Richter HE. Comparison of 2 transvaginal && surgical approaches and perioperative behavioral therapy for apical vaginal prolapse: the OPTIMAL randomized trial. JAMA 2014; 311:1023–1034. This was a 2 2, multicenter, RCT that first randomized to formal PFPT or control and then secondary randomization to uterosacral ligament suspension or SSLS in women requiring pelvic prolapse and SUI surgery. There was no difference in success, with perioperative physical therapy or between surgical intervention groups at 2 years. 28. US Food and Drug Administration. Administration UFAD. FDA public health notification: serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence [internet] 2008. Available from: http://www.fda.gov/medical devices/safety/alertsandnotices/publichealthnotifications/ucm061976.htm. [Accessed 30 April 2014] 29. US Food and Drug Administration. Administration UFAD. FDA safety communication: update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse [internet] 2011. Available from: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ ucm262435.htm. 30. The American Urogynecologic Society. AUGS position statement on the && restriction of surgical options for pelvic floor disorders [internet] 2013. Available from: http://www.augs.org/guidelines-statements. [Accessed 30 April 2014] The AUGS addressed the FDA mesh warnings and stated that the decision to use such devices should be made by both the surgeon and patient and reiterated that the warning only applied to transvaginal mesh and not slings for incontinence or abdominal mesh. &
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31. Altman D, Va¨yrynen T, Engh ME, et al. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N Engl J Med 2011; 364:1826– 1836. 32. Su T-H, Lau H-H, Huang W-C, et al. Single-incision mesh repair versus & traditional native tissue repair for pelvic organ prolapse: results of a cohort study. Int Urogynecol J 2014; 25:901–908. The use of a single incision transvaginal mesh kit improved 1-year outcome in the anterior compartment, but not in the apical or posterior compartment. 33. Charles Nager MD. Study of Uterine Prolapse Procedures - Randomized & Trial (SUPeR) [internet]. clinicaltrials.gov. Available at: https://pfdn.rti.org/ ResearchStudies/ActiveStudies/SUPeR.aspx. [Accessed 30 April 2014] This is an ongoing RCT, which will evaluate success at 3-year follow-up, comparing vaginal hysterectomy with uterosacral ligament suspension to hysteropexy using a sacrospinous mesh system. 34. Lane FE. Repair of posthysterectomy vaginal-vault prolapse. Obstet Gynecol 1962; 20:72–77. 35. Nygaard IE, McCreery R, Brubaker L, et al. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol 2004; 104:805–823. 36. Nygaard I, Brubaker L, Zyczynski HM, et al. Long-term outcomes following && abdominal sacrocolpopexy for pelvic organ prolapse. JAMA 2013; 309: 2016–2024. A multicenter RCT showed higher treatment failure of ASC both with and without urethropexy, at 7 years, than previously reported. 37. Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic & organ prolapse in women. Cochrane Database Syst Rev 2013; 4:CD004014. In this Cochrane review, ASC was shown to have lower reoccurrence rates and less dyspareunia but longer operating and recovery times than SSLS. 38. Akyol A, Akca A, Ulker V, et al. Additional surgical risk factors and patient & characteristics for mesh erosion after abdominal sacrocolpopexy. J Obstet Gynaecol Res 2014; 40:1368–1374. This was retrospective cohort that reported that the greatest risk for mesh complications in ASC was in those with stage 3 to 4 prolapse, previous hysterectomy, concomitant hysterectomy, and more than three procedures being performed concomitantly. 39. Nosti PA, Umoh Andy U, Kane S, et al. Outcomes of abdominal and minimally & invasive sacrocolpopexy: a retrospective cohort study. Female Pelvic Med Reconstr Surg 2014; 20:33–37. This retrospective cohort found that there was no difference in outcomes between ASC and minimally invasive assisted sacrocolpopexy. 40. Freeman RM, Pantazis K, Thomson A. A randomised controlled trial of & abdominal versus laparoscopic sacrocolpopexy for the treatment of posthysterectomy vaginal vault prolapse: LAS study. International 2013. This multicenter, prospective, two-sided equivalence trial demonstrated no difference in patient reported satisfaction or apical prolapse at 1 year when comparing ASC to laparoscopic sacrocolpopexy. 41. Akl MN, Long JB, Giles DL, et al. Robotic-assisted sacrocolpopexy: technique and learning curve. Surg Endosc 2009; 23:2390–2394. 42. Paraiso MFR, Jelovsek JE, Frick A, et al. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. Obstet Gynecol 2011; 118:1005–1013. 43. Anger JT, Mueller ER, Tarnay C, et al. Robotic compared with laparoscopic & sacrocolpopexy: a randomized controlled trial. Obstet Gynecol 2014; 123:5–12. This was a multicenter, randomized trial comparing robotic to laparoscopic sacrocolpopexy, which found equal subjective and objective outcomes at 6 months. 44. Barber MD, Amundsen CL, Paraiso MFR, et al. Quality of life after surgery for genital prolapse in elderly women: obliterative and reconstructive surgery. Int Urogynecol J 2006; 18:799–806. 45. Zebede S, Smith AL, Plowright LN, et al. Obliterative LeFort colpocleisis in a & large group of elderly women. Obstet Gynecol 2013; 121 (2 Pt 1):279– 284. To date; this was the largest retrospective, single center study evaluating LeFort colpocleisis, which reported very high anatomic success and patient satisfaction, with minimal complications.
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