Evidence- Based Surgical Management Of POP: Traditional Repair Diaa E.E. Rizk MSc, FRCOG, FRCS, MD Professor and Chairman of Obstetrics and Gynaecology, College of Medicine and Medical Sciences, Arabian Gulf University, Manama, Bahrain.

DISCLOSURES Mediterranean Incontinence & Pelvic Floor Society [MIPS] Chairman, Executive Board International Uro-Gynecological Association [IUGA] Member, Research and Development Committee Editor, International Urogynecology Journal Commercial affiliations and/or Financial relationships None

The pelvis fulfils more extensive functions in the female body than in the male. In the female, it shelters the largest part of the sexual apparatus in addition to the distal end of the intestinal canal and urinary passages and thereby assumes great importance in reproduction. Carl Litzmann (A German Anatomist); Die Foramen des Beckens, 1861.

Introduction Pelvic organ prolapse [POP] is a dynamic condition which may REGRESS at the same or higher rate as incidence. Surgically treated POP represents the severe end of the clinical spectrum. The direct cost of POP surgery is greater than $1 billion per year. Peri-operative death is rare (3 per 10,000 operations) although that figure underestimates mortality occurring outside of the index hospitalization for surgery.

Clinical Importance POP is more frequently encountered in older women and in highly parous societies in both Gynaecological and Urological practice. It can also be a complication of surgical treatment e.g. hysterectomy. It is significant because of its increasing prevalence and adverse effect on the quality of life of the woman.

Public Health Importance The prevalence of POP increases with age. Therefore, the changing demographics of the world’s population will result in more patients. The demand for health care services related to POP is expected to increase.

Did Howard A. Kelly (1858-1953) expect this?

Current controversies in surgical management A. Apical vaginal prolapse (uterine and vaginal vault) 1. Abdominal sacral colpopexy versus vaginal sacrospinous colpopexy. 2. Vaginal hysterectomy versus uterine preservation. 3. Vaginal McCall culdoplasty and uterosacral ligament plication versus vaginal sacrospinous colpopexy and repair.

Current controversies in surgical management B. Anterior vaginal wall prolapse 1. Anterior repair versus abdominal paravaginal repair. 2. For midline cystocele defects, a traditional anterior repair versus anterior repair with graft reinforcement. C. Posterior vaginal wall prolapse 1. Posterior repair versus a transanal repair. 2. Posterior repair versus an abdominal posterior repair. 3. Posterior repair versus posterior repair with graft reinforcement.

Current controversies in surgical management D. Any type of POP 1. Laparotomy versus laparoscopic versus robotic approach. 2. Occult stress urinary incontinence [SUI] treated at the time of POP surgery versus left untreated. 3. Use of native tissue versus mesh or grafts. 4. One type of mesh/graft versus another type. 5. One type of suture versus another type.

Objectives of Operations Relieve or improve POP symptoms and associated lower urinary and gastrointestinal tracts symptoms. In some women, restore normal vaginal anatomy and maintain or improve sexual function. In other women, an obliterative approach is more appropriate and still achieves symptom relief.

Type of Procedures 1) Restorative which use the patient’s endogenous support structures. 2) Compensatory which attempt to replace deficient support with some type of graft. 3) Obliterative which close the vagina.

Use of Grafts The need to improve the outcome of traditional surgical treatment of POP has led to increased use of grafts. The long-term and high success rate (>80%) of mid- urethral sling procedures using synthetic meshes for the surgical treatment of Stress Urinary Incontinence [SUI] had an additional influence. There is, however, LACK of high-quality evidence to support the ROUTINE use of synthetic meshes for POP repairs, AS YET (NICE 2008, FDA 2011).

Cochrane Review 2013 (Maher et al) 40 RCT evaluating 3773 women. Abdominal sacral colpopexy was better than vaginal sacrospinous colpopexy for recurrent vault prolapse (RR 0.23, 95% CI 0.07-0.77) and dyspareunia (RR 0.39, 95% CI 0.18-0.86). Sacrospinous colpopexy was quicker, cheaper and women had an earlier return to activities of daily living.

Cochrane Review 2013 (Maher et al) Anterior repair was associated with more recurrent prolapse than polyglactin (RR 1.39, 95% CI 1.02-1.9), porcine dermis (RR 2.72, 95% CI 1.20- 6.14), polypropylene (RR 2.14, 95% CI 1.23- 3.74) or armed transobturator (RR 3.55, 95% CI 2.29- 5.51) meshes. For posterior prolapse, vaginal approach was associated with a lower recurrent prolapse than the transanal approach (RR 0.24, 95% CI 0.09-0.64). Addition of TVT to endopelvic fascia plication (RR 5.5, 95% CI 1.36-22.32) and Burch colposuspension to sacral colpopexy (RR 2.13, 95% CI 1.39-3.24) were followed by a lower risk of postoperative SUI.

Cochrane Review 2013 (Maher et al) Conclusions: Adequately powered RCT clinical trials are urgently needed. Prospect -UK, TVM III- Sweden (in progress).

Review of synthetic meshes 2009 (Bako and Dar) Anterior wall erosion rate: 2-25%. Tension-free insertion of synthetic mesh does not appear to eliminate the risk. Posterior wall erosion rate: 6-13%. Apical support erosion rate: 3.5% to 12%. Increased to 16% if sutures were placed vaginally and attached to an abdominally introduced mesh and to 40% if the mesh was introduced vaginally. .

Review of synthetic meshes 2009 (Bako and Dar) Risk factors Age Estrogen deficiency. Type and pore size of synthetic mesh. Route of placement and fixation. Type of concomitant operations particularly hysterectomy.

Review of synthetic meshes 2009 (Bako and Dar) Other complications: Mesh-related infections ranges from 0% to 8%. Foreign body reaction, fibrosis, fistula. Leg Pain syndromes. Mesh shrinkage and extensive fibrosis may lead to dyspareunia and buttock pain.

Review of synthetic meshes 2009 (Bako and Dar) Conclusions: There is lack of strong evidence to support ROUTINE use in anterior and posterior repairs. There is insufficient good evidence on the long-term safety of synthetic mesh in pelvic reconstructive surgery. There are few RCT comparing mesh augmentation techniques with traditional repairs for anterior and posterior vaginal wall prolapse; most of the reported studies are retrospective series or uncontrolled.

What is long-term follow up? The efficacy and safety of surgical interventions requires to be judged over a longer timescale than that of non-surgical treatments. The ICI (1999) defined durations of surgical follow up: short term being up to 3 months, medium term from 3 to 12 months and long term over 12 months. The consensus view is that in order to be considered safe and efficacious in the long-term, surgical procedures for POP require evaluation over at least 5 years.

Long-Term Outcomes 2013 (Funk et al) 27,809 anterior vaginal wall prolapse surgeries using native tissue versus mesh repair. Conclusions: 5-year cumulative risk of any repeat surgery was significantly higher for vaginal mesh versus native tissue repair (15.2% vs 9.8%, p<0.0001) with a 5-year risk of mesh revision/removal of 5.9%. 5-year risk of surgery for recurrent prolapse was similar between vaginal mesh and native tissue groups (10.4% vs 9.3%, p=0.7).

Evidence-based Surgical Management The uterus plays a PASSIVE role in prolapse, vaginal hysterectomy ALONE does not address the underlying problem. The same procedures performed for vaginal suspension can be performed with uterine conservation: uterosacral or sacrospinous fixation by the vaginal approach or sacral hysteropexy by the abdominal approach. For pregnancy and delivery after prolapse repair, decisions regarding mode of delivery should be made on a case-by-case basis; evidence to guide such decisions is LACKING. .

Evidence-based Surgical Management Restoration of apical support is indicated once the uterus is removed using suspension procedures to sacrospinous ligaments, uterosacral ligaments and iliococcygeus fascia or muscle. Round ligament suspension is NOT effective in treating or preventing vault prolapse. The use of ROUTINE perineorrhaphy and levator plication has been STOPPED because of postoperative dyspareunia except when postoperative sexual activity is not anticipated.

Evidence-based Surgical Management There is NO CLEAR risk–benefit information for mesh use and many are being incorporated RAPIDLY into clinical practice despite associated serious complications. Cadaveric fascia should not be used as graft material for abdominal sacral colpopexy because of a higher risk of recurrent prolapse than with synthetic mesh. Cystoscopy should be performed intra-operatively to assess bladder or ureteral damage after all prolapse procedures with risk of injury to bladder or ureters (Uterosacral ligament suspension, risk of 11% of ureteral injury + Paravaginal repair + Sacral colpopexy).

Evidence-based Surgical Management Obliterative procedures are highly successful for POP repair - approaching100% in most series. Should be considered in the elderly and medically fragile patient who does not desire a functional vagina. Concomitant hysterectomy appears to add morbidity. QOL and patient symptoms generally improve (bowel, voiding function) and up to 90% of patients are satisfied with the results.

Evidence-based Surgical Management Occult stress-continent women with positive stress test are at higher risk for postoperative SUI after POP repair alone versus with women with negative stress test. For women with positive stress test who are having vaginal prolapse repair, TVT or TOT reduces postoperative SUI (RR 5.5, 95% CI 1.36-22.32). For stress-continent women planning sacral colpopexy, regardless of the results of preoperative stress testing, the addition of Burch procedure reduces the likelihood of postoperative SUI (RR 2.13, 95% CI 1.39-3.24)- The Colpopexy and Urinary Reduction Efforts (CARE) trial.

Evidence-based Surgical Management The risk of post-operative SUI is definitely increased in women with occult SUI but the majority of patients will NOT develop troublesome symptoms post-operatively. The risk reported in current studies does NOT warrant an anti-incontinence procedure at the time of surgery for POP in women with occult SUI (NNT= 6-10) with the added morbidity of these procedures. However, if performed, the risks as well as the benefits need to be discussed with the patient very clearly.

Conclusions 1- Native tissue repair of POP is increasing and the results are better than previously thought with high patient satisfaction and acceptable re-operation rates. 2- Greater surgical experience is correlated with fewer trans-vaginal mesh complications. 3- Some trans-vaginal mesh complications are refractory and might not always be surgically correctable.

Conclusions 4- The consequences of interventions for unsuccessful trans-vaginal mesh surgery is not usually considered compared to the relatively treatable complications of native tissue repair. 5- The results of the FDA’s analysis may be criticized methodologically if applied to all patients with POP. 6- Vaginal mesh repair should be reserved for high-risk individuals in whom the benefit of mesh placement may justify the risk.

Recommendations Powered and prospective RCT comparing trans-vaginal mesh techniques with traditional repairs for POP are needed as most of the reported studies are small, retrospective or uncontrolled. The FDA is considering revising its regulatory policy about clearance of trans-vaginal meshes for POP repair and include clinical performance data after the 2011 Notification. A standard protocol must be implemented for new trans- vaginal meshes introduced to the market with continued audit and development of a patient registry.

The New Government Regulations On June 17th 2014, the Scottish Health Minister asked for all trans-vaginal polypropylene mesh procedures to be suspended in Scotland pending a national independent review. This includes mesh tapes for SUI and POP. The decision followed 18 months of campaigning by the Scottish Mesh Survivors, an advocacy group of women who suffered adverse events that has culminated in a successful parliament petition. Currently, mesh devices are under review by European Commission Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Australian Therapeutic Goods Administration (TGA) and UK Medicines and Healthcare Products Regulatory Agency (MHRA).

The SCENIHR REPORT- December 2015 In the context of treating SUI, use of a synthetic mesh is currently considered the standard of care. Mesh implants can be used for POP repair. Placement of mesh by vaginal route should be considered a secondary option if primary surgery has failed or exceptionally as a first option when native tissue repair is expected to fail. It is important to consider that larger surface areas of mesh are needed for POP repair than for treating SUI. Sufficient data are NOT available on the long-term use of non-absorbable meshes for POP repair so it is normally not recommended for young women.