Fourth International Consultation On Incontinence (ICI) - Surgery For Pelvic Organ Prolapse Committee Highlights

Main Category: Urology / Nephrology
Article Date: 26 Jul 2008 - 0:00 PDT

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PARIS, FRANCE (UroToday.com) - Dr. Brubaker began by noting the scarcity of new RCTs since the previous consultation in this field. She noted the quick adoption of new technologies and procedures that are not evidence based. She conveyed the committee's disappointment that pressing questions remain unanswered, such as proper indication for prolapse surgery and valid, universally accepted outcome measures. There is also a lack of data on the best "primary" repair and on ways to minimize post-operative urinary problems, such as de novo urgency and incontinence and dyspareunia.

The first procedure addressed was surgery for vaginal vault prolapse. The committee reviewed 3 RCTs (1996, 1998 ad 2004) comparing abdominal vs. vaginal approach. Better anatomical outcomes were obtained abdominally but with a higher cost and morbidity. While experts suggest customizing the surgery to the individual patient, she noted that most clinicians are more comfortable with one approach and rarely deviate. There is Level 1 evidence to recommend using synthetic graft material over biological material to bridge the apex of the vagina to the sacrum during abdominal sacrocolpopexy (ASC). Concomitant hysterectomy (3-5 times increased risk) and smoking history increase the risk of mesh extrusion/erosion. There is not yet enough data to support superiority of laparoscopic or robotic-assisted approaches. There is controversy on the role of concomitant hysterectomy with vault prolapse repair, and the use of hysteropexy is rising in popularity. As stated above, the risk of mesh erosion with the combined procedure is significantly higher. The committee noted one Level 1 trial that showed inferior outcomes with uterine-preserving procedures, although there are Level 2-3 data with conflicting results. The committee also felt that current urodynamic testing with prolapse reduction was insufficient in predicting post-operative SUI, but that there is an increased risk of de novo SUI if occult SUI exists pre-operatively. The CARE trial, which showed lower rates of post-operative SUI with concomitant Burch colposuspension at the time of ASC compared with no Burch, was briefly reviewed.

Vaginal approaches for POP repair were discussed next. Two RCTs revealed conflicting evidence with respect to the use of absorbable mesh with anterior colporrhaphy. There are three trials (Level 1 evidence) supporting the use of non-absorbable synthetic mesh with anterior repairs, but not enough evidence exists to support use in apical or posterior repairs. Mesh extrusion rates are 5-17%. With respect to apical suspensions, there is no evidence supporting superiority of technique between sacrospinous fixation and uterosacral ligament suspension. The former technique has higher rates of anterior compartment recurrence and the latter shows higher rates of ureteral compromise. There is Level 3 evidence on the use of mesh (mostly prefabricated kits) supporting use in apical repairs. Dr. Brubaker next discussed Level 1 evidence on posterior repairs. A 2006 trial compared site-specific defect repair vs. pubococcygeal plication vs. porcine graft and found the highest failure rates with porcine graft. She also presented Level 2 evidence from a 2005 study comparing site-specific repair vs. fascial plication; success rates were 67% vs. 86% (p=.001). Level 3 evidence was presented on the use of polypropylene mesh for posterior repairs showing high rates of extrusion and dyspareunia. The committee recommended against the use of mesh in this procedure.

Dr. Brubaker discussed the general topic of use of mesh in POP repair with several questions. If mesh is used for the primary repair, what operation should be performed for recurrence? Are more complications associated with subsequent repairs if mesh was used for the primary repair? What is the ideal mesh to use? Unfortunately at this point there are no answers to these questions, although she did recommend against the use of Gore-Tex, as erosion rates are significantly higher than with other materials. Colpectomy and colpocleisis were recommended in women who are not sexually active. The committee noted a low rate of "sexual regret" in women undergoing these procedures.

Dr. Brubaker reviewed the committee's recommendations with respect to POP repair. Grade A recommendations were give to the use of ASC for apical prolapse and to the use of synthetic mesh over biological graft for this procedure. Synthetic graft improves 1-year outcomes for anterior repairs, but this benefit must be weighed against the risk of mesh complications. Transvaginal repair is preferred over transanal repair for posterior prolapse. Grade B recommendation was given to a concomitant Burch procedure at the time of ASC in women without preoperative SUI. As concomitant hysterectomy at the time of ASC increases the risk of mesh erosion, the committee also gave a Grade B recommendation to consideration of alternative plans. For anterior repairs with hysterectomy, avoiding mesh is reasonable. Sacrospinous fixation and uterosacral ligament suspension were recommended equally for the vaginal approach to vault prolapse (Grade B). For posterior repairs, there are no data supporting the use of synthetic mesh; porcine dermis repair is inferior to the other techniques (Grade B). Levator plicaation should be used with caution in sexually active women due to increased rates of dyspareunia (Grade B). For Grade C recommendations, the committee recommended the consideration of apical suspension at the time of any vaginal prolapse repair. Fascial plication has superior outcomes to site-specific repair in the posterior compartment. Porcine dermis, in one study, was superior to traditional anterior colporrhaphy. The committee also recommended against the use of mesh in vaginal repairs if an intraoperative proctotomy occurred. A number of Grade D (expert opinion) recommendations were also listed. The committee found insufficient evidence to support any technique of primary prolapse repair or for specific vaginal procedures. There is also not enough evidence to provide guidance regarding the use of mesh following intraoperative cystotomy. The committee also stated that an anatomic finding, in the absence of symptoms, is rarely an indication for surgery, and that surgical alternatives should be presented to women considering prolapse repair.

Dr. Brubaker concluded with a discussion of research priorities in the coming years. Superior validated outcome measures are needed to better assess anatomic and functional outcomes after surgery. RCTs are needed regarding the optimal repair of post-hysterectomy prolapse, comparing the use of mesh vs. native tissue for apical repairs and comparing different techniques for apical suspension. The best management of continent women undergoing prolapse repair is also an area of interest. The benefits of peri-operative physiotherapy need to be determined, and more studies are needed concerning surgical approaches after primary mesh repair failure. Finally, Dr. Brubaker stated that more data was needed regarding the use of mesh kits for prolapse repair, even though their clinical use is already widespread. The committee encouraged the creation and use of registries for new devices to allow proper data collection and to determine the safety and efficacy of these products.

Linda Brubaker, MD, Committee Chair

Moderated by Linda Cardozo, MD, and Alan Wein, MD, at the Fourth International Consultation on Incontinence (ICI) - July 5 - 8, 2008. Palais des Congres, Paris, France.

Written by William Jaffe, MD, a Contributing Editor with UroToday.com

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