Fourth International Consultation On Incontinence (ICI) - Surgery For Urinary Incontinence In Women Committee Highlights

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

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PARIS, FRANCE (UroToday.com) - Dr. Smith presented committee 14's findings. He noted that the total number of anti-incontinence procedures has risen slightly over the last decade but that TVT-type procedures have dramatically overtaken the colposuspension as the dominant form of treatment. He discussed a number of different procedures used in women, beginning with anterior colporrhaphy.

There is Level 2 evidence that anterior colporrhaphy is equivalent to needle suspension but inferior to open colposuspension. Anterior colporrhaphy, along with needle suspensions, Marshall-Marchetti-Krantz procedure and paravaginal repair should not be recommended alone for SUI (Grade A-B). Level 1 evidence shows that open colposuspension is equivalent to retropubic mid-urethral slings and traditional bladder neck slings. Level 2 evidence shows equivalency with trans-obturator slings. Risk of post-operative voiding dysfunction is highest with bladder neck slings, followed by colposuspension, and lowest with TVT (Level 1 evidence). Post-operative prolapse is higher after colposuspension than with TVT, and the risk of de novo urgency is similar (Level 1). Overall, the committee gave a Grade

A recommendation for open colposuspension in treating SUI. The level of evidence is somewhat lower with respect to laparoscopic colposuspension, but equivalence with the open procedure has been demonstrated in expert hands (Level 1-2). TVT has been shown to have similar or higher cure rates with shorter operative and recovery times (Level 1-2 evidence). This procedure was given a Grade B recommendation as an option for treatment.

There is Level 1 evidence supporting the efficacy of traditional bladder neck slings, although there is less evidence regarding choice of sling material. Autologous fascial may be superior to synthetic or biological graft (Level 2), and adverse events related to graft material might be higher with synthetic or biological materials (Level 3). Autologous fascial slings were given a Grade A recommendation by the committee.

Injectable urethral bulking agents are inferior to other forms of treatment (Level 2), but no specific evidence can recommend superiority of any agent over another (Level 2). Autologous fat, however, was shown to be equivalent to sham treatment (Level 1). The committee made a Grade B recommendation that patients should be informed that bulking agents are inferior in terms of efficacy to other treatments, that multiple treatments may be required, and that efficacy decreases over time.

Dr. Smith reviewed the data on synthetic mid-urethral sling (MUS) procedures. The committee reviewed numerous RCTs including five comparing MUS with Burch, four with laparoscopic Burch, two with fascial slings and one with no treatment. Between TVT and Burch, there were no significant differences with respect to efficacy, but operative times and convalescence were shorter with TVT. Bladder perforation was three times more common with TVT (9%), but the need for intermittent catheterization or subsequent prolapse surgery was higher in the Burch groups. TVT was superior in terms of efficacy and recovery compared to the laparoscopic Burch. Different MUS procedures have also been compared, and there is Level 2 evidence that TVT is superior to the SPARC procedure. Intravaginal slingplasty (IVS) may be equivalent to TVT but with higher complication rates, mostly related to mesh complications (Level 2). There have numerous RCTs comparing TVT to transobturator procedures and the TVT-O vs. the outside-to-in approach; no products or techniques have been proven to be superior in terms of efficacy or complications. Retropubic MUS such as the SPARC have also been studied with transobturator tapes, and similar efficacy has been shown. The rates of bladder perforation are higher with the retropubic approach are higher while the rates of urethral injury are higher with the transobturator technique. Dr. Smith stated the committee did not find enough evidence either for or against the newer "mini" slings, such as the TVT secure.

The committee reviewed a number of variables with respect to outcomes of MUS procedures. There is conflicting Level 3 evidence on the predictive value of UDS for outcomes after MUS. The committee recommended further research on optimal tape position, the value of the intraoperative cough test and best anesthesia practice. The committee found only Level 5 (expert opinion) evidence regarding absolute contraindications to MUS, which include urethral diverticulum, urethrovaginal fistulae, intraoperative urethral injury and untreated urological malignancy. There are several risk factors for complications after MUS including radiation, UTI, current steroid use, future pregnancy, anticoagulation and vaginal atrophy. The committee considers these relative contraindications.

Dr. Smith addressed the topic of procedural therapy and surgery for refractory detrusor overactivity. The only positive recommendations were given to sacral neuromodulation (SNS) (Grade B), posterior tibial nerve stimulation (PTNS) (Grade C) and augmentation cystoplasty (Grade C). SNS is effective for urgency incontinence (Level 2), OAB (Level 3) and idiopathic non-obstructive urinary retention (Level 4) with good durability (Level 3). PTNS is also effective, but the durability was questioned (Level 3-4). One slide was presented on treatment of urethral diverticulae. No Grade A recommendations were given due to lack of evidence, and the optimal diagnostic algorithm and need for concomitant SUI surgery has yet to be determined. There seems to be a higher long-term recurrence rate (~17%) than is usually seen in shorter-term studies. Evidence is also lacking for the optimal diagnosis and treatment of iatrogenic vesicovaginal fistulae, and no Grade A recommendations were made.

Dr. Smith discussed the committee's findings with regards to complications of anti-incontinence surgery. It is difficult to determine the true incidence of complications, as reporting is variable and most studies will be underpowered secondary to the relative low incidence of most complications. The British National Institute for Health and Clinical Excellence (NICE) recommends maintaining a case volume of at least 20 procedures per year to maintain skills. There is Level 2-3 evidence that proper training will reduce complications. With respect to outcome measures, Dr. Smith presented a slide showing that the "cure" rate after surgery can vary from 25% to 85% depending on the outcome variable selected. The committee advised using multiple outcome measures (questionnaires, pad-tests, urodynamics, complications, etc.) until a comprehensive outcome tool is developed.

Tony Smith, 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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