By 12 months, efficacy declined in all groups: 32% of all women reported they were “much” or “very much” better, and 36% denied symptoms of stress incontinence. There was no difference in efficacy across the three groups by the end of the follow-up period.
WHAT THIS EVIDENCE MEANS FOR PRACTICE
The modest success rate of the conservative measures for treating SUI that were studied here, and the decline in their efficacy over time, might be discouraging at first glance. But more than one third of patients experienced benefit in the end—in the face of low risk. Consider a pessary or behavioral therapy to be a workable, low-risk option for your patients who have SUI, therefore. Combining those two measures does not, however, provide superior results.
TOT, retropubic slings equally effective for SUI—but complications differ
Richter H, Albo M, Zyczynski H, et al; Urinary Incontinence Treatment Network. Retropubic versus transobturator midurethral slings for stress incontinence. N Engl J Med. 2010;362(22):2066–2076.
This large, randomized, prospective multi-center study from the well-respected Pelvic Floor Disorders Network demonstrated that the efficacy of retropubic and TOT slings is equivalent. At the same time, the trial highlighted important differences in the complication profiles of these two surgical approaches. Given the high success rate of retropubic slings, the study was designed as an equivalence trial, with the principal aim of demonstrating whether both approaches share a similar success rate.
Study design. Investigators recruited women who had been given a diagnosis of SUI and were planning to undergo surgical correction, randomizing 597 who had predominant stress loss symptoms and a positive stress test (urodynamics were not required); 565 completed the 12-month follow-up.
Findings. Objective and subjective cure rates were similar in both groups at 12 months. (“Objective cure” was defined as a negative stress test, negative pad test, and no re-treatment within the follow-up period; “subjective cure” was defined as no re-treatment, no episodes of leakage on a voiding diary, and no self-report of stress loss.)
At 12 months, the objective cure rate was 81% for the retropubic sling and 78% for the TOT sling (the difference of three percentage points had a 95% confidence interval [CI] of –3.6–9.6). Despite very close findings, the subjective cure rate was lower in the TOT group (56%) than in the retropubic group (62%) (the difference of just over six percentage points had a 95% CI of –1.6–14.3) and did not meet criteria for equivalence.
There was no difference between the two groups in the incidence of urge incontinence; patient satisfaction; and quality-of-life outcomes.
But divergence was seen in complications. A higher incidence of voiding dysfunction that required re-operation was seen in the retropubic group (2.7%) than in the TOT group (0%) (P = .004). The retropubic sling group also exhibited a higher incidence of mesh exposure and bladder perforation. The TOT group had a higher incidence of neurologic sequelae (numbness, weakness) than the retropubic group (9.4% and 0.04%, respectively) (P = .01).
WHAT THIS EVIDENCE MEANS FOR PRACTICE
This well-designed trial confirmed the current standard of practice and supports the findings of a recent Cochrane review that reported a success rate of 88% for the retropubic approach and 84% for the TOT approach.9 The trial also demonstrated that you can anticipate similar success rates with retropubic and TOT approaches to placing a mid-urethral sling.
Note: The design of this study did not call for urodynamic evaluation, but more than 85% of subjects did undergo such testing, including measurement of the Valsalva leak-point pressure (VLPP) and the maximum urethral-closure pressure (MUCP). The investigators’ linear regression analysis revealed no change in outcomes between the two approaches when adjusting for VLPP and MUCP. This supportive finding suggests that a TOT sling would be just as beneficial as a retropubic sling in women who have ISD—although other recent studies that specifically addressed this matter came to a different conclusion.
Intrinsic sphincter deficiency might be a risk factor for failure of a TOT sling
Schierlitz L, Dwyer P, Rosamilla A, et al. Effectiveness of tension-free vaginal tape compared with TOT tape in women with stress urinary incontinence and intrinsic sphincter deficiency: a randomized controlled trial. Obstet Gynecol. 2008;112(6):1253–1261.
In the trial by Richter and colleagues that we reviewed above, the investigators found that ISD—defined as low VLPP or low MUCP—did not have an impact on outcomes after placement of retropubic and TOT slings. Yet, other recent studies have concluded differently: In this trial from Australia, researchers concluded that a retropubic sling was more effective than a TOT sling in women who had ISD.