COMPARATIVE STUDY
CONTROLLED CLINICAL TRIAL
JOURNAL ARTICLE
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Midurethral slings versus the standard pubovaginal slings for women with neurogenic stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: Preliminary reports show promising data on tension-free vaginal tape (TVT) in women with lower motor neuron lesion (LMNL) presenting with stress urinary incontinence (SUI). We compared efficacy and safety of TVT to pubovaginal sling (PVS) in treating SUI in women with LMNL.

METHODS: This was a pilot, nonrandomized clinical trial evaluating women with SUI associated with pathology at or below S2 spinal segment. Failure was defined as leakage of urine during cough test at 250 ml bladder volume. Primary outcome was time to treatment failure based on positive cough stress test. Other outcomes were Urogenital Distress Inventory Short Form-6 (UDI-6), Incontinence Impact Questionnaire Short Form-7 (IIQ-7) and urodynamics. Regression models were used to adjust for confounders.

RESULTS: The study evaluated 40 women: 20 TVT and 20 PVS, and cure rates were 80 and 85 %, respectively. Time to treatment failure in the TVT group was comparable with the PVS group, with an unadjusted hazard ratio (HR) of 2.90 [95 % confidence interval (CI), 0.61-15.42, P = 0.154]. After adjusting for confounders, adjusted HR for treatment failure was 1.04 (95 % CI, 0.12-8.66, likelihood ratio chi-square P = 0.973). Both groups showed significant reductions in UDI-6 and IIQ-7 scores after surgery. One patient had mesh erosion in the TVT group.

CONCLUSIONS: TVT is feasible, effective and safe for women with LMNL presenting with SUI, with comparable treatment outcomes to PVS. TVT might be of benefit to women who do not use clean intermittent catheterization (CIC) at baseline.

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