A randomised trial of a retropubic tension‐free vaginal tape versus a mini‐sling for stress incontinence

OBJECTIVE: To compare a mini-sling with a retropubic tension-free vaginal tape (TVT) in the treatment of stress urinary incontinence (SUI) and urodynamic stress incontinence (USI). DESIGN: Randomised trial. SETTING: Urogynaecology unit in large UK district general hospital. POPULATION: Women with USI resistant to conservative management and requiring a suburethral sling. METHODS: A total of 71 women with SUI and confirmed USI were randomised to undergo treatment with either a retropubic TVT or mini-sling. Follow-up was at 6 weeks, with a history, examination and quality of life questionnaire, and at 6 months with further subjective evaluation and twin-channel subtraction cystometry and pressure-flow studies. MAIN OUTCOME MEASURES: The presence of SUI at 6 weeks and 6 months after treatment. RESULTS: The mini-sling was associated with a significantly higher rate of persistent SUI at 6 weeks (OR 9.49, 95% CI 2.8-32.6) and 6 months (OR 8.14, 95% CI 2.7-24.7), and of USI at 6 months (OR 7.58, 95% CI 2.7-24.7). The rate of complication was similar in the two groups. CONCLUSIONS: The mini-sling is associated with a higher failure rate than a retropubic TVT. Longer term and multicentre outcome data are necessary to explore these findings further. Until this is available, the mini-sling should be used with caution.