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.