Three-year results from a randomised trial of a retropubic mid-urethral sling versus the Miniarc single incision sling for stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: There are limited long-term efficacy data on single-incision slings. The primary aim of this study was to evaluate the success rate of a single-incision sling versus a retropubic mid-urethral sling for cure of SUI at 3 years' follow-up, in order to assess whether there is a deterioration in efficacy over time. The secondary aims were to assess re-operation rates for each procedure and to evaluate any differences in disease-specific quality of life.
METHODS: This study was a 3-year questionnaire-based follow-up of a randomised controlled trial of the Miniarc single-incision sling versus the Advantage retropubic mid-urethral sling. Patients were considered failures if they documented stress incontinence on the symptom domain of the King's Health questionnaire (KHQ) or had undergone repeat surgery for stress incontinence.
RESULTS: Follow-up was available from 35 out of 38 women in the single-incision sling group (92.1 %) and from 26 out of 33 in the retropubic mid-urethral sling group (79.0 %). The overall 3-year failure rate was 20 out of 38 (52.6 %) in the single-incision sling group and 3 out of 33 (9.0 %) in the retropubic mid-urethral sling group (odds ratio 10.0, 95 % confidence interval 2.6-38.4). In the single-incision sling group, the failure rate increased from 40.5 % at 6 months to 52.6 % at 3 years with corresponding figures of 3 to 9 % in the retropubic mid-urethral sling group.
CONCLUSIONS: In this study, there was a significantly higher 3-year failure rate for the single-incision sling versus the retropubic mid-urethral sling. Both procedures had reduced efficacy over time.

RCT Entities:   Population Interventions Outcomes