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.