Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence

Abstract

Background: Midurethral slings have become the most preferred surgical treatment for female urinary incontinence.

Objective: To compare the efficacy and safety of two midurethral sling procedures with a different technique of sling insertion 5 yr after intervention.

Design, setting, and participants: Multicenter randomized clinical trial conducted in seven public hospitals in Finland including primary cases of stress urinary incontinence.

Intervention: Surgical treatment with the retropubic tension-free vaginal tape (TVT) procedure or the transobturator tension-free vaginal tape (TVT-O) procedure.

Outcome measurements and statistical analysis: Objective treatment success criteria were a negative stress test, a negative 24-h pad test, and no retreatment for stress incontinence. Patient satisfaction was assessed by condition-specific quality-of-life questionnaires.

Results and limitations: A total of 95% of the included women could be assessed according to the protocol 5 yr after surgery. The objective cure rate was 84.7% in the TVT group and 86.2% in the TVT-O group, with no statistical difference between the groups. Subjective treatment satisfaction was 94.2% in the TVT group and 91.7% in the TVT-O group, with no difference between groups. Complication rates were low, with no difference between groups.

Conclusions: Both objective and subjective cure rates were >80% in both groups even when women lost to follow-up were included as failures. The complication rates were low, with no difference between the groups. No late-onset adverse effects of the tape material were seen.

Patient summary: Female urinary stress incontinence can be treated surgically with minimally invasive midurethral sling procedures. Two main approaches of sling placement have been developed: the retropubic and the transobturatory. We compared both approaches and followed the patients for 5 yr. We found no difference in cure rate between the procedures, and patient satisfaction was high.

Trial registration: ClinicalTrials.gov identifier NCT00379314.

Keywords: Midurethral slings; Randomized multicenter trial; Retropubic and transobturator procedures.