Long-term efficacy of the trans-obturator and retropubic mid-urethral slings for stress urinary incontinence: update from a randomized clinical trial.

Purpose: To report the extended long-term results of the use of tension-free vaginal tape(TVT) and trans-obturator tape (TOT) for the treatment of female stress urinary incontinence (SUI).

Methods: A prospective, multicentre randomized clinical trial comparing the use of TVT and TOT was used to evaluate 87 patients. The inclusion criteria were stress or mixed UI associated with urethral hyper mobility (the stress component was clinically predominant), while the exclusion criteria were previous anti-incontinence surgery and/or pelvic organ prolapse. The objective cure criteria were a negative provocative stress test and a negative 1-h pad test, with no further treatment for SUI. The subjective cure criteria were a 3-day voiding diary, quality-of-life questionnaires (UDI6-IIQ7), and patient satisfaction on a scale from 0 to 10.

Results: Eighty-seven patients were evaluated (47 TOT and 40 TVT) at a median follow-up of 100 months. Subjective and objective cure rates were 59.6 and 70.2 % in the TOT group and 75 and 87.5 % in the TVT group. The mid-to-long-term trend was a decreasing continence rate in patients who underwent TOT, compared with a stable rate for TVT. The Kaplan-Meier survival curve showed that continence rate decreased for up to 25 months after surgery, with stabilization thereafter for the TVT group while continuing to drop in the TOT group, with no inter-group difference.

Conclusion: The patients in both groups were highly satisfied at long-term follow-up. The overall continence rate worsened for both groups within 25 months. While the results tend to stabilize in the TVT group, a further decline in the TOT was observed.