Background: The aim of this study was to assess the efficacy and safety of a new minimally-invasive surgical procedure using trans-obturator Tape (TOT) to treat female stress urinary incontinence.

Methods: This clinical trial study was performed from 2003 to 2004 in the Gynecology Department of Imam Hospital, Vali-e-Asr, Tehran, Iran. A total of 35 women with stress urinary incontinence underwent the TOT procedure. All patients underwent pre-operative clinical examination, cough-stress test (full bladder), uroflowmetry and post-voiding residual volume assessment.

Results: The mean age of patients was 50 years, ranging from 26 to 74 years, with an average urinary stress incontinence duration of six years. The mean time of follow-up was 14 months (at 1, 6, 12 and 24 months) and the average duration of surgery was about 20 minutes. The perioperative complication rate was 9% with no vascular, nerve or bowel injuries. The rate of hemorrhagic side effects (spontaneously-absorbed hematoma and blood loss not requiring blood transfusion) was 2.9%. Post-operative urinary retention and vaginal erosion occurred in one case each; the former was treated by intermittent self-catheterization. In total, 91.4% of patients were completely cured and 8.6% were improved without failure of treatment.

Conclusions: The present study confirms the results obtained by Delorme and coworkers, and allows us to consider TOT as a safe, minimally invasive and efficient short-term surgical technique for the treatment of female stress urinary incontinence, alone or in combination with prolapse repair. Following this study, a randomized control trial is recommended to compare TOT with the gold standard surgery for women with urinary incontinence.