Objectives To objectively assess the success rate at 6 months after tension-free vaginal tape obturator (TVT-O) procedure. To assess subjective success rates, complications, patient satisfaction, and quality of life (QOL).
Design A prospective observational study.
Setting A tertiary referral urogynaecology practice.
Population A cohort of 100 consecutive women who underwent the TVT-O procedure between March and October 2004.
Methods The TVT-O technique was performed as described. Three standardised QOL questionnaires were completed preoperatively at 6 months and 12 months. At 6 months, a urogenital history, visual analogue scale score (VAS) for patient satisfaction, uroflow, and urinary stress test were performed. After 12 months, a urogenital history and patient satisfaction verbal analogue score (VeAS) were obtained by telephone interview.
Main outcome measure Objective success rate of the TVT-O procedure was measured by negative stress test. Secondary outcomes were subjective success rates at 6 and 12 months, pre- and postoperative comparison of urodynamic parameters, complications, postoperative symptomatology, QOL analysis, and patient satisfaction.
Results Mean follow up was 18.5 months. Objective success rate was 95%. Subjective success rates were 92 and 84% at 6 and 12 months. Complications included recurrent urinary tract infection (six), voiding difficulty (two), persistent groin discomfort (three), haematoma (one), wound infection (one), vaginal tape erosion (one), and urethral irritation (one). Prevalence of de novo urge incontinence was 4.1 and 4.8% at 6 and 12 months. QOL analysis showed significant improvements in QOL scores postoperatively. Visual and verbal analogue scores indicated high patient satisfaction (VAS, VeAS ≥ 80%) in 77 and 67% at 6 and 12 months.
Conclusion The TVT-O is a safe and effective treatment for female stress urinary incontinence.