Randomized trial of tension-free vaginal tape and tension-free vaginal tape-obturator for urodynamic stress incontinence in women.

We compared the efficacy and complications of tension-free vaginal tape and tension-free vaginal tape-obturator.Women with pure urodynamic stress incontinence undergoing only primary continence surgery were randomized to tension-free vaginal tape or tension-free vaginal tape-obturator at 2 centers between March 2005 and March 2007. Primary outcome was objective cure rate at 6 months, defined by a 24-hour pad test of less than 5 gm. Secondary outcomes were the subjective cure rate on the Patient Global Impression of Improvement, quality of life on the King's Healthcare Questionnaire and symptom severity scores on the International Consultation on Incontinence Questionnaire.A total of 127 women were recruited. The study was stopped early due to excess leg pain in the tension-free vaginal tape-obturator group. Of the women 66 were randomized to tension-free vaginal tape and 61 were randomized to tension-free vaginal tape-obturator. Analysis was done by intent to treat. The objective and subjective cure rate at 6 months for tension-free vaginal tape vs tension-free vaginal tape-obturator was 69.7% vs 72.1% and 72.7% vs 67.2% (p = 0.76 and 0.49, respectively). Cure rates at 1 year were similar but loss to followup was high. Objective and subjective cure rates at 1 year for tension-free vaginal tape vs tension-free vaginal tape-obturator were 50% vs 41% and 53% vs 42.6% (p = 0.31 and 0.24, respectively). More women complained of leg pain after receiving a tension-free vaginal tape-obturator (26.4% vs 1.7%, p = 0.0001). The incidence of perioperative complications was low and similar between the groups. Time to discharge home and time to normal activity were not significantly different.Short-term cure rates at 6 months were similar. Tension-free vaginal tape-obturator caused more transient leg pain. Each procedure achieved a high cure rate and a low complication rate.