Laparoscopic Burch colposuspension versus tension-free vaginal tape: a randomized trial.

OBJECTIVE To compare the laparoscopic Burch colposuspension with the tension-free vaginal tape procedure (TVT) for efficacy. METHODS Seventy-two women from 2 institutions were randomized: 36 to laparoscopic Burch colposuspension and 36 to TVT. Multichannel urodynamic tests were performed preoperatively and 1 year after surgery. A research nurse administered the Urogenital Distress Inventory, Incontinence Impact Questionnaire, and pelvic examinations using the pelvic organ prolapse quantification system preoperatively, and at 6 months, 1 year, and 2 years after surgery. Voiding diaries were collected at 1 and 2 years. Primary outcome was objective cure, which was defined as no evidence of urinary leakage during postoperative urodynamic studies. Secondary outcomes included subjective continence, perioperative and postoperative data, and quality of life. RESULTS Thirty-three laparoscopic Burch colposuspension and 33 TVT patients were analyzed with a mean follow-up of 20.6 +/- 8 months (range 12-43). Mean operative time was significantly greater in the laparoscopic Burch colposuspension group compared with the TVT group, 132 versus 79 minutes, respectively (P = .003). Multichannel urodynamic studies in 32 laparoscopic Burch colposuspension and 31 TVT patients showed a higher rate of urodynamic stress incontinence at 1 year in the laparoscopic Burch colposuspension group, 18.8% versus 3.2% (P = .056). There was a significant improvement in the number of incontinent episodes per week and in Urogenital Distress Inventory and Incontinence Impact Questionnaire scores in both groups at 1 and 2 years after surgery (P < .001). However, postoperative subjective symptoms of incontinence (stress, urge, and any urinary incontinence) were reported significantly more often in the laparoscopic Burch colposuspension group than in the TVT group (P < .04 for each category). CONCLUSION The TVT procedure results in greater objective and subjective cure rates for urodynamic stress incontinence than does laparoscopic Burch colposuspension.