Laparoscopic Burch Colposuspension versus Tension-Free Vaginal Tape: A Randomized Trial

Abstract

Many of the benefits of the tension-free vaginal tape procedure for treatment of stress incontinence are derived from its minimally invasive surgical approach. The authors theorized that laparoscopic Burch colposuspensionmight offer the same advantages and conducted this randomized, prospective trial to compare the 2 procedures. Seventy-two women with primary urodynamic stress incontinence requiring surgical correction participated in the study. Thirty-six were randomized to undergo a standard laparoscopic Burch colposuspension, and 36 were randomized to the tension-free vaginal tape (TVT) procedure. Each participant underwent multichannel urodynamic tests at enrollment and one year after surgery. In addition, patients were evaluated with the Urogenital Distress Inventory, Incontinence Impact Questionnaire, pelvic examinations, and patients' voiding diaries at 6 months, 1 year, and 2 years after surgery. Low enrollment and lack of adequate funding led to the decision to stop the trial with a median follow up of 18 months. Thirty-three patients in each study arm were available for analysis. Both groups were similar in clinical and demographic characteristics, except that women who underwent Burch colposuspension were more likely to undergo concomitant lysis of adhesions (32% compared with 11% in the TVT group). Hysterectomy was performed in 25% of patients in each group. The only significant differences in operative data between the two procedures were that total operating room time and length of operation were greater in the Burch colposuspension group (P <0.001 for both). Complication rates were similar in each group. Among those undergoing Burch colposuspension, operative complications included detection of bladder sutures in 2 patients and 1 bowel injury. Conversion to laparotomy was necessary in 3 patients. Two were the result of severe adhesions; and, in one, there were difficulties performing total laparoscopic hysterectomy. In the TVT group, there were 2 cystotomies and 1 blood transfusion. Postoperatively, one hematoma and one pelvic abscess occurred in each group. Four patients in the Burch procedure group and two in the TVT group had low hematocrit levels. In addition, among the women who had Burch colposuspension, one patient had a postoperative ileus, one required readmission for pulmonary embolism, one developed pyelonephritis, and two eventually underwent collagen injections. Among those undergoing TVT, voiding dysfunctions necessitated mesh transection in two patients, one of who also underwent concomitant bone anchor pubovaginal sling. Another patient developed vaginal erosion of the TVT mesh. Compared with enrollment, at the 1- and 2-year evaluations, patients reported significant overall improvement in incontinence episodes per week, pads required per week, percentage of patients using pads, the Urogenital Distress Inventory, and the Incontinence Impact Questionnaire (range, P < 0.01 to P < 0.001). Overall satisfaction was similar for women treated by either procedure and ranged from 8.2 to 9.0 on a visual analog scale of 0 (not at all satisfied) to 10 (extremely satisfied). In multichannel urodynamic test results at 1 year after surgery, 18.8% of patients who underwent laparoscopic Burch colposuspension had urodynamic stress incontinence compared with 3.2% of those who had TVT (P = 0.056).