J Persson1, P Wølner-Hanssen. 1. Department of Obstetrics and Gynecology, Lund University Hospital, Sweden. jan.persson@gyn.lu.se
Abstract
OBJECTIVE: To compare 1-year cure rates after laparoscopic Burch colposuspension using one double-bite or two single-bite sutures on each side of the urethra. METHODS:Consecutive women with primary stress urinary incontinence at one university hospital were included. Preoperative clinical and urodynamic evaluation included cystoscopy, cystouretrometry at rest and stress, and a standardized pad test. Immediately before surgery, the patients were randomized to have one or two polytetrafluoroethylene (GoreTex CV 2; W. L. Gore Inc., Flagstaff, AZ) sutures placed on each side of the urethra. During surgery, access to the space of Retzius was achieved by transperitoneal videolaparoscopic technique. Women were scheduled for postoperative interview and pad test 1 year after surgery. RESULTS: We included 161 women in the study; 78 were randomized to one suture (group A) and 83 to two sutures (group B). Median time for surgery was significantly shorter for group A than for group B (60 compared with 77 minutes; P < .001). We examined 158 women 1 year after surgery, at which time 148 performed a pad test. Objective cure rate was significantly higher in group B than in group A (83% compared with 58%; P = .001). CONCLUSION: Two single-bite sutures resulted in a significantly higher objective short-term cure rate than one double-bite suture on each side of the urethra.
RCT Entities:
OBJECTIVE: To compare 1-year cure rates after laparoscopic Burch colposuspension using one double-bite or two single-bite sutures on each side of the urethra. METHODS: Consecutive women with primary stress urinary incontinence at one university hospital were included. Preoperative clinical and urodynamic evaluation included cystoscopy, cystouretrometry at rest and stress, and a standardized pad test. Immediately before surgery, the patients were randomized to have one or two polytetrafluoroethylene (GoreTex CV 2; W. L. Gore Inc., Flagstaff, AZ) sutures placed on each side of the urethra. During surgery, access to the space of Retzius was achieved by transperitoneal videolaparoscopic technique. Women were scheduled for postoperative interview and pad test 1 year after surgery. RESULTS: We included 161 women in the study; 78 were randomized to one suture (group A) and 83 to two sutures (group B). Median time for surgery was significantly shorter for group A than for group B (60 compared with 77 minutes; P < .001). We examined 158 women 1 year after surgery, at which time 148 performed a pad test. Objective cure rate was significantly higher in group B than in group A (83% compared with 58%; P = .001). CONCLUSION: Two single-bite sutures resulted in a significantly higher objective short-term cure rate than one double-bite suture on each side of the urethra.