Laparoscopic burch colposuspension: A randomized controlled trial comparing two transperitoneal surgical techniques

OBJECTIVE: To compare the effectiveness of two transperi- toneal laparoscopic Burch procedures. METHODS: The sample size required was 30 subjects per group to detect a statistically significant estimated differ- ence of 15% between two surgical procedures with an 􏰍 􏰌 0.05 and a power of 0.7. Sixty women affected by genuine stress incontinence (GSI) were enrolled and randomly as- signed to two groups of 30 women each. All women were treated with the transperitoneal laparoscopic Burch proce- dure using nonabsorbable sutures (group A) or Prolene mesh (Ethicon, Somerville, NJ) fixed with tacks or staples (group B). The failure rate was defined subjectively and objectively. The subjective evaluation was performed by asking the women to rate their urine loss on a visual analog scale. The objective evaluation was a clinical evaluation using multichannel urodynamic studies. RESULTS: The subjective failure rate was not significantly different between the two groups at 3 months (0% for both groups), 6 months (3.7% versus 3.8% for groups A and B, respectively), and 12 months (7.4% versus 15.4% for groups A and B, respectively) after surgery. At 3 months (3.7% versus 3.8% for groups A and B, respectively) and 6 months (7.4% versus 15.4% for groups A and B, respectively) fol- low-up, the objective failure rate was not significantly dif- ferent between the two groups. However, at 12 months after the surgical procedure, the objective failure rate was significantly lower in group A than in group B (11.1% versus 26.9%, respectively; P < .05). CONCLUSION: Transperitoneal laparoscopic Burch colposus- pension performed using sutures was more effective than the mesh technique.