Minimally Invasive Burch Colposuspension to Reduce De Novo Stress Incontinence: The MICRO Randomized Trial.

OBJECTIVE

The objective was to determine whether the addition of prophylactic retropubic colposuspension is superior to no anti-incontinence procedure during minimally invasive surgical sacrocolpopexy for stress-continent patients in decreasing rates of postoperative de novo stress urinary incontinence (SUI).

METHODS

In this randomized superiority trial, we recruited stress-continent prolapse patients undergoing either conventional or robotic-assisted laparoscopic sacrocolpopexy with negative preoperative supine cough stress tests. Patients were randomized to receive either prophylactic retropubic colposuspension or no retropubic colposuspension (control). The primary outcome was the composite measure of postoperative de novo SUI at 3 months, which included either (1) "Yes" to Question #17 on the Pelvic Floor Distress Inventory-20 endorsing symptoms of urinary leakage with coughing, sneezing, laughing, (2) positive retrofill cough stress test, or (3) any SUI treatment after sacrocolpopexy. Using data from the Colpopexy and Urinary Reduction Efforts trial, a sample size of 42 participants would demonstrate the addition of prophylactic retropubic colposuspension to be superior to control with a superiority margin of 15%.

RESULTS

Fifty patients underwent randomization, with 26 assigned to prophylactic retropubic colposuspension and 24 as controls. Three months after surgery, 50.0% of the patients in the retropubic colposuspension group and 41.7% of controls met one or more criteria for de novo SUI (P = 0.555). There was no difference between the retropubic colposuspension and control groups in symptoms of urinary frequency, urgency incontinence, or urinary retention at 3 months.

CONCLUSIONS

Among stress-continent patients undergoing minimally invasive surgical sacrocolpopexy in this single-center study, the addition of prophylactic retropubic colposuspension was not superior to no retropubic colposuspension in preventing postoperative de novo SUI at 3 months after surgery.