Minimally Invasive Burch Colposuspension to Reduce De Novo Stress Incontinence: The MICRO Randomized Trial
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 42 participants or records.
Read the paper
Related studies
- Understanding the factors influencing fall armyworm (Spodoptera frugiperda J.E. Smith) damage in African smallholder maize fields and quantifying its impact on yield. A case study in Eastern Zimbabwe
- Alarming situation of emerging H5 and H7 avian influenza and effective control strategies
- Livestock and food security: vulnerability to population growth and climate change
- Atmosphere–ocean oxygen and productivity dynamics during early animal radiations
- Characterization of the global distribution and diversified plasmid reservoirs of the colistin resistance gene mcr-9
- The global seroprevalence of Toxoplasma gondii in pigs: A systematic review and meta-analysis
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.