A Randomized Trial of Urodynamic Testing Before Stress-Incontinence Surgery

摘要

Urodynamic testing is often performed preoperatively for stress urinary incontinence. However, previous studies have not demonstrated improved surgical outcomes with such testing. No randomized controlled trials have addressed this issue.This multicenter, randomized, noninferiority trial compared outcomes at 1 year among women with uncomplicated stress urinary incontinence who underwent preoperative urodynamic testing and office evaluation before their planned surgery and those who received evaluation only. Treatment success at 12 months, the primary outcome, was defined as a reduction on the Urogenital Distress Inventory score of 70% or more and a Patient Global Impression of Improvement response of "very much better" or "much better." A predetermined noninferiority margin of 11 percentage points was selected on the basis of clinical judgment.Of the 630 patients evaluated, 315 were randomized to office evaluation with urodynamic tests and 315 to evaluation only. Treatment was successful in 76.9% (203/ 264) of women in the urodynamic-testing group as compared with 77.2% (200/259) of those in the evaluation-only group; the between-group difference of -0.3 percentage points (95% confidence interval, -7.5 to 6.9) was consistent with noninferiority. No significant between-group differences were found for secondary measures, including incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women in the urodynamic-testing group were significantly less likely to receive a diagnosis of an overactive bladder and were more likely to receive a diagnosis of voiding-phase dysfunction than those in the evaluation-only group. However, this change in preoperative diagnosis after urodynamic testing did not result in significant differences in treatment selection or outcomes.These findings indicate that routine preoperative urodynamic testing for women with uncomplicated stress urinary incontinence does not improve outcomes at 1 year over that found with in-office evaluation alone.