OBJECTIVE: To compare efficacy and safety of retropubic Burch urethropexy and a midurethral sling in women with stress urinary incontinence (SUI) undergoing concomitant pelvic floor repair with sacrocolpopexy. METHODS: Women were randomly assigned to Burch retropubic urethropexy (n=56) or retropubic midurethral sling (n=57) through dynamic allocation balancing age, body mass index, history of prior incontinence surgery, intrinsic sphincter deficiency, preoperative incontinence diagnosis, and prolapse stage. Overall and stress-specific continence primary outcomes were ascertained with validated questionnaires and a blinded cough stress test. RESULTS: Enrollment was June 1, 2009, through August 31, 2013. At 6 months, no difference was found in overall (29 midurethral sling [51%] compared with 23 Burch [41%]; P=.30) (odds ratio [OR] 1.49, 95% confidence interval [CI] 0.71-3.13) or stress-specific continence rates (42 midurethral sling [74%] compared with 32 Burch [57%]; P=.06) (OR 2.10, 95% CI 0.95-4.64) between groups. However, the midurethral sling group reported greater satisfaction (78% compared with 57%; P=.04) and were more likely to report successful surgery for SUI (71% compared with 50%; P=.04) and to resolve pre-existing urgency incontinence (72% compared with 41%; P=.03). No difference was found in patient global impression of severity or symptom improvement, complication rates, or mesh exposures. CONCLUSION: There was no difference in overall or stress-specific continence rates between midurethral sling and Burch urethropexy groups at 6 months. However, the midurethral sling group reported better patient-centered secondary outcomes.
RCT Entities:
OBJECTIVE: To compare efficacy and safety of retropubic Burch urethropexy and a midurethral sling in women with stress urinary incontinence (SUI) undergoing concomitant pelvic floor repair with sacrocolpopexy. METHODS:Women were randomly assigned to Burch retropubic urethropexy (n=56) or retropubic midurethral sling (n=57) through dynamic allocation balancing age, body mass index, history of prior incontinence surgery, intrinsic sphincter deficiency, preoperative incontinence diagnosis, and prolapse stage. Overall and stress-specific continence primary outcomes were ascertained with validated questionnaires and a blinded cough stress test. RESULTS: Enrollment was June 1, 2009, through August 31, 2013. At 6 months, no difference was found in overall (29 midurethral sling [51%] compared with 23 Burch [41%]; P=.30) (odds ratio [OR] 1.49, 95% confidence interval [CI] 0.71-3.13) or stress-specific continence rates (42 midurethral sling [74%] compared with 32 Burch [57%]; P=.06) (OR 2.10, 95% CI 0.95-4.64) between groups. However, the midurethral sling group reported greater satisfaction (78% compared with 57%; P=.04) and were more likely to report successful surgery for SUI (71% compared with 50%; P=.04) and to resolve pre-existing urgency incontinence (72% compared with 41%; P=.03). No difference was found in patient global impression of severity or symptom improvement, complication rates, or mesh exposures. CONCLUSION: There was no difference in overall or stress-specific continence rates between midurethral sling and Burch urethropexy groups at 6 months. However, the midurethral sling group reported better patient-centered secondary outcomes.
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