Mixed urinary incontinence (MUI) is common and can be challenging to manage.
We present the protocol design and rationale of a trial comparing the efficacy of 2 procedures for the treatment of women with MUI refractory to oral treatment. The Midurethral sling versus Botulinum toxin A (MUSA) trial compares the efficacy of intradetrusor injection of 100 U of onabotulinimtoxinA (an office-based procedure directed at the urgency component) versus midurethral sling (MUS) placement (a surgical procedure directed at the stress component).
The MUSA is a multicenter, randomized trial of women with MUI electing to undergo procedural treatment for MUI at 7 clinical centers in the NICHD Pelvic Floor Disorders Network. Participants are randomized to either onabotulinumtoxinA 100 U or MUS. OnabotulinimtoxinA recipients may receive an additional injection between 3 and 6 months. Participants may receive additional treatment (including crossover to the alternative study intervention) between 6 and 12 months. The primary outcome is change from baseline in Urogenital Distress Inventory (UDI) at 6 months. Secondary outcomes include change in UDI at 3 and 12 months, irritative and stress subscores of the UDI, urinary incontinence episodes, predictors of poor treatment response, quality of life and global impression outcomes, adverse events, use of additional treatments, and cost effectiveness.
Recruitment and randomization of 150 participants is complete and participants are currently in the follow-up phase.
This trial will provide information to guide care for women with MUI refractory to oral treatment who seek surgical treatment with either onabotulinumtoxinA or MUS.
Urogynecology (Philadelphia, Pa.). 2024 Jan 11 [Epub ahead of print]
Heidi S Harvie, Holly E Richter, Vivian W Sung, Christopher J Chermansky, Shawn A Menefee, David D Rahn, Cindy L Amundsen, Lily A Arya, Carolyn Huitema, Donna Mazloomdoost, Sonia Thomas, NICHD Pelvic Floor Disorders Network
Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL., Department of Obstetrics and Gynecology, Alpert Medical School of Brown University/Women and Infants Hospital, Providence, RI., Department of Urology, University of Pittsburgh School of Medicine, Pittsburgh, PA., Department of Obstetrics and Gynecology, Kaiser Permanente San Diego, San Diego, CA., Department of Obstetrics and Gynecology, University of Texas Southwestern, TX., Department of Obstetrics and Gynecology, Duke University Medical Center, Durham., From the Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania., RTI International, Research Triangle Park, NC., Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.