drugset / Trial / NCT04171531
Sling vs Botox for Mixed Incontinence
Phase 3
Completed
150 enrolled
NICHD Pelvic Floor Disorders Network
Duke University · collabEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabKaiser Permanente · collabRTI International · collabUniversity of Alabama at Birmingham · collabUniversity of California, San Diego · collabUniversity of Pennsylvania · collabUniversity of Pittsburgh · collabUniversity of Texas Southwestern Medical Center · collabWomen and Infants Hospital of Rhode Island · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment.
Timeline
- Start
- 2020-06-08
- Primary completion
- 2024-02-12
- Completion
- 2024-02-12
Publications
- Harvie HS, Menefee SA, Richter HE, Sung VW, Chermansky CJ, Rahn DD, Amundsen CL, Arya LA, Rhodes E, Mazloomdoost D, Thomas S; National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Midurethral Sling vs OnabotulinumtoxinA in Females With Urinary Incontinence: The MUSA Randomized Clinical Trial. JAMA. 2025 Jun 3;333(21):1887-1896. doi: 10.1001/jama.2025.4682.
- Harvie HS, Richter HE, Sung VW, Chermansky CJ, Menefee SA, Rahn DD, Amundsen CL, Arya LA, Huitema C, Mazloomdoost D, Thomas S; NICHD Pelvic Floor Disorders Network. Trial Design for Mixed Urinary Incontinence: Midurethral Sling Versus Botulinum Toxin A. Urogynecology (Phila). 2024 May 1;30(5):478-488. doi: 10.1097/SPV.0000000000001422. Epub 2024 Jan 11.
- Harvie HS, Sung VW, Neuwahl SJ, Honeycutt AA, Meyer I, Chermansky CJ, Menefee S, Hendrickson WK, Dunivan GC, Mazloomdoost D, Bass SJ, Gantz MG; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Cost-effectiveness of behavioral and pelvic floor muscle therapy combined with midurethral sling surgery vs surgery alone among women with mixed urinary incontinence: results of the Effects of Surgical Treatment Enhanced With Exercise for Mixed Urinary Incontinence randomized trial. Am J Obstet Gynecol. 2021 Dec;225(6):651.e1-651.e26. doi: 10.1016/j.ajog.2021.06.099. Epub 2021 Jul 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Botulinum toxin type A | Protein / enzyme biologic | 100 iu | Other |