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.
Mixed urinary incontinence (MUI), defined as the presence of both stress urinary incontinence (SUI) and urgency urinary incontinence (UUI), is a challenging condition for which clinicians frequently use multiple sequential treatments that have undergone limited evaluation in rigorous clinical trials. The Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A (MUSA) trial will estimate the effect of Botulinum toxin A (Botox A ®) compared to mid-urethral sling for the treatment of MUI symptoms in 146 women. MUSA is a randomized 2-arm clinical trial. The purpose of MUSA is to: * compare treatment with either Botulinum toxin A (Botox A ®) or mid-urethral sling for women with MUI * characterize patient characteristics associated with treatment response The primary objective is to estimate the effect of intradetrusor injections Botulinum toxin A (Botox A ®) compared to mid-urethral sling for treatment of MUI in 146 women 6 months after treatment. The change in severity of MUI symptoms will be measured using the Urogenital Distress Inventory. Secondary outcomes include: • Urogenital Distress Inventory Stress and Irritative subscales Other outcomes include: * Urogenital Distress Inventory Obstructive subscale * Patient bladder diary metrics including numbers of daily incontinence episodes and voids and voiding frequency * Other patient reported outcomes/validated instruments and associated scales and subscales: EQ-5D, IIQ-LF, OABq-LF, OAB-SATq, PISQ-IR, PGI-I, PGI-S, PGSC, and SF-36 * Physical measures of effectiveness: Postvoid Residual Volume The study will continue with an additional 6 month observational period until 12 months post treatment. A supplemental study will characterize baseline putative proteins/protein pathways in women with MUI associated with change in UDI after treatment with MUS or onabotulinum toxin A. Those results are not reported with this record.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Botulinum toxin A will be prepared by dissolving 100 units of botulinum toxin A into 10 ml of injectable saline. Indigo carmine or methylene blue 0.1 ml will be added to each syringe of botulinum toxin A. The treating physician will inject a total of 10 ml of the Botox A® into approximately 15 to 20 different detrusor muscle sites under direct visualization.
Mid-urethral Sling Procedure includes retropubic as well as transobturator full length slings. "Mini-sling" and "single-incision" sling will not be allowed due to potential risk for higher failure rate.
University of Alabama at Birmingham, Department of Obstetrics and Gynecology
Birmingham, Alabama, United States
University of California at San Diego
La Jolla, California, United States
Kaiser Permanente
San Diego, California, United States
UDI-LF Total Score Change From Baseline
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI scale has a range from 0 to 300 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
UDI-LF Stress Score Change From Baseline
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Stress subscale has a range from 0 to 100 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
UDI-LF Irritative Score Change From Baseline
The Urogenital Distress Inventory is a standardized a measure of overactive bladder symptoms and health-related quality of life. The UDI Irritative subscale has a range from 0 to 100 with higher scores indicating greater distress. The outcome is calculated as the difference in score at 3, 6, or 12 months and the score at baseline.
Time frame: 3, 6, 9, and 12 Months
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Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Magee-Women's Hospital, Department of Obstetrics and Gynecology
Pittsburgh, Pennsylvania, United States
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States