MUSA
Trial question
What is the role of onabotulinumtoxinA in women with moderate-to-severe mixed urinary incontinence?
Study design
Multi-center
Open label
RCT
Population
150 female patients.
Inclusion criteria: female patients, aged ≥ 21 years, with moderate-to-severe stress and urgency urinary incontinence not responding to conservative treatments.
Key exclusion criteria: anterior or apical prolapse at or beyond the hymen; planned concomitant surgery for anterior or apical prolapse; prior sling; oral overactive bladder medication use; post-void residual volume > 150 mL on two occasions within the past 6 months; urinary catheter use.
Interventions
N=72 onabotulinumtoxinA (intradetrusor injection of onabotulinumtoxinA 100 IU).
N=78 midurethral sling (synthetic polypropylene mesh midurethral sling).
Primary outcome
Mean reduction in mixed incontinence symptoms as measured by Urogenital Distress Inventory total score at 6 months
66.8 points
84.9 points
84.9 points
63.7 points
42.5 points
21.2 points
0.0 points
OnabotulinumtoxinA
Midurethral
sling
No significant
difference ↔
No significant difference in mean reduction in mixed incontinence symptoms as measured by Urogenital Distress Inventory total score at 6 months (66.8 points vs. 84.9 points; MD -18.1, 95% CI -40.7 to 4.6).
Secondary outcomes
Significantly lower reduction in mean Urogenital Distress Inventory stress score at 6 months (25.1 points vs. 45.2 points; MD -20.1, 95% CI -31.9 to -8.4).
No significant difference in mean reduction in Urogenital Distress Inventory irritative score at 6 months (32.9 points vs. 27.4 points; MD 5.5, 95% CI -4.3 to 15.3).
No significant difference in mean reduction in Urogenital Distress Inventory total score at 12 months (60.5 points vs. 84.9 points; MD -24.4, 95% CI -47.7 to 1.1).
Safety outcomes
No significant difference in adverse events.
Conclusion
In female patients, aged ≥ 21 years, with moderate-to-severe stress and urgency urinary incontinence not responding to conservative treatments, onabotulinumtoxinA was not superior to midurethral sling with respect to mean reduction in mixed incontinence symptoms as measured by Urogenital Distress Inventory total score at 6 months.
Reference
Heidi S Harvie, Shawn A Menefee, Holly E Richter et al. Midurethral Sling vs OnabotulinumtoxinA in Females With Urinary Incontinence: The MUSA Randomized Clinical Trial. JAMA. 2025 May 5. Online ahead of print.
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