Phase 3
Completed N=150
Sling vs Botox for Mixed Incontinence
Urinary Incontinence, Stress · Urinary Incontinence, Urge
Source: ClinicalTrials.gov NCT04171531 ↗
Enrolled (actual)
150
Serious AEs
7.9%
Results posted
Mar 2025
Primary outcomePrimary: UDI-LF Total Score Change From Baseline — -82.2; -84.6; -74.9; -89.1 units on a scale
◆ Published Evidence
Emerging
13citations · ~3 / year
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.
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.
Linked Publications (3)
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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.
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Midurethral Sling vs OnabotulinumtoxinA in Females With Urinary Incontinence: The MUSA Randomized Clinical Trial.
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Trial Design for Mixed Urinary Incontinence: Midurethral Sling Versus Botulinum Toxin A.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY UDI-LF Total Score Change From Baseline |
-82.2; -84.6; -74.9; -89.1; -63.1; -85.6 | — |
| SECONDARY UDI-LF Stress Score Change From Baseline |
-27.9; -46.4; -30.2; -45.1; -20.2; -42.3 | — |
| SECONDARY UDI-LF Irritative Score Change From Baseline |
-40.8; -28.1; -35.8; -30.6; -32.7; -30.8 | — |
Eligibility Criteria
Inclusion Criteria
- Reporting at least "moderate bother" from UUI item on UDI
- "Do you experience urine leakage associated with a feeling of urgency?"
- Reporting at least "moderate bother" from SUI item on UDI
- "Do you experience urine leakage related to physical activity, coughing, or sneezing?"
- Diagnosis of SUI defined by a positive cough stress test (CST) or UDE within the past 18 months
- Presence of UUI on bladder diary with > 4 Urgency IE/3-day diary
- Urinary symptoms >3 months
- Persistent symptoms despite at least one or more conservative treatments (e.g. supervised behavioral therapy, physical therapy) as determined adequate by the physician.
- Inadequate response to oral overactive bladder medications (including anti-cholinergic and/or beta-mimetic medication) unless patient is
- intolerant of oral overactive bladder medications, or
- oral overactive bladder medications are contraindicated as determined by the treating provider.
- Urodynamics within past 18 months
- Demonstrates ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization.
Exclusion Criteria
- Anterior or apical compartment prolapse at or beyond the hymen (>0 on POPQ), regardless if patient is symptomatic
- Women with anterior or apical prolapse above the hymen ( 0
- Women undergoing only rectocele repair or other repair unrelated to anterior or apical compartment are eligible
- Women undergoing hysterectomy for any indication will be excluded
- Active pelvic organ malignancy
- Age 150 cc on 2 occasions within the past 6 months, or current catheter use
- Participation in other trial that may influence results of this study
- Unevaluated hematuria
- Prior sling, synthetic mesh for prolapse, implanted nerve stimulator for urinary incontinence
- Spinal cord injury or advanced/severe neurologic conditions including Multiple Sclerosis, Parkinsons, Myasthenia Gravis, Charcot-Marie-Tooth
- Women on overactive bladder medication/therapy will be eligible after 3 week wash-out period
- Non-ambulatory
- History of serious adverse reaction to synthetic mesh
- Not able to complete study assessments per clinician judgment, or not available for 6 month follow-up
- Diagnosis of and/or history of bladder pain or chronic pelvic pain
- Women who had intravesical Botox injection within the past 12 months
- Women who have undergone anterior or apical pelvic organ prolapse repair within the past 6 months
Data sourced from ClinicalTrials.gov (NCT04171531) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.