Phase 3
N=150
Sling vs Botox for Mixed Incontinence
Urinary Incontinence, Stress · Urinary Incontinence, Urge
Bottom Line
View on ClinicalTrials.gov: NCT04171531 ↗Enrolled (actual)
150
Serious AEs
7.9%
Results posted
Mar 2025
Primary outcome: Primary: UDI-LF Total Score Change From Baseline — -82.2; -84.6; -74.9; -89.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Botox® injection (Drug); Mid-urethral sling (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- NICHD Pelvic Floor Disorders Network
- Primary completion
- Feb 2024
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 | — |
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.
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). 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.