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Phase 3 N=150 Randomized Treatment

Sling vs Botox for Mixed Incontinence

Urinary Incontinence, Stress · Urinary Incontinence, Urge

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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