CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 150 enrolled
Drug / intervention
Botox® injection +1 moredrug
Likely dose
Botox® injection 100 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04171531
NCT04171531Phase 3Completed
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Treatment for Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A

NICHD Pelvic Floor Disorders Network·interventional·Posted Nov 21, 2019·Updated Jun 3, 2025

In Brief

A Phase 3 clinical trial evaluating Botox® injection and Mid-urethral sling for Urinary Incontinence, Stress and Urinary Incontinence, Urge. Completed, enrolled 150 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Incontinence, Stress, Urinary Incontinence, Urge
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Women and Infants Hospital of Rhode Island, Duke University, University of Pennsylvania, University of Pittsburgh, University of California, San Diego, Kaiser Permanente, University of Texas Southwestern Medical Center, University of Alabama at Birmingham, RTI International

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedNov 21, 2019
Enrollment StartJun 8, 2020
Primary CompletionFeb 12, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 6.6 years ago

Interventions

Botox® injectiondrug

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 slingdevice

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.