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Sling vs Botox for Mixed Incontinence

NCT04171531 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-06-03

Study results available
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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.

Conditions

  • Urinary Incontinence, Stress
  • Urinary Incontinence, Urge

Interventions

DRUG

Botox® injection

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.

DEVICE

Mid-urethral sling

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.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Women and Infants Hospital of Rhode Island

    collaborator OTHER

  • Duke University

    collaborator OTHER

  • University of Pennsylvania

    collaborator OTHER

  • University of Pittsburgh

    collaborator OTHER

  • University of California, San Diego

    collaborator OTHER

  • Kaiser Permanente

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    collaborator OTHER

  • University of Alabama at Birmingham

    collaborator OTHER

  • RTI International

    collaborator OTHER

  • NICHD Pelvic Floor Disorders Network

    lead NETWORK

Principal Investigators

  • Heidi S Harvey, MD · University of Pennsylvania

  • Marie Gantz, PhD · RTI International

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-08
Primary Completion
2024-02-12
Completion
2024-02-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04171531 on ClinicalTrials.gov