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NCT03104517 · ClinicalTrials.gov registry record · Phase 3
Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
A Phase 3 study of Stress Urinary Incontinence, sponsored by Cook MyoSite.
- Active
- Registry status
- Phase 3
- Development phase
- 96
- Enrollment target
- 20
- Study locations
NCT03104517: Active Phase 3 study of Stress Urinary Incontinence, sponsored by Cook MyoSite.
NCT03104517 is a Phase 3 study of Stress Urinary Incontinence that is active but no longer recruiting, run by Cook MyoSite. The registered enrollment target is 96 participants, below the 160-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (40% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03104517, a Phase 3 study of Stress Urinary Incontinence, is active but no longer recruiting, sponsored by Cook MyoSite.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 96 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in the reduction of stress incontinence episode frequency in adult female patients with post-surgical persistent or recurrent stress urinary incontinence (SUI). Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo.
Primary Outcome
Stress leak frequency
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL AMDC-USR (iltamiocel)
Study Locations (20)
California
- San Diego Clinical Trials - La Mesa
- UCLA Women's Health Clinical Research Unit/Department of OBGYN - Los Angeles
- Stanford Hospital and Clinics - Stanford
- American Association of Female Pelvic Medicines Research Institute - Westlake Village
New York
- AccuMed Research Associates - Garden City
- Northwell Health/The Arthur Smith Institute for Urology - Lake Success
- Columbia University Irving Medical Center - New York
Texas
- Houston Methodist Hospital - Houston
- Cedar Health Research - Irving
Arizona
- Del Sol Research Management, LLC - Tucson
District of Columbia
- MedStar Georgetown Hospital Department of Urology - Washington D.C.
Kansas
- University of Kansas Health System - Kansas City
Michigan
- Bennett Institute of Urogynecology and Incontinence - Grand Rapids
New Mexico
- University of New Mexico Women's Care Clinic - Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2019-04-23 |
| Est. Completion | 2027-09 |
| Phase | Phase 3 |
What the registry record for NCT03104517 still lists
NCT03104517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 160-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Stress Urinary Incontinence appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03104517 names 20 study sites across 14 states, led by California, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT03104517 about?
NCT03104517 is a clinical study titled "Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence". This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in the reduction of stress incontinence episode frequency in adult female patients with post-surgical persistent or recurrent stress...
What is the current status of trial NCT03104517?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 96 participants. The study started on 2019-04-23. Estimated completion is 2027-09.
What conditions does trial NCT03104517 study?
This clinical trial studies the following conditions: Stress Urinary Incontinence.
What interventions are being tested in trial NCT03104517?
The interventions under investigation include: Placebo (OTHER), AMDC-USR (iltamiocel) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03104517?
This trial is sponsored by Cook MyoSite, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03104517 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Kansas, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03104517's enrollment target sits among peer trials
96 18th of 35 higher than 18 of 35 other Stress Urinary Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress Urinary Incontinence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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