Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Stress Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT03104517

Run by

Cook MyoSite

People needed

96

Starts

2019-04-23

Expected to finish

2027-09-01

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Adult female patient ≥ 18 years of age who has primary and moderate-to-severe symptoms of SUI for at least 6 months, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.
• History of previous surgery for treatment of SUI. Previous surgery could include midurethral sling, retropubic suspension, or bladder neck sling. Bulking agents alone are not considered previous surgery for treatment of SUI.
• Must be willing and able to comply with the study procedures, be mentally competent and able to understand all study requirements, and must agree to read and sign the informed consent form prior to any study-related procedures.
• Must have completed 100% of the screening 3-day diary evening reports.

You may not qualify if…

• Patient has symptoms of only urge incontinence as confirmed by basic evaluation of etiology from a patient medical history, including a focused incontinence history.
• Patient has symptoms of mixed urinary incontinence where urge incontinence is the predominant factor.
• Patient has had stress urinary incontinence symptoms less than 6 months prior to signing the informed consent.
• Patient has not previously attempted conservative treatment prior to signing the informed consent. (Examples of conservative treatment include behavior modifications, bladder exercises, biofeedback, pelvic floor muscle therapy, etc.)
• Patient BMI ≥ 35.
• Patient routinely has more than 2 episodes of awakening to void during normal sleeping hours.
• If taking a medication known to affect lower urinary tract function, including but not limited to, anticholinergics, beta 3 adrenergic receptor agonists, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitor (SNRI) or selective serotonin reuptake inhibitor (SSRI) antidepressants, diuretics, or alpha-adrenergic blockers, patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics), cannot be maintained on a stable dose and/or frequency for at least 2 weeks prior to screening or is likely to change during the course of the study.
• History of cancer in pelvic organs, ureters, or kidneys.
• Patient is pregnant, lactating, or plans to become pregnant during the course of the study.

Where it is running

• Del Sol Research Management, LLC — Tucson, Arizona, United States
• San Diego Clinical Trials — La Mesa, California, United States
• UCLA Women's Health Clinical Research Unit/Department of OBGYN — Los Angeles, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• American Association of Female Pelvic Medicines Research Institute — Westlake Village, California, United States
• MedStar Georgetown Hospital Department of Urology — Washington D.C., District of Columbia, United States
• University of Kansas Health System — Kansas City, Kansas, United States
• Bennett Institute of Urogynecology and Incontinence — Grand Rapids, Michigan, United States
• University of New Mexico Women's Care Clinic — Albuquerque, New Mexico, United States
• AccuMed Research Associates — Garden City, New York, United States
• Northwell Health/The Arthur Smith Institute for Urology — Lake Success, New York, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Atrium Health — Charlotte, North Carolina, United States
• Cleveland Clinic/Glickman Institute-Q10 — Cleveland, Ohio, United States
• Magee Women's Hospital of UPMC — Pittsburgh, Pennsylvania, United States
• Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic — Sioux Falls, South Dakota, United States
• Vanderbilt University Medical Center, Dept. of Urologic Surgery — Nashville, Tennessee, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Cedar Health Research — Irving, Texas, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Derriford Hospital — Plymouth, Devon, United Kingdom

Full record on ClinicalTrials.gov

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