Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

Completed · Phase 3 · Has a placebo group

Conditions studied: Stress Urinary Incontinence

In brief

This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.

Key facts

Study ID

NCT01893138

Run by

Cook MyoSite

People needed

311

Starts

2013-11-21

Expected to finish

2020-11-10

Last updated by the study team

2023-01-05

Who can join

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

You may qualify if…

• Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.

You may not qualify if…

• Patient has symptoms of pure 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, etc.)
• Patient has more than 2 episode of awakening to void during normal sleeping hours.
• Patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics) known to affect lower urinary tract function, including but not limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers, for at least 2 weeks prior to screening or is likely to change during the course of the study.
• Patient is pregnant, lactating, or plans to become pregnant during the course of the study.
• Patient refuses to provide written informed consent.
• Patient is not at least 18 years of age.
• Patient is not available for the follow-up evaluations as required by the protocol.

Where it is running

• Mayo Clinic Arizona Phoenix Campus — Phoenix, Arizona, United States
• The American Association of Female Pelvic Medicine Specialists — Agoura Hills, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Stanford University — Stanford, California, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Emory University — Atlanta, Georgia, United States
• NorthShore University HealthSystem — Skokie, Illinois, United States
• IU Health Physicians Urogynecology — Indianapolis, Indiana, United States
• Female Pelvic Medicine & Urogynecology Institute of Michigan — Grand Rapids, Michigan, United States
• Mercy Health Saint Mary's Campus — Grand Rapids, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• NYU Urology Associates — New York, New York, United States
• Premier Medical Group of the Hudson Valley PC — Poughkeepsie, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• McKay Urology — Charlotte, North Carolina, United States
• The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Greenville Health System — Greenville, South Carolina, United States
• Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic — Sioux Falls, South Dakota, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Methodist Urology Associates — Houston, Texas, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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