Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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.

Official Title

A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.
Exclusion Criteria:
  1. * 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.


Eric R. Sokol, MD
Eric R. Sokol, MD
Urogynecologist, Pelvic surgeon, Minimally invasive gynecologic surgeon, Pelvic reconstructive surgeon, Obstetrician and Gynecologist (OB-GYN)
Professor of Obstetrics and Gynecology (Gynecology-Urogynecology) and, by courtesy, of Urology

Contact us to find out if this trial is right for you.


Eric Sokol, MD