Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
Trial ID or NCT#
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.
A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence
- - Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.
- - 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.
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Eric Sokol, MD