Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study

Study Overview
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Brief Summary
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This is a clinical trial to study the safety and effectiveness of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of female stress urinary incontinence (SUI).

Detailed Description
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Study comparing intrasphincteric injection of AMDC-USR with placebo. Subjects unblinded after 12 months visits, but followed for 2 years. Subjects randomized to placebo could elect to receive open-label AMDC-USR after completing 12 months visit.

Official Title
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A Double-blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Effectiveness of Cook MyoSite Incorporated AMDC in Female Patients With Stress Urinary Incontinence

Conditions
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Urinary Incontinence, Stress

Intervention / Treatment
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* Biological: AMDC-USR
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation. Exclusion Criteria: 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 for at least 1 month 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 randomization 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMDC-USR<br>Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded. Subjects were followed for 2 years after initial AMDC-USR treatment. | Biological: AMDC-USR<br>* AMDC-USR Treatment<br>|
| Placebo Comparator: Placebo<br>Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded and could elect to receive open-label AMDC-USR treatment. Subjects that received unblinded AMDC-USR treatment were followed for 2 years after initial placebo treatment. | Biological: Placebo<br>* Placebo treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Response (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months | A composite primary endpoint of responder rate was used, where a subject was considered a responder if she had ≥ 50% reduction from baseline in stress Incontinence Episode Frequency (stress IEF; reported stress leaks from 3-day diary) or ≥ 50% reduction in leakage from baseline as determined by either the in-office pad weight test or the 24-hour pad weight test. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Incontinence, Stress, Tissue Therapy (Cell Therapy), Transplantation, Autologous