Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study

Phase 3

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
AMDC-USR	AMDC-USR	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.
Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Response (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months	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.

Secondary Outcome Measures

Name	Time	Method

Locations (10): Southern Alberta Institute of Urology
🇨🇦
Calgary, Alberta, Canada
Foothills Medical Center
🇨🇦
Calgary, Alberta, Canada
Mount Sinai Hospital
🇨🇦
Toronto, Ontario, Canada
Victoria Gynecology and Continence Clinic
🇨🇦
Victoria, British Columbia, Canada
Sunnybrook Health Sciences Centre
🇨🇦
Toronto, Ontario, Canada
Praxisklinik Urologie Rhein-Ruhr
🇩🇪
Mülheim, Germany
Worthing Hospital
🇬🇧
Worthing, United Kingdom
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦
Sherbrooke, Quebec, Canada
Centre for Applied Urological Research Queens University
🇨🇦
Kingston, Ontario, Canada
Can-Med Clinical Research Inc.
🇨🇦
Victoria, British Columbia, Canada