Autologous Muscle-derived Cells Female Stress Urinary Incontinence Clinical Study
This trial is active, not recruiting.
|Condition||urinary incontinence, stress|
|Treatments||amdc, placebo control|
|Start date||December 2011|
|End date||February 2016|
|Trial size||150 participants|
|Trial identifier||NCT01382602, 10-019|
This is a clinical trial is to study the safety and effectiveness of autologous muscle-derived cells (AMDC) for the treatment of female stress urinary incontinence (SUI).
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Calgary, Canada||Foothills Medical Center||no longer recruiting|
|Calgary, Canada||Southern Alberta Institute of Urology||no longer recruiting|
|Victoria, Canada||Victoria Gynecology and Continence Clinic||no longer recruiting|
|Victoria, Canada||Can-Med Clinical Research Inc.||no longer recruiting|
|Kingston, Canada||Centre for Applied Urological Research Queen s University||no longer recruiting|
|Toronto, Canada||Sunnybrook Health Sciences Centre||no longer recruiting|
|Toronto, Canada||Mount Sinai Hospital||no longer recruiting|
|Sherbrooke, Canada||Center Hospitalier de Fleurimont||no longer recruiting|
|Mülheim, Germany||Praxisklinik Urologie Rhein-Ruhr||no longer recruiting|
|Worthing, United Kingdom||Worthing Hospital||no longer recruiting|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
Number of stress incontinence episodes or pad weight
time frame: 12 Months
Incidence of treatment-related serious adverse events and the incidence of protocol-defined treatment- or procedure-related adverse events
time frame: 12 Months
Female participants at least 18 years old.
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.
|Official title||A Double-blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Effectiveness of Cook MyoSite Incorporated AMDC in Female Patients With Stress Urinary Incontinence|
|Principal investigator||Lesley K. Carr, MD, FRCSC|
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