Urinary Incontinence, Stress Clinical Trial
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
Verified date | April 2018 |
Source | Cook MyoSite |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 150 |
Est. completion date | January 29, 2017 |
Est. primary completion date | February 3, 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Center | Calgary | Alberta |
Canada | Southern Alberta Institute of Urology | Calgary | Alberta |
Canada | Centre for Applied Urological Research Queens University | Kingston | Ontario |
Canada | Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec |
Canada | Mount Sinai Hospital | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | Can-Med Clinical Research Inc. | Victoria | British Columbia |
Canada | Victoria Gynecology and Continence Clinic | Victoria | British Columbia |
Germany | Praxisklinik Urologie Rhein-Ruhr | Mülheim | |
United Kingdom | Worthing Hospital | Worthing |
Lead Sponsor | Collaborator |
---|---|
Cook MyoSite |
Canada, Germany, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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