Autologous Muscle-Derived Cells Female Stress Urinary Incontinence Clinical Study
- Conditions
- Female Stress Urinary IncontinenceMedDRA version: 14.1Level: SOCClassification code 10038359Term: Renal and urinary disordersSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2011-003599-35-DE
- Lead Sponsor
- Cook MyoSite, Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 246
•The patient is female and has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 184
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 62
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Determine effectiveness and safety of AMDC compared to placebo;Secondary Objective: Determine quality of life improvements, durability of improvement in responders and evaluation of additional effectiveness and safety measures after treatment with AMDC;Primary end point(s): Number of stress incontinence episodes or pad weight<br><br>Incidence of treatment-related serious adverse events and the incidence of protocol-defined treatment- or procedure-related adverse events <br>;Timepoint(s) of evaluation of this end point: 12 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Percent of patients maintaining success at 24 months<br><br>Change from baseline in disease specific quality of life measurements<br><br>Changes in alternative effectiveness and safety measure;Timepoint(s) of evaluation of this end point: 24 months<br><br>6, 12, 24 months<br><br>6, 12, 24 months