Clinical Study Investigating Autologous Muscle-Derived Cells for treatment of Female Stress Urinary Incontinence Patients
- Conditions
- Female Stress Urinary IncontinenceMedDRA version: 20.0Level: PTClassification code 10066218Term: Stress urinary incontinenceSystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2014-002919-41-DE
- Lead Sponsor
- Cook MyoSite Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 267
• Female patient 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 222
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
• 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 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: Evaluate the efficacy and safety of the Cook MyoSite Incorporated Autologous Muscle Derived Cells.;Secondary Objective: Determine quality of life improvements, durability af improvement in responders and evaluation of additional effectiveness and safety measures after treatment with AMDC.;Primary end point(s): Number of diary-reported stress incontinence episodes. <br>The efficacy endpoint is defined as the percentage of patients who have at least 50 % (= 50 %) reduction in stress incontinence episodes at 12 months using ITT population where ITT population is defined as patients who are randomized to either AMDC-USR or placebo control treatment group. ;Timepoint(s) of evaluation of this end point: 12 months.
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 12 months except for evaluation of treatment durability at 24 months.;Secondary end point(s): • Percentage of patients with at least 75% reduction in stress incontinence episodes from baseline at 12 months; <br>• Percentage of patients with 0 or 1 stress incontinence episodes at 12 months; and<br>• Improvement (reduction) in frequency of stress incontinence episodes from baseline at 12 months;<br>• Quality of life at 12 months as determined by Incontinence Quality of Life (IQOL) Assessment, Incontinence Impact Questionnaire – Short Form (IIQ – 7), Urogenital Distress Inventory – Short Form (UDI – 6), and Global Quality of Life Assessment (GQOL); <br>• Association of quality of life improvement with stress incontinence episode reduction at 12 months;<br>• Incontinence severity as determined by Sandvik Incontinence Severity Index (ISI) at 12 months; and<br>• Treatment durability at 2 years<br><br>