Autologous Muscle-Derived Cells Female Stress Urinary IncontinenceClinical Study

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 246

Inclusion Criteria

• The patient is female and has primary symptoms af SUl, as confirmed by patient medicai h istory 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) yes
F.1.3.1 Number of subjects for this age range 62

Exclusion Criteria

• Patient has symptoms af pure urge incontinence as confirmed by basic evaluation af etiology from a patient med icai history, including a focused incontinence history.
• Patient has symptoms af mixed urinary incontinence where urge incontinence is the pr edominant factor.
• Patient has had stress u rinary 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, blad der
exercises, biofeedback, etc.)
• Patient has more than 2 episode af awakening to void during normal sleeping hours.
• Patient cannot be ma intained 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 af 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 ava ila ble 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 efficacy and safety of AMDC compared to placebo;Secondary Objective: Determine quality af lite improvements, durability af improvement in<br>responders and evaluation af additional effectiveness and safety<br>measures atter 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<br>of protocol-defined treatment- or procedure-related adverse events;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 measures;Timepoint(s) of evaluation of this end point: 24 months<br><br>6, 12, 24 months<br><br>6, 12, 24 months

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