Autologous Muscle-Derived Cells Female Stress Urinary IncontinenceClinical Study

Phase 1

• Conditions: Female Stress Urinary Incontinence; MedDRA version: 14.1Level: SOCClassification code 10038359Term: Renal and urinary disordersSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2011-003599-35-BE
• Lead Sponsor: Cook MyoSite, Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-29
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 246

Inclusion Criteria

• 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) yes
F.1.3.1 Number of subjects for this age range 62

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified