Autologous Muscle-Derived Cells Female Stress Urinary Incontinence Clinical Study

Phase 1

• Conditions: Female Stress Urinary Incontinence; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-01
• Study Completion: 2017-01-29
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 143

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