A Double blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Effectiveness of Cook MyoSite Incorporated AMDC in Female Patients with Stress Urinary Incontinence

Phase 3

Withdrawn

• Conditions: 10046590; bladder leakage; Loss of urine on effort

• Registration Number: NL-OMON39970
• Lead Sponsor: William Cook Europe, Regulatory Affairs, Clinical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 30

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.

Exclusion Criteria

• Patient has symptoms af pure urge incontinence as confirmed by basic evaluation af etiology from a patient medical history, including a focused incontinence history.
• Patient has symptoms af 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 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 available for the follow-up evaluations as required by the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The principle objective of the study is to determine the effectiveness and<br /><br>safety of Autologous Muscle-Derived Cells (AMDC) in the treatment of female<br /><br>patients with stress urinary incontinence.<br /><br><br /><br>Effectiveness: Is treatment with AMDC effective at 12 months after treatment<br /><br>in reducing the number of stress incontinence episodes or reducing the pad<br /><br>weight?<br /><br><br /><br>Safety: Are the side effects or medical events associated with AMDC treatment<br /><br>compared to the benefit acceptable after 12 months?</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>For secondary objectives, the study will examine if effectiveness is maintained<br /><br>long term (2 years). The study will also look at how the AMDC treatment<br /><br>affects the quality of life of the patients, which will use a number of quality<br /><br>of life assessments. Safety will also be examined at timepoints other than 12<br /><br>months.</p><br>