At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 150 enrolled
Drug / intervention
AMDC-USR +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Effectiveness of Cook MyoSite Incorporated AMDC in Female Patients With Stress Urinary Incontinence
In Brief
A Phase 3 clinical trial evaluating AMDC-USR and Placebo for Urinary Incontinence, Stress. Completed, enrolled 150 participants across 10 sites in 3 countries.
Detailed Summary
This is a clinical trial to study the safety and effectiveness of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of female stress urinary incontinence (SUI).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Incontinence, Stress
CountriesCanada, Germany, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 2011
Enrollment StartNov 2011
Primary CompletionFeb 2016
Study CompletionJan 2017
TodayJul 2026
First PostedJun 27, 2011
Enrollment StartNov 4, 2011
Primary CompletionFeb 3, 2016
Study CompletionJan 29, 2017
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 15.0 years ago
Interventions
AMDC-USRbiological
AMDC-USR Treatment
Placebobiological
Placebo treatment