At a glance
ClinicalIndex Comparison RecordN/ACompleted· 345 enrolled
Drug / intervention
Bulkamid +1 moredevice
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 Single-Masked, Randomized, Multi-Center, 2-Arm Parallel Study Comparing the Safety and Effectiveness of Bulkamid® and Contigen® as Bulking Agents for the Treatment of Stress Urinary Incontinence in Females
In Brief
A clinical study evaluating Bulkamid and Contigen for Stress Urinary Incontinence. Completed, enrolled 345 participants across 34 sites in 3 countries.
Detailed Summary
The primary purpose of this study is to demonstrate the safety and effectiveness of Bulkamid® in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStress Urinary Incontinence
CountriesCanada, France, United States
CollaboratorsRegulatory and Clinical Research Institute Inc
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2008
Enrollment StartApr 2008
Primary CompletionMay 2013
TodayJul 2026
First PostedMar 5, 2008
Enrollment StartApr 1, 2008
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 18.3 years ago
Interventions
Bulkamiddevice
Bulking injection with Bulkamid injection device
Contigendevice
Transurethral bulking injection