Bulking Agents for the Treatment of Stress Urinary Incontinence in Females
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||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|
- Proportion of subjects with at least a 50% reduction from baseline in both leakage, as measured by the 24h Pad Test, and Daily number of incontinence episodes [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- Incidence of device- and procedure-related serious adverse events through 12 months follow-up. [ Time Frame: Baseline through 12 months ] [ Designated as safety issue: Yes ]
- 24hr Pad Test [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
- Subject Perception of Effectiveness [ Time Frame: 3, 6. 9 and 12 months ] [ Designated as safety issue: No ]
- IQoL [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
- ICIQ-UI Short Form [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Bulkamid Hydrogel injection
Bulking injection with Bulkamid injection device
Active Comparator: 2
Transurethral bulking injection
The study is a single-masked, randomized, comparative multi-center, 2-arm parallel study intended to demonstrate the safety and effectiveness of Bulkamid® vs. Contigen® for the treatment of stress urinary incontinence (SUI)due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence.
Subjects will be randomized to receive either a polyacrylamide hydrogel (Bulkamid®) treatment, or a collagen treatment (Contigen®) using a 2:1 ratio and will be masked to the treatment. Screening baseline evaluations and collagen skin testing will be completed to determine eligible subjects. Following a negative skin test, a subject will be randomized and treated with Bulkamid® or the comparator device at the Treatment Visit.
Subjects that are not continent will be considered for re-injection. A maximum of 3 injections (initial + 2 re-injections) are allowed. After the last injection, subjects will attend the 3-Month, 6-Month and 12-Month Follow-up Visits plus a telephone contact at 9 months.
The study will record objective incontinence measurements, subject's perception of effectiveness and quality of life assessments. Adverse events will be recorded throughout the study.
Each subject will be followed for 12 months from the last injection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629083
Show 34 Study Locations
|Study Director:||Silvia Garcia-Codony||Contura|