Bulking Agents for the Treatment of Stress Urinary Incontinence in Females
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|ClinicalTrials.gov Identifier: NCT00629083|
Recruitment Status : Completed
First Posted : March 5, 2008
Results First Posted : February 7, 2020
Last Update Posted : February 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stress Urinary Incontinence||Device: Bulkamid Device: Contigen||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||345 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Study Start Date :||April 2008|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Bulkamid Hydrogel injection
Bulking injection with Bulkamid injection device
Active Comparator: 2
Transurethral bulking injection
- Primary Effectiveness Endpoint [ Time Frame: 12 Months ]The number 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
- The Number of Participants With Device- and Procedure-related Serious Adverse Events Through 12 Months Follow-up. [ Time Frame: 12 months ]The number of participants with device- and procedure-related serious adverse events through 12 months follow-up.
- 24hr Pad Test [ Time Frame: 12 months ]A measure of urine leaked during a 24-hour period on a known weight and quantity of pads at the 12-month endpoint.
- Number of Subjects Reporting as a Responder [ Time Frame: 12 months ]At the 12-month primary endpoint follow-up visit, the subject was asked to provide her perception of treatment effectiveness by circling the most accurate description of her condition: cured/dry; much improved; improved; no change; worse. The response was dichotomized into responder or non-responder. A subject was classified as a responder if she reported that the treatment had cured, much improved, or improved her incontinence condition.
- IQoL [ Time Frame: 12 months ]The IQoL is a validated instrument consisting of 22 questions grouped into three subscales: avoidance and limiting behaviors; psychosocial impacts, and social embarrassment. It is a subject self-reported quality-of-life measure specific to urinary problems that is used to assess the impact of urinary incontinence and urinary problems and their treatment. The subject scores each question on a scale of 1 to 5 with higher scores indicating more positive responses. The maximum score was 110 points and the minimum score was 22.
- ICIQ-UI Short Form [ Time Frame: 12 months ]The ICIQ-UI Short Form assesses the impact of symptoms of incontinence on quality of life and outcome of treatment. The questionnaire consists of three questions with a maximum score of 21 and a minimum score of zero (0). A lower score represents a decrease in the severity of symptoms (i.e., improvement).
- Number of Incontinence Episodes [ Time Frame: 12 months ]The total number of incontinence episodes experienced by the subject over three consecutive days.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629083
|Study Director:||Silvia Garcia-Codony||Contura|