NCT00629083

Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 345 (actual)
• Sponsor: Contura · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Bulkamid	Bulking injection with Bulkamid injection device
DEVICE	Contigen	Transurethral bulking injection

Timeline

• Start date: 2008-04-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2008-03-05
• Last updated: 2020-02-07
• Results posted: 2020-02-07

Locations

34 sites across 3 countries: United States, Canada, France

Regulatory

• FDA-regulated device study