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Bulking Agents for the Treatment of Stress Urinary Incontinence in Females

Study:

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

Rationale:

n/a

Purpose:

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 Status: Recruiting

Recruiting:
n/a

Condition Intervention Phase
Stress Urinary Incontinence Device: Bulkamid
Device: Contigen		 N/A

Verified by Contura January, 2011

Sponsored by: Contura
Information provided by: Contura
ClinicalTrials.gov identifier: NCT00629083

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Cleveland Clinic
Weston, Florida 33331
United States

Silvia Garcia-Codony., Study Director

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.