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
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
Stanford is now accepting new patients for this trial.
- device : Contigen
- device : Bulkamid
Ages Eligible For Study:
- Be female 18 or more years of age. - Females of childbearing potential or <2 years post-menopausal must be using 2 forms of contraception. - Suffer from SUI for at least 6 months. - Have failed 2 previous non-invasive therapies for 3 months each. - Have at least 3 incontinence episodes measured over 3 days. - Have a baseline 24h pad test weight greater than or equal to 5 gm. - Have VLPP ? 100 cm H2O. - Have maximum cystometric capacity equal or higher than (?) 250 mL. - Have PVR urine ? 100 mL. - Have a life expectancy of more than 2 years.