Research Topic: Stress Urinary Incontinence (SUI)
Study Title: Study to assess the Safety and Effectiveness of the UrOActive® artificial urinary sPHincter In the treAtment of Stress Urinary Incontinence in Men
Research Team:
Benjamin Breyer, MD, MAS, FACS, Principal Investigator (PI)
Natalie Rios, Clinical Research Coordinator
Sponsor: UroMems, Inc.
Study Overview
The SOPHIA2 study is to determine the safety and effectiveness (i.e., how well it works) of a new artificial urinary sphincter (AUS) called UroActive® device for the treatment of SUI symptoms.
Stress Urinary Incontinence (SUI) is a common type of urinary incontinence (urine leakage) and has been commonly reported among men. Men with SUI often leak urine when they are involved in physical activity such as coughing, sneezing, laughing, or exercising. This tends to have a significant negative impact on quality of life including depression, anxiety, sexual dysfunction and social isolation.
The treatment you will receive in this study is intended to relieve SUI symptoms. Your participation may also benefit other people as information leaned from this study may help further advance the development of more effective treatment.
Who can join?
- Age range: 22+
- Diagnosed with Stress Urinary Incontinence over past 6 months
- Failed approved non-invasive SUI treatment
What to Expect During the Study
Survey, UroActive device implant, extra clinic visit.
In person and remote
UCSF Bayfront Hospital
UCSF Outpatient Urology Bayfront
- Participation in this study will help researchers evaluate treatments for stress urinary incontinence (SUI) and advance the development of more effective therapies for future patients.
- The treatment you receive in this study is intended to help relieve your SUI symptoms.
FAQ's
Five (5) years and 6 months
Screening visit, Baseline visit, Implant Day, Healing Period, Device Activation visit, 2-Weeks visit, 4-Weeks visit,8-Weeks visit, 21-Weekvisit, 47-Week phone visit, 12-Week visit, 26-Week visit, and 1 year follow-up visit, 39-Week visit, then year 2, 3, 5 follow-up visits.
paid up to $1,700 (assuming 5 unscheduled visits) for taking part in this study.
10 UCSF patients
Contact us
Natalie Rios, Clinical Research Coordinator
[email protected]
(415) 723-1456