The APPROVE Trial: A Randomized Controlled Trial Evaluating the Efficacy and Safety of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The APPROVE trial is a multi-centered, randomized controlled trial designed to assess differences in symptom improvement, quality of life, bladder symptoms, satisfaction with treatment and continued treatment efficacy in women with overactive bladder (OAB) randomized to a prescription digital therapeutic (PDTx) app called RiSolve compared to standard behavioral education (handouts).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 22
Healthy Volunteers: f
View:
• Women ≥ 22 years old
• Bothersome OAB symptoms (defined as bother rating ≥ 5 on ICIQ-FLUTS question #3b or #9b)
• English-speaking
• Willing to forego other treatment outside of medications for the 8-week trial period
• Use of at least one mobile App
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
California
Stanford University
RECRUITING
Palo Alto
Washington, D.c.
MedStar Health
RECRUITING
Washington D.c.
Illinois
University of Chicago
RECRUITING
Chicago
Massachusetts
Curavit
ACTIVE_NOT_RECRUITING
Boston
North Carolina
Atrium Health Wake Forest Baptist
RECRUITING
Winston-salem
Pennsylvania
Allegheny Health
RECRUITING
Pittsburgh
South Carolina
Medical University of South Carolina Health
RECRUITING
Charleston
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Wisconsin
University of Wisconsin
RECRUITING
Madison
Contact Information
Primary
Patricia Moriarty
approvetrial@medstar.net
202-877-0486
Backup
Alexis Dieter, MD
202-877-6526
Time Frame
Start Date: 2025-03-17
Estimated Completion Date: 2028-07
Participants
Target number of participants: 596
Treatments
Experimental: Intervention - RiSolve PDTx App
Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.
Active_comparator: Control - Standard Therapy
Participants randomized to the control will receive a brief explanation of behavioral therapy with details provided in the form educational handouts including the American Urogynecologic Society (AUGS) Overactive Bladder and Pelvic Floor Muscles and Bladder Training Patient Fact Sheets.
Related Therapeutic Areas
Sponsors
Collaborators: Foundation for Female Health Awareness (FFHA)
Leads: Medstar Health Research Institute