Actively Recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Led by Medstar Health Research Institute · Updated on 2025-10-27
596
Participants Needed
10
Research Sites
171 weeks
Total Duration
On this page
Sponsors
M
Medstar Health Research Institute
Lead Sponsor
F
Foundation for Female Health Awareness (FFHA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women 22 years old or older
- Experiencing bothersome overactive bladder symptoms (bother rating of 5 or more on specific symptom questions)
- Able to speak and understand English
- Willing to avoid other non-medication treatments for 8 weeks during the trial
- Regular user of at least one mobile app
You will not qualify if you...
- Stress-predominant mixed urinary incontinence (stress symptoms greater than urge symptoms)
- Voiding dysfunction as indicated by responses to symptom questionnaire
- Bladder pain indicated by responses to symptom questionnaire
- Use of overactive bladder medications within the past 2 weeks
- Current use of intermittent or indwelling catheter
- History of bladder, urethral, colon, anal, or cervical cancer
- Current or prior use of sacral neuromodulation, tibial stimulation, or botulinum toxin injections for bladder
- Current treatment with antibiotics or drugs for urinary tract infection
- Undergoing or unwilling to avoid pelvic floor physical therapy or prescription devices during the 8-week treatment
- Planned pelvic organ prolapse surgery within 12 months
- Pelvic surgery within the past 6 months
- Planned pessary fitting (eligible after fitting completed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Actively Recruiting
2
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
3
MedStar Health
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
4
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Curavit
Boston, Massachusetts, United States, 02116
Active, Not Recruiting
6
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
7
Allegheny Health
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
8
Medical University of South Carolina Health
Charleston, South Carolina, United States, 29425
Actively Recruiting
9
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
10
University of Wisconsin
Madison, Wisconsin, United States, 53715
Actively Recruiting
Research Team
P
Patricia Moriarty
CONTACT
A
Alexis Dieter, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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