CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials.
Kenneth F Schulz, Douglas G Altman, David Moher...
https://pubmed.ncbi.nlm.nih.gov/20410783Actively Recruiting
Phase Not Applicable
Age: 22Years +
FEMALE
ID06797245
The APPROVE Trial: Evaluating a Prescription Digital Therapeutic App Compared to Standard Behavioral Education for Overactive Bladder in Women
Led by Medstar Health Research Institute · Updated on 2025-10-27
596
Participants Needed
10
Research Sites
104 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
Researchers are evaluating the effectiveness of a prescription digital therapeutic app called RiSolve compared to standard behavioral education through informational handouts for women with overactive bladder (OAB). This trial focuses on women diagnosed with OAB, including symptoms like urinary urgency, urge urinary incontinence, urinary frequency, nocturia, and mixed incontinence with predominant OAB symptoms. The study aims to assess improvements in symptoms, quality of life, bladder function, patient satisfaction, and ongoing treatment effects. Participants are randomly assigned to one of two groups: one group receives access to the RiSolve app for 10 weeks following activation, which offers behavioral therapy and cognitive behavioral therapy for OAB; the other group receives standard behavioral education via patient handouts from the American Urogynecologic Society. After the initial 8 weeks, those in the control group may choose to switch to the RiSolve app treatment. The trial includes follow-up assessments at 6 and 12 months to monitor ongoing symptoms. During the study, participants will complete questionnaires such as the Overactive Bladder Questionnaire short-form (OAB-q SF) to measure symptom severity and quality of life, bladder diaries, and other validated tools to assess urinary symptoms and treatment satisfaction. Researchers will also track treatment adherence, accessibility, adverse events, and use of other therapies. The primary outcome is measured after 8 weeks, with continued symptom evaluation throughout the 12-month follow-up period to gather comprehensive data on treatment effects and patient experience.
CONDITIONS
Brief Title
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Who Can Participate
Age: 22Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Women aged 22 years or older
- Experiencing bothersome overactive bladder symptoms as defined by specific questionnaire ratings
- Able to speak English
- Willing to avoid other treatments outside of medications during the 8-week trial period
- Use at least one mobile app on a personal device
You will not qualify if you...
- Stress-predominant mixed urinary incontinence
- Voiding dysfunction as indicated by questionnaire responses
- Bladder pain as indicated by questionnaire responses
- Use of overactive bladder medications within the past two weeks
- Current use of intermittent or indwelling catheter
- History of bladder, urethral, colon, anal, or cervical cancer
- Previous use of sacral neuromodulation, tibial stimulation, or certain botulinum toxin injections
- Currently taking antibiotics or drugs for urinary tract infections
- Undergoing or unwilling to avoid pelvic floor physical therapy or prescription devices during the 8-week period
- Planning pelvic organ prolapse surgery within 12 months
- Pelvic surgery within the past 6 months
- Planning to undergo pessary fitting during the study period (eligible after fitting or completing antibiotic therapy)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 10 weeks
Participants receive either access to the RiSolve prescription digital therapeutic app or standard behavioral education with informational handouts for overactive bladder management.
1 baseline visit and multiple remote app interactions or education sessions
Follow-up
Duration - Up to 12 months
Participants are followed and asked about their symptoms and any treatments at 6 and 12 months after treatment.
2 follow-up visits
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
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Research Team
P
Patricia Moriarty
A
Alexis Dieter, MD
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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