Evaluating a digital app for treating overactive bladder in women
The APPROVE Trial: A Randomized Controlled Trial Evaluating the Efficacy and Safety of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women
This study is testing a new app designed to help women with overactive bladder by providing therapy techniques to see if it can improve their symptoms better than regular educational materials.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 596 (estimated) |
| Ages | 22 Years and up |
| Sex | Female |
| Sponsor | Medstar Health Research Institute Academic / other |
| Locations | 10 sites (Birmingham, Alabama and 9 other locations) |
| Trial ID | NCT06797245 on ClinicalTrials.gov |
What this trial studies
The APPROVE trial is a multi-centered, randomized controlled trial aimed at assessing the effectiveness of a prescription digital therapeutic app called RiSolve in improving symptoms of overactive bladder (OAB) in women. Participants will be randomized to receive either the RiSolve app, which provides behavioral and cognitive behavioral therapy, or standard behavioral education through informational handouts. The primary outcome will be measured by improvements in OAB-related health after 8 weeks, with secondary outcomes including quality of life and symptom severity. This innovative approach seeks to enhance treatment options for women suffering from OAB.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 22 and older who experience bothersome symptoms of overactive bladder.
Not a fit: Patients with stress-predominant mixed urinary incontinence or significant bladder pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide women with a new, effective digital treatment option for managing overactive bladder symptoms.
How similar studies have performed: Other studies have shown promise in using digital therapeutics for various conditions, suggesting potential success for this novel approach in treating OAB.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Stress-predominant mixed urinary incontinence (defined as QUID stress score \> QUID urge score) * Voiding dysfunction defined as response ≥ 2 on ICIQ-FLUTS question #7a * Bladder pain defined as response ≥ 2 on ICIQ-FLUTS question #4a * Use of an OAB medication (anticholinergic or beta-agonist) within the past two weeks * Currently using intermittent or indwelling catheter * History of bladder/urethral, colon/anal, or cervical cancer * Current or prior use of sacral neuromodulation, tibial stimulation or onabotulinum toxin type A intradetrusor injection * Currently taking antibiotics/drugs for urinary tract infection\^ * Currently undergoing or unwilling to forego pelvic floor physical therapy with a physical therapist or prescription device for the 8-week intervention period * Planning surgery for pelvic organ prolapse within 12 months of randomization * Pelvic surgery within the past 6 months * Planning to undergo pessary fitting ° * Those on antibiotics for urinary tract infection will be eligible for enrollment 2 weeks after completing antibiotic therapy with subjective resolution of UTI symptoms °Will be eligible after completing pessary fitting https://researchdata.medstar.net/redcap/surveys/?s=MM7WN7EXACX4PNXJ
Where this trial is running
Birmingham, Alabama and 9 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Stanford University — Palo Alto, California, United States (Recruiting)
- MedStar Health — Washington D.C., District of Columbia, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- Curavit — Boston, Massachusetts, United States (Active_not_recruiting)
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (Recruiting)
- Allegheny Health — Pittsburgh, Pennsylvania, United States (Recruiting)
- Medical University of South Carolina Health — Charleston, South Carolina, United States (Recruiting)
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Patricia Moriarty
- Email: approvetrial@medstar.net
- Phone: 202-877-0486
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.