NCT06797245 APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
| NCT ID | NCT06797245 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medstar Health Research Institute |
| Condition | Overactive Bladder (OAB) |
| Study Type | INTERVENTIONAL |
| Enrollment | 596 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 596 participants in total. It began in 2025-03-17 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06797245 clinical trial?
This trial is open to female participants only, aged 22 Years or older, studying Overactive Bladder (OAB). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06797245 currently recruiting?
Yes, NCT06797245 is actively recruiting participants. Contact the research team at approvetrial@medstar.net for enrollment information.
Where is the NCT06797245 trial being conducted?
This trial is being conducted at Birmingham, United States, Palo Alto, United States, Washington D.C., United States, Chicago, United States and 6 additional locations.
Who is sponsoring the NCT06797245 clinical trial?
NCT06797245 is sponsored by Medstar Health Research Institute. The trial plans to enroll 596 participants.