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APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
NCT06797245 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DEVICE RiSolve App
- BEHAVIORAL AUGS Patient Handouts
Study Locations (10)
Alabama
- University of Alabama at Birmingham — Birmingham
California
- Stanford University — Palo Alto
District of Columbia
- MedStar Health — Washington D.C.
Illinois
- University of Chicago — Chicago
Massachusetts
- Curavit — Boston
North Carolina
- Atrium Health Wake Forest Baptist — Winston-Salem
Pennsylvania
- Allegheny Health — Pittsburgh
South Carolina
- Medical University of South Carolina Health — Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 596 participants |
| Start Date | 2025-03-17 |
| Est. Completion | 2028-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06797245
The ClinicalTrials.gov registry entry for NCT06797245 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 596 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medstar Health Research Institute, which has 130 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Nocturia appearing as the primary indexed condition, and to 2 interventions — of which RiSolve App is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06797245 reports 10 study locations spanning 10 distinct geographic areas — top geographies include Alabama, California, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06797245 about?
NCT06797245 is a clinical study titled "APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women". 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 therap...
What is the current status of trial NCT06797245?
This trial is currently recruiting. It is a NA study. The enrollment target is 596 participants. The study started on 2025-03-17. Estimated completion is 2028-07.
What conditions does trial NCT06797245 study?
This clinical trial studies the following conditions: Nocturia, Overactive Bladder (OAB), Urinary Frequency, Urinary Urgency, Urinary Urge Incontinence (UUI). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06797245?
The interventions under investigation include: RiSolve App (DEVICE), AUGS Patient Handouts (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06797245?
This trial is sponsored by Medstar Health Research Institute, which has 130 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06797245 being conducted?
This trial has 10 study locations across Alabama, California, District of Columbia, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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