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NCT06797245 · ClinicalTrials.gov registry record · NA
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
A NA study of Nocturia and Overactive Bladder (OAB), sponsored by Medstar Health Research Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 596
- Enrollment target
- 10
- Study locations
NCT06797245: Recruiting NA study of Nocturia and Overactive Bladder (OAB), sponsored by Medstar Health Research Institute.
NCT06797245 is a NA study of Nocturia and Overactive Bladder (OAB) that is actively recruiting participants, run by Medstar Health Research Institute. The registered enrollment target is 596 participants, above the 250-participant average among 9 other Nocturia trials with a reported enrollment target (138% higher). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06797245, a NA study of Nocturia and Overactive Bladder (OAB), is actively recruiting participants, sponsored by Medstar Health Research Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 596 participants
- Enrollment target
- 10
- Study locations
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).
Primary Outcome
The OAB-q SF is utilized to assess the impact of OAB symptoms on the patient's life,35 and has been shown to be responsive to reductions in urinary urgency, frequency and incontinence during anticholinergic therapy.3 The scale ranges from 0 to 100 with a higher score indicating worse symptom severity. The MID is defined as a change of 10 points
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 |
What NCT06797245 shows while recruiting
NCT06797245 is an interventional study that assigns participants to a tested intervention. The registered 596 participants enrollment target is mid-sized for trials with a published cap, above the 250-participant average among 9 other Nocturia trials with a reported enrollment target (138% higher).
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.
NCT06797245 lists 10 locations in 10 states (Alabama, California, District of Columbia).
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).
What interventions are being tested in trial NCT06797245?
The interventions under investigation include: RiSolve App (DEVICE), AUGS Patient Handouts (BEHAVIORAL).
Who is sponsoring clinical trial NCT06797245?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06797245's enrollment target sits among peer trials
596 2nd of 9 the highest of 9 other Nocturia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nocturia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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