Clinical Trial

APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women

Study acronym: APPROVE
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated October 27, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2025-01-22; most recent amendment 2025-10-24.
Status change: Not Yet Recruiting → Recruiting 2025-03-19
Status change: Recruiting → Not Yet Recruiting 2025-02-20
Trial Details
NCT Number NCT06797245
Lead Sponsor Medstar Health Research Institute
Collaborators: Foundation for Female Health Awareness
Conditions Overactive Bladder (OAB), Urinary Urgency, Urinary Urge Incontinence (UUI), Nocturia, Urinary Frequency
Enrollment 596 participants
Start Date 2025-03-17
Primary Completion 2026-07 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2025-10-27