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

Study acronym: APPROVE
StatusRecruiting
PhaseNot applicable
Started
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 5 to 10v8
  2. Study sites: 3 to 5v7
  3. Study sites: 2 to 3v6
  4. Site contacts updated at 1 of 2 sites
    • Eligibility criteria expanded, about 1 word
    v5
  5. Study sites: 1 to 2v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2025 to Mar 17, 2025
    • Site details revised
    v3
  2. Trial status: Recruiting to Not Yet Recruiting
    • Start date: Feb 2025 to Mar 2025
    • Site details revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06797245
Lead Sponsor Medstar Health Research Institute
Collaborators: Foundation for Female Health Awareness
Conditions
(from sponsor)		 Overactive Bladder (OAB), Urinary Urgency, Urinary Urge Incontinence (UUI), Nocturia, Urinary Frequency
Related terms Nocturia, Urinary Bladder, Overactive, Urinary Incontinence, Urge
Enrollment 596 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov