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

NCT06797245 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 596

Last updated 2025-10-27

No results posted yet for this 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

  • Overactive Bladder (OAB)
  • Urinary Urgency
  • Urinary Urge Incontinence (UUI)
  • Nocturia
  • Urinary Frequency

Interventions

DEVICE

RiSolve App

Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.

BEHAVIORAL

AUGS Patient Handouts

AUGS "Overactive Bladder" and "Pelvic Floor Muscles and Bladder Training" Patient Fact Sheets will be provided and reviewed.

Sponsors & Collaborators

  • Foundation for Female Health Awareness (FFHA)

    collaborator UNKNOWN

  • Medstar Health Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2026-07-31
Completion
2028-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06797245 on ClinicalTrials.gov