Status:

RECRUITING

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

Lead Sponsor:

Medstar Health Research Institute

Collaborating Sponsors:

Foundation for Female Health Awareness (FFHA)

Conditions:

Overactive Bladder (OAB)

Urinary Urgency

Eligibility:

FEMALE

22+ years

Phase:

NA

Brief 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 t...

Detailed Description

In this trial, we will employ a randomized controlled trial design to determine if women with overactive bladder (OAB) treated with the RiSolve prescription digital therapeutic (PDTx) demonstrate grea...

Eligibility Criteria

Inclusion Criteria:

  • Women ≥ 22 years old
  • Bothersome OAB symptoms (defined as bother rating ≥ 5 on ICIQ-FLUTS question #3b or #9b)
  • English-speaking
  • Willing to forego other treatment outside of medications for the 8-week trial period
  • Use of at least one mobile App

Exclusion Criteria:

  • Stress-predominant mixed urinary incontinence (defined as QUID stress score > QUID urge score)

  • Voiding dysfunction defined as response ≥ 2 on ICIQ-FLUTS question #7a

  • Bladder pain defined as response ≥ 2 on ICIQ-FLUTS question #4a

  • Use of an OAB medication (anticholinergic or beta-agonist) within the past two weeks

  • Currently using intermittent or indwelling catheter

  • History of bladder/urethral, colon/anal, or cervical cancer

  • Current or prior use of sacral neuromodulation, tibial stimulation or onabotulinum toxin type A intradetrusor injection

  • Currently taking antibiotics/drugs for urinary tract infection^

  • Currently undergoing or unwilling to forego pelvic floor physical therapy with a physical therapist or prescription device for the 8-week intervention period

  • Planning surgery for pelvic organ prolapse within 12 months of randomization

  • Pelvic surgery within the past 6 months

  • Planning to undergo pessary fitting °

    • Those on antibiotics for urinary tract infection will be eligible for enrollment 2 weeks after completing antibiotic therapy with subjective resolution of UTI symptoms °Will be eligible after completing pessary fitting

https://researchdata.medstar.net/redcap/surveys/?s=MM7WN7EXACX4PNXJ

Key Trial Info

Start Date :

March 17 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2028

Estimated Enrollment :

596 Patients enrolled

Trial Details

Trial ID

NCT06797245

Start Date

March 17 2025

End Date

July 1 2028

Last Update

October 27 2025

Active Locations (10)

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Page 1 of 3 (10 locations)

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35249

2

Stanford University

Palo Alto, California, United States, 94304

3

MedStar Health

Washington D.C., District of Columbia, United States, 20010

4

University of Chicago

Chicago, Illinois, United States, 60637