Back to search results

APPROVE Trial: Evaluating RiSolve for Overactive Bladder in Women

The APPROVE trial is studying a new digital therapy called RiSolve for women with overactive bladder (OAB). OAB can cause symptoms like a sudden, strong need to urinate (urinary urgency), leaking urine (urinary urge incontinence), needing to urinate often, and waking up at night to urinate (nocturia). This study will compare the RiSolve app to standard educational handouts. We want to see if the RiSolve app can better improve OAB symptoms and quality of life. To join, you must be a woman at least 22 years old, speak English, have bothersome OAB symptoms, and be willing to use a mobile app. The study is currently recruiting 596 participants.

Study design
This is a randomized controlled trial involving 596 women. Participants will be randomly assigned to either use the RiSolve app or receive educational handouts.
What's involved
Participants assigned to the RiSolve app will use it for 10 weeks. All participants will have their OAB symptoms and quality of life measured at 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 8 weeks after treatment begins.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06797245

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

Recruiting
NAAges 22+InterventionalTreatment
Medstar Health Research Institute
~596 participants
Updated 2025-10-27 on ClinicalTrials.gov
What's tested:RiSolve AppAUGS Patient Handouts

At a glance

Recruiting sites
9 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overactive Bladder Questionnaire short-form (OAB-q SF)
Measured over 8 Weeks

Conditions

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

Explore related trials

Overactive Bladder

Where it's being run

10 sites across 10 states
Alabama1
California1
District of Columbia1
Illinois1
Massachusetts1
North Carolina1
Pennsylvania1
South Carolina1

Who to contact

Patricia Moriarty
[email protected]
202-877-0486
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Overactive Bladder Questionnaire short-form (OAB-q SF)8 Weeks

    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