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App-Approved: new digital therapy could ease bladder urgency in women

NCT ID NCT06797245

Symptom relief Sponsor: Medstar Health Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a prescription app called RiSolve can reduce overactive bladder symptoms in women better than standard educational handouts. About 596 women will use the app for 10 weeks or receive paper guides. Researchers will measure changes in symptom severity and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RiSolve app (a prescription digital therapeutic)
What this could lead to
If it works, this could offer women a convenient, drug-free way to manage overactive bladder symptoms at home.
What could go wrong
This is a relatively early-stage trial with no prior large-scale results. The app may not outperform simple handouts, and benefits might be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 596 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Nocturia overactive bladder Urinary Incontinence, Urge

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nocturia Overactive bladder (OAB) Urinary frequency Urinary urge incontinence (UUI) Urinary urgency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Allegheny Health

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Atrium Health Wake Forest Baptist

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Curavit

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02116, United States

  • MedStar Health

    RECRUITING

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

  • Medical University of South Carolina Health

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

    Contact Email: •••••@•••••

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35249, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53715, United States

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