RiSolve App for Overactive Bladder in Women

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

Recruiting N/A Interventional Study
Overactive Bladder (OAB) Urinary Urgency Urinary Urge Incontinence (UUI) Nocturia Urinary Frequency
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
22 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
596 (estimated)
Sponsor
Medstar Health Research Institute · Other
Who this trial is looking for

This trial is looking for women with bothersome overactive bladder symptoms. Participants will use a digital app called RiSolve for 8 weeks and will not use other treatments during this time.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am a woman aged 22 or older.
  • I have bothersome overactive bladder symptoms.
  • I can speak English.
  • I am willing to stop other treatments for 8 weeks.
  • I use at least one mobile app.

You may not be able to join if

  • I have a history of stress-predominant mixed urinary incontinence.
  • I have voiding dysfunction.
  • I have bladder pain.
  • I used overactive bladder medication in the last two weeks.
  • I currently use a catheter.
  • I have a history of bladder, colon, or cervical cancer.
  • I have received certain bladder treatments like sacral neuromodulation or Botox.
  • I am currently taking antibiotics for a urinary tract infection.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Check Your Eligibility
About This Trial

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 Locations
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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: * St…
Contacts

Patricia Moriarty

202-877-0486

approvetrial@medstar.net

CONTACT

Alexis Dieter, MD

202-877-6526

CONTACT