APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Recruiting
N/AInterventional Study
Overactive Bladder (OAB)Urinary UrgencyUrinary Urge Incontinence (UUI)NocturiaUrinary 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.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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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Status
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…
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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