NCT06797245 · Medstar Health Research Institute
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
(APPROVE)
What this study is about
The APPROVE trial is a multi-centered, randomly assigned controlled trial designed to assess differences in symptom improvement, quality of life, bladder symptoms, satisfaction with treatment and continued treatment effectiveness in women with overactive bladder (OAB) randomly assigned to a prescription digital therapeutic (PDTx) app called RiSolve compared to standard behavioral education (handouts).
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Palo Alto, California
- Washington D.C., District of Columbia
- Chicago, Illinois
- Boston, Massachusetts
- Winston-Salem, North Carolina
- Pittsburgh, Pennsylvania
- Charleston, South Carolina
- Dallas, Texas
- Madison, Wisconsin
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 27, 2025 · Source of record for eligibility and locations