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New treatment option for Overactive Bladder (OAB)
Official title APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
ClinicalTrials.gov ID: NCT06797245
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Palo Alto, California, United States
- Washington D.C., District of Columbia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Winston-Salem, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- Charleston, South Carolina, United States
- Dallas, Texas, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Palo Alto, California, United States; Washington D.C., District of Columbia, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Winston-Salem, North Carolina, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.