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

Launched by MEDSTAR HEALTH RESEARCH INSTITUTE · Jan 22, 2025

Keywords

ClinConnect Summary

The APPROVE trial is a research study designed to help women with overactive bladder (OAB), a condition that causes frequent urges to urinate, sometimes leading to accidents. This trial is comparing a digital app called RiSolve, which provides treatment support, to standard educational materials like handouts. The goal is to see how well each option helps improve bladder symptoms, quality of life, and overall satisfaction with treatment.

To participate in the trial, women must be at least 22 years old, speak English, and have bothersome OAB symptoms that affect their daily life. Participants need to be willing to avoid other treatments (except medications) for the duration of the 8-week study. If you're selected, you will use the app or the handouts and provide feedback on your experience. This trial is currently recruiting participants, so if you or someone you know is struggling with OAB, this might be a good opportunity to consider.

Gender

FEMALE

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:
• • 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