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).
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
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
Parallel
RiSolve App
DeviceParticipants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.
AUGS Patient Handouts
BehavioralAUGS "Overactive Bladder" and "Pelvic Floor Muscles and Bladder Training" Patient Fact Sheets will be provided and reviewed.
Overactive Bladder Questionnaire short-form (OAB-q SF)
The OAB-q SF is utilized to assess the impact of OAB symptoms on the patient's life,35 and has been shown to be responsive to reductions in urinary urgency, frequency and incontinence during anticholinergic therapy.3 The scale ranges from 0 to 100 with a higher score indicating worse symptom severity. The MID is defined as a change of 10 points
OAB-q SF Health-Related Quality of Life (HRQL)
The OAB-q SF Health-Related Quality of Life (HRQL) subscale is a13-item health-related quality of life subscale of the OAB-q SF. The scale ranges from 0 to 100 with a higher score indicating better quality of life. The MID is defined as a change of 10 points.
Patient Global Impression of Severity (PGI-S)
Patient Global Impression of Severity (PGI-S) is a single item questionnaire to assess a person's impression of disease severity. For purposes of this trial, it will ask participants to "Check the one number that best describes how your urinary tract condition is now" on a 4-point Likert scale ranging from (1) "normal" to (4) "severe". The PASS threshold PGI-S score is \< 3.
Patient Global Impression of Improvement (PGI-I)
The Patient Global Impression of Improvement (PGI-I) is a single item questionnaire to assess an individual's impression of change in urinary symptoms. For purposes of this trial the PGI-S has been adapted by removing "taking medication" and it will ask participants to "Check the one number that best describes how your urinary tract condition is now, compared with how it was before you began this study" on a 7-point Likert scale ranging from (1) "very much better" to (7) "very much worse". The PASS threshold PGI-I score is \< 3.
3-Day Bladder Diary
A 3-day Bladder Diary will be an electronic bladder diary collected over a 3-day (72 hour) period focusing specifically on number of voids per day, number of voids per night, and number of urinary incontinence (UI) episodes and whether these events are associated with urgency.
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Medstar Health Research Institute
Lead sponsor
Foundation for Female Health Awareness (FFHA)
Collaborator
