Clinical trial NCT06797245: APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Official title: The APPROVE Trial: A Randomized Controlled Trial Evaluating the Efficacy and Safety of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overactive Bladder (OAB)
Urinary Urgency
Urinary Urge Incontinence (UUI)
Nocturia
Urinary Frequency
Keywords: Overactive Bladder (OAB)
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Foundation for Female Health Awareness (FFHA)
First posted: 2025-01-28
Enrollment: 596
Sex: FEMALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: In this trial, we will employ a randomized controlled trial design to determine if women with overactive bladder (OAB) treated with the RiSolve prescription digital therapeutic (PDTx) demonstrate greater improvement in OAB-related health as compared to standard behavioral education with informational handouts. RiSolve is a digital therapeutic device intended to provide behavioral therapy and cognitive behavioral therapy (CBT) for adult women who have been diagnosed with OAB, which includes urinary urgency with or without urge urinary incontinence (UUI), urinary frequency, nocturia, and mixed incontinence with predominant OAB symptoms. RiSolve is indicated as an 8-week treatment to reduce the symptoms of OAB.

For the purposes of this trial, the primary outcome to determine improvement in OAB-related health will be defined as achieving the MID (defined as an improvement of 10 points or more) on the OAB-q SF Symptom Severity subscale after 8 weeks of treatment. Secondary outcomes will include achieving the MID on the OAB-q SF Health-Related Quality of Life subscale, meeting the patient's acceptable symptoms state (PASS) on the Patient Global Impression of Severity (PGI-S) and Patient Global Impression of Improvement (PGI-I), and improvements in frequency, nocturia and urge urinary incontinence (UUI) on a 3-day bladder diary and on the ICIQ-FLUTS. Participants will be randomized to either PDTx therapy (active) or standard treatment of behavioral education (control). Participants randomized to control will have the option to crossover to PDTx after the initial 8 weeks of the trial if desired. Participants will continue to be followed and asked about their symptoms at 6 and 12 months.

The impact of this trial has enormous potential to improve treatment of OAB. The ability to offer behavioral therapy via PDTx will reduce patient burden while simultaneously increasing quality of life for women suffering from OAB and decreasing provider burden. The high-quality data from this study will be used to support a marketing application with the FDA through the De Novo pathway for an accessible, low-burden, efficient intervention to help millions of women currently suffering from this burdensome condition.

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

Primary outcomes:
measure: Overactive Bladder Questionnaire short-form (OAB-q SF)
timeFrame: 8 Weeks
Secondary outcomes:
measure: OAB-q SF Health-Related Quality of Life (HRQL)
timeFrame: 8 Weeks
measure: Patient Global Impression of Severity (PGI-S)
timeFrame: 8 Weeks
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: 8 Weeks
measure: 3-Day Bladder Diary
timeFrame: 8 Weeks
measure: Questionnaire for Urinary Incontinence Diagnosis (QUID)
timeFrame: 8 Weeks
measure: International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
timeFrame: 8 Weeks
measure: Short Personal Experience Questionnaire (SPEQ)
timeFrame: 8 Weeks
measure: Mobile Application Rating Scale: user version (uMARS)
timeFrame: 8 Weeks
measure: Treatment Satisfaction
timeFrame: 8 Weeks
measure: Treatment accessibility
timeFrame: 8 Weeks
measure: Treatment adherence
timeFrame: 8 Weeks
measure: Other Treatments
timeFrame: 12 Months
measure: Adverse Events
timeFrame: 12 Months
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Health
state: District of Columbia
city: Boston
country: United States
facility: Curavit
state: Massachusetts
Study officials:
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