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

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).

Conditions

Overactive Bladder (OAB), Urinary Urgency, Urinary Urge Incontinence (UUI), Nocturia, Urinary Frequency

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Study Overview

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Study Details

Study overview

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).

The APPROVE Trial: a Randomized Controlled Trial Evaluating the Efficacy and Safety of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women

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

Condition
Overactive Bladder (OAB)
Intervention / Treatment

-

Contacts and Locations

Washington

MedStar Health, Washington, District of Columbia, United States, 20010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medstar Health Research Institute,

Study Record Dates

2028-07