RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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

Quick Facts

Study Start:2025-03-17
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06797245

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.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women ≥ 22 years old
  2. * Bothersome OAB symptoms (defined as bother rating ≥ 5 on ICIQ-FLUTS question #3b or #9b)
  3. * English-speaking
  4. * Willing to forego other treatment outside of medications for the 8-week trial period
  5. * Use of at least one mobile App
  1. * Stress-predominant mixed urinary incontinence (defined as QUID stress score \> QUID urge score)
  2. * Voiding dysfunction defined as response ≥ 2 on ICIQ-FLUTS question #7a
  3. * Bladder pain defined as response ≥ 2 on ICIQ-FLUTS question #4a
  4. * Use of an OAB medication (anticholinergic or beta-agonist) within the past two weeks
  5. * Currently using intermittent or indwelling catheter
  6. * History of bladder/urethral, colon/anal, or cervical cancer
  7. * Current or prior use of sacral neuromodulation, tibial stimulation or onabotulinum toxin type A intradetrusor injection
  8. * Currently taking antibiotics/drugs for urinary tract infection\^
  9. * Currently undergoing or unwilling to forego pelvic floor physical therapy with a physical therapist or prescription device for the 8-week intervention period
  10. * Planning surgery for pelvic organ prolapse within 12 months of randomization
  11. * Pelvic surgery within the past 6 months
  12. * Planning to undergo pessary fitting °
  13. * 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

Contacts and Locations

Study Contact

Melissa G Goodwin
CONTACT
202-877-6502
melissa.g.goodwin@medstar.net
Alexis Dieter, MD
CONTACT
2027-877-6526

Study Locations (Sites)

MedStar Health
Washington, District of Columbia, 20010
United States

Collaborators and Investigators

Sponsor: Medstar Health Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-17
Study Completion Date2028-07

Study Record Updates

Study Start Date2025-03-17
Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

  • Overactive Bladder (OAB)

Additional Relevant MeSH Terms

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