Recruiting

Digital Therapeutic

Sponsor:

Medstar Health Research Institute

Code:

NCT06797245

Conditions

Overactive Bladder (OAB)

Urinary Urgency

Urinary Urge Incontinence (UUI)

Nocturia

Urinary Frequency

Eligibility Criteria

Sex: Female

Age: 22+

Healthy Volunteers: Not accepted

Interventions

RiSolve App

AUGS Patient Handouts

Study Details

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).

Conditions

Overactive Bladder (OAB)

Urinary Urgency

Urinary Urge Incontinence (UUI)

Nocturia

Urinary Frequency

Study ID

NCT06797245

Start date

Mar 17, 2025

Status verified date

Jun, 2025

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

596 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention - RiSolve PDTx App

Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.

active comparator: Control - Standard Therapy

Participants randomized to the control will receive a brief explanation of behavioral therapy with details provided in the form educational handouts including the American Urogynecologic Society (AUGS) "Overactive Bladder" and "Pelvic Floor Muscles and Bladder Training" Patient Fact Sheets.

Interventions

RiSolve App

Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.

AUGS Patient Handouts

AUGS "Overactive Bladder" and "Pelvic Floor Muscles and Bladder Training" Patient Fact Sheets will be provided and reviewed.

Primary outcome measure

  • Overactive Bladder Questionnaire short-form (OAB-q SF) [ Time Frame: 8 Weeks ]

Central Contacts and Locations

Central contacts

Patricia Moriarty

202-877-0486approvetrial@medstar.net

Alexis Dieter, MD

202-877-6526

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35249

Contacts

Elizabeth Kilpatrick

205-801-5830ekilpatrick@uabmc.edu

Principal Investigator:

Gabriela Halder, MD

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Shyairra Dodd

650-497-5175gynresearch@stanford.edu

Principal Investigator:

Eric Sokol, MD

MedStar Health

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Kendra Green

(202) 997-4536kendra.s.green@medstar.net

Principal Investigator:

Robert Gutman, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Samsel

773-795-8777tara.samsel@bsd.uchicago.edu

Principal Investigator:

Margaret Mueller, MD

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Vyas

3336-713-4098svyas@wakehealth.edu

Principal Investigator:

Candace Parker-Autry, MD

Allegheny Health

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Winkelman

412-578-4368Monica.Winkelman@ahn.org

Principal Investigator:

Erin Lavelle, MD

Medical University of South Carolina Health

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Payne

843-792-7525paynej@musc.edu

Principal Investigator:

Amy Askew, MD

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Agnes Burris, RN

214-645-3833agnes.burris@utsouthwestern.edu

Principal Investigator:

Maria E. Florian-Rodriguez, MD, FACOG

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53715

Contacts

Rosenbaum

608-263-6240lrosenbaum2@wisc.edu

Principal Investigator:

Jon Pennycuff, MD

More Information

Sponsor

Medstar Health Research Institute

Last update posted

Oct 27, 2025

Last verified

Jun, 2025

Keywords

  • Overactive Bladder (OAB)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2025-10-27.