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

NCT06797245 | Recruiting DMC

• 1 other identifier: APPROVE
• Study Type: interventional
• Target: 596
• Locations: 1 country
• Sites: 10

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

Keywords

Overactive Bladder (OAB)

Outcome Measures

Primary Outcomes (1)

• 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

  8 Weeks

Secondary Outcomes (13)

• OAB-q SF Health-Related Quality of Life (HRQL)

  8 Weeks

• Patient Global Impression of Severity (PGI-S)

  8 Weeks

• Patient Global Impression of Improvement (PGI-I)

  8 Weeks

• 3-Day Bladder Diary

  8 Weeks

• Questionnaire for Urinary Incontinence Diagnosis (QUID)

  8 Weeks

Study Arms (2)

Intervention - RiSolve PDTx App

EXPERIMENTAL

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

Device: RiSolve App

Control - Standard Therapy

ACTIVE COMPARATOR

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.

Behavioral: AUGS Patient Handouts

Interventions

RiSolve App DEVICE

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

Intervention - RiSolve PDTx App

AUGS Patient Handouts BEHAVIORAL

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

Control - Standard Therapy

Eligibility Criteria

• Age: 22 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Foundation for Female Health Awareness (FFHA): collaborator

Study Sites (10)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

RECRUITING

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

MedStar Health

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

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Curavit

Boston, Massachusetts, 02116, United States

ACTIVE NOT RECRUITING

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Allegheny Health

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Medical University of South Carolina Health

Charleston, South Carolina, 29425, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

University of Wisconsin

Madison, Wisconsin, 53715, United States

RECRUITING

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MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge; Nocturia

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Central Study Contacts

Patricia Moriarty

CONTACT

202-877-0486; approvetrial@medstar.net

Alexis Dieter, MD

CONTACT

202-877-6526

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)