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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Medstar Health Research Institute
Study ID
NCT06797245
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RiSolve App — DEVICE
    Participants randomized to intervention will be given access to the RiSolve PDTx app for 10 weeks after initial activation.
  • AUGS Patient Handouts — BEHAVIORAL
    AUGS "Overactive Bladder" and "Pelvic Floor Muscles and Bladder Training" Patient Fact Sheets will be provided and reviewed.

Study Details

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).

Key Dates

Start date
Mar 17, 2025
Status verified
Jun 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2028

Study Design

Enrollment
596 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35249
Elizabeth Kilpatrick
[email protected]
205-801-5830
Gabriela Halder, MD (PRINCIPAL_INVESTIGATOR)
Holly Richter, MD (SUB_INVESTIGATOR)
Gena Dunivan, MD (SUB_INVESTIGATOR)
David Ellington, MD (SUB_INVESTIGATOR)
Thomas Powell, MD (SUB_INVESTIGATOR)
Stanford UniversityPalo AltoCalifornia94304
Shyairra Dodd
[email protected]
650-497-5175
Eric Sokol, MD (PRINCIPAL_INVESTIGATOR)
MedStar HealthWashington D.C.District of Columbia20010
Kendra Green
[email protected]
(202) 997-4536
Robert Gutman, MD (PRINCIPAL_INVESTIGATOR)
Cheryl Iglesia, MD (SUB_INVESTIGATOR)
Lee Ann Richter, MD (SUB_INVESTIGATOR)
Andrew Sokol, MD (SUB_INVESTIGATOR)
Alexis Dieter, MD (SUB_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Samsel
[email protected]
773-795-8777
Margaret Mueller, MD (PRINCIPAL_INVESTIGATOR)
CuravitBostonMassachusetts02116-
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27103
Vyas
[email protected]
3336-713-4098
Candace Parker-Autry, MD (PRINCIPAL_INVESTIGATOR)
Allegheny HealthPittsburghPennsylvania15224
Winkelman
[email protected]
412-578-4368
Erin Lavelle, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South Carolina HealthCharlestonSouth Carolina29425
Payne
[email protected]
843-792-7525
Amy Askew, MD (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical CenterDallasTexas75390
Agnes Burris, RN
[email protected]
214-645-3833
Maria E. Florian-Rodriguez, MD, FACOG (PRINCIPAL_INVESTIGATOR)
University of WisconsinMadisonWisconsin53715
Rosenbaum
[email protected]
608-263-6240
Jon Pennycuff, MD (PRINCIPAL_INVESTIGATOR)

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