NCT06797245View on ClinicalTrials.gov

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

NARecruitingINTERVENTIONAL
Enrollment

596

Participants

Timeline

Start Date

March 17, 2025

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2028

Conditions
Overactive Bladder (OAB)Urinary UrgencyUrinary Urge Incontinence (UUI)NocturiaUrinary Frequency
Interventions
DEVICE

RiSolve App

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

BEHAVIORAL

AUGS Patient Handouts

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

Trial Locations (5)

20010

RECRUITING

MedStar Health, Washington D.C.

35249

RECRUITING

University of Alabama at Birmingham, Birmingham

75390

RECRUITING

UT Southwestern Medical Center, Dallas

94304

RECRUITING

Stanford University, Palo Alto

02116

RECRUITING

Curavit, Boston

Sponsors
All Listed Sponsors
collaborator

Foundation for Female Health Awareness (FFHA)

UNKNOWN

lead

Medstar Health Research Institute

OTHER