Overactive Bladder Telemedicine Non-inferiority Trial (OAB Telemed)

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Overactive Bladder

Treatments: Other: SUFU Clinical Care Pathway for Overactive Bladder; Other: Telemedicine

Study type: Interventional

Funder types: Other

Identifiers

NCT05117918

21-000458

Details and patient eligibility

About

In this study, the investigators aim to validate the telemedicine paradigm as a feasible alternative to traditional in-person clinic visits for the management of overactive bladder (OAB).

Full description

This is a single-center, prospective randomized controlled trial. The study population will consist of two primary cohorts stratified based on the method of follow-up, either traditional in-person clinic visit or telemedicine appointment. The primary outcome will be satisfaction with OAB treatment. Secondary endpoints include rate of progression to third line therapies, changes in OAB symptom scores, safety, and cost. This non-inferiority trial is designed to provide an alternative option for care delivery that may result in improved patient satisfaction and compliance, and decreased cost, time, and travel burden for patients.

Enrollment: 177 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Idiopathic overactive bladder diagnosis, both OAB wet and OAB dry

Exclusion criteria

• Active Urinary Tract Infection (UTI)
• Stage 3 or 4 prolapse
• Underlying neurologic condition contributing to OAB
• Use of catheter

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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177 participants in 2 patient groups, including a placebo group

Traditional In-Person Clinic Visit Arm

Placebo Comparator group

Description:

Patients will receive overactive bladder (OAB) treatment as described in the Society for Urodynamics and Female Pelvic Medicine and Urogenital Reconstruction (SUFU) OAB clinical care pathway. These patients will have all visits in-person

Treatment:

Other: SUFU Clinical Care Pathway for Overactive Bladder

Telemedicine Arm

Experimental group

Description:

Patients will receive OAB treatment as described in the SUFU OAB clinical care pathway but all visits will be performed via telemedicine

Treatment:

Other: SUFU Clinical Care Pathway for Overactive Bladder

Other: Telemedicine