Overactive Bladder Telemedicine Non-inferiority Trial

University of California, Los Angeles177 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

177

Conditions

Overactive Bladder

Interventions

SUFU Clinical Care Pathway for Overactive BladderOTHER

Treatment of OAB via the SUFU clinical care pathway

TelemedicineOTHER

Delivery of care via telemedicine

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UCLA

Los Angeles, California, United States

Outcomes

Primary Outcomes

Patient Satisfaction

Treatment Satisfaction Visual Analogue Scale (TS-VAS), scale scored from 0 - 100 with 100 indicating highest satisfaction

Time frame: 1 year

Secondary Outcomes

PGII

Patient Global impression of improvement (PGII), minimum of 0, maximum of 6 with 0 indicating the patient is most improved

Time frame: 1 year

Incidence of Treatment-emergent adverse events (safety and tolerability)

Adverse events related to treatment requiring emergency room visits, urgent care visits, hospital admissions

Time frame: 1 year

Accumulated cost of visit to patient (Cost)

Cost of parking, travel, and other visit-associated expenses to patient

Time frame: 1 year

Accumulated time of visit for patient (Time)

Time of travel to visit, time of visit, wait time of visit

Time frame: 1 year

Overactive Bladder Symptoms

Overactive Bladder Questionnaire Short-Form (OAB-q SF), scale from 6-36 with 36 indicating the most severe OAB symptoms

Time frame: 1 year

Data from ClinicalTrials.gov

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