Overactive Bladder Telemedicine Non-inferiority Trial (OAB Telemed)

A Prospective Study Evaluating the Feasibility of Telemedicine Use in the Overactive Bladder Clinical Care Pathway: a Non-inferiority Study Assessing Patient Satisfaction and Progression to Third Line Overactive Bladder Therapies

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).

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Other: SUFU Clinical Care Pathway for Overactive Bladder; Other: Telemedicine

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Traditional In-Person Clinic Visit Arm; 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	Other: SUFU Clinical Care Pathway for Overactive Bladder; Treatment of OAB via the SUFU clinical care pathway
Experimental: Telemedicine Arm; Patients will receive OAB treatment as described in the SUFU OAB clinical care pathway but all visits will be performed via telemedicine	Other: SUFU Clinical Care Pathway for Overactive Bladder; Treatment of OAB via the SUFU clinical care pathway; Other: Telemedicine; Delivery of care via telemedicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Treatment Satisfaction Visual Analogue Scale (TS-VAS), scale scored from 0 - 100 with 100 indicating highest satisfaction	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PGII	Patient Global impression of improvement (PGII), minimum of 0, maximum of 6 with 0 indicating the patient is most improved	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	1 year
Accumulated cost of visit to patient (Cost)	Cost of parking, travel, and other visit-associated expenses to patient	1 year
Accumulated time of visit for patient (Time)	Time of travel to visit, time of visit, wait time of visit	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	1 year

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive
• Other Study ID Numbers: 21-000458

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No