Overactive Bladder Telemedicine Non-inferiority Trial

Overactive Bladder Clinical Trial

— OAB Telemed  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05117918
• Other study ID #: 21-000458
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: December 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Other:
• SUFU Clinical Care Pathway for Overactive Bladder
Treatment of OAB via the SUFU clinical care pathway
• Telemedicine
Delivery of care via telemedicine

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction	Treatment Satisfaction Visual Analogue Scale (TS-VAS), scale scored from 0 - 100 with 100 indicating highest satisfaction	1 year
Secondary	PGII	Patient Global impression of improvement (PGII), minimum of 0, maximum of 6 with 0 indicating the patient is most improved	1 year
Secondary	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
Secondary	Accumulated cost of visit to patient (Cost)	Cost of parking, travel, and other visit-associated expenses to patient	1 year
Secondary	Accumulated time of visit for patient (Time)	Time of travel to visit, time of visit, wait time of visit	1 year
Secondary	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