Overactive Bladder Telemedicine Non-inferiority Trial

Not Applicable

Completed

• Conditions: Overactive Bladder
• Interventions: Other: SUFU Clinical Care Pathway for Overactive Bladder; Other: Telemedicine

• Registration Number: NCT05117918
• Lead Sponsor: University of California, Los Angeles

Brief 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).

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 Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-11
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedicine Arm	SUFU Clinical Care Pathway for Overactive Bladder	Patients will receive OAB treatment as described in the SUFU OAB clinical care pathway but all visits will be performed via telemedicine
Traditional In-Person Clinic Visit Arm	SUFU Clinical Care Pathway for Overactive Bladder	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
Telemedicine Arm	Telemedicine	Patients will receive OAB treatment as described in the SUFU OAB clinical care pathway but all visits will be performed via telemedicine

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
PGII	1 year	Patient Global impression of improvement (PGII), minimum of 0, maximum of 6 with 0 indicating the patient is most improved
Incidence of Treatment-emergent adverse events (safety and tolerability)	1 year	Adverse events related to treatment requiring emergency room visits, urgent care visits, hospital admissions
Overactive Bladder Symptoms	1 year	Overactive Bladder Questionnaire Short-Form (OAB-q SF), scale from 6-36 with 36 indicating the most severe OAB symptoms
Accumulated cost of visit to patient (Cost)	1 year	Cost of parking, travel, and other visit-associated expenses to patient
Accumulated time of visit for patient (Time)	1 year	Time of travel to visit, time of visit, wait time of visit

Trial Locations

Locations (1)

UCLA; 🇺🇸 Los Angeles, California, United States