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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05117918
Other study ID # 21-000458
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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