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
1 other identifier
interventional
177
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 18, 2021
CompletedFirst Posted
Study publicly available on registry
November 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedDecember 12, 2023
December 1, 2023
2.2 years
August 18, 2021
December 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Patient Satisfaction
Treatment Satisfaction Visual Analogue Scale (TS-VAS), scale scored from 0 - 100 with 100 indicating highest satisfaction
1 year
Secondary Outcomes (5)
PGII
1 year
Incidence of Treatment-emergent adverse events (safety and tolerability)
1 year
Accumulated cost of visit to patient (Cost)
1 year
Accumulated time of visit for patient (Time)
1 year
Overactive Bladder Symptoms
1 year
Study Arms (2)
Traditional In-Person Clinic Visit Arm
PLACEBO COMPARATORPatients 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
EXPERIMENTALPatients will receive OAB treatment as described in the SUFU OAB clinical care pathway but all visits will be performed via telemedicine
Interventions
Treatment of OAB via the SUFU clinical care pathway
Eligibility Criteria
You may qualify if:
- Idiopathic overactive bladder diagnosis, both OAB wet and OAB dry
You may not qualify if:
- Active Urinary Tract Infection (UTI)
- Stage 3 or 4 prolapse
- Underlying neurologic condition contributing to OAB
- Use of catheter
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Urology, Chief, Division of Female Pelvic Medicine and Reconstructive Surgery
Study Record Dates
First Submitted
August 18, 2021
First Posted
November 11, 2021
Study Start
July 1, 2021
Primary Completion
August 31, 2023
Study Completion
August 31, 2023
Last Updated
December 12, 2023
Record last verified: 2023-12