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Overactive Bladder Telemedicine Non-inferiority Trial (OAB Telemed)

Primary Purpose

Overactive Bladder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SUFU Clinical Care Pathway for Overactive Bladder
Telemedicine
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overactive Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCLARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Traditional In-Person Clinic Visit Arm

Telemedicine Arm

Arm Description

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

Patients will receive OAB treatment as described in the SUFU OAB clinical care pathway but all visits will be performed via telemedicine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PGII
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)
Adverse events related to treatment requiring emergency room visits, urgent care visits, hospital admissions
Accumulated cost of visit to patient (Cost)
Cost of parking, travel, and other visit-associated expenses to patient
Accumulated time of visit for patient (Time)
Time of travel to visit, time of visit, wait time of visit
Overactive Bladder Symptoms
Overactive Bladder Questionnaire Short-Form (OAB-q SF), scale from 6-36 with 36 indicating the most severe OAB symptoms

Full Information

First Posted
August 18, 2021
Last Updated
November 3, 2021
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05117918
Brief Title
Overactive Bladder Telemedicine Non-inferiority Trial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional In-Person Clinic Visit Arm
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Telemedicine Arm
Arm Type
Experimental
Arm Description
Patients will receive OAB treatment as described in the SUFU OAB clinical care pathway but all visits will be performed via telemedicine
Intervention Type
Other
Intervention Name(s)
SUFU Clinical Care Pathway for Overactive Bladder
Intervention Description
Treatment of OAB via the SUFU clinical care pathway
Intervention Type
Other
Intervention Name(s)
Telemedicine
Intervention Description
Delivery of care via telemedicine
Primary Outcome Measure Information:
Title
Patient Satisfaction
Description
Treatment Satisfaction Visual Analogue Scale (TS-VAS), scale scored from 0 - 100 with 100 indicating highest satisfaction
Time Frame
1 year
Secondary Outcome Measure Information:
Title
PGII
Description
Patient Global impression of improvement (PGII), minimum of 0, maximum of 6 with 0 indicating the patient is most improved
Time Frame
1 year
Title
Incidence of Treatment-emergent adverse events (safety and tolerability)
Description
Adverse events related to treatment requiring emergency room visits, urgent care visits, hospital admissions
Time Frame
1 year
Title
Accumulated cost of visit to patient (Cost)
Description
Cost of parking, travel, and other visit-associated expenses to patient
Time Frame
1 year
Title
Accumulated time of visit for patient (Time)
Description
Time of travel to visit, time of visit, wait time of visit
Time Frame
1 year
Title
Overactive Bladder Symptoms
Description
Overactive Bladder Questionnaire Short-Form (OAB-q SF), scale from 6-36 with 36 indicating the most severe OAB symptoms
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Weinberger
Phone
(310) 794-7700
Email
JMWeinberger@mednet.ucla.edu
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Weinberger
Phone
310-794-7700
Email
JMWeinberger@mednet.ucla.edu

12. IPD Sharing Statement

Learn more about this trial

Overactive Bladder Telemedicine Non-inferiority Trial

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