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Overactive Bladder Telemedicine Non-inferiority Trial (OAB Telemed)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05117918
Recruitment Status : Recruiting
First Posted : November 11, 2021
Last Update Posted : November 11, 2021
Sponsor:
Information provided by (Responsible Party):
Victor W. Nitti, MD, 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).

Condition or disease Intervention/treatment Phase
Overactive Bladder Other: SUFU Clinical Care Pathway for Overactive Bladder Other: Telemedicine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Telehealth

Arm Intervention/treatment
Placebo Comparator: Traditional In-Person Clinic Visit Arm
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
Other: SUFU Clinical Care Pathway for Overactive Bladder
Treatment of OAB via the SUFU clinical care pathway

Experimental: Telemedicine Arm
Patients will receive OAB treatment as described in the SUFU OAB clinical care pathway but all visits will be performed via telemedicine
Other: SUFU Clinical Care Pathway for Overactive Bladder
Treatment of OAB via the SUFU clinical care pathway

Other: Telemedicine
Delivery of care via telemedicine




Primary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: 1 year ]
    Treatment Satisfaction Visual Analogue Scale (TS-VAS), scale scored from 0 - 100 with 100 indicating highest satisfaction


Secondary Outcome Measures :
  1. PGII [ Time Frame: 1 year ]
    Patient Global impression of improvement (PGII), minimum of 0, maximum of 6 with 0 indicating the patient is most improved

  2. Incidence of Treatment-emergent adverse events (safety and tolerability) [ Time Frame: 1 year ]
    Adverse events related to treatment requiring emergency room visits, urgent care visits, hospital admissions

  3. Accumulated cost of visit to patient (Cost) [ Time Frame: 1 year ]
    Cost of parking, travel, and other visit-associated expenses to patient

  4. Accumulated time of visit for patient (Time) [ Time Frame: 1 year ]
    Time of travel to visit, time of visit, wait time of visit

  5. Overactive Bladder Symptoms [ Time Frame: 1 year ]
    Overactive Bladder Questionnaire Short-Form (OAB-q SF), scale from 6-36 with 36 indicating the most severe OAB symptoms



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05117918


Contacts
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Contact: James Weinberger (310) 794-7700 JMWeinberger@mednet.ucla.edu

Locations
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United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: James Weinberger    310-794-7700    JMWeinberger@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
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Responsible Party: Victor W. Nitti, MD, Professor of Urology, Chief, Division of Female Pelvic Medicine and Reconstructive Surgery, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT05117918    
Other Study ID Numbers: 21-000458
First Posted: November 11, 2021    Key Record Dates
Last Update Posted: November 11, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations