Overactive Bladder Telemedicine Non-inferiority Trial

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    132
  • sponsor
    University of California, Los Angeles
Updated on 20 November 2021
Accepts healthy volunteers

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.

Details
Condition Bladder Disorders, bladder disorder, Overactive Bladder
Treatment telemedicine, SUFU Clinical Care Pathway for Overactive Bladder
Clinical Study IdentifierNCT05117918
SponsorUniversity of California, Los Angeles
Last Modified on20 November 2021

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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