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Completed

NCT Number: NCT05117918

Overactive Bladder Telemedicine Non-inferiority Trial

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).

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SUFU Clinical Care Pathway for Overactive Bladder

Other

Treatment of OAB via the SUFU clinical care pathway

Telemedicine

Other

Delivery of care via telemedicine

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study 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

Acronym: OAB Telemed

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 11, 2021
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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