MedDataX Logo

Overactive Bladder Telemedicine Non-inferiority Trial

NCT ID: NCT05117918

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overactive Bladder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type PLACEBO_COMPARATOR

SUFU Clinical Care Pathway for Overactive Bladder

Intervention Type OTHER

Treatment of OAB via the SUFU clinical care pathway

Telemedicine Arm

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

Group Type EXPERIMENTAL

SUFU Clinical Care Pathway for Overactive Bladder

Intervention Type OTHER

Treatment of OAB via the SUFU clinical care pathway

Telemedicine

Intervention Type OTHER

Delivery of care via telemedicine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SUFU Clinical Care Pathway for Overactive Bladder

Treatment of OAB via the SUFU clinical care pathway

Intervention Type OTHER

Telemedicine

Delivery of care via telemedicine

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Victor W. Nitti, MD

Professor of Urology, Chief, Division of Female Pelvic Medicine and Reconstructive Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UCLA

Los Angeles, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

21-000458

Identifier Type: -

Identifier Source: org_study_id