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NCT02758938 · ClinicalTrials.gov registry record · NA

Urological Biofeedback Game Software

A NA study of Lower Urinary Tract Symptoms, sponsored by University of Wisconsin, Madison.

Completed
Registry status
NA
Development phase
30
Enrollment target
1
Study location

NCT02758938 is a NA study of Lower Urinary Tract Symptoms that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 30 participants, below the 749-participant average among 21 other Lower Urinary Tract Symptoms trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02758938, a NA study of Lower Urinary Tract Symptoms, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
NA
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

The goal of this study is to test the usability of updated biofeedback game software developed to help train the muscles involved in lower urinary tract dysfunction (LUTD) through electromyography (EMG) controlled video games. A Windows-DOS based biofeedback game system is currently used at the investigator's institution to help treat LUTD in pediatric patients. This system, however, is outdated and needs to be replaced with updated hardware and software. A new updated system was recently created by University of Wisconsin-Madison (UW) Biomedical Engineering students. This system utilizes a FDA approved EMG device (SRS Medical Aware™ EMG Dual Muscle Monitor) paired with biofeedback game software that was developed by the students. The investigators wish to test the usability of the new software to identify areas that need improvement to make the software more user-friendly. This study will evaluate the end users' (i.e., physician, biofeedback nurses, patients) perception of the updated software. In determining usability, we hope to 1) decrease risk of end user error; 2) make the software intuitive (easier to use); 3) decrease reliance on the user manual; 4) decrease need for training; and 5) increase understanding of software operation. This will be an ongoing study in which we continuously monitor the usability of the software as it is updated based on end-user feedback. The investigators plan to do all usability testing under the same IRB protocol. If further testing involves items not discussed here, a "new change" will be made to the IRB application.

Interventions

  • OTHER Urologic biofeedback software

Study Locations (1)

Wisconsin

  • American Family Children's Hospital - Madison

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2016-06
Est. Completion 2018-09
Phase NA

Sponsor

University of Wisconsin, Madison

1,039 total trials

What the Registry Record Tells You About NCT02758938

The ClinicalTrials.gov registry entry for NCT02758938 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 749-participant average among 21 other Lower Urinary Tract Symptoms trials with a reported enrollment target (96% lower). The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lower Urinary Tract Symptoms appearing as the primary indexed condition, and to 1 intervention - of which Urologic biofeedback software is the first listed.

NCT02758938 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.

Frequently Asked Questions

What is clinical trial NCT02758938 about?

NCT02758938 is a clinical study titled "Urological Biofeedback Game Software". The goal of this study is to test the usability of updated biofeedback game software developed to help train the muscles involved in lower urinary tract dysfunction (LUTD) through electromyography (EMG) controlled video games. A Windows-DOS based biofeedback game system is currently used at the inv...

What is the current status of trial NCT02758938?

This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2016-06. Estimated completion is 2018-09.

What conditions does trial NCT02758938 study?

This clinical trial studies the following conditions: Lower Urinary Tract Symptoms.

What interventions are being tested in trial NCT02758938?

The interventions under investigation include: Urologic biofeedback software (OTHER).

Who is sponsoring clinical trial NCT02758938?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02758938 being conducted?

This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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