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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: Completed NA study of Lower Urinary Tract Symptoms, sponsored by University of Wisconsin, Madison.
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. According to ClinicalTrials.gov, the official US trial registry.
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 This system, however, is outdated and needs to be replaced with updated hardware and software.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.
Primary Outcome
This survey will measure the medical value that the software provides to the physician. The physician will be asked to rate certain items on a scale of 1 to 5 - 1 indicating "strongly agree" and 5 indicating "strongly disagree". Each item must score a 4 or 5 for the software to be considered "usable".
Conditions Studied
Interventions
- OTHER Urologic biofeedback software
Study Locations (1)
Wisconsin
- American Family Children's Hospital - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-06 |
| Est. Completion | 2018-09 |
| Phase | NA |
What the finished NCT02758938 record still lists
NCT02758938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 749-participant average among 21 other Lower Urinary Tract Symptoms trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT02758938's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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