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Urological Biofeedback Game Software
NCT02758938 · View on ClinicalTrials.gov ↗
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 This system, however, is outdated and needs to be replaced with updated hardware and software.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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02758938
The ClinicalTrials.gov registry entry for NCT02758938 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 943 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02758938 reports 1 study location spanning 1 distinct geographic area — top geographies include Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02758938?
The interventions under investigation include: Urologic biofeedback software (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02758938?
This trial is sponsored by University of Wisconsin, Madison, which has 943 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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