Urological Biofeedback Game Software

NCT02758938 | Completed

• 1 other identifier: 2015-0235
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 This system, however, is outdated and needs to be replaced with updated hardware and software.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

Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (4)

• Physician Feedback Form

  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".

  15 minutes

• Nurse Feedback Form

  This survey will identify the software's "ease of use" for the nurse. The nurses 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".

  15 minutes

• Patient Feedback Form

  This survey will identify the patient's satisfaction with the software. The patients 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".

  15 minutes

• System Usability Scale (SUS)

  This is a validated survey that measures that software's usability. Usability will be defined as a SUS score greater than or equal to 85 (Orfanou et al. 2015).

  15 minutes

Study Arms (4)

Patient Subjects

EXPERIMENTAL

Patients that are part of the UW LUTD Program (n=30) will undergo 3 weekly biofeedback sessions each lasting 1 hour. All interactive biofeedback sessions will be conducted by American Family Children's Hospital nurses that are experienced in standard biofeedback techniques. After the patient has completed all of the biofeedback sessions, he/she will complete a feedback form about their satisfaction with the device.

Other: Urologic biofeedback software

Biofeedback Nurse Subjects

EXPERIMENTAL

The nurses (n=3) involved in the biofeedback portion of the UW LUTD Program will undergo a Nurse Training Session where they will be asked to "think aloud" while completing an outlined scenario. Their feedback will be used to update the software to make it more user friendly. After the session, they will be asked to complete the System Usability Scale (SUS). Additionally, after guiding patients through biofeedback sessions using the new software, they will be asked to complete the Nurse Feedback Form.

Other: Urologic biofeedback software

Biofeedback Physician Subject

EXPERIMENTAL

The physician (n=1) that oversees the UW LUTD Program will assess data from each patients session. Based on the information he gathers from the session, he will complete a feedback form. Each patient's EMG activity will be stored by the video game which will allow the physician to review the patient's performance. Specifically, the physician will look for the minimum relaxation and the maximum contraction levels of the patient throughout play as well as muscular isolation.

Other: Urologic biofeedback software

Focus Group Subjects

EXPERIMENTAL

A Focus Group session will involve the physician involved in this study, an advisor on the project and staff involved in the project as well as three random individuals outside of the project (n=7). These individuals will provide feedback on the software that will be used to improve the software.

Other: Urologic biofeedback software

Interventions

Urologic biofeedback software OTHER

All subjects (end users) will be walked through the urologic biofeedback software training suite. Each end user will follow a protocol that is specific to their role. Upon completing their session(s) with the software, each end user will provide appropriate feedback.

Biofeedback Nurse Subjects; Biofeedback Physician Subject; Focus Group Subjects; Patient Subjects

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years old
• years of age
• Diagnosed with LUTD
• Currently undergoing biofeedback in the UW LUTD Program

You may not qualify if:

• Patients who cannot complete the 6-week training program
• Patients receiving other treatment methods for LUTD throughout the program
• Currently conducting biofeedback treatment in the UW LUTD Program
• Oversees biofeedback treatment and the UW LUTD Program

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

American Family Children's Hospital

Madison, Wisconsin, 53705, United States

Location

Related Publications (2)

• McKenna PH, Herndon CD, Connery S, Ferrer FA. Pelvic floor muscle retraining for pediatric voiding dysfunction using interactive computer games. J Urol. 1999 Sep;162(3 Pt 2):1056-62; discussion 1062-3. doi: 10.1016/S0022-5347(01)68065-0.

  PMID: 10458431 BACKGROUND

• Herndon CD, Decambre M, McKenna PH. Interactive computer games for treatment of pelvic floor dysfunction. J Urol. 2001 Nov;166(5):1893-8.

  PMID: 11586256 BACKGROUND

Related Links

• Sawyer D. Do It By Design: An Introduction to Human Factors in Medical Devices 1996
• Orfanou et al. Perceived Usability Evaluation of Learning Management Systems: Empirical Evaluation of the System Usability Scale 2015

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: May 3, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

US (1)