Self-Catheterization Mirror System for Female Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test a modified mirror system for female patients to use during self-catheterization.

Detailed Description
-----------------
Many female patients have difficulties with self-catheterization. Mirrors currently used for this procedure have limited stability and visibility to easily view the urethral opening during catheterization, particularly for individuals with motor impairments. This can be especially frustrating because catheterization is performed frequently throughout the day and may need to occur at home or in public facilities. The purpose of this study is to test the usability and efficacy of a modified self-catheterization mirror system for female patients. The modified self-catheterization mirror system makes adjustments to a standard, hospital-provided cathing mirror to help female patients with a range of motor abilities catheterize themselves in various postures and settings. Namely, the system offers (1) an alternative way to hold the mirror, by suspending it between the legs rather than attaching it to the toilet, and (2) lights that can be turned on for improved visibility during the self-catheterization process.

Official Title
-----------------
Self-Catheterization Mirror System for Female Patients

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Device: Modified Self-Catheterization Mirror


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females age 13 or older Urinary retention related to spinal cord injury or other medical conditions resulting in need for catheterization Individuals with sufficient upper limb function to catheterize independently or with minimal assistance, or as deemed appropriate for the study by the Principle Investigator. Exclusion Criteria: Individuals younger than 13 years old Individuals with cognitive deficits or visual impairments that may impact safe use of the devices used Severe ROM restrictions of the upper and/or lower extremities Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients performing intermittent catheterization<br> | Device: Modified Self-Catheterization Mirror<br>* Following training, participants will have a modified mirror available for self-catheterization, as well as a standard, hospital-provided mirror. They will record the mirror used, position, and time for self-catheterization. They will also complete the System Usability Scale for each mirror related to self-operation and user satisfaction.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Usability Scale | Patient-reported usability and experience when using the mirror, with scores ranging from 0-100 (higher scores indicating higher usability performance). | 1-7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Self-Cath | Average time needed to set up the mirror and self-catheterize | 1-7 days |