Self-Catheterization Mirror System for Female Patients

Not Applicable

Completed

• Conditions: Spinal Cord Injury
• Interventions: Device: Modified Self-Catheterization Mirror

• Registration Number: NCT05406258
• Lead Sponsor: Shirley Ryan AbilityLab

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.

Study Timeline

• Study Start: 2022-01-11
• Primary Completion: 2022-03-02
• Study Completion: 2022-03-31
• Status Verified: 2022-06
• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-06
• Last Update Submitted: 2022-06-07
• Last Update Posted: 2022-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients performing intermittent catheterization	Modified Self-Catheterization Mirror	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to Self-Cath	1-7 days	Average time needed to set up the mirror and self-catheterize

Trial Locations

Locations (1)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States