Self-Catheterization Mirror System for Female Patients

Spinal Cord Injury Clinical Trial

Official title:

Self-Catheterization Mirror System for Female Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05406258
• Other study ID #: STU00215439
• Status: Completed
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: March 31, 2022

Study information

• Verified date: June 2022
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: March 31, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Modified Self-Catheterization Mirror
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.

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Self-Cath	Average time needed to set up the mirror and self-catheterize	1-7 days