Self-Catheterization Mirror System for Female Patients

Shirley Ryan AbilityLab

Status: Completed

Conditions: Spinal Cord Injury

Treatments: Device: Standard Self-Catheterization Mirror; Device: Modified Self-Catheterization Mirror

Study type: Interventional

Funder types: Other

Identifiers

NCT05406258

STU00215439

Details and patient eligibility

About

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

Full 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.

Enrollment: 2 patients

Sex: Female

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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 Range of Motion restrictions of the upper and/or lower extremities
• Pregnant

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Modified Self-Catheterization Mirror

Experimental group

Description:

Following training, participants will have a modified mirror for self-catheterization. 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.

Treatment:

Device: Modified Self-Catheterization Mirror

Standard Self-Catheterization Mirror

Active Comparator group

Description:

Following training, participants will have a standard, hospital-provided mirror for self-catheterization. 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.

Treatment:

Device: Standard Self-Catheterization Mirror