Self-Catheterization Mirror System for Female Patients

Shirley Ryan AbilityLab2 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Spinal Cord Injury

Interventions

Modified Self-Catheterization MirrorDEVICE

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.

Standard Self-Catheterization MirrorDEVICE

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.

Eligibility

Sex: FEMALEMin age: 13 Years

Medical Language ↔ Plain English

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

Locations (1)

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Outcomes

Primary Outcomes

System Usability Scale

Patient-reported usability and experience when using the mirror, with scores ranging from -20 to +20 (higher scores indicating higher usability performance). This assessment included 10 items with statements that participants scored on a Likert scale from strongly disagree (-2) to strongly agree (+2).

Time frame: This assessment was only completed once at the end of each arm within 3 days prior to inpatient discharge.

Secondary Outcomes

Time to Self-Cath

Participants timed themself each time they used the during the study period. The time needed to set up the mirror and self-catheterize was averaged for all attempts during the study period.

Time frame: 1-7 days

Data from ClinicalTrials.gov

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