Self-Catheterization Mirror System for Female Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Shirley Ryan Abilitylab
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Modified Self-Catheterization Mirror
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.
|
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.
|
|
Active Comparator: Standard Self-Catheterization Mirror
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System Usability Scale
Time Frame: This assessment was only completed once at the end of each arm within 3 days prior to inpatient discharge.
|
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). |
This assessment was only completed once at the end of each arm within 3 days prior to inpatient discharge.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Self-Cath
Time Frame: 1-7 days
|
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.
|
1-7 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00215439
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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