Back to resultsSelf-Catheterization Mirror System for Female Patients
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified Self-Catheterization Mirror
Sponsored by
About this trial
This is an interventional device feasibility trial for Spinal Cord Injury
Eligibility Criteria
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
Sites / Locations
- Shirley Ryan AbilityLab
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients performing intermittent catheterization
Arm Description
Outcomes
Primary Outcome Measures
System Usability Scale
Patient-reported usability and experience when using the mirror, with scores ranging from 0-100 (higher scores indicating higher usability performance).
Secondary Outcome Measures
Time to Self-Cath
Average time needed to set up the mirror and self-catheterize
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05406258
Brief Title
Self-Catheterization Mirror System for Female Patients
Official Title
Self-Catheterization Mirror System for Female Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 11, 2022 (Actual)
Primary Completion Date
March 2, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients performing intermittent catheterization
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Modified Self-Catheterization Mirror
Intervention Description
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.
Primary Outcome Measure Information:
Title
System Usability Scale
Description
Patient-reported usability and experience when using the mirror, with scores ranging from 0-100 (higher scores indicating higher usability performance).
Time Frame
1-7 days
Secondary Outcome Measure Information:
Title
Time to Self-Cath
Description
Average time needed to set up the mirror and self-catheterize
Time Frame
1-7 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Self-Catheterization Mirror System for Female Patients
We'll reach out to this number within 24 hrs