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Self-Catheterization Mirror System for Female Patients

Sponsor
Shirley Ryan AbilityLab (Other)
Overall Status
Completed
CT.gov ID
NCT05406258
Collaborator
(none)
2
Enrollment
1
Location
1
Arm
2.6
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Modified Self-Catheterization Mirror
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Self-Catheterization Mirror System for Female Patients
Actual Study Start Date :
Jan 11, 2022
Actual Primary Completion Date :
Mar 2, 2022
Actual Study Completion Date :
Mar 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients performing intermittent catheterization

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.

Outcome Measures

Primary Outcome Measures

  1. System Usability Scale [1-7 days]

    Patient-reported usability and experience when using the mirror, with scores ranging from 0-100 (higher scores indicating higher usability performance).

Secondary Outcome Measures

  1. Time to Self-Cath [1-7 days]

    Average time needed to set up the mirror and self-catheterize

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shirley Ryan AbilityLab Chicago Illinois United States 60611

Sponsors and Collaborators

  • Shirley Ryan AbilityLab

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Megan O'Brien, Principal Investigator, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier:
NCT05406258
Other Study ID Numbers:
  • STU00215439
First Posted:
Jun 6, 2022
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Spinal Cord Injuries

Study Results

No Results Posted as of Jun 10, 2022