NCT05406258

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

July 17, 2025

Completed
Last Updated

July 17, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

June 1, 2022

Results QC Date

April 23, 2025

Last Update Submit

June 27, 2025

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • 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).

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

Secondary Outcomes (1)

  • Time to Self-Cath

    1-7 days

Study Arms (2)

Modified Self-Catheterization Mirror

EXPERIMENTAL

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.

Device: Modified Self-Catheterization Mirror

Standard Self-Catheterization Mirror

ACTIVE COMPARATOR

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.

Device: Standard Self-Catheterization Mirror

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.

Modified Self-Catheterization Mirror
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.

Standard Self-Catheterization Mirror

Eligibility Criteria

Age13 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Results Point of Contact

Title
Dr. Megan O'Brien, PhD
Organization
Shirley Ryan AbilityLab
mobrien02@sralab.org
312-238-2289

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 6, 2022

Study Start

January 11, 2022

Primary Completion

March 2, 2022

Study Completion

March 31, 2022

Last Updated

July 17, 2025

Results First Posted

July 17, 2025

Record last verified: 2025-06

Locations

US(1)