Spinal Cord InjuryNCT05406258
Self-Catheterization Mirror System for Female Patients
A study testing Modified Self-Catheterization Mirror and Standard Self-Catheterization Mirror in people with Spinal Cord Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The purpose of this study is to test a modified mirror system for female patients to use during self-catheterization. Read more about this study
- Who is it for?
- Ages 13 years and older, women only
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Modified Self-Catheterization Mirror and Standard Self-Catheterization Mirror
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2022to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test a modified mirror system for female patients to use during self-catheterization.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Modified Self-Catheterization Mirror, Standard Self-Catheterization Mirror
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Standard Self-Catheterization Mirror |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 1-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start11 Jan 2022
- Primary completion2 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan O'Brien, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406258
- Sponsor's protocol ID
- STU00215439
- Status last verified
- Jun 2025
- First submitted
- 1 Jun 2022
- Last updated
- 17 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Catheterization Mirror System for Female Patients
- ClinicalTrials.gov ID
- NCT05406258
- Acronym / sponsor ID
- STU00215439
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Posted 17 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Self-Catheterization Mirror | Experimental | Device: Modified Self-Catheterization MirrorFollowing 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 Mirror | Active comparator | Device: Standard Self-Catheterization MirrorFollowing 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Self-Catheterization MirrorFollowing 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 MirrorFollowing 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 |
Primary outcome
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).
1 secondary outcome
Time to Self-Cath
Time frame: 1-7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Self-Catheterization Mirror and Standard Self-Catheterization Mirror in people with Spinal Cord Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: This assessment was only completed once at the end of each arm within 3 days prior to inpatient discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.