Spinal Cord Injury
Conditions
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.
Interventions
DEVICEModified 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.
DEVICEStandard 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.
Sponsors
Shirley Ryan AbilityLab
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to No maximum
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 Range of Motion restrictions of the upper and/or lower extremities * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Self-Cath | 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. |
Countries
United States
Participant flow
Pre-assignment details
Only one participant completed both arms of the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| 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. | 1 |
| Total | 2 |
Baseline characteristics
| Characteristic | Standard Self-Catheterization Mirror | Total | Modified Self-Catheterization Mirror |
|---|---|---|---|
| Age, Customized | 1 Participants | 2 Participants | 1 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 1 participants | 2 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
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).
Time frame: This assessment was only completed once at the end of each arm within 3 days prior to inpatient discharge.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Self-Catheterization Mirror | System Usability Scale | 4 score on a Likert scale |
| Standard Self-Catheterization Mirror | System Usability Scale | 7 score on a Likert scale |
Secondary
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.
Time frame: 1-7 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Modified Self-Catheterization Mirror | Time to Self-Cath | 13.81 minutes |
| Standard Self-Catheterization Mirror | Time to Self-Cath | 20 minutes |