Trial Outcomes & Findings for Self-Catheterization Mirror System for Female Patients (NCT NCT05406258)

NCT ID: NCT05406258

Last Updated: 2025-07-17

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2 participants
• Primary outcome timeframe: This assessment was only completed once at the end of each arm within 3 days prior to inpatient discharge.
• Results posted on: 2025-07-17

Participant Flow

Only one participant completed both arms of the study.

Participant milestones

Measure	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.	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.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Modified Self-Catheterization Mirror n=1 Participants 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 Mirror n=1 Participants 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.	Total n=2 Participants Total of all reporting groups
Age, Customized	1 Participants n=1 Participants	1 Participants n=1 Participants	2 Participants n=2 Participants
Sex: Female, Male Female	1 Participants n=1 Participants	1 Participants n=1 Participants	2 Participants n=2 Participants
Sex: Female, Male Male	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	1 participants n=1 Participants	1 participants n=1 Participants	2 participants n=2 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Modified Self-Catheterization Mirror n=1 Participants 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 Mirror n=1 Participants 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.
System Usability Scale	4 score on a Likert scale	7 score on a Likert scale

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Modified Self-Catheterization Mirror n=1 Participants 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 Mirror n=1 Participants 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.
Time to Self-Cath	13.81 minutes Interval 7.0 to 20.0	20 minutes Interval 20.0 to 20.0

Adverse Events

Modified Self-Catheterization Mirror

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Self-Catheterization Mirror

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Megan O'Brien, PhD

Shirley Ryan AbilityLab

Phone: 312-238-2289

Email: mobrien02@sralab.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place