Self-Catheterization Mirror System for Female Patients
Phase: NA
Conditions: Spinal Cord Injury
Sponsor: Shirley Ryan AbilityLab

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PROTOCOL TITLE:  Self-Catheterization Mirror System for Female Patients  
 
 
PRINCIPAL INVESTIGATOR: 
Megan O’Brien 
Shirley Ryan AbilityLab 
312-238-2289 
mobrien02@sralab.org 
 
 
VERSION DATE: 
11.22.2021 
 
  
STUDY SUMMARY: 
 
Investigational Agent(s)  
(Drugs or Devices) 
Self-Catheterization Mirror 
IND / IDE / HDE #   
Indicate 
Special Population(s) 
None 
Sample Size 30 
Funding Source Shirley Ryan AbilityLab 
Indicate the type of consent 
to be obtained 
Written  
Site Shirley Ryan Ability Lab 
Research Related Radiation 
Exposure 
No  
DSMB / DMC / IDMC No 
 
 
 
 

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OBJECTIVES: 
The purpose of this study is to evaluate the usability of a modified self-catheterization mirror 
compared to a standard self-catheterization mirror as well as to obtain user feedback through 
patient experience with the use of a modified self-catheterization mirror. 
 
 
BACKGROUND: 
Intermittent catheterization is a procedure to empty the bladder for individuals with voiding 
difficulties, such as resulting from neurologic injury (e.g., spinal cord injury or multiple sclerosis) 
or obstruction. IC can maintain or improve urological function and to reduce the risk of bladder 
infections [1,2]. Self-catheterization is a standard method for managing short-term or long-term 
bladder dysfunction for many individuals. However, many female patients have difficulties with 
self-catheterization [3]. Mirrors currently used for this procedure have insufficient stability and 
visibility to easily view the urethral opening during catheterization, particularly for individuals with 
motor impairments and urinary retention related to spinal cord injury or other medical conditions. 
This can be especially frustrating because catheterization is performed frequently (typically 
every 4-6 hours) and may need to occur at home or in public facilities.  
 
 
Figure 1. The standard self-catheterization mirror for 
female patients. This setup poses significant challenges 
for female patients to catheterize themselves, with limited 
stability and visibility to view the urethral opening. 
 
 
This project will develop and test a portable, cost-effective product to help female patients with a 
range of motor abilities catheterize themselves in various postures and settings. The long-term 
goal is to improve the self-catheterization experience for patients during inpatient education and 
after hospital discharge. 
 
 
STUDY ENDPOINTS: 
Our primary outcome is the patient-reported usability and experience when using the mirror. Our 
secondary outcome is the average time needed to set up the mirror and self-catheterize. These 
measures will be obtained for all patients and compared between the modified mirror and the 
standard mirror.  
 
We expect that participants will be in this research study during two weeks of their inpatient 
rehabilitation stay at the Shirley Ryan AbilityLab, spanning two phases of testing that will each 
last up to 1 week. 
 
 

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STUDY INTERVENTION(S) / INVESTIGATIONAL AGENT(S): 
We have developed modifications to a standard catheter mirror, which are intended to improve 
stability and visibility during the self-catheterization procedure for women with motor 
impairments and urinary retention related to spinal cord injury or other medical conditions. The 
modified mirror (Figure 2) features the standard catheter mirror, held in a surrounding case, 
with adjustable straps for suspension between the legs whether the individual is in a seated 
position, reclined, or in a standing position. This also provides flexibility for the mirror’s angle to 
be manipulated for better viewing. The mirror also features LED lights that can be turned on to 
improve visibility, so that individuals may view the urethral opening easier during catheterization. 
 
 
Figure 2. The modified self-catheterization mirror system includes the 
standard mirror, held in a surrounding case, with adjustable straps for 
suspension between the legs and LED lights that can be turned on/off. 
 
 
All modified self-catheterization mirrors will be stored in a locked area at Shirley Ryan AbilityLab 
and will only be accessible to immediate study team members. 
 
 
PROCEDURES INVOLVED: 
Screening: This study will involve recruitment of female patients participating in self-
catheterization at the Shirley Ryan AbilityLab (SRAlab). Clinicians at this location will be 
informed of the inclusion and exclusion criteria for this study in order to refer 
appropriate patients to the study. Potential research subjects will be referred to authorized 
research personnel and will also be identified based on inclusion and exclusion criteria using the 
Cerner application. 
 
Testing: There will be two phases of the testing, with each phase lasting up to 1 week. Phase 1 
will test their experience with the standard mirror, and Phase 2 will test their experience with the 
modified mirror. This order is determined so that all participants attain practice with self-
catheterization and study procedures with the standard mirror first, in alignment with the 
standard of care. The modified mirror will not be given to the participants until Phase 2 testing 
begins. 
 
Phase 1 (Standard mirror): Subjects will self-catheterize every 4-6 hours, depending 
on their physician’s orders, using the standard mirror. This will allow the subjects to self-
catheterize at different times of the day and in various positions. This mirror will have 
already been provided for self-catheterizing patients by the hospital, and patients will 
have been trained to self-catheterize by their standard care team. 

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Subjects will be given a log sheet specifying the catheterization trial number and the 
assigned mirror. For each catheterization, subjects will record the position used, the 
mirror used, and the time it took to complete mirror set up and successfully insert a 
catheter. They will record this information after each catheterization within the phase. 
 
Phase 2 (Modified mirror): Upon completion of Phase 1 testing, subjects will be trained 
to use the features of the modified mirror in a single training session. Study staff will 
demonstrate the attachment of the mirror and help the subject practice the attachment 
and use of the mirror in any of the positions (seated, reclined in the patient’s hospital 
bed, and standing). If a subject is unable to achieve and maintain a position 
independently or with minimal assistance, the training in that position will be skipped. 
Study staff will confirm any positions that the subject uses to self-catheterize (confirmed 
against the Phase 1 log sheet), and train the subject to utilize the modified mirror in 
those positions. Training will be considered successful if the subject can set up the 
modified mirror 3 times independently in all possible self-catheterization positions. At the 
end of the training session, the subject will be asked if they would be comfortable using 
the mirror independently.  
 
A subsequent training session will be scheduled if the subject (1) cannot set up the 
modified mirror 3 times independently in their possible self-catheterization positions, or 
(2) does not feel comfortable using the mirror independently. If the subject does not 
meet these criteria after a second training session, they will be asked to fill out a 
questionnaire regarding their experience with the device (see “Questionnaires” below) 
and study procedures will end; patients who do not complete a successful training 
session will not be invited to complete Phase 2 testing. 
 
Immediately following the completion of a successful training session, subjects will begin 
the Phase 2 testing, following identical procedures as in Phase 1 but asked to use the 
modified mirror. Subjects will record the mirror used, position, and time for self-
catheterization in a new log sheet. Subjects will continue to have the standard mirror 
during this phase, and will be encouraged to use this standard mirror instead for any trial 
if needed for successful self-catheterization. 
 
 
Questionnaires: Subjects will complete a questionnaire (System Usability Scale) at the end of 
each testing phase related to self-operation and user satisfaction with the use of the assigned 
mirror. They may also complete these questionnaires at the completion of the study. 
 
 
DATA AND SPECIMEN BANKING 
Data will be collected and kept confidential and compliant with HIPAA requirements. All 
personal information and study documentation that can identify participants will be kept secure 
to protect their privacy and will never be shared at any time with any person or entity. Data 
collected during the study and shared with others will reference participants only by an 
alphanumeric code (i.e., de-identified). The “master list” linking personal information to the 
alphanumeric code will not be shared. Electronic data will be stored on a secure and password-
protected network and devices managed by the Shirley Ryan AbilityLab. Electronic folders will 
be private with limited access as determined by the PI. 
 

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De-identified data will be stored indefinitely. If participants give written consent to be contacted 
for future studies, this information will be kept separate from de-identified data files, in locked 
cabinets accessible only by authorized research personnel. All other information will be 
destroyed in accordance with HIPAA and IRB compliant guidelines. 
 
 
SHARING RESULTS WITH PARTICIPANTS 
Participants will be recording their own results in a time log, as well as providing their own 
experiences and satisfaction with the use of a modified mirror during self-catheterization. There 
is no intent to share additional information about results with participants. 
 
 
STUDY TIMELINES 
- Subjects will each participate in the study for two testing phases, each lasting a period of 
up to 1 week 
- This study will enroll participants for up to 9 months. 
- This study is projected to be completed by June 2023 
 
 
INCLUSION AND EXCLUSION CRITERIA 
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 
 
 
RECRUITMENT METHODS 
This study will involve recruitment of individuals who require self-catheterization due to urinary 
retention related to spinal cord injury or other medical conditions. Clinicians at Shirley Ryan 
AbilityLab (18th-25th floors) will be informed of the inclusion and exclusion criteria for this study 
for the referral of appropriate subjects. Potential subjects will be screened and evaluated by the 
research team. Clinicians on the 18th-25th floors will be trained on the use of the modified 
mirror and will help introduce the modified mirror to eligible and willing participants. 
 
 
COMPENSATION FOR PARTICIPATION IN RESEARCH ACTIVITIES 
Participants will be compensated up to $20 for their participation through the ClinCard system. 
When a subject completes participation, funds will be approved and loaded onto the card. 
These funds are provided for the subject’s participation in the study.  
 

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For each participant, SRAlab will issue a ClinCard, which is a specially designed debit card for 
clinical research. Funds will be loaded as appropriate. The funds will be available within 1 day 
after being loaded and can be used at the participant’s discretion. Participants will be issued 
one card for the duration of the study. If the participant withdraws from the study early,  she will 
be reimbursed for these expenses for the portion of the study that was completed. If the card is 
lost or stolen, participants may call (866) 952-3795 or ask a coordinator for a replacement 
ClinCard. 
 
 
WITHDRAWAL OF PARTICIPANTS 
If a participant has an adverse event, requiring therapeutic intervention and/or the experience 
interrupts usual daily activities, the subject will be withdrawn from the research study without 
their consent. This may include injury or impaired skin integrity due to the use of the modified 
mirror. 
 
If a participant chooses to withdraw from the study, they will be thanked for their time and asked 
if they wish to disclose why they have decided to withdraw from the study. From that point, all 
data that was already collected on the participant will be retained and missing data from 
continued data collection will be treated as a loss to follow up. 
 
 
RISKS TO PARTICIPANTS 
The modified self-catheterization mirror is a prototype device with no significant risk to 
participants. The device utilizes a standard catheter mirror, enables it to be suspended between 
the legs, and improves visibility using commercially-available resources such as adjustable 
straps and miniaturized LED lights. The system can easily be adjusted to fit participants and 
adhere to different positional needs during self-catheterization. Use of the device can be 
stopped at any time when completing self-catheterization.  
 
Physical risks from this study may include skin breakdown, urinary tract infection, and muscle 
soreness. 
 
 
Another possible risk is discomfort, skin pressure/friction, or bruising caused by the 
device straps, which has the potential to lead to skin breakdown or abrasions. This risk 
will be minimized by a thorough skin check performed by clinicians before and after 
device use, and application of foam dressings or bandages as needed. Use of the 
modified mirror will be discontinued for any participant with skin breakdown. 
 
 
Risk of a urinary tract infection due to use of the device. This risk will be minimized by 
emphasis of utilizing a sterile environment during self-catheterization and following 
hospital protocols regarding hygiene and cleanliness of devices and equipment.  
 
 
There is a risk of muscle soreness from being in a certain position for a prolonged period 
of time during the self-catheterization process. Clinicians will monitor subject activity and 
subjective reports of pain or discomfort throughout the process. Assisted repositioning 
and/or rest periods will be provided as needed. 
 
 
Embarrassment or discomfort discussing self-care may be associated with this study. All 
staff members assisting with this study are trained professionals and familiar with the 
intermittent catheterization process.  

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Clinicians will monitor device functionality and participant comfort during use and intervene if an 
unforeseen challenge occurs. During study procedures, a standard mirror will always be 
available to the patient if needed in the event that use of the modified mirror is obstructive to the 
self-catheterization process. 
 
Risk of confidentiality will be minimized by not including personal identifying information on 
forms (Self-Catherization Log, questionnaire, etc.) and by conducting data collection in a private 
setting. 
 
Some of the questions included in the questionnaire may be upsetting or uncomfortable for the 
participant to answer. If they do not wish to answer a question, they may skip it. 
 
No psychological, financial, or legal risks to participants are anticipated. 
 
 
POTENTIAL BENEFITS TO PARTICIPANTS 
There may be no direct benefit to the participants. The main benefit of participation in this study 
is understanding the real-world challenges faced by patients performing self-catheterization, 
which may help other people through future development of devices and procedures. The 
modified mirror is intended to increase stability and visibility for individuals needing to self-
catheterize, and ultimately, make the self-catheterization process easier for them. There is 
potential for participants to experience these benefits during use. 
 
 
DATA MANAGEMENT AND CONFIDENTIALITY 
Data will be collected and kept confidential and compliant with HIPAA requirements. All 
personal information and study documentation that can identify participants will be kept secure 
to protect their privacy and will never be shared at any time with any person or entity. Data 
collected during the study and shared with others will reference participants only by 
alphanumeric code. The “master list” linking personal information to the alphanumeric code will 
not be shared. Electronic data will be stored on a secure and password protected network and 
devices managed by the Shirley Ryan AbilityLab. Electronic folders will be private with limited 
access as determined by the PI. 
 
 
PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF PARTICIPANTS 
Data will be reviewed by researchers after each intervention session. Any and all adverse 
events will be documented and reported in compliance with IRB regulations. If they occur in the 
presence of researchers, prompt medical attention will be requested via assessment by the 
resident on call. Health status will be assessed at all visits to ensure participant safety. Events 
will be recorded in case report forms. Participants will be encouraged to contact research staff 
or the PI to report any changes in health status. If participants experience major changes in 
health status, study participation will either be suspended or terminated depending on severity.  
 
If any new information is identified concerning the safety of the study device, participants will be 
notified. This available information may affect the participant’s decision to remain in the study. 
 
 
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS 

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Subject records will be kept confidential. Precautions will be taken to protect the privacy 
interests of subjects. Participation in this study is completely voluntary. The purpose of the study 
and intended use of a subject’s medical information as well as precautions taken to keep the 
study information and data confidential will all be explained to each participant. All collected 
data will be kept confidential and compliant with HIPAA standards. 
 
 
COMPENSATION FOR RESEARCH-RELATED INJURY 
The PI of the study is required to be notified promptly in the instance of any injury or illness 
inflicted on the participant as a result of the study. The hospital [Researchers, Shirley Ryan 
AbilityLab, Northwestern University and all affiliated clinical sites] will not pay for medical care 
required because of a bad outcome resulting from participation in this study. However, the 
subject may still seek to get paid back for care required because of a bad outcome resulting 
from participation in this study. 
 
 
ECONOMIC BURDEN TO PARTICIPANTS 
Subjects will be compensated for their participation in the study. 
 
 
CONSENT PROCESS 
Before recruitment and enrollment onto this study, the participant will be given a full explanation 
of the study and will be given the opportunity to review the consent form. Each consent form 
must include all the relevant elements as approved by the Northwestern University Institutional 
Review Board.  
 
Trained research personnel will guide the participant through consenting process. Participant 
will be given detailed explanation of the purpose, time line, commitment, procedures, data 
handling, and privacy and confidentiality of information pertaining to the study. Once this 
essential information has been provided to the participant and the investigator is assured that 
the participant understands the implications of participating in the study, the participant will be 
asked to give consent to participate in the study by signing an IRB approved consent form. 
Subjects will be consented with a new consent form if changes are made to the protocol. Prior 
to participation in the trial, the written informed consent form must be signed and personally 
dated by the participant or authorized guardian and by the person who conducted the informed 
consent discussion.  
 
The consent process will take place at the Shirley Ryan AbilityLab in Room 11-1401 or on an 
AbilityLab floor (patient room or private meeting space). 
 
 
PARTICIPANTS WHO ARE NOT YET ADULTS (infants, children, teenagers) 
Participants will be asked their age upon study screen. Any child under the age of 18 years will 
be considered a minor. If the participant is determined a minor, every effort will be made to 
ensure the screening process proceeds with a parent or an authorized legal guardian present. 
The consent and protocol will be explained by a trained researcher to both the present 
parent/authorized legal guardian and the minor. The parent or authorized legal guardian will 
then be asked to consent on behalf of the minor, in accordance with the DHHS and the 
USFDA’s subpart D. The parent or authorized legal guardian will also be given the opportunity 
present at all training and testing sessions. 

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Consent will be obtained from one parent even if the other parent is alive, known, competent, 
reasonably available, and shares legal responsibility for the care and custody of the child. This 
will be done to ensure the protocol is carried through in a timely manner. 
 
Permission will also be obtained from an authorized legal guardian if necessary. Efforts will be 
made to determine whether the guardian is in fact legally authorized by ensuring the child lives 
with the aforementioned guardian. Assent will be obtained from all children. Verbal assent will 
be obtained for children unable to give written consent. Assent will be documented in the IRB 
approved consent form. 
 
 
NON-ENGLISH SPEAKING PARTICIPANTS 
Non-English speaking subjects will be permissible for recruitment and enrollment in the study 
(Spanish, Arabic, and Polish).  
 
An interpreter who speaks the participant’s primary language will be scheduled through the 
Shirley Ryan AbilityLab Interpreter Services department to attend all research appointments 
during which the participant is scheduled if necessary as determined by the participant. 
 
 
PROTECTED HEALTH INFORMATION (PHI AND HIPAA) 
Subjects records will be kept completely confidential. Every possible precaution will be taken to 
protect the privacy interests of subjects. Trained research personnel will explain the purpose of 
the study and intended use of a subject’s medical information and the precautions taken to keep 
the study information and data confidential. Data will be collected and kept confidential and 
compliant with HIPAA standards.  
 
Participants will be assigned an alphanumeric study ID. Identifying data will be kept in locked 
cabinets and password protected servers completely separate from de-identified data. Research 
data will be de-identified and stored in locked cabinets in the lab accessible only by authorized 
research personnel. Electronic data will be de-identified and kept on secure, password 
protected servers at the Shirley Ryan Ability Lab. Only authorized research staff will be able to 
access any of the formerly mentioned data. De-identified data will be kept indefinitely. 
 
Study documentation will be collected and stored and kept confidential and compliant with 
HIPAA requirements. Identifying data will be held for 7 years after the study is completed and 
published. 
 
All personal information (names, addresses, email or phone numbers, etc.) gathered for this 
study that can identify participants will be kept secure to protect their privacy and will never be 
shared at any time with any person or entity. Data collected during the study and shared with 
others will reference participants only by an alphanumeric code. The “master list” linking 
personal information to the alphanumeric code will not be shared, and will be kept by the study 
PI in a secure location. All  personal information linking participants to their data will be 
destroyed after 7 years following the completion of the study 
 
 
QUALIFICATIONS TO CONDUCT RESEARCH AND RESOURCES AVAILABLE 
All sessions will occur at Shirley Ryan AbilityLab (355 East Erie St. Chicago, IL 60611) 

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An acute inpatient rehabilitation and research hospital. Each unit is staffed with 21 full time 
employee nurses; with virtually no cross-over. Study procedures will occur on the inpatient floor 
in private, single-patient care rooms. 
 
All study team members will be trained on the study protocol and procedures. The study team 
members are employees of the Shirley Ryan AbilityLab. They are familiar with the study site and 
are experienced with the study population.  There will be medical resources including a resident 
on call and nursing staff available 24 hours a day if needed in case of an emergency.  
 
 
 
 
REFERENCES 
 
1. Wyndaele, J. Intermittent catheterization: which is the optimal technique? Spinal 
Cord 40, 432–437 (2002). https://doi.org/10.1038/sj.sc.3101312 
2. Lapides J, Diokno AC, Silber SJ, Lowe BS. Clean intermittent self‐catheterization in the 
treatment of urinary disease. J Urol. 1972; 107(3): 458‐ 461. 
3. Logan K, Shaw C, Webber I, Samuel S, Broome L. Patients’ experiences of learning clean 
intermittent self‐catheterization: a qualitative study. J Adv Nurs. 2008; 62(1): 32‐ 40.