Assessment of the Effectiveness and Ease of Use of DirectVision- a Direct Visualization System for Urinary Catheterization: Results of a Single Center Prospective Study
Phase: NA
Conditions: Urethral Diseases
Sponsor: The Pur Clinic

Version 2 9-24-15  
Version 1 will not be accepted after 11-1-15 (delete information on the footer prior to IRB 
submission) 
 
 
CLINICAL RESEARCH PROTOCOL 
 
 
 
 
ASSESSMENT OF THE EFFECTIVENESS AND EASE OF USE 
OF DIRECTVISION® - A DIRECT VISUALIZATION SYSTEM 
FOR URINARY CATHETERIZATION: RESULTS OF A 
SINGLE-CENTER PROSPECTIVE STUDY  
 
Principal Investigator: 
Mohamed Etafy  
South Lake Hospital- Urology Department  
1900 Don Wickham Dr, Clermont FL 34711  
3523948757  
mhamdan102@gmail.com 
 
Sub – Investigator:  
Sijo Parekattil   
South Lake Hospital- Urology Department   
1900 Don Wickham Dr, Clermont FL 34711 
sijo@orlandohealth.com 
 
Jamin Brahmbhatt 
South Lake Hospital- Urology Department  
1900 Don Wickham Dr, Clermont FL 34711 
Jamin@orlandohealth.com 
  
 
Research Coordinator(s) N/A 
 
Study Site(s) 
South Lake Hospital- Urology Department  
1900 Don Wickham Dr, Clermont FL 34711 
3523948757 
 
Sponsor: 
PercuVision LLC 
2030 Dividend Drive 
Columbus, OH 43228 
Study Product: 
PercuVision - DirectVision System 
Protocol Number: 
16.129.10 
 
  Protocol Version:         Version 1,      2/28/2017  
 
 

 
Page 2 of 10 
 
Table of Contents 
 
 
 
 
 
1. 
Research Synopsis 
 
 
 
 
 
4 
2. 
Background and Significance 
 
 
 
6 
3. 
Objectives 
 
 
 
 
 
 
6 
3.1 
Primary Objective  
 
 
 
6 
3.2 
Secondary Objectives 
 
 
 
6 
4. 
Study design/methodology  
 
 
 
7 
5. 
Study Population 
 
 
 
 
 
8 
 
5.1 
Inclusion 
 
 
 
 
 
8 
5.2 
Exclusion Criteria 
 
 
 
 
8 
6. 
Study Duration/ Study Timeline 
 
 
 
8 
7. 
Statistical Analysis Plan 
 
 
 
 
8 
8. 
Informed Consent Process  
 
 
 
8 
9.  
Privacy and confidentiality  
 
 
 
8 
10. 
Risk/Benefit  
 
 
 
 
 
9 
 
10.1 
Risks to Participants  
 
 
 
9 
10.2 
Benefits to Participant 
 
 
 
9 
11. 
Safety Monitoring, Interim Analysis, Stopping Rules 
9 
12. 
Conflict of Interest  
 
 
 
 
10 
13. 
Publication and Presentation Plans 
 
 
10 
14. 
References 
 
 
 
 
 
 
10 
15. 
Appendices 
 
15.1 
Appendix I 
Title  
 
 
 
10 
 
15.2 
Appendix II Title  
 
 
 
10 
 
 
15.3 
Appendix III Title  
 
 
 
10 
 
 
 
 
 
 
 
 

 
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List of Abbreviations: 
 
CDC     Center for Disease Control and Prevention  
BPH    Benign prostatic hyperplasia 
DUC    Difficult urinary catheterization 
FDA    Food and Drug Administration 
VGCD   Visually-guided catheterization device 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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ASSESSMENT OF THE EFFECTIVENESS AND EASE OF USE OF DIRECTVISION- A 
DIRECT VISION SYSTEM FOR URINARY CATHETERIZATION: RESULTS OF A 
SINGLE-CENTRE PROSPECTIVE STUDY  
 
1. 
Research Synopsis  
The Center for Disease Control and Prevention (CDC) reports that one in four patients 
hospitalized in the United States is catheterized to void the bladder or monitor urinary 
output. In the male population, Dr. Singh, an urologist estimates that about 20% of 
catheterizations are difficult. Driving a catheter blindly, guessing whether to push the 
catheter forward or manipulate it to get around a point of resistance leads to the risk of 
injury which increases the more the catheter is manipulated. Additional adverse events 
include: urosepsis, UTI and bladder perforation. The standard of care treatment for 
patients with difficult urinary catheterization (DUC) is to proceed with a cystoscopic 
catheter placement or suprapubic tube placement.  
PercuVision has the only Foley catheter with a micro-endoscope for visualization and 
navigation of the urethra for nurses and other qualified health care professionals. 
Moreover, it allows urologists to place a guidewire under direct vision rather than calling 
for a flexible cystoscope which is considered a minor procedure. 
In this study, we plan on assessing the effectiveness and ease of use of the PercuVision 
DirectVision® System device. 
 
1.1 
Study Title 
Assessment of the effectiveness and ease of use of the DirectVision System - A catheter-
based direct visualization system for urinary catheterization: results of a single-center 
prospective study.  
 
1.2 
Study Population 
We will prospectively enroll any patient over 18 years old with a standard indication for 
difficult urinary catheterization from March 6th, 2017 (if approved by IRB) to December 
6th, 2017.  
 
1.3 
Study Design 
This is a prospective unblinded randomized study where we will prospectively enroll any 
patient over the age of 18 years (except pregnant patients) with a Urology consult for a 
standard indication for difficult urinary catheterization from March 6th, 2017 to 
December 6th, 2017. The prospective subjects will be randomized to either catheter 
placement via DirectVision or catheter placement via cystoscope. We will gather details 
such as name, age of patient, address, sex of patient, urological history of patient,  
indication for Foley catheter placement, number of attempts by referring service and  
level of training of the person who tried placing the catheter, time to place catheter via 
DirectVision/cystoscope, ancillary tools used (Coude catheter, guidewires, dilators, 
suprapubic tube, cystoscope, etc), findings (false passage, stricture, bladder neck 

 
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contracture, obesity, mental impairment, BPH, etc), adverse outcome, degree of 
difficulty, presence of pain and hematuria.  
 
 
 
1.4 
Sample Size 
We hope to enroll a total number of 75-100 subjects. We usually receive about 10-20 
consults a month for difficult Foley catheter placement.  
 
1.5 
Study Duration 
We estimate that the study duration will be 9 months. We plan on enrolling patients until 
December 6th, 2017.   
 
1.6 
Primary Objective 
To assess the effectiveness of using DirectVision for all cases of difficult urinary 
catheterization prior to proceeding cystoscopically. The following outcomes will be 
measured (Set up time/total procedure time to place catheter placed via 
DirectVision/cystoscope, ancillary tools used, findings, adverse outcome, degree of 
difficulty, presence of pain and hematuria).  
 
1.7 
Secondary Objectives 
To evaluate the cost to place a catheter using DirectVision versus via flexible cystoscope.  

 
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2. 
Background and Significance 
Difficult urinary catheter (DUC) insertion is one of the most common reasons for 
urological consultation in hospitals. Despite the prevalence of consultation, literature 
regarding DUC is extremely limited and focuses predominantly on techniques of 
successful catheter placement, rather than understanding the clinical situations associated 
with difficult catheterization consults.  
Although the incidence of DUC is unknown, many causes have been identified, including 
anxiety, poor technique, urethral stricture, phimosis, anasarca, bladder neck contracture, 
false passages, benign prostatic hyperplasia, unfavorable body habitus and patient 
positioning1. 
Routine placement of transurethral catheters can be challenging in some situations, such 
as urethral strictures, severe phimosis and false passages. Intravaginal retraction of the 
urethral meatus can complicate Foley placement in postmenopausal females. In men, 
blind urethral procedures with mechanical or metal sounds without visual guidance or 
guidewire assistance are now discouraged due to the increased risk of urethral trauma and 
false passages 2. 
Complications of DUC can include urethral abscess, necrotizing infection, rectal injury, 
urethral stricture, urinary tract infection, urosepsis, hematuria requiring transfusion, as 
well as extreme physical and emotional distress to the patient1. 
All health care professionals and staff, who are authorized to place urinary catheters, 
should be instructed in proper techniques and encouraged to call for help if they 
encounter difficulties beyond their ability to resolve 2. 
Since ancient Greece, urinary catheters have been placed blindly. Urinary catheterization 
is considered an essential skill for physicians and, in the past, required surgery when 
blinded attempts failed. The last major advancement in urinary catheterization occurred 
when rubber catheters were introduced in the 18th century 4. 
DirectVision is a new visually-guided catheterization device (VGCD) that uses a camera 
visual guide / microendoscope within a triple lumen flexible urinary catheter with an 
angled tip, essentially combining the functionality of a urinary catheter with a cystoscope. 
DirectVision uses fiber-optic bundle of 6,000 integrated fibers to provide illumination 
and transmit real-time video. This pilot study suggests that the VGCD is feasible and safe 
to use in the clinical setting 3.  
Flexible cystoscopy is currently the national/international standard of care for placement 
of complex Foley catheter. DirectVision has been FDA-approved for difficult urinary 
catheterization.  
All investigators performing urinary catheterization either via flexible cystoscope or via 
DirectVision have adequate training and experience if both procedures are being 
compared.  
Procedures done via flexible cystoscopy or DirectVision will be covered by insurance 
(including Medicaid/Medicare).  
In this prospective study, we plan on assessing the effectiveness and ease of use of 
DirectVision - A direct visualization system for urinary catheterization. 
 
3. 
Objectives 
Our objectives are to assess the effectiveness of using DirectVision for all cases of 
difficult urinary catheterization prior to proceeding cystoscopically and additionally to 

 
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assess the cost difference between catheter placement via flexible cystoscope versus 
DirectVision.  
 
3.1 
Primary Objective 
To assess the effectiveness of using DirectVision for all cases of difficult urinary 
catheterization prior to proceeding cystoscopically. 
Outcomes such as Set up time/total procedure time to place catheter placed via 
DirectVision/cystoscope, ancillary tools used, findings, adverse outcome, degree of 
difficulty, presence of pain and hematuria will be measured.  
 
3.2 
Secondary Objectives 
To evaluate the cost difference to place a catheter using DirectVision versus via flexible 
cystoscope.  
 
4. 
Study design/methodology 
This is a prospective unblinded randomized (alternating assignment) study where we will 
prospectively enroll any patient over the age of 18 years (except pregnant patients) with a 
Urology consult for a standard indication for difficult urinary catheterization from March 
6th, 2017 (if approved by IRB) to December 6th, 2017.  
Nurses and providers will be asked to call Urology for any patient who was found to have 
a DUC. A DUC in this study will be characterized as any catheterization that was not 
successful after one attempt. Then the prospective subjects will be randomized to either 
catheter placement via DirectVision or catheter placement via cystoscope by Dr Calixte, 
Dr Parekattil or Dr Brahmbhatt. We will gather details such as name, age of patient, 
address, sex of patient, urological history of patient,  indication for Foley catheter 
placement, number of attempts by referring service and  level of training of the person 
who tried placing the catheter,  time to place catheter via DirectVision/cystoscope, 
ancillary tools used (Coude catheter, guidewires, dilators, suprapubic tube, cystoscope, 
etc), findings (false passage, stricture, bladder neck contracture, obesity, mental 
impairment, BPH, etc), adverse outcome, degree of difficulty, presence of pain and 
hematuria.  
Normally a 16Fr flexible cystoscope with a light source is used when difficult urinary 
catheterization are encountered.  
After successful catheterization via cystoscopy or DirectVision, we will follow the 
patient for 1-3 days as needed to ensure adequate Foley drainage.  
DirectVision is an innovative device from DirectVision System; Westerville, Ohio which 
consists of a microendoscope that inserts into 1 lumen of a 3-way/trilumen Foley 
catheter. The microendoscope is connected to a camera and LED (light emitting diode), 
transporting light to the catheter tip and an image back to the LCD (liquid crystal display) 
monitor for real time visualization of the urethra during catheter placement. Irrigation is 
used during catheter placement to assist in expanding the urethra, activating the 
lubricious coating of the catheter, and preventing debris from covering the lens at the 
distal tip of the catheter. A curved (Coude´) tip assists in navigating the normal S-shaped 
curve of the bulbous urethra. The procedure may be performed by any health professional 
(surgeon, physician, nurse, or allied health staff) trained to insert Foley catheters. The 

 
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minimal training required to learn equipment may be incorporated into existing nursing 
or residency training.  
PercuVision (sponsor) will offer a grant to the PUR Clinic. Part of the grant will be used 
to gift the hospital with a cystoscopy cart which will hold disposable supplies to help 
make access to supplies easier ($1733). $1000-1200 will be taken from the grant to 
provide a 30 minutes presentation about DirectVision to the nurses at South Lake. The 
sessions will go during one week span. We will provide a continental service ($3/person) 
for the early day session and a lunch session ($5/person). The food will be catered from 
our South Lake Cafeteria. The target would be 200 RNs who work during the hours of 
0800 – 1700. Physicians will be compensated $100 for completion of each research form.  
PercuVision will also pay the Hospital overhead ~3000$ and the IRB fees ($2375 for the 
initial fee for a sponsored study is $2375 and $900 for the annual continuing fee).  
   
 
5. 
Study Population 
We will prospectively enroll any patient over 18 years with a standard indication for 
difficult urinary catheterization (failed catheterization after one attempt) from March 6th, 
2017 (if approved by IRB) to December 6th, 2017.  
 
5.1 
Inclusion Criteria 
Any patient over 18 years with a standard indication for difficult urinary catheterization 
from March 6th, 2017 (if approved by IRB) to December 6th, 2017 between the hours of 
8AM and 5PM. 
 
 
5.2 
Exclusion Criteria 
Any patient younger than 18 years of age, pregnant patients, patients who present 
between 5PM and 8AM.  
 
6. 
Study Duration/ Study Timeline 
We estimate that the study duration will be 9 months. We plan on starting to enroll 
subjects once approved by IRB around March 6th, 2017 (if approved by IRB) to 
December 6th, 2017  
 
 Stage 1 
Enrollment of subjects  6 months 
 Stage 2 
Data analysis and presentation and publication  3 months 
 
 
7. 
Statistical Analysis Plan 
Due to the lack of data in the comparison between DirectVision and flexible cystoscopy, 
we are creating this prospective study to assess the effectiveness and ease of use of 
DirectVision. This is an initial study to obtain preliminary data and likely only 
descriptive data will be gathered. We will subdivide the data into groups such as set up 
time/total procedure time to place catheter placed via DirectVision/cystoscope, ancillary 
tools used, findings, adverse outcome, degree of difficulty, presence of pain and 

 
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hematuria etc. The outcomes data will be collected in a data collection sheet. The 
outcomes data will then be analyzed and compared using ANOVA. 
We hope to enroll a total number of 75-100 subjects in both arms (DirectVision versus 
Flexible cystoscopy). We usually receive about 10-20 consults a month for difficult Foley 
catheter placement. There will likely be 50 subjects from each arm.  
 
 
8. 
Informed Consent Process 
An informed consent will be obtained. The subjects will be patient over 18 years who 
have a consult for difficult urinary catheterization.  
 
9. 
Privacy and Confidentiality 
The records of this study will be kept private and will be protected to the fullest extent 
provided by law. The data collection sheet will be stored in computers that are password 
protected to safeguard confidentiality. These Orlando Health computers are located in our 
Urology offices at South Lake hospital which are in locked room and require authorized 
access. 
The consents will be stored in file cabinets located in a locked room in our PUR clinic 
office.  
The consents and datasheet will be stored in a locked office of the investigators and 
maintained for a minimum of three years after the completion of the study. 
Human subjects’ names will be kept on a password protected file and will be linked only 
with a study identification number for this research. The study identification number will 
be kept separate from the data collected, and will be destroyed according to Orlando 
Health policy after three years.   
Only the investigators Dr Etafy, Dr Parekattil and Dr Brahmbhatt will have access to the 
data. No portable storage will be used for research data. The data will only be stored in 
the Orlando Health computers.  
This research presents no greater than minimal risks to the patients and will not affect the 
rights and welfare of any of the subjects.  
 
 
10. 
Risk/Benefit 
 
10.1 
Risk to participants: 
Risks of cystoscopy (standard of care): subjects may subsequently experience blood in 
the urine, abdominal pain and burning sensation when urinating, infection from germs 
introduced in the urinary tract.  
Risks of DirectVision are the same as the risks of cystoscopy.  
Breach of confidentiality is a possible risk in this prospective study which will be 
mitigated by the use of password-protected computers.  
 
10.2 
Benefits to Participants: 
We are hoping that the benefits to the patient will be decrease risk of infection, pain, 
bleeding, or risk of stricture formation from several tries of blind catheter placements. 
Moreover, the study will provide an opportunity to gain a better understanding of which 

 
Page 10 of 10 
treatment options confer the best results for patients suffering with difficult urinary 
catheterization.  
 
11. 
Safety Monitoring, Interim Analysis, and Stopping Rules 
Breach of confidentiality is a possible risk in this prospective study which will be 
mitigated by the use of password-protected computers. There are also the usual risks that 
come with procedures such as infection, bleeding and pain. There are no other risks 
foreseen to the patients in this study.  
There will be no interim review because known risks do not pose a threat of serious 
adverse events and the risks for both procedures are the same.  
We do not anticipate any safety issue that will result in the suspension of this prospective 
study. The patient identifiable information will be deleted from the list at the earliest 
convenience after the completion of the study and the rest of the data which will only 
contained non-identifiable information will be kept indefinitely.  
Additionally, any event or finding resulting in a temporary or permanent suspension of 
the study will be reported to the IRB and to the Corporate Office of Research Operations 
(CORO) in a timely fashion.  
 
12. 
Conflict of Interest 
There will be a grant provided to PUR clinic to gift the hospital with a cystoscopy cart, to 
pay for food during educational sessions and for research forms completion by the 
physicians as mentioned above.   
 
13. 
Publication and Presentation Plans 
We are planning on publishing when all the data have been gathered.  
 
 
 
14. 
References 
1. Bacsu et al. A prospective analysis of consultation for difficult urinary catheter 
insertion at tertiary care centres in Northern Alberta. Can Urol Ass J. Sept-Oct 
2013; 7(9-10): 343-347.  
2. Ghaffary et al. A practical approach to difficult urinary catheterizations. Cur Urol 
Rep. 2013 Dec;14(6):565-79. 
3.  Banks et al. Feasibility study of a visually guided male urinary catheterization 
device. Journal of Urology. 2009; 181(4): p454. 
4. Willette et al. Best practices for blind catheterizations and algorithm to manage 
difficult urinary catheterization, including direct visualization of the urethra 
during placement. West J Emerg Med 2012. 
 
 
15. 
Appendices  
Data sheet collection