Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention
Phase: NA
Conditions: Neurogenic Bladder, Urinary Retention, Urologic Diseases
Sponsor: Spinal Singularity

 
FREEDOM Study - CIP-0002 
  
 
 
Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter – 
Wireless Urinary Prosthesis for Management of chronic Urinary Retention 
 
Short Title: FREEDOM Study 
 
Protocol Number: CIP-0002 (formerly ES-NIH-01) - Revision 03 
 
Date: September 2020 
 
Investigation Device: 
Gen 2 Connected Catheter System and Accessories 
ClinicalTrials.gov ID: 
NCT04059159 

Spinal Singularity, Inc. 
 
 
 
 
 
 
 
 
 
FREEDOM Study 
 
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Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter –  
Wireless Urinary Prosthesis for Management of chronic Urinary Retention 
 
Short Title: FREEDOM Study 
 
Protocol Number: CIP-0002 (formerly ES-NIH-01) - Revision 03 
 
Date: September 2020 
 
Investigation Device:  
Gen 2 Connected Catheter System and Accessories 
 
Sponsored By: 
Spinal Singularity, Inc. 
105 Avenida de la Estrella, Suite 3 
San Clemente, CA 92672 USA 
Telephone: +1 (949) 436-7974 
Facsimile: +1 (949) 607-3175 
info@spinalsingularity.com 
www.spinalsingularity.com 
 
CONFIDENTIAL - DO NOT COPY 
 
This clinical investigational protocol (CIP) contains confidential information for use by the 
principal investigator(s) and their designated representatives participating in this clinical 
investigation.   
It should be held confidential and maintained in a secure location.  It should not be copied or made 
available for review by any unauthorized person or firm 
This study will be conducted in compliance with the clinical investigation protocol and applicable 
regulatory requirements. 
 
CONFIDENTIAL INFORMATION 
No use or disclosure of this document outside Spinal Singularity, Inc. is permitted without prior 
written authorization from Spinal Singularity, Inc. 

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Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter –  
Wireless Urinary Prosthesis for Management of chronic Urinary Retention 
 
FREEDOM Study 
 
Protocol Signature Page 
CIP-0002 (formerly ES-NIH-01), Revision 03 
 
September, 2020 
 
The Principal Investigator (PI) and Spinal Singularity, Inc. (Sponsor) hereby agree to conduct this clinical 
study in accordance with the study design and specific provisions of this clinical investigation protocol 
(CIP). Further the Principal Investigator and the Sponsor agree to conduct this clinical study in accordance 
with applicable US FDA CFRs, EN ISO 14155:2011, other applicable regulatory requirements and 
applicable legal requirements. The recording and reporting of Serious Adverse Events (SAEs) must be 
followed according to the SAE Handling Plan provided within this CIP. 
 
With signatures below, the following persons below confirm their acceptance of the content of this CIP 
and agree to adhere to the requirements. The PI will provide copies of this CIP and all pertinent 
information to the study personnel under their supervision and their site or the central Independent Ethics 
Committee/Institutional Review Board (IEC/IRB). The PI will discuss this material with them and ensure 
they are fully informed regarding the conduct of the study according to this CIP, applicable regulatory 
requirements, and site or central IEC/IRB requirements.  
 
With signatures below, I agree to and understand the material presented in this CIP and will not publicly 
disclose in any manner the design, results, or conclusions of this clinical investigation without prior written 
consent of Spinal Singularity, Inc. 
 
 
_________________________________________________________________________________ 
Clinical Site Name 
 
 
 
_______________________________________________ 
 
________________________ 
Site Principal Investigator (Signature) 
 
 
 
 
Date 
 
 
 
 
 
_______________________________________________ 
Site Principal Investigator (Printed Name) 
 
_______________________________________________ 
 
________________________ 
Sponsor (Signature) 
 
 
 
 
 
 
Date 
 
 
 
 
 
_______________________________________________ 
Sponsor (Printed Name) 
 

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Table of Contents 
1 
Protocol Synopsis ................................................................................................................... 6 
2 
List of Abbreviations ........................................................................................................... 10 
3 
Introduction and Background ............................................................................................ 11 
3.1 
Chronic Urinary Retention .............................................................................................. 11 
4 
Investigational Device Description ..................................................................................... 13 
4.1 
Principles of Operation ................................................................................................... 15 
5 
Proposed Intended Use ........................................................................................................ 15 
6 
Study Rationale .................................................................................................................... 15 
7 
Risk-Benefit Analysis .......................................................................................................... 16 
7.1 
Risk Analysis .................................................................................................................. 16 
7.2 
Risk Mitigation ............................................................................................................... 17 
7.3 
Potential Benefits ............................................................................................................ 18 
8 
Clinical Study Design .......................................................................................................... 18 
8.1 
Study Objective ............................................................................................................... 19 
8.2 
Screening Phase .............................................................................................................. 19 
8.3 
Test Phase ....................................................................................................................... 19 
8.4 
Follow-Up Phase ............................................................................................................. 20 
8.5 
Primary Endpoints .......................................................................................................... 20 
8.5.1 
Primary Efficacy ...................................................................................................... 20 
8.5.2 
Primary Safety ......................................................................................................... 20 
8.6 
Secondary Endpoints ...................................................................................................... 20 
8.7 
Subject Selection ............................................................................................................. 20 
8.7.1 
Inclusion Criteria ..................................................................................................... 21 
8.7.2 
Exclusion Criteria .................................................................................................... 21 
8.8 
Number Sites and Sample Size ....................................................................................... 22 
8.9 
Study Duration ................................................................................................................ 22 
8.10 Site and Physician Selection ........................................................................................... 22 
9 
Study Procedure .................................................................................................................. 22 
9.1 
Informed Consent Procedure .......................................................................................... 23 
9.2 
Eligibility Screening ....................................................................................................... 23 
9.2.1 
Insertion and Initial Voiding Assessment ................................................................ 25 
9.2.2 
User (Subject) Training ........................................................................................... 25 

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9.2.3 
Device Positioning and Sizing Assessment ............................................................. 26 
9.2.4 
Bladder Filling Period ............................................................................................. 26 
9.2.5 
Voiding Assessment(s) ............................................................................................ 26 
9.2.6 
Expectation Management for New Users – Anti-Cholinergic and other medications
 
26 
9.2.7 
Clinic Assessment Completion and Subject Discharge ........................................... 27 
9.3 
Device Tolerability Screening ........................................................................................ 27 
9.4 
Test Phase ....................................................................................................................... 27 
9.5 
Follow-Up Phase ............................................................................................................. 28 
9.6 
Unscheduled Follow-up Visits ........................................................................................ 28 
9.7 
Subject Loss to Follow-Up or Withdrawal ..................................................................... 30 
9.7.1 
Subject Discontinuation/Withdrawal Criteria ......................................................... 30 
9.8 
End of Study ................................................................................................................... 31 
10 Statistical Considerations .................................................................................................... 32 
10.1 Primary Endpoint Hypothesis ......................................................................................... 32 
10.2 Sample Size Justification ................................................................................................ 32 
10.3 Statistical Analysis .......................................................................................................... 32 
11 Definition of Adverse Events .............................................................................................. 33 
11.1 Adverse Event (AE) ........................................................................................................ 33 
11.2 Serious Adverse Event (SAE) ......................................................................................... 33 
11.3 Unanticipated Adverse Device Effect (UADE) .............................................................. 34 
11.4 Serious Adverse Device Effect (SADE) ......................................................................... 34 
11.5 Unanticipated Serious Adverse Device Effect (USADE) ............................................... 34 
11.6 Device Technical Observation ........................................................................................ 34 
11.7 Adverse Event Classification and Reporting Requirements ........................................... 34 
11.8 Reporting of all Adverse Events ..................................................................................... 35 
11.8.1 Device and Procedure-Related Adverse Event ........................................................ 36 
11.8.2 Concomitant Medication-Related Adverse Event ................................................... 36 
11.8.3 Pre-Existing Condition-Related Adverse Event ...................................................... 36 
11.9 Anticipated Adverse Events ............................................................................................ 36 
12 Training ................................................................................................................................ 37 
13 Data Management ................................................................................................................ 38 
13.1 Subject Identification ...................................................................................................... 38 

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13.2 Central Database ............................................................................................................. 38 
13.3 Data Monitoring and Quality Control ............................................................................. 38 
14 Study Responsibilities and Management ........................................................................... 39 
14.1 Investigator Responsibilities ........................................................................................... 39 
14.2 Subject Enrollment Process ............................................................................................ 40 
14.3 Ethics Committee (EC) / Institutional Review Board (IRB) .......................................... 40 
14.4 Informed Consent Form (ICF) ........................................................................................ 40 
14.5 Case Report Forms (CRFs) ............................................................................................. 40 
14.6 Records ........................................................................................................................... 41 
14.7 Reports ............................................................................................................................ 42 
14.8 Sponsor Responsibilities  ................................................................................................ 43 
14.8.1 Confidentiality ......................................................................................................... 43 
14.8.2 Amending the Investigational Study Protocol ......................................................... 43 
14.8.3 Protocol Deviations ................................................................................................. 43 
14.8.4 Site Noncompliance and Nonperformance .............................................................. 44 
14.8.5 Device Accountability ............................................................................................. 44 
14.8.6 Sponsor Reporting Responsibilities ......................................................................... 44 
15 Study Administration .......................................................................................................... 45 
15.1 Monitoring Procedures .................................................................................................... 45 
15.1.1 Monitoring Visit ...................................................................................................... 46 
15.1.2 Study Closure .......................................................................................................... 47 
16 Clinical Trial Oversight ...................................................................................................... 47 
16.1 Safety Monitoring ........................................................................................................... 47 
17 Potential Device Change ..................................................................................................... 47 
18 Publication Policy ................................................................................................................ 47 
19 Reimbursement .................................................................................................................... 48 
20 References ............................................................................................................................. 48 
 
 
 

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1 PROTOCOL SYNOPSIS 
Study Title 
Evaluation of the Safety and Clinical Performance of the Gen 2 Connected 
Catheter – Wireless Urinary Prosthesis for Management of chronic Urinary 
Retention 
Short Title 
FREEDOM Study 
Study Sponsor 
Spinal Singularity, Inc. (San Clemente, California, USA) 
Protocol Number 
CIP-0002 (formerly ES-NIH-01) 
 
Study Objective 
The objective of this study is to evaluate the safety and essential 
performance of the Gen 2 Connected Catheter in males with chronic Urinary 
Retention, both in a clinical setting and an extended period of home use.  
This is a non-significant risk (NSR) study. 
Study Design 
Multi-center, single-arm NSR study. 
Estimated Study 
Duration 
12 months 
Investigational 
Device 
Gen 2 Connected Catheter System and Accessories 
 
Proposed 
Indications for 
Use 
The Gen 2 Connected Catheter is a replaceable urinary prosthesis that is 
intended for use in male patients (subjects) 18 years of age or older who 
have impaired bladder emptying due to chronic Urinary Retention, and who 
are capable of operating the device in accordance with the provided 
instructions for use, or who have trained caregivers capable of doing the 
same. The device must be replaced every 7 days (or less).  
Number of 
Subjects 
The number of subjects to be enrolled in the study (ITT) as defined by EN 
ISO 14155; is 36 subjects.  Of these, it is expected only 24 of the subjects 
will be found to meet the basic eligibility criteria to be tested for device 
tolerability screening. 
Assuming a 33% dropout after the device tolerability screening, the final 
number of evaluable subjects required is a minimum of 16 subjects. 
 
Duration of 
Study and 
Follow-up 
The study will be divided into 3 phases after the Eligibility Screening.  Each 
subject will be in the study for a total of 7 weeks. 
1. Device Tolerability Screening – up to one week of Gen 2 
Connected Catheter use 
2. Test – 4 weeks of Gen 2 Connected Catheter use 
3. Follow-up – Phone screen for AE for 2 weeks  
During each phase, there will be weekly appointments to evaluate the 
subjects and device performance. 

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Study Population 
Adult males with chronic Urinary Retention 
Study Sites 
Up to 4 sites in the USA 
Inclusion Criteria 
1. Males > 18 diagnosed with chronic Urinary Retention 
2. Must be clinically suitable and capable of safely managing bladder 
using an intermittent voiding or indwelling strategy 
a. Must have stable urinary management history as determined 
by the Investigator OR: 
b. Must have urodynamic profile suitable for the Gen 2 
Connected Catheter (including bladder capacity ≥ 200mL 
without uninhibited bladder contractions) 
3. Subject’s lower urinary tract anatomy must fall within the ranges 
serviceable by the Gen 2 Connected Catheter device, as specified in 
the Investigational Device Instructions For Use. 
Exclusion Criteria 
1. Active symptomatic urinary tract infection, as defined in this clinical 
investigation protocol (subjects may receive the device after UTI has 
been treated) 
2. Significant risk profile or recent history of urethral stricture (e.g. 
stricture within past 90 days) 
3. Significant risk profile or recent history of clinically significant 
(uncontrolled) autonomic dysreflexia 
4. Significant intermittent urinary incontinence (between 
catheterizations) 
5. Uninhibited bladder contractions and/or Vesicoureteral reflux that is 
not reliably controlled with medication or alternate therapy (e.g. 
Botox injection) 
6. Pre-existing urinary pathologies and/or morphological abnormalities 
of the lower urinary tract or bladder (assessed during in-depth 
medical screening, including cystoscopy and urine analysis) 
a. Urinary tract inflammation or neoplasm 
b. Urinary fistula 
c. Bladder diverticulum (outpouching) > 5cm in size 
d. Chronic pyelonephritis (secondary to upper urinary tract 
infection(s) within past 6 months) 
e. Impaired kidney function or renal failure 
f. Active gross hematuria 
g. Active urethritis 

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h. Bladder stones 
7. Dependence on an electro-magnetic medical implant (e.g. cardiac 
pacemaker or implanted drug pump) or external device 
8. Any unsuitable comorbidities as determined by the Investigator or 
complications related to use of certain medications 
9. Any physical or cognitive impairments that diminish the subject’s 
ability to follow directions or otherwise safely use the Gen 2 
Connected Catheter System 
10. Catheter Assessment Tool screening yields unacceptable results 
Primary Efficacy 
Endpoint 
Primary efficacy: Post-void residual urine volume (PVR) with the use of the 
Connected Catheter 
 
A subject is considered a responder to the treatment if a minimum of 80% of 
their PVR values met the following criteria 
 
PVR is ≤ 50 mL OR 
PVR is ≤ baseline PVR with the standard of care catheter 
 
If a subject drops out before the conclusion of the study after passing the 
Device Tolerability Screening, their PVR data will still be included in the 
primary analysis. 
Primary Safety 
Endpoint 
Rate of device related SAE 
Secondary End 
Points 
1. Successful device insertion, anchoring, and removal 
2. Successful sealing of the catheter valve 
3. Quality of life improvement as measured by SCI-QOL Survey 
4. UTI occurrence rate 
5. Lower Urinary Tract injury rate 
Study and Data 
Management 
Spinal Singularity, Inc. 
105 Avenida De La Estrella, Suite 3  
San Clemente, CA 92672, USA 
Tel: +1 (949) 436-7974 
Fax: + 1 (949) 607-3175 
Study Safety 
Monitor 
Dr. Jaime Landman, MD,  
Professor of Urology and Radiology Chairman,  
Department of Urology  

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University of California, Irvine 

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2 
LIST OF ABBREVIATIONS 
Abbreviation Definition 
AE 
Adverse Event 
AD 
Autonomic Dysreflexia 
ASIA 
American Spinal Injury Association 
BPH 
Benign Prostatic Hyperplasia 
CAT 
Catheter Assessment Tool 
CAUTI 
Catheter Associated Urinary Tract Infection 
CIC 
Clean Intermittent Catheterization 
CFU 
Colony Forming Units 
CRA 
Clinical Research Associate 
eCRF 
Electronic Case Report Form 
EC 
Ethics Committee 
EDC 
Electronic Data Capture 
FDA 
Food & Drug Administration 
HAI 
Healthcare Acquired Infection 
IC 
Informed Consent 
ICF 
Informed Consent Form 
IR 
Insertion / Removal 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
ITT 
Intent to Treat Population 
LUT 
Lower Urinary Tract 
NIDRR 
National Institute of Disability and Rehabilitation Research 
PVR 
Post-Void Residual Volume 
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Event 
SCI 
Spinal Cord Injury 
SCI-QOL 
Spinal Cord Injury Quality of Life 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Effect 
UTI 
Urinary Tract Infection 

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3 INTRODUCTION AND BACKGROUND 
3.1 
Chronic Urinary Retention 
Urinary retention is a condition in which an individual is unable to fully empty their bladder from 
urine.  While urinary retention is not a disease, it can be a symptom of many other health issues in 
both males and females.  Urinary retention presents itself in both acute and chronic cases.  Acute 
Urinary Retention is sudden and can be extremely painful. 
Chronic Urinary Retention develops over time and is the persistent inability to completely empty 
the bladder resulting in elevated post-void residual (PVR) volumes. Chronic Urinary Retention  
generally occurs over a long period and is typically not painful.  The causes of chronic Urinary 
Retention can be categorized as obstructive, infectious/inflammatory, neurologic, pharmacologic, 
or other.  Table 3-1 gives examples of these categories. 
 
Table 3-1: Examples of Causes of Chronic Urinary Retention  
Category 
Examples 
Obstructive1 
Benign prostatic hyperplasia (BPH) 
Meatal stenosis 
Paraphimosis 
Penile constricting bands 
Phimosis 
Prostate cancer 
Urethral stricture 
Infectious or Inflammatory1 
Guilliain-Barre syndrome 
Balanitis 
Prostatic abscess 
Prostatitis 
Herpes simplex virus 
Neurological1 
Spinal cord injury 
Intervertebral disk disease 
Spinal stenos 
Spinal bifida occulta 
Stroke 
Multiple sclerosis 

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Category 
Examples 
Diabetes mellitus 
Pharmacological1-3 
Anticholinergics 
Tricyclic antidepressants 
Anti-psychotics 
Antispasmodics 
Antihistamines, 
NSAIDs 
Muscle relaxants 
Opioid analgesics 
Amphetamines  
Other 
Trauma 
Post-operative complications 
Psychogenic conditions 
 
Common methods to manage Chronic Urinary Retention from a physiological standpoint include 
medication and catheterization.  In some cases, surgical intervention may be required, but are 
invasive and are only used as a last resort.  Medications such as alpha-blockers have been effective 
in both males and females, but have many possible side effects such as: 
• 
Dizziness 
• 
Fainting 
• 
Headaches 
• 
Lightheadedness 
• 
Low blood pressure 
• 
Rash or itchiness of the skin 
• 
Nausea 
• 
Swollen legs or ankles. 
• 
Tiredness, weakness or feeling lethargic. 
• 
Sleep disturbance. 
• 
Tremor. 
• 
In some cases, erectile dysfunction in males 
 

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Because of these side effects, catheterization is often used as an alternative to manage chronic 
Urinary Retention .  Both intermittent catheterization and the use of indwelling catheter are valid 
treatment options, although indwelling catheters are typically only used when long-term care is 
needed.  With both methods of catheterization there is risk of urethral injury and UTI with the rate 
of occurrence for UTI being higher with the use of indwelling catheters.  Indwelling urinary 
catheters also require the subject to have a drainage bag with them to collect the urine which can 
negatively affect the subject’s quality of life.  Traditional indwelling catheters are typically fixated 
within the bladder with an inflatable balloon.  If the balloon bursts it cause bladder injury and the 
catheter will migrate or fall out of the patient completely.  Additionally, the catheter often extends 
outside of the body which interferes with sexual activity. 
The Gen 2 Connected Catheter aims to bring an improved experience for patient’s requiring 
catheterization.  The Gen 2 Connected Catheter does not need to be replaced as often as catheters 
used for intermittent catheterization but does not remain in place as long as typical indwelling 
urinary catheters.  It also provides increased convenience over indwelling urinary catheters as the 
device does not protrude outside of the body, allowing for sexual activity, and does not require the 
subjects to carry a drainage bag.  It also does not have a balloon as it uses two anchoring features 
located in the urethra and the bladder.  The Gen 2 Controller allows the subjects to control voiding.  
Additionally, the increased frequency of replacement versus indwelling catheters may decrease 
the occurrence of UTI in the subjects versus traditional indwelling catheters that may be left in the 
body for up to 29 days. 
 
4 INVESTIGATIONAL DEVICE DESCRIPTION 
To address the many drawbacks of current standard-of care urinary catheters, Spinal Singularity, 
Inc. has developed the Gen 2 Connected Catheter System and Accessories. The Gen 2 Connected 
Catheter System consists of the Gen 2 Connected Catheter (hereafter referred to as the Connected 
Catheter), the Gen 2 Insertion / Removal  Tool (hereafter referred to as the IR Tool) and the Gen 
2 Controller (hereafter referred to as the Controller). The Gen 2 Catheter Assessment Tool 
(hereafter referred to as the CAT) is an optional accessory for clinicians to support initial and 
continued determination of whether the Connected Catheter may be an option for a suitable 
potential patient. The Connected Catheter (Figure 4-1) is a fully internal, indwelling urinary 
prosthesis designed for improved bladder management in males with urinary retention disorders 
requiring catheterization. The Connected Catheter is a sterile, disposable, extended-use device that 
resides fully internally to the male lower urinary tract (urethra + bladder neck) for an intended use 
life of up to 7 days per Connected Catheter. 
 

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In contrast to indwelling Foley and clean intermittent catheters, the Connected Catheter enables 
both natural bladder filling and convenient, voluntary voiding by the user, without the need for 
external drainage apparatus or frequent self-catheterization. Instead, the user initiates voiding by 
placing a wireless hand-held Controller near the magnetic valve in the base of the penis. When 
activated, the Controller will open the valve and actively pump urine from the bladder, then seal 
once voiding is complete. The Connected Catheter is retained in place by using varying diameters 
to provide anchoring at different locations in the urethra. The Connected Catheter is designed to 
be easily inserted and removed either by a clinician, caregiver, or the user himself, using a sterile, 
single-use, IR Tool. 
Figure 4-1: Overview of System 
 
The Gen 2 Connected Catheter System and Accessories are manufactured by Spinal Singularity, Inc. 
Each device (Connected Catheter, IR Tool, Controller and CAT) are manufactured and labeled in 
accordance with Spinal Singularity Inc.’s Quality Management System procedures. These 
procedures are in compliance with applicable FDA regulations and in conformance with ISO 
standards for Device Traceability and Identification. In doing so, Spinal Singularity, Inc. and 
Research Staff will maintain full traceability of every investigational device throughout the 
duration of the study using lot numbers and serial numbers. Accountability of all investigational 
devices will be maintained by the clinical research staff and Spinal Singularity, Inc. will also track 
serial numbers of each investigational device utilized in the study. 
 
All portions of the Gen 2 Connected Catheter System and Accessories will contact the subject’s 
body in some fashion for a period of time. To maintain subject’s safety, thorough testing of each 
device has been conducted to ensure appropriate levels of electrical safety, biocompatibility and 

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sterility. Although the requirements for each device are different, test results have shown that the 
product meets applicable FDA regulations and ISO standards. 
 
4.1 
Principles of Operation 
The basic principle of the Connected Catheter is to allow the subject to void their bladder using a 
wireless Controller and a magnetic valve.  A summary of the treatment is provided below only as 
an overview.  The IFU should always be followed and if different from this section, the IFU should 
be followed. 
1. Using the IR tool and lubrication, the Connected Catheter is inserted in the urethra.  The 
valve (end of the Catheter) should be positioned near the scrotum before the IR tool is 
removed. 
2. To urinate, locate the valve by feeling with a hand.  Position the Controller near the 
valve – the end of the valve should align with the blue line on the Controller. 
3. Press and hold the button on the Controller for 3 seconds to open the valve and urinate.  
The Controller should be kept in line with the valve as much as possible. 
4. When the bladder has been emptied, re-align the Controller with the valve and press the 
button on the Controller and move the Controller towards the tip of the penis.  This will 
close the valve. 
5. Empty the receptacle if necessary. 
 
5 PROPOSED INTENDED USE 
The Gen 2 Connected Catheter is a replaceable urinary prosthesis that is intended for use in male 
patients (subjects) 18 years of age or older who have impaired bladder emptying due to chronic 
Urinary Retention, and who are capable of operating the device in accordance with the provided 
instructions for use, or who have trained caregivers capable of doing the same. The device must 
be replaced every 7 days (or less).  
The Gen 2 Connected Catheter System is intended for use by prescription only. 
 
6 STUDY RATIONALE 
The FREEDOM study is designed to show that the Connected Catheter is able to effectively drain 
the bladder and the patient to control voiding function.  Measurement of post void residual (PVR) 
volume will be a key performance parameter in this study.  The study is designed to show that the 
subject’s PVR volume with the Connected Catheter is similar to using standard catheter (CIC or 
indwelling Foley-type catheters) without compromising the safety of the subjects. We expect an 
improvement in the subject’s quality of life with the Connected Catheter once he is used to having 
the Connected Catheter inside the anterior urethra.   
The Connected Catheter does not need to be replaced as often as catheters used for intermittent 
catheterization, but does not remain in place as long as typical indwelling urinary catheters.  It also 

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provides increased convenience over indwelling urinary catheters as the device does not protrude 
outside of the body, allowing for sexual activity, and does not require the subjects to carry a 
drainage bag.  It uses two anchoring features, one located in the bulbar urethra and one in the 
bladder.  The Controller allows the subjects to control their voiding while using normal restroom 
facilities.  Additionally, the increased frequency of replacement versus indwelling catheters may 
decrease the occurrence of UTI in the subjects versus traditional indwelling catheters that may be 
left in the body for up to 29 days. 
7 RISK-BENEFIT ANALYSIS 
7.1 
Risk Analysis 
Complications and risks that exist for other indwelling urinary catheters may also exist for the 
Connected Catheter.  Section 11.9 contains an extensive list of possible adverse events.  The major 
risks and symptoms are described below. 
 
Table 7-1: Major Risks for the Connected Catheter 
Risk 
Description 
Urinary Tract Infection 
(UTI) 
UTI is defined in this protocol as bacteriuria ≥ 105 CFU per mL, 
plus at least one NIDRR consensus-defined symptom.  If 
infection is suspected, appropriate diagnostic and therapeutic 
measures should be taken.  
Asymptomatic Bacteriuria 
The presence of bacteria in the properly collected urine of a 
patient that has no signs or symptoms of a urinary tract 
infection. 
Bladder Spasms 
When the bladder muscle squeezes suddenly without warning, 
causing an urgent need to release urine. The spasm can 
force urine from the bladder, causing leakage. 
Dysuria 
Pain experienced while urinating.  Dysuria can be caused by 
UTI, inflammation of the LUT, sexually transmitted diseases, 
and more.  The operation of the device should not cause pain 
while voiding.  If this occurs, a clinician should evaluate the 
subject to determine the likely cause and follow the standard of 
care.  If necessary, the device may be removed. 
Genitourinary pain 
Initial discomfort may occur when first using the device.  Pain 
should be properly evaluated by a clinician and the cause(s) 
identified.  Genitourinary pain can have many causes unrelated 
to the device itself ranging from enlarged prostate to 
fibromyalgia to infection.  The proper standard of care should 
be followed once the cause(s) are identified. 

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Risk 
Description 
Hematuria 
Blood in the urine may be caused by LUT injury, UTI, kidney 
or bladder stones, enlarged prostate, the device itself (from 
insertion, removal, migration, improper sizing), and more.  
During initial use of the device minor hematuria may be 
observed.  If it continues or worsens, then follow the standard 
of care to diagnose and alleviate the symptom. 
Stricture 
Hardening of the tissue.  May be caused by frequent catheter use 
and/or false passage. 
Urethral Trauma 
False passage may be associated with improper and/or frequent 
catheter use.   
Urinary Incontinence 
Leaking may occur through or around the catheter if the bladder 
spasms, or the catheter valve is not closed properly. 
Urinary retention 
If patient is unable to empty the bladder, then Urinary Retention 
may occur.   
Discomfort  
Discomfort is often associated with frequent catheterization. 
 
These complications may occur at any time during (or shortly following) Connected Catheter 
insertion, usage, or removal, and may require additional medical treatment. All the above medical 
complications can be easily treated by the standard of care. Each of the above risks is comparable 
or lower with the Connected Catheter compared to intermittent catheterization in terms of 
likelihood and severity. In addition to the above risks, there may be other risks that are unforeseen 
at this time. 
7.2 
Risk Mitigation 
Spinal Singularity, Inc. is committed to minimizing the risks to human research subjects in all of 
its clinical studies, and has taken measures to minimize risk, including the following: 
The Gen 2 Connected Catheter System and Accessories have been designed and developed 
according to Spinal Singularity Inc.’s Product Development Process (PDP), which is utilized in 
conjunction with a rigorous standard operating procedure (SOP) for Risk Management (including 
risk mitigation). This Risk Management SOP is based on the industry best-practice standards 
detailed by EN ISO 14971:2012 (“Application of Risk Management to Medical Devices”). Spinal 
Singularity, Inc. also maintains detailed procedures (SOPs and DOPs) for Risk Evaluation, Design 
Controls, and Control of Quality Records. 
Pre-clinical performance testing of the Gen 2 Connected Catheter System: the essential functions 
of the Gen 2 Connected Catheter System (insertion, voiding, sealing, and removal) has been 
thoroughly tested in a series of design verification and validation tests. Connected Catheter product 
will not be released by Spinal Singularity, Inc. for investigational clinical use until the Gen 2 

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Connected Catheter System has passed a defined set of performance and acceptance criteria 
required for clinical product. 
The subject eligibility criteria for participation in this study have been carefully defined to ensure 
their medical suitability and minimize the risk of complications. 
This clinical investigation protocol specifies that the initial insertion and Clinic Assessment of the 
Gen 2 Connected Catheter System will be performed in a clinical setting, with subjects under direct 
supervision, where the Connected Catheter device can be immediately removed and any necessary 
medical care can be administered in the case of any acute medical complications (device-related 
or otherwise). 
This protocol involves close subject monitoring and evaluation at consecutive stages of Connected 
Catheter performance assessment, with subjects allowed to progress to the Test Phase of the study 
only if they exhibit good Connected Catheter tolerability and demonstrate the ability to effectively 
use the Gen 2 Connected Catheter System as trained. 
As part of their training to use the Gen 2 Connected Catheter System, subjects will be trained to 
remove the Connected Catheter using the IR Tool and will be provided with an IR Tool to keep 
available at all times throughout the Test Phase, in the event that the Connected Catheter must be 
removed at any time. 
During the Test Phase of the Study, subjects will maintain the phone number of the clinic should 
any adverse events arise. Staff will provide any necessary medical or device-related guidance. 
All Study Investigators will be thoroughly trained in this clinical investigation protocol, including 
the Gen 2 Connected Catheter System and Accessories Clinician Instructions for Use (IFU) and 
procedural elements of the study. 
7.3 
Potential Benefits 
The potential benefits to future patients suffering from chronic Urinary Retention are listed below.  
For study subjects, similar benefit may be experienced albeit temporary only during the study until 
the device is commercially available.  However, the potential longer-term benefit to the patients 
suffering with chronic Urinary Retention outweigh the risks of participation in this study.  
The benefits when using the Connected Catheter may include, but are not limited to, the following: 
1. Improvement in the comfort and/or convenience of urinary management while using the 
Gen 2 Connected Catheter System. 
2. Improvement in quality of life related to urinary function and overall social confidence. 
3. Reduction in the risk of urinary tract infection, genitourinary injury, and other medical 
complications associated with the use of standard urinary catheters. 
4.  A collection bag is not required while using the Connected Catheter. 
8 CLINICAL STUDY DESIGN 
The FREEDOM Study is a prospective, open, single-arm, non-significant risk (NSR) study to be 
performed in the United States with consecutive enrollment to evaluate the safety and efficacy of 
the Connected Catheter System in treating subjects with chronic Urinary Retention.  All patients 

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that sign an informed consent form are considered to be part of the intended-to-treat (ITT) 
population.   
The study will be broken up into 4 phases – Eligibility screening, Device Tolerability screening, 
Connected Catheter use, and Follow-Up.  Figure 8-1 shows an overview of the study with the 
estimated sample size enrolled and treated. 
Figure 8-1: Study and Subject Flowchart  
8.1 
Study Objective 
The objective of this study is to evaluate the safety and essential performance of the Connected 
Catheter in males with chronic Urinary Retention, both in an acute clinical setting and an extended 
period of home use. 
8.2 
Screening Phase 
The Screening Phase is divided into two phases – Standard Eligibility and Device Tolerability 
phases.  During Standard Eligibility screening, subjects will be evaluated according to the 
inclusion and exclusion criteria listed in this clinical investigation protocol including assessment 
of their urinary status using their standard of care management system.  Additionally, the subjects 
will be assessed as outlined in Section 9.2. 
Subjects that pass the eligibility screening will enter a 7-day trial period (Device Tolerability 
Screening) in which they will use the Connected Catheter.  They will be taught how to insert and 
remove the Connected Catheter as well as how to operate the device.  Any subject that is unable 
to demonstrate proficiency in the operation of the device will not continue to the Test Phase of the 
study.  During this time, subjects that use the Connected Catheter will be assessed for any pain or 
discomfort while using the device.  Subjects that are unable or unwilling to complete the days of 
device use will not continue to the Test Phase of the study. 
8.3 
Test Phase 
During this period, the subjects will use the Connected Catheter to manage their chronic Urinary 
Retention.  The subjects will remove the device themselves under supervision of a trained 
clinician.  A new Connected Catheter will be inserted by the subjects under the supervision of a 

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trained clinician.  There will be weekly follow-ups during this period to complete assessments as 
outlined in Table 9-2.   
8.4 
Follow-Up Phase 
This phase is 2 weeks long, and the subjects will return to using their previous method to manage 
their chronic Urinary Retention.  There will be weekly phone calls during this period to screen for 
any signs or symptoms of Adverse Events as outlined in Table 9-2. 
8.5 
Primary Endpoints 
8.5.1 Primary Efficacy 
During each follow-up, and during the initial device insertion and evaluation, the Post-Void 
Residual (PVR) urine volume will be measured via ultrasound.   
 
A subject will be considered a responder to the device if at least 80% of the subject’s available 
PVR values are: 
 
a. Less than 50 mL OR 
b. Equal or less than baseline PVR with the standard urinary management system 
 
If a subject drops out before the conclusion of the study after passing the Device Tolerability 
Screening, their PVR data will still be included in the primary analysis. 
8.5.2 Primary Safety 
Any adverse events and serious adverse events related to the use of the investigational device will 
be analyzed with descriptive statistics and nominal 95% confidence interval. There will be no 
formal statistical hypothesis test for primary safety.    
8.6 
Secondary Endpoints 
The following secondary endpoints will provide additional characterization of the Connected 
Catheter in the treatment of chronic Urinary Retention and to support potential labeling claims. 
1. Successful device insertion, anchoring, and removal 
2. Successful sealing of the Connected Catheter valve 
3. Quality of life improvement as measured by SCI-QOL Survey and other surveys 
4. UTI occurrence rate 
5. Lower Urinary Tract injury rate 
These endpoints will be analyzed with descriptive statistics and nominal 95% confidence interval. 
8.7 
Subject Selection 
Only subjects who meet all inclusion criteria and no exclusion criteria, agree to comply with the 
follow-up visit schedule and provide informed consent will be eligible to be treated and participate 
in the study. If a subject moves away during the study, every effort should be made to maintain 

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the follow-up schedule including having an appropriate physician follow the subject. 
8.7.1 Inclusion Criteria 
1. Males > 18 years old diagnosed with chronic Urinary Retention  
2. Must be clinically suitable and capable of safely managing bladder using an intermittent 
voiding or indwelling strategy 
3. Must have stable urinary management history as determined by the Investigator  
OR: 
4. Must have urodynamic profile suitable for the Connected Catheter (including bladder 
capacity ≥ 200mL without uninhibited bladder contractions) 
5. Subject’s lower urinary tract anatomy must fall within the ranges serviceable by the 
Connected Catheter device, as specified in the Investigational Device Instructions For 
Use. 
8.7.2 Exclusion Criteria 
1. Active symptomatic urinary tract infection, as defined in this protocol (subjects may 
receive the device after UTI has been treated) 
2. Significant risk profile or recent history of urethral stricture (e.g. stricture within past 90 
days) 
3. Significant risk profile or recent history of clinically significant (uncontrolled) 
autonomic dysreflexia 
4. Significant intermittent urinary incontinence (between catheterizations) 
5. Uninhibited bladder contractions and/or Vesicoureteral reflux that is not reliably 
controlled with medication or alternate therapy (e.g. Botox injection) 
6. Pre-existing urinary pathologies and/or morphological abnormalities of the lower 
urinary tract or bladder (assessed during in-depth medical screening, including 
cystoscopy and urine analysis) 
7. Urinary tract inflammation or neoplasm 
8. Urinary fistula 
9. Bladder diverticulum (outpouching) > 5cm in size 
10. Chronic pyelonephritis (secondary to upper urinary tract infection(s) within past 6 
months) 
11. Impaired kidney function or renal failure 
12. Active gross hematuria 
13. Active urethritis 
14. Bladder stones 
15. Dependence on an electronic medical implant (e.g. cardiac pacemaker or implanted drug 
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16. Any unsuitable comorbidities as determined by the Investigator or complications related 
to use of certain medications 
17. Any physical or cognitive impairments that diminish the subject’s ability to follow 
directions or otherwise safely use the Connected Catheter System 
18. Catheter Assessment Tool screening yields unacceptable results 
8.8 
Number of Sites and Sample Size 
Up to 4 sites in the United States are planned for this study.   
The number of subjects to be enrolled in the study (ITT) as defined by EN ISO 14155; is 36 
subjects.  Of these, it is expected only 24 of the subjects will be found to meet the basic eligibility 
criteria to be tested for device tolerability screening. 
Assuming a 33% dropout after the device tolerability screening, the final number of evaluable 
subjects required is a minimum of 16 subjects (See 10.1). 
8.9 
Study Duration 
Each subject will enter the study for 6 weeks after passing the Device Tolerability Screening.  The 
study duration to complete enrollment, monitor and collect the data is anticipated to be 12 months. 
8.10 Site and Physician Selection 
Sites will be selected based on the availability of the subject pool to be included in the study and 
the sites’ ability to perform the research in compliance with FDA regulations and guidelines and 
applicable international standards and regulations. 
The sites and physicians are required to comply with FDA regulations and guidelines and 
applicable international standards and regulations (the definition of subject enrollment is per this 
clinical investigation protocol).  In addition, the sites must be able to comply requirements 
specified by the central institutional review boards (IRB) or ethics committees (EC) and / or the 
sites respective IRB or EC.   
Physicians selected must have experience in performing cystoscopies and treating Urinary 
Retention and other urological conditions for adult males.  Selected physicians will be trained in 
the use of the Gen 2 Connected Catheter System and Accessories prior to enrolling subjects.  The 
principal investigator will ensure that only trained sub-investigators who satisfy the physician 
selection criteria can perform any part of the study interventional procedure.  
Healthcare professionals or site staff that assist or perform the follow-up evaluations do not need 
to be trained on the use of the Gen 2 Connected Catheter System and Accessories, but must be 
delegated and trained to perform the follow-up visit procedures. 
9 STUDY PROCEDURE  
Throughout the study, any urinary or other health issues potentially related to use, and requiring 
medical attention, will be treated according to Standard of Care.  Table 9-2 outlines the evaluations 
completed during each visit.  The site may pre-screen potential subjects by reviewing medical 
records to identify potential study subjects. Once identified, these subjects are approached to 
discuss the study, asked to participate and sign the IRB approved informed consent form. The site 

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may not initiate any study-specific (non-standard of care) procedures without first obtaining 
informed consent. 
9.1 
Informed Consent Procedure 
Written Informed Consent must be obtained for each prospective subject before any study- specific 
tests or screening procedures are performed on that subject.   The informed consent process must 
be performed by the Principal Investigator (PI) or their authorized designee.  They will be 
responsible for ensuring subjects understand all relevant aspects of the study.   
9.2 
Eligibility Screening 
Eligibility screening of prospective subjects will be conducted by a Site Investigator and/or a 
designated Research Coordinator. Subjects who wish to enroll will undergo the following 
assessments at Screening Appointment.  The subject will sign an Informed Consent Form 
administered by a designated Principal Investigator or authorized designee. 
Subject eligibility will be assessed on the basis of Screening Appointment data, according to the 
eligibility criteria listed above.  
Table 9-1: Subject Screening Criteria 
Evaluation 
Accepted interval 
prior to Eligibility 
Screening 
Appointment 
(unless specified 
otherwise) 
Condition 
Informed consent  
Within 30 days 
prior 
Prior to any study-specific 
procedures  
General Medical Evaluation  
a. baseline vitals  
b. physical examination 
c. Lower Urinary Tract 
(LUT) function and 
measurements 
Within 30 days 
prior  
Evaluation is complete and 
adequately documented in report 
for assessment 
Medical History 
a. Date and etiology of 
Urinary Retention 
diagnosis 
b. Review of past medical 
history (neurological, 
urological and systemic) 
Within 30 days 
prior  
Evaluation is complete and 
adequately documented in report 
for assessment 

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Evaluation 
Accepted interval 
prior to Eligibility 
Screening 
Appointment 
(unless specified 
otherwise) 
Condition 
c. Urinary management 
history: method(s) of 
bladder management and 
dates of major changes 
d. History of urinary 
complications (UTIs, false 
passage, stricture, etc.) 
e. Level and severity of 
spinal cord injury (if 
applicable; including ASIA 
Score, if known by subject) 
Lower Urinary Tract Evaluation – 
visual evaluation of lower urinary 
tract, and baseline anatomical 
measurements.   
Within 30 days 
prior  
Evaluation is complete and 
adequately documented in report 
for assessment 
Catheter Assessment Tool (CAT) 
Evaluation 
Within 30 days 
prior  
Evaluation is complete and 
adequately documented in report 
for assessment 
Baseline Urinalysis and Urine 
Culture 
Within 30 days 
prior  
If the patient has a UTI 
(bacteriuria ≥ 105 CFU per mL, 
plus at least one NIDRR 
consensus-defined symptom), 
they must undergo treatment 
before the initial insertion. 
Voiding Characterization 
a. Pre-Void Bladder Volume 
– measured by ultrasound 
b. Voided urine volume 
c. Post-Void Residual 
Volume – measured by 
ultrasound 
Within 30 days 
prior 
Bladder must contain at least 200 
mL of urine before conducting 
the test.   

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Evaluation 
Accepted interval 
prior to Eligibility 
Screening 
Appointment 
(unless specified 
otherwise) 
Condition 
Bladder Management SCI-QOL 
Survey (short form) 
Within 30 days 
prior 
Evaluation is complete and 
adequately documented in report 
for assessment 
Current Catheter Experience 
Survey 
Within 30 days 
prior 
Evaluation is complete and 
adequately documented in report 
for assessment 
USQNB-IC Survey 
Within 30 days 
prior 
Evaluation is complete and 
adequately documented in report 
for assessment 
Medications 
Within 30 days 
prior 
All medications taken are 
properly documented. 
 
All subjects screened for this study will be captured on the site’s Screening and Enrollment Log, 
which will record at a minimum, the prospective subject’s ID #, subject’s initials, date of screening 
and the reason(s) for study exclusion (if applicable). The Screening and Enrollment Log will use 
numeric subject identifier numbers. 
9.2.1 Insertion and Initial Voiding Assessment 
The Insertion Procedure is to begin with the insertion of the Connected Catheter using the IR Tool, 
according to device training procedures and Instructions for Use (IFU).  The initial insertion will 
be performed by a trained clinician.  Once the Connected Catheter has been placed, a urine sample 
will be collected and sent out for urinalysis and urine culture.  Note that the subject must have at 
least 200 mL of urine in the bladder, as measured by ultrasound, prior to voiding and sample 
collection.  After the bladder is emptied, a member of the research team (physician, nurse, etc.) 
will measure PVR volume using an ultrasound bladder scanner and record this reading. 
9.2.2 User (Subject) Training 
A trained, designated member from the Sponsor or a trained member of Study Site’s research team 
will instruct the subject on how to use the Connected Catheter - insertion, bladder voiding, and 
removal - using a training model. A short, initial training will take place before insertion of the 
Connected Catheter and will continue intermittently throughout the Insertion Appointment, in 
between the positioning and sizing assessment, as well as between voiding cycles, until the subject 
demonstrates proficiency in Connected Catheter insertion, voiding, and removal procedures to the 
research staff. If the subject is unable to demonstrate proficiency in the Connected Catheter voiding 

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or removal procedure, then he may be allowed to complete the Clinic Assessment, but not allowed 
to proceed to the Test Phase.  Each subject will be requested to refrain from sexual activity until 
the first follow-up appointment (up to 7 days).  After the first Connected Catheter use is completed, 
the subjects will be informed that normal sexual activity may occur with caution.  Device 
performance and impact on sexual will be evaluated in the Connected Catheter Safety and 
Performance Survey administered during each appointment where the device is replaced. 
9.2.3 Device Positioning and Sizing Assessment 
The subject will undergo a positioning and sizing assessment to evaluate if any migration of the 
Connected Catheter has occurred in the lower urinary tract by performing a set of mobility 
maneuvers intended to simulate the subject’s activities of daily living. These maneuvers will be 
tailored to the subject’s physical ability level (e.g. ambulatory vs. non-ambulatory) and will 
include common motions such as walking (or wheeling), sit-to-stand transitions, ascending and 
descending stairs as applicable to each subject. Any observed instances of Connected Catheter 
migration will be recorded. If an observed instance of migration is suspected to be due to incorrect 
sizing, the Connected Catheter may be removed, and a different size inserted (per IFU). 
9.2.4 Bladder Filling Period 
In between voiding cycles, the subject is to remain in the vicinity of the study site until voiding 
urgency is felt or the scheduled timed void(s) has occurred. During this bladder filling period, the 
subject should consume adequate fluids (>300 mLs) to promote bladder filling.  The bladder must 
contain at least 200 mL of urine, as measured by ultrasound, before performing the voiding 
assessment.  Subjects must consume fluid until the required minimum volume of urine in the 
bladder is achieved. 
9.2.5 Voiding Assessment(s) 
Prior to bladder voiding, the research staff will task the patient to locate the Connected Catheter 
end and assess if any migration has occurred. Next, the subject is to perform bladder voiding using 
the Controller, and the PVR Volume is then measured and recorded. The subject will remain in the 
vicinity of Study clinic premises for additional bladder filling and voiding cycles, to be conducted 
in the same manner without repeating the positioning and sizing assessment.  A total of 3 voiding 
cycles will be performed during the initial insertion visit and twice during each Test Phase visit. 
9.2.6 Expectation Management for New Users – Anti-Cholinergic and other medications 
Subjects transitioning from other methods of bladder management should expect a short period of 
time in which their body adapts to the Connected Catheter. This may include various symptoms 
including discomfort and pain. The Clinical Research staff should educate and inform the subject 
about this possibility and help to manage their expectations as they become accustomed to the 
device. 
Subjects with higher levels of sensation may have a more difficult time adapting to the Connected 
Catheter. For all subjects, the clinician should review subject’s history for any anti-cholinergic or 
other medications (e.g. Myrbetriq) that the subject has been treated with previously and consider 
starting an appropriate course of medication 1-2 weeks prior to the initial insertion and continue 
at least 1-2 weeks after the Connected Catheter has been inserted. This medication may help to 
alleviate any discomfort as the subject transitions to the Connected Catheter. Additionally, it may 

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help indwelling catheter users to increase bladder capacity as they begin using the Connected 
Catheter. 
There are no other medical devices or medications that will be utilized during this study. 
9.2.7 Clinic Assessment Completion and Subject Discharge 
Prior to discharge, the subject will complete the Connected Catheter User Experience Survey. If 
the Connected Catheter fulfills the objective performance criteria for all areas of essential 
performance (insertion, voiding and anchoring) then the subject will leave with their current 
Connected Catheter inserted, be scheduled for the next office appointment (at Day 7 ± 1), and will 
be discharged from the Study Site for the Device Tolerability Screening Phase. 
9.3 
Device Tolerability Screening 
During the Device Tolerability Screening, subjects will use the Connected Catheter to manage 
their chronic Urinary Retention .  The duration of Tolerability Screening will be up to 7 days after 
the patient has had the first device inserted.  The purpose of this screening is to ensure that the 
subjects can both tolerate the device and learn how to operate it properly.  Any subject that 
experiences significant discomfort or cannot demonstrate proficiency in the operation of the device 
(or does not have a caretaker) will not proceed to the test phase of the study.  Patients that are able 
to successfully use the device for up to 7 days and wish to continue the study will progress to the 
test phase. The data collection during the Device Tolerability Screening is identical to the data 
during the Test Phase.  The subjects will be trained to manage his bladder using the Connected 
Catheter via the Controller on an intermittent voiding strategy.  Instructions for Use (IFU) will be 
provided to the subject regarding how to properly use the Connected Catheter.  The same 
assessments used in the Test Phase will be done at the end of the Device Tolerability Screening 
phase. 
9.4 
Test Phase 
The Test phase will require three (3) Exchange Appointments and a final Removal Appointment.  
Each appointment will assess PVR, voided volume, quality-of-life (QOL), and urinary tract injury, 
adverse events, medication, and other study assessment.  Additionally, the subjects will be asked 
to fill out a User Experience Survey and Safety and Performance Survey and the device will be 
evaluated for fit, migration, placement, and removal. 
At each exchange visit, the clinic research staff will follow these procedures: 
1. Patient Arrival – Vital Signs and other measurements 
2. Bladder Volume – Measurement using Ultrasound to ensure at least 200 mL of urine 
3. Patient empties bladder – PVR volume measurement using Ultrasound 
4. Patient removes Connected Catheter 
5. Patient waits for bladder to fill – additional surveys completed 
6. Patient inserts new Connected Catheter and bladder emptied – PVR volume measured 
7. Patient Departure 
 

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For the final device removal visit the clinic research staff will follow these procedures: 
1. Patient Arrival – Vital Signs and other measurements 
2. Bladder Volume – Measurement using Ultrasound to ensure at least 200 mL of urine 
3. Patient empties bladder – PVR volume measurement using Ultrasound 
4. Patient removes Connected Catheter 
5. Patient completes all surveys 
6. Patient departure 
 
Once the patient completes the final device removal visit the patient will enter the follow-up phase.  
9.5 
Follow-Up Phase 
During the Follow-Up Period, subjects will use their previous method of bladder management for 
2 weeks following their Final Device Removal Appointment.  During this period, the patient will 
receive a phone call each week to screen for the occurrence and/or persistence of lower urinary tract 
symptoms and other issues that may be related to Connected Catheter usage, using the Follow-Up 
Phone Call Survey.  If any issues are identified that may require clinician intervention, then the 
research staff will schedule the patient for a clinic appointment with the appropriate provider.  At 
this appointment, the clinician will screen for any complications and attempt to document any 
symptoms that may be indicative of a complication related to Connected Catheter use. 
9.6 
Unscheduled Follow-up Visits 
If subjects are seen for unscheduled/interim visits because of an AE, appropriate Case Report 
Form(s), including the AE CRF, will be completed, if applicable.  At the investigator’s discretion, 
some of the evaluations and tests may be repeated if indicated.  Sponsor requests that if any 
additional tests or procedures listed within this clinical investigation protocol are performed during 
an unscheduled visit the investigator provide the results on the Unscheduled Visit CRF. 
Table 9-2: Schedule of Visits  
 
Eligibility 
Screening 
Device 
Tolerability 
Screening 
Test 
Phase  
Follow-
Up  
Unscheduled 
Compliance window 
 
7 ± 1 days  
7 ± 1 
days 
7 ± 1 
days 
 
Basic Vital 
Measurements 
Ö 
Ö 
Ö 
 
Ö 
Physical Examination 
Ö 
 
 
 
 
Urinary Tract Visual 
Examination 
Ö 
 
 
 
 

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Eligibility 
Screening 
Device 
Tolerability 
Screening 
Test 
Phase  
Follow-
Up  
Unscheduled 
(cystoscopic, if 
necessary) 
Catheter Assessment 
Tool (CAT) 
Evaluation 
Ö 
 
 
 
 
Medical History 
Ö 
 
 
 
 
UTI Assessment 
including Urinalysis  
Ö 
Ö 
Ö 
 
 
PVR Measurement 
Ö 
Ö 
Ö 
 
 
Voiding Volume 
Measurement 
Ö 
Ö 
Ö 
 
Ö 
SCI-QOL Bladder 
Management Survey  
Ö 
Ö 
Ö 
 
 
Current Catheter 
Experience Survey 
Ö 
 
 
 
 
Medication(s) used 
Ö 
Ö 
Ö 
 
Ö 
Connected Catheter 
User Experience 
Survey 
 
Ö 
Ö 
 
 
Connected Catheter 
Safety and 
Performance Survey 
 
Ö 
Ö 
 
 
USQNB-IC Survey 
Ö 
Ö 
Ö 
 
 
Connected Catheter 
Weekly Assessment 
Includes: 
• Device 
Insertion 
Assessment 
• Device Sizing 
 
Ö 
Ö  
 
 

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Eligibility 
Screening 
Device 
Tolerability 
Screening 
Test 
Phase  
Follow-
Up  
Unscheduled 
and 
Positioning  
• Catheter 
Sealing  
• PVR 
Measurement 
• Voided 
Volume 
• Catheter 
Migration 
• Urethral Injury 
Assessment 
• Device 
Removal 
Assessment 
• QOL Survey 
Follow-Up Phone 
Screening for 
Potential AE  
 
 
 
Ö 
 
Adverse event(s) 
review 
 
Ö 
Ö 
Ö 
Ö 
There are weekly appointments during the Test Phase and weekly phone calls during the 
Follow-Up Phase 
9.7 
Subject Loss to Follow-Up or Withdrawal 
9.7.1 Subject Discontinuation/Withdrawal Criteria 
9.7.1.1 Voluntary Withdrawal 
Participation in this clinical investigation is entirely voluntary. Further, once the subject has been 
enrolled in the study, he may withdraw his consent to participate in the study at any time, without 
further obligation or penalty.  If a subject officially withdraws from the study, the investigator 
must ensure that the reason for the withdrawal is documented. 
If the subject had an AE, the subject should be followed until the resolution of the AE, if possible.  
Data from these subjects will be included in the analysis up to the point of each subject’s 
withdrawal. 

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9.7.1.2 Involuntary Withdrawal 
Likewise, there may be a reason identified by the Investigator that deems the subject no longer 
suitable for the study, in which case the subject may be withdrawn by an Investigator. In either case, 
the 
Investigator 
should 
contact 
the 
Sponsor 
to 
discuss 
the 
circumstances 
for 
discontinuation/withdrawal. Reasons for discontinuation or withdrawal may include, but are not 
limited to the following: 
1. Subject is uncooperative with compliance of required study tests, medical management 
and/or Study procedures 
2. Investigator determines that subject has developed a condition for which continued 
participation in the study is potentially harmful to the subject 
3. Subject withdraws his consent 
4. Subject is lost to follow-up 
5. Subject has a significant protocol violation 
6. Subject is found to have been incorrectly enrolled in the study 
7. Sponsor terminates the study 
9.7.1.3 Data Withdrawal Due to Exclusion Criteria 
A subject’s data may be excluded from the analysis if the subject is later found not to meet one or 
more major exclusion criteria.  However, these subjects will continue to be followed per the 
requirements of their particular arm unless instructed otherwise by the IRB/EC.   
9.7.1.4 Subjects Lost to Follow Up 
All reasonable efforts (at least 3 contact attempts via phone/email, or registered letters) will be 
made to obtain complete data for all subjects, before they are considered lost to follow-up. Missing 
observations may occur due to subjects who are lost to follow-up or demonstrate noncompliance 
with the required assessments. 
9.7.1.5 Data Collection & Follow-Up for Discontinued/Withdrawn Subjects 
All subjects enrolled in the study are considered eligible for follow-up and will be required to 
adhere to the assessment schedule found in Table 9-2. Subjects may withdraw from the clinical 
study or discontinue their participation at any time without any further obligation, penalty, or 
prejudice. If a subject withdraws from the study, the reason for withdrawal will be documented. If 
the withdrawal is a result of an adverse event, an Adverse Event Form must also be completed. 
Subjects who withdraw consent after treatment will not be required to undergo follow-up but will 
still be considered part of the subject cohort.  In addition to withdrawing from the study voluntarily, 
subjects may also be withdrawn from the study by the investigative team, as necessary to ensure 
each subject’s safety and welfare.  Regardless of who initiates a given withdrawal, every attempt 
will be made to conduct an exit/final appointment prior to each subject withdrawal from the study. 
The reason for early discontinuation will be documented in the source documents and electronic 
case report forms (eCRFs).  Data collected up to the time of study withdrawal will be included in 
the data analysis. 
9.8 
End of Study 

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Subjects receiving the device may exit the study at the end of the study (i.e., the study is 
discontinued by the Sponsor) or when the subject has completed the final follow-up visit, whichever 
comes first, unless the subject opted to find an alternative treatment.   
An End of Study CRF will be completed at the time the study is completed, discontinued, or lost to 
follow-up for each subject. 
10 STATISTICAL CONSIDERATIONS 
10.1 Primary Endpoint Hypothesis 
The primary endpoint analysis consists of a one-sided test of the null hypothesis that no more than 
60% of users are responders to the device against the alternative that more than 60% of users are 
responders, as given below:  
Ho:   R ≤ 60 %  
Ha:  R > 60 % 
Where, 
R = % of users who are responders 
 
In this study, R is estimated as the percent of subjects who are responders, and a subject will be 
considered a responder to the device if at least 80% of that subject’s individual available PVR 
values are: 
a. Less than 50 mL OR 
b. Equal or less than baseline PVR with the subject’s standard urinary management 
system 
10.2 Sample Size Justification 
Based upon historical data and experience with the device, the estimate of R is expected to exceed 
90% in this study. Limited descriptive statistical methods will be utilized to analyze data collected 
from this protocol.  Although there will be limited power achieved with the number of patients 
completing this study, this data will provide a foundation for further clinical research with 
additional statistical rigor.  
10.3 Statistical Analysis 
Data from all the sites will be pooled together assuming poolability analysis show that the data are 
poolable.   
The primary efficacy endpoint will be hypothesis tested based on the mITT population.  An 
analysis of all subjects that dropped out during or after the device tolerability screening will be 
provided. 
The primary efficacy outcome will be assessed using an exact binomial test at the 0.05 significance 
level, in a one-sided test of the null hypothesis that the user responder rate is 0.60 or less, against 
the alternative hypothesis that the user responder rate is greater than 0.60. 

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For the primary safety endpoint, device related SAE will be analyzed with descriptive statistics 
and nominal 95% confidence intervals. Serious adverse events from all subjects that were treated 
with the investigational device will be included.  Based on the sample size calculations, the source 
of the SAE will be from all 60 subjects that tested the device.  There will be no formal statistical 
hypothesis testing. 
Similarly, the secondary endpoints will be analyzed with descriptive statistics and nominal 95% 
confidence intervals. 
Tipping point analyses will be conducted to investigate issues such as the possible impact of 
missing data.   
11 DEFINITION OF ADVERSE EVENTS 
11.1 Adverse Event (AE) 
An Adverse Event is defined as any untoward medical occurrence, unintended disease or injury or 
any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other 
persons, whether or not related to the investigational medical device. 
Adverse Event Identification: A condition that is one of the following: 
1. A unique symptom or event that is a change from the subject’s baseline status 
2. A series of symptoms or events that can be categorized as a single entity based on 
definitions found herein 
3. A specific diagnosis responsible for a clinical change 
4. A worsening or exacerbation of a pre-existing condition 
11.2 Serious Adverse Event (SAE) 
An adverse event is considered to be a serious adverse event (SAE) when the subject outcome is 
any of the following:  
1. Death  
2. Life-threatening  
3. In-patient hospitalization or prolongation of an existing hospitalization  
4. Persistent or significant disability/incapacity  
5. Substantial disruption of a person’s ability to conduct normal life functions, i.e. the 
adverse event resulted in a significant, persistent or permanent change, impairment, 
damage or disruption in the subject’s body function/structure including chronic 
diseases, physical activities and/or quality of life  
6. Congenital anomaly or birth defect  
7. Required medical or surgical intervention to prevent permanent impairment of a body 
function or damage to a body structure  
8. If the AE does not fit the other outcomes, but the event may jeopardize the health of the 
subject or require medical or surgical intervention (treatment) to prevent one of the 

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outcomes listed above  
An SAE may or may not be related to the study procedure.  
Note: A planned hospitalization for a pre-existing condition, or a procedure required by the 
protocol without serious deterioration in health, is not considered a serious adverse event. 
11.3 Unanticipated Adverse Device Effect (UADE) 
Any serious adverse effect on health and safety or any life-threatening problem or death caused 
by, or associated with, a device, if that effect, problem, or death was not previously identified in 
nature, severity, or degree of incidence in the investigational plan or application (including a 
supplementary plan, related documentation or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or welfare of subject. 
11.4 Serious Adverse Device Effect (SADE) 
An adverse device effect that has resulted in any of the consequences characteristic of a serious 
adverse event. 
11.5 Unanticipated Serious Adverse Device Effect (USADE) 
A serious adverse device effect which by its nature, incidence, severity or outcome, has 
not been identified in the current version of the risk analysis report. 
11.6 Device Technical Observation 
An observation of a medical device with respect to its identity, quality, durability, reliability, safety 
or performance. Device deficiencies that did not lead to an AE but could have led to a medical 
occurrence will be reported, under the following circumstances: 
1. if either suitable action had not been taken, 
2. if intervention had not been made, or 
3. if circumstances had been less fortunate. 
11.7 Adverse Event Classification and Reporting Requirements 
Adverse events will be assigned an attribution according to the Investigator’s believed primary 
cause. Events will be categorized by relationship to the Investigational Device, Insertion 
Procedure, concomitant medications, pre-existing condition, intercurrent condition, intercurrent 
intervention, or other. 
Adverse events should be classified according to their underlying cause, if known (e.g., fever 
resulting from infection should be reported as “infection”). Symptoms related to a diagnosis should 
not be reported as separate AEs. In the above example, fever is a symptom caused by infection and 
should be reported as infection only.  
Concomitant AEs that are unrelated (in the clinician’s judgment) should be reported as separate 
events.  
AE determination is based on three levels of evidence:  
Level 1 – final diagnosis  

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Level 2 – signs  
Level 3 – symptoms  
Every effort should be made to collect Level 1 evidence of any AE. If an AE has all three levels 
of evidence, the AE should be reported only once at the highest level of severity, which is the final 
diagnosis (Level 1). A single AE should not be reported as multiple AEs based on separate 
symptoms and signs.  
In cases where a diagnosis is not possible, AE determination should be based on the next highest 
level of evidence (i.e., Level 2: signs), followed by symptoms (Level 3), if symptoms are all that 
are available to the investigator.  
A corrective action (e.g. catheterization) itself is not an AE but the reason of the catheterization 
may be an AE. The AE determination always should be based on the reason that a corrective action 
was taken. Note: there may be multiple signs or symptoms representing only one AE. 
 
Figure 11-1: AE Determination and Outcome Flowchart 
The AEs in the study may be further coded by Medical Dictionary for Regulatory Activities 
(MedDRA) and graded according to Common Terminology Criteria for Adverse Events (CTCAE) 
for the purpose of regulatory reporting or publication. 
11.8 Reporting of all Adverse Events 
The signs, symptoms and sequelae of an underlying AE should not be reported as separate AEs. 
All AEs must be documented on an eCRF.  All AEs also must be described by (a) duration (start 
and resolution dates); (b) adjudicated for severity; (c) relationship to the study device; (d) action 
taken to resolve the event; (e) outcome of the event; and (f) whether or not such event is considered 
to have been serious.  Additional information, such as procedural notes, treatment notes, or a 
signed clinical summary, may be required as supporting documentation for the reported AE. 

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11.8.1 Device and Procedure-Related Adverse Event 
A description of how an AE relates to the study procedure will be reported on the Adverse Event 
eCRF and starts from the first use of the device and be determined by the Investigator using the 
following definitions: 
• Definite:  The AE follows a reasonable temporal sequence from the time of the first 
insertion procedure, which includes AEs that occur during the index procedure or during 
the follow-up period. 
• Probable:  The AE follows a reasonable temporal sequence from the time of the first 
insertion procedure, and the possibility can be excluded that factors other than the index 
procedure, such as underlying disease, concomitant drugs, or concurrent treatment caused 
the AE. 
• Possible:  The AE follows a reasonable temporal sequence from the time of the first insertion 
procedure and the possibility of insertion procedure involvement cannot be excluded.  However, 
other factors such as underlying disease, concomitant medications, or concurrent treatment are 
presumable. 
• Unlikely:  The AE has an improbable temporal sequence from the time of the first 
insertion procedure, or such AE can be reasonably explained by other factors, including 
underlying disease, concomitant medication, or concurrent treatment. 
• Not related: The AE has no temporal sequence from the time of the first insertion procedure, 
or it can be explained by other factors, including underlying disease, concomitant 
medication, or concurrent treatment. 
11.8.2 Concomitant Medication-Related Adverse Event 
An adverse event is considered to be concomitant medication related when, in the judgment of the 
Investigator, it is reasonable to believe that the event is associated with concomitant medications 
used in conjunction with the Investigational Device and is not otherwise specific to the 
Investigational Device (e.g. bleeding associated with anticoagulation medication). 
11.8.3 Pre-Existing Condition-Related Adverse Event 
An adverse event is considered to be related to a pre-existing condition when, in the judgment of 
the Investigator, it is reasonable to believe that the event is associated with the subject’s pre- 
existing condition and is not specific to the Investigational Device or Insertion Procedure. Pre- 
existing conditions that are aggravated or become more severe during or after the Insertion 
Procedure should be evaluated on a case-by-case basis to determine if the event may be more 
appropriately classified as device or Insertion Procedure-related. 
11.9 Anticipated Adverse Events 
The following is a list of potential anticipated adverse events that may occur while using the 
Connected Catheter. 
1. Asymptomatic Bacteriuria 
2. Autonomic Dysreflexia (for individuals with spinal cord injury) 

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3. Bladder or Urethral Perforation (False Passage) 
4. Bladder or Urethral Spasms 
5. Change in frequency or urgency to urinate 
6. Discharge or Cloudy Urine 
7. Discomfort 
8. Dysuria (Painful Urination) 
9. General Fever 
10. Genitourinary pain 
11. Hematuria (Blood in Urine) 
12. Injury to the Lower Urinary Tract (LUT) and/or Genitals 
13. Interference with Sexual Activity 
14. Part or All of the Connected Catheter Becoming Temporarily Stuck in the LUT 
15. Scarring of LUT 
16. Systemic Infection 
17. Urinary Incontinence 
18. Urinary Retention 
19. Urethral Stricture 
20. Urinary Tract Infection 
21. Urinary Tract Inflammation or Irritation 
12 TRAINING 
The Sponsor will be responsible for training of appropriate clinical site study personnel. To ensure 
proper procedural technique, uniform data collection and protocol compliance, the Sponsor will 
present a formal training session to personnel at each study site.  At this training session, the study 
protocol, techniques for the identification of eligible subjects, instructions on data collection, 
schedule follow-ups, and regulatory requirements will be reviewed. 
The training of clinical site personnel will be the responsibility of Spinal Singularity (Sponsor). This 
procedure may only be performed by qualified Investigators who are familiar with the Connected 
Catheter procedures and techniques. A formal training program consisting of instructive and 
interactive sessions will be performed with participating Investigators and study personnel 
identified at each site prior to subject treatment. Spinal Singularity-affiliated personnel will be 
available to assist with the technical aspects of the device/procedure training, as well as protocol-
related training. During the Site Initiation Visit (SIV) or other site visit, training related to specific 
procedures for using the EDC system such as entering and editing eCRF data, and reviewing and 
resolving queries will be provided to investigative sites. This training will be documented on a 
training record. It is ultimately the responsibility of the Investigator to ensure that all clinical site 
personnel participating in this study are properly trained. 

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13 DATA MANAGEMENT 
13.1 Subject Identification 
Subjects that successfully pass the screening tests and wish to participate in the study will be 
assigned a unique identification code (ID) that is numeric. 
In addition to the ID, each subject’s initials will be used as an identifier included on documentation 
submitted to the Sponsor, as applicable. 
13.2 Central Database 
Applicable study documentation will be collected and compiled in a central database or in hard copy files, 
as applicable.  Appropriate quality control measures will be established to ensure accurate and complete 
transfer of information from the study documentation to the central database or other document 
location(s). 
The Investigator or designee must record the information required by this clinical investigation 
protocol in source documentation that must be made available to Sponsor representative or designee 
for review. An authorized site representative will enter all applicable data into a 21 CFR 11 
compliant Electronic Data Capture (EDC) system via Electronic Case Report Forms (eCRFs). 
13.3 Data Monitoring and Quality Control 
Spinal Singularity, Inc. will designate a qualified Monitor (Clinical Research Associate [CRA]) to 
verify that study data is supported by adequate source documentation, which is complete, accurate 
and verifiable. Instances of inconsistent, missing or illogical data will be communicated to the 
Investigator or designee and queried for resolution. 
Completed eCRFs will be verified by the qualified CRA at the investigational sites at regular 
intervals throughout the study. The Investigator will allow the monitor and/or representative of the 
Sponsor, and any regulatory body to review and inspect the study files, subject eCRFs, subject 
medical records and other study related documents as required. 
Spinal Singularity, Inc. will monitor and manage the data for this investigational study.  
 
The main clinical contact at Spinal Singularity, Inc. will be: 
Shannon Metzger  
Shannon@spinalsingularity.com 
+1 (602) 391-9310 
 
The alternate clinical contact at Spinal Singularity, Inc. will be:  
Derek Herrera 
Derek@spinalsingularity.com 
+1 (470) 222-5323 
 
All general Study inquiries may also be sent to ES01@spinalsingularity.com 

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Data will be reviewed periodically by an independent research monitor and a Data and Safety 
Monitoring Board (DSMB). These monitors will ensure overall safety of the study by analyzing 
any potential trends or issues that result during the study. The research monitors will assist the 
Sponsor in ensuring safe execution of this clinical investigation protocol and, if any issues arise, 
help determine any time when it may be necessary to temporarily halt the study. 
The Independent Safety Monitor for the Study will be: 
Dr. Jaime Landman, MD,  
Professor of Urology and Radiology Chairman,  
Department of Urology  
University of California, Irvine 
14 STUDY RESPONSIBILITIES AND MANAGEMENT 
The proposed study will be performed in accordance with all requirements set forth in the U.S. 
regulations, 21 Code of Federal Regulations (CFR) Parts 812.2(b), 50, 54, and 56, the World 
Medical Association Declaration of Helsinki, EN ISO 14155:2011 (as applicable) and any other 
applicable local laws, regulations, or guidelines.  
14.1 Investigator Responsibilities  
Each investigator is responsible for ensuring the investigation is conducted according to all signed 
agreements, this clinical investigation protocol, EC/IRB requirements, and applicable laws and 
regulations.  Also, Investigators may not begin enrollment until Sponsor or its designee receives 
and approves (when necessary) the following documents: 
• Signed Investigator Agreement 
• Financial disclosure forms for all participating investigators 
• EC/IRB roster (or IRB registration number from the Office of Human Research Protection) 
• EC/IRB protocol and ICF approvals 
• Investigators’ current curricula vitae (CV) 
• Signed Site Delegation of Authority (DOA) Log 
It is acceptable for Investigators to delegate one or more of the above functions to an associate or 
Co or Sub-Investigator, or a trained Study Coordinator; however, the Investigator remains 
responsible for the proper conduct of the clinical investigation, including obtaining and 
documenting proper study informed consent, collecting all required data, submitting accurate and 
complete eCRFs, etc. 
At each study site, appropriate procedures must be followed to maintain subject confidentiality 
according to appropriate local regulations (e.g., Health Insurance Portability and Accountability 
Act (HIPAA) in the U.S.).  Each site may have its own internal procedures or requirements for use 
and release of subject medical information in research studies.  Each Investigator is responsible 
for obtaining appropriate approvals, consents, or releases of medical information as dictated by 
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The study is not transferable to other sites attended by the Investigator unless prior approval is 
obtained from the appropriate EC/IRB and the Sponsor. 
14.2 Subject Enrollment Process 
All study candidates, after pre-screening, must appropriately consent to participate in the study, as 
administrated by qualified study site personnel using an IRB and Sponsor-approved informed 
consent form (ICF) prior to beginning any aspect of the study procedure or tests that are not 
standard of care for the site.  Investigational sites will be required to document the consent process 
within each enrolled subject’s medical record.  Administering the questionnaires can be done prior 
to signing the ICF. 
Only subjects who meet the inclusion/exclusion criteria, who signed the study enrollment informed 
consent will be considered enrolled in the study.  
Timely communication by each site is critical to avoid over enrolling when the enrollment is close 
to the end of each phase.  
14.3 Ethics Committee (EC) / Institutional Review Board (IRB)  
Investigators must submit this clinical investigation protocol to their respective Ethics Committee 
(EC) and or Institutional Review Board (IRB) and obtain the EC’s/IRB’s written approval before 
being allowed to conduct and participate in the study.  Each Investigator is responsible for fulfilling 
any conditions of approval imposed by their respective EC/IRB, such as regular reporting, study 
timing, etc.  Investigators will provide the Sponsor or its designee with copies of such approvals 
and reports. 
14.4 Informed Consent Form (ICF) 
The Sponsor will provide a template informed consent form (ICF) to each study site for EC/IRB 
submission.  The template may be modified to suit the requirements of the individual study site 
but the Sponsor must pre-approve all changes to the ICF prior to initial submission to the EC/IRB.   
Each Investigator or assigned designee must administer this approved ICF to each prospective 
study subject and obtain the subject's signature or a legally-approved designee’s signature along 
with the date of consent prior to enrollment in the study.  The ICF must be obtained in accordance 
with the applicable guidelines on 21 CFR 50, 54 and 56, the Declaration of Helsinki, EN ISO 
14155 or local regulations and laws, whichever represents the greater protection of the individual.  
Subjects must be informed about their right to withdraw from the study at any time and for any 
reason without sanction, penalty, or loss of benefits to which the subject is otherwise entitled and 
also be informed that withdrawal from the study will not jeopardize their future medical care.  A 
copy of their signed ICF must be given to each subject enrolled in the study.  The institutional 
standard subject consent form does not replace the Connected Catheter study ICF. 
14.5 Case Report Forms (CRFs) 
The Sponsor will provide standardized case report forms (CRFs) for each individual subject.  The 
CRFs will be electronic via a 21 CRF Part 11 compliant EDC, and will be used to record study 
data, and are an integral part of the study and subsequent reports.   
The electronic CRFs for individual subjects will be provided by the Sponsor via a web portal.  
After the data have been monitored and submitted, corrections will be initiated via a data query to 

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be completed by study site personnel.  This data query will be done electronically via the web 
portal.  Electronic CRFs must be approved and signed by the Investigator in the appropriate spaces 
provided using his/her electronic signature. 
Electronic Case Report Forms (eCRFs) will be used to collect all subject data during the course of 
the study. eCRFs must be fully completed for each subject and electronically signed by the 
Investigator when complete. The eCRFs should be a complete and accurate record of subject’s 
data collected during the study according to EN ISO 14155:2011 standard. Regulations and Good 
Clinical Practice (GCP) guidelines require that Investigators maintain information in the study 
subject's medical records that corroborate data collected on the eCRFs. To comply with these 
regulatory requirements, the following information should be maintained: 
1. Medical history/physical condition of the subject before involvement in the study 
sufficient to verify protocol entry criteria. 
2. Dated and signed notes on the day of entry into the study including the study Investigator, 
study name, subject number assigned and a statement that consent was obtained. 
3. Dated and signed notes from every subject appointment with reference to the CRFs for 
further information, if appropriate (for specific results of procedures and exams). 
4. Information related to adverse events. 
5. Subject's condition upon completion of or withdrawal from the study. 
6. Discharge summaries/procedure reports. 
14.6 Records 
Each Investigator must maintain the following accurate, complete, and current records relating to 
the conduct of the study investigation.  The final responsibility for maintaining such records 
remains with the Investigator.  These records include, but not limited to: 
• All signed agreements; 
• IRB/EC approval letter(s); 
• Signed ICF; 
• Records of AEs, including supporting documents; 
• Records of protocol deviations, including supporting documents 
• Records showing receipt, use and disposition of all investigational devices, including: 
o Date, quantity, model and lot or serial numbers of devices received, 
o Name of person(s) who received, used or disposed of each device, 
o The number of devices returned to the Sponsor and the reason(s) for return; 
• All correspondence related to the study; 
• Records of each subject’s case history, including study-required CRFs, signed ICF, all 
relevant observations of AEs, the condition of each subject upon entering and during the 
course of the investigation, relevant medical history, the results of all diagnostic testing, 
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• Study personnel visit log; 
• Signature authorization and delegation log; and, 
• Any other records that applicable regulation requires to be maintained. 
14.7 Reports 
Table 14-1 lists those reports that are the investigator's responsibility to deliver to the Sponsor.  
Each study investigator must follow the EC/IRB reporting requirements for their respective site.  
If applicable regulations or EC/IRB requirements mandate stricter reporting requirements than 
those listed, the stricter requirements must be followed. 
Table 14-1:  Reports Required from Investigators to Sponsor 
Type of Report 
Prepared by PI for 
Notification Time Frame 
UADE 
Sponsor, EC/IRB 
Within 10 working days of 
knowledge 
Death 
Sponsor, EC/IRB 
Written reports (e.g., via e-mail) 
within 48 hours 
SAE  
Sponsor 
 
Within 10 working days of 
knowledge  
 
EC/IRB, if required Per IRB requirement 
Device malfunction with clinical 
sequelae 
Sponsor 
 
EC/IRB, if required 
Within 48 hours via written 
communication.  Return the device to 
sponsor within 48 hours. 
Serious protocol deviations (e.g., 
ICF not obtained, to protect the 
life or physical well-being of a 
subject in an emergency) 
Sponsor 
 
EC/IRB, if required 
Within 5 working days of knowledge 
 
Per IRB requirement 
Withdrawal of EC/IRB approval 
Sponsor 
Within 5 working days of knowledge 
Annual progress report 
Sponsor, EC/IRB 
Annually 
Final report 
Sponsor, EC/IRB 
Within 3 months of study completion 
or termination 
Note: Each IRB/EC may require more stringent reporting requirements that those listed in this 
table. 

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14.8 Sponsor Responsibilities  
Spinal Singularity, Inc. is the Sponsor of this study.  The Sponsor’s responsibilities in the study 
include: 
• Selecting the Principal Investigator(s), all clinical investigators and study sites, and other 
consultants or personnel (e.g., monitors) who participate in the study. 
• Provide study protocol, device, and GCP training to participating study sites, in quantities 
sufficient to support study activities, per agreements executed with the study sites. 
• Select all qualified clinical Investigators and study sites and other consultants or personnel 
(e.g., monitor) who participate in the study. 
• Provide financial support to each study site. 
• Follow/promote all regulatory standards per appropriate regulations for study sites, core 
laboratories, and other participants, and ensure compliance by periodically monitoring 
sites. 
• Ensure completion of site monitoring of clinical data at each clinical study site.  
• Retain ownership of all clinical data generated in this study, and control the use of the data 
for appropriate purposes only.   
• Review and approve publication of study results in the literature. 
14.8.1 Confidentiality 
All information and data sent to the Sponsor concerning subjects or their participation in this study 
will be considered confidential according to HIPAA regulations.  Data used in the analysis and 
reporting of this evaluation will be used in a manner without identifiable reference to the subject.  
Investigators will consent to visits by Sponsor’s staff and its authorized representatives, as well as 
by the U.S. FDA or any other local governmental body, to review the study subjects’ medical 
records, including any test or laboratory data that might have been recorded on diagnostic test 
media.   
14.8.2 Amending the Investigational Study Protocol 
Neither any Investigator nor the Sponsor will modify this Clinical Investigational Protocol without 
first obtaining concurrence of the other in writing.  All changes to the Clinical Investigational 
Protocol must be submitted to the EC/IRB for review and approval.  Any change that would require 
alteration to the ICF must receive approval from the applicable EC/IRB prior to implementation.  
Following approval, any Investigational Protocol amendment must be distributed to all protocol 
recipients at the site. 
14.8.3 Protocol Deviations 
A protocol deviation/violation is generally an unplanned excursion from the protocol that is not 
implemented or intended as a systematic change. An Investigator failed to perform tests or 
examinations as required by the protocol or failures on the part of study subjects to complete 
scheduled visits as required by the protocol, would be considered protocol deviations. These types 

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of deviations are reported to the sponsor and in accordance with the IRB policy. 
A Protocol Deviation CRF must be completed by the site for each study protocol deviation (e.g., 
failure to obtain informed consent, enrolling a subject who does not meet inclusion / exclusion 
criteria, not performing required testing, missed follow-up window, etc.).  An Investigator must 
notify the Sponsor and the reviewing EC/IRB of any deviation from the Study Protocol that was 
done to protect the life or physical well-being of a subject.  Such notice should be given as soon 
as possible, but no later than five (5) working days after the emergency occurred. 
14.8.4 Site Noncompliance and Nonperformance 
Repeat serious protocol deviations will be closely monitored.  If excessive deviations or a failure 
to reduce deviations are noted, the Sponsor reserves the right to suspend study enrollment at that 
site until a sufficient system is in place at the site to reduce further deviations.  
After a site completes all required approvals and training, a Site Initiation Visit (SIV) will be 
conducted as a final check of the site readiness.  If a site is not able to enroll its first subject 3 
months after “Ready to Enroll” status, the Sponsor may elect to terminate the investigational site 
and allocate the slot to another candidate site.   
The Sponsor reserves the right to terminate an investigational site from the study for any of the 
following reasons including, but not limited to: 
1. Failure to obtain Informed Consent 
2. Failure to report safety events (i.e. Adverse events) 
3. Repeated protocol violations 
4. Repeated failure to complete Electronic Case Report Forms 
5. Failure to enroll an adequate number of subjects 
14.8.5 Device Accountability 
The Gen 2 Connected Catheter Systems allocated for investigational site use will be stored in a 
secured area until use.  Each site will be responsible for tracking the receipt and disposition of all 
investigational Gen 2 Connected Catheter System devices.  The unused Gen 2 Connected Catheter 
Systems must be returned to the Sponsor at the end of the study. 
14.8.6 Sponsor Reporting Responsibilities 
Table 14-2 lists those reports that are the Sponsor's responsibility and timelines to report to the 
IRB. If applicable regulations or IRB requirements mandate stricter reporting requirements than 
those listed, the stricter requirements must be followed. 
 

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Table 14-2: Sponsor Reporting Responsibilities 
Type of Report 
Report Prepared For 
Sponsor Reporting Responsibilities 
Reporting Time Frame  
Report Prepared For  
Unanticipated Adverse 
Device Effect (UADE)  
Investigators, IRBs   
Written - Within 10 working 
days from the time the 
Sponsor first learns of the 
effect.  
Withdrawal of IRB Approval 
or other action on part of the 
IRB that affects the study  
Investigators, IRBs  
Written – Within 5 working 
days.  
Device Recall  
Investigators, IRBs  
Written – Within 30 working 
days.  
Inappropriate Informed 
Consent  
IRB  
Investigator’s report 
submitted within 5 working 
days of notification  
Study Closure  
Investigators, IRBs  
Within 10 days  
Final Report  
Investigators, IRBs 
 
Final report - within 6 months 
of study closure  
15 STUDY ADMINISTRATION 
15.1 Monitoring Procedures 
It is the responsibility of the study Sponsor to ensure that proper monitoring of this investigation 
is conducted.  Appropriately trained personnel, appointed by the study Sponsor, will complete any 
monitoring that is done.  The monitoring will be the responsibility of Sponsor study personnel with 
an address as listed in the title page of this document.  Monitor(s) will ensure that the investigation 
is conducted in accordance with:  
• 
The signed Investigator’s Agreement 
• 
The Investigational Plan  
• 
Appropriate laws and regulations  
• 
Any conditions of approval imposed by the reviewing EC/IRB and/or other regulatory 
agencies 
 
The clinical study will be monitored according to the guidelines summarized below.  The Sponsor 
may choose to perform random inspections throughout the study as an element of quality 
assurance.  Investigators will allow auditing of their clinical investigation procedures. 

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A study specific Monitoring Plan is created and implemented to standardize monitoring activities 
across centers and ensure human subject protection and verify data integrity.  The monitors will 
receive study specific and SOP training prior to conducting any monitoring visits.  Study monitors 
are selected based on their training, qualifications and experience to monitor the progress of an 
investigation.  Study monitors may be Sponsor’s employees or representatives.  This study 
monitoring will include a site qualification, study initiation, interim, and close out visits.  All study 
monitors will be required to follow the Sponsor’s monitoring plan and monitoring standard 
operating procedures (SOPs).  
The study monitoring will be executed by a Sponsor representative. 
15.1.1 Monitoring Visit 
The following factors will be taken into account when determining the frequency of the monitoring 
visits: subject accrual rate at each center, total number of subjects enrolled at each center, and 
Clinical Investigation Protocol compliance at each center.  It is anticipated each site will be 
monitored at least once upon the completion of the follow-up visits for all enrolled subjects at the 
study site.  Monitors will require direct access to subjects’ medical records pertinent to the study 
(and study inclusion criteria), study management documents, regulatory documents and Subject 
Informed Consent documents, as well as other potential applicable records not listed here.   
Monitors may ensure the clinical investigators have and continue to have staff and facilities to 
conduct the clinical investigation safely and effectively.  Monitors may conduct the following 
monitoring activities throughout the study: 
• 
Verification that the current IRB-approved informed consent was signed and dated by 
each subject prior to participating in the study required procedures. 
• 
Verification of documentation in the subject’s record that informed consent was signed 
prior to initiation of the study procedures and that a copy of the signed and dated consent 
was provided to the subject. 
• 
Source documentation verification by reviewing the eCRFs against source 
documentation for accuracy and completeness of information. 
• 
Verification that the Investigational Devices are being used according to the Clinical 
Investigation Protocol, Instructions for Use and, all malfunctions / IFU deficiencies are 
reported. as required. 
• 
Verification that subjects met study enrollment criteria. 
• 
Confirmation that the study is being conducted according to the Clinical Investigation 
Protocol and applicable regulations. 
• 
Verification that study deviations are documented and reported. 
• 
Verification that the procedures for recording and reporting adverse events to the 
sponsor are followed. 
• 
Ensuring proper error correction. 
• 
Verification of training documentation of all study personnel participating in study 
related activities. 

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• 
Reviewing all correspondence and regulatory documents, including confirmation of 
IRB-approved Clinical Investigation Protocol or amendments. 
• 
Resolution of outstanding issues and completion of assigned tasks will be documented 
by the monitors. 
Each monitoring visit will be documented via a monitoring report and follow-up letter.  The follow 
up visit letter will be sent to the Investigator to document issues identified, corrective actions and 
if applicable preventive actions.  At subsequent visits the issues resolved will be documented in 
this letter to demonstrate resolution.  Monitoring visits will be conducted by trained monitors and 
designees.  The Monitoring Plan identifies the frequency of monitoring and training requirements 
of the monitors. 
15.1.2 Study Closure 
Study closure is defined as a specific date that is determined by study completion and/or regulatory 
requirements have been satisfied per the Clinical Investigation Protocol (CIP) and/or by decision 
of the Sponsor or IRB.  Study closure visits will be conducted at all enrolling clinical sites in order 
to review record retention requirements with site personnel.  A telephone contact may take the 
place of a study closure visit if appropriate (e.g., low subject enrollment, recent monitoring visit, 
etc.)   
16 CLINICAL TRIAL OVERSIGHT 
16.1 Safety Monitoring 
Evaluation and adjudication of safety data (e.g. serious adverse events, all deaths, etc.) will be 
performed on an ongoing basis by the Independent Research Monitor.  The Independent Research 
Monitor for this study will be Dr. Jaime Landman, MD.  Data and reports will be reviewed and 
adjudicated pursuant to the guidelines outlined in this clinical investigation protocol and Dr. 
Landman will have full authority to stop the study in accordance with ethical practices and 
stopping rules.   
In addition to these reports, data will be aggregated for review and analysis periodically.  These 
reports will be shared with the Independent Research Monitor and the monitor will be offered the 
opportunity to provide insight or input into any observable trends in the data.   
17 POTENTIAL DEVICE CHANGE 
Future product line extensions or design changes may be introduced into the study in a controlled 
manner based on feedback from Investigators.  In addition, manufacturing changes may be 
introduced in a controlled manner.  All design and manufacturing process changes will be 
performed under the Sponsor’s design control and other relevant processes and will be fully tested 
to ensure that it meets specifications prior to introduction to the study.   
18 PUBLICATION POLICY 
The results of the clinical study maybe used by the Sponsor (and its subsidiaries and affiliates) for 
the purposes of national and international registration, publication and information for medical 
professionals. If necessary, regulatory authorities will be notified of the Investigator’s name, 

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address, qualifications and extent of involvement. The Sponsor and the Investigators are 
committed to the publication of the results of this study in a peer-reviewed journal. 
All publications and presentations related to this study will be developed per the latest publication 
policy by the Sponsor. 
19 REIMBURSEMENT 
Spinal Singularity, Inc. will not receive payment or reimbursement for any devices used during 
execution of this clinical study.  All investigational devices utilized will be provided to patients / 
clinics at no cost.   
 

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Am Fam Physician.77(5):643-50 (2008). 
2. Verhamme, K.M. et al. Drug-induced urinary retention: incidence, management and 
prevention. Drug Safety. 31(5):363-88 (2008). 
3. Drake, M.J. et al. Drug-induced bladder and urinary disorder. Incidence, prevention and 
management. Drug Safety. 19 (1): 45-55 (1998) 
4. Esclarín De Ruz, A., García Leoni, E. & Herruzo Cabrera, R. Epidemiology and risk 
factors for urinary tract infection in patients with spinal cord injury. J. Urol. 164, 1285–
9 (2000). 
5. https://www.auanet.org/guidelines/chronic-urinary-retention