Artificial Urinary Sphincter Clinical Outcomes
Conditions: Stress Urinary Incontinence
Sponsor: Boston Scientific Corporation

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 1 of 62 
 
 
Artificial Urinary Sphincter Clinical Outcomes 
AUSCO 
U0669 
CLINICAL INVESTIGATION PLAN 
 
 
 
National Clinical Trial (NCT) Identified Number: NCT04088331 
 
Sponsored By 
Boston Scientific Corporation (BSC) 
300 Boston Scientific Way 
Marlborough, MA 01752, USA 
 
 
 
 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. The protocol should be 
held confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 2 of 62 
  
 
Contact Information 
Role 
Contact  
Clinical Contact 
Amanda Vail 
Urology and Pelvic Health 
10700 Bren Road West 
Minnetonka, MN 55343 
Coordinating Principal 
Investigator(s) 
Melissa Kaufman, MD 
Associate Professor of Urology 
Vanderbilt University Medical Center 
1301 Medical Center Drive, Suite 3823 
Nashville, TN 37232 
Vendors/External 
Organizations 
A list of vendors/external organizations involved in the trial is 
maintained by the sponsor. 
 
 
 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 3 of 62 
 
Original Release: July 12, 2019 
 
Current Version: November 10, 2021 
 
 
 
 
Revision Version 
Protocol 
Date 
Template 
number 
and version 
Protocol 
Section 
Modified 
Summary of Changes 
Justification for Modification 
Revision A 
(Initial) 
July 12, 
2019 
92120219 / 
Ver C 
N/A 
N/A 
Initial Release 
Revision B 
December 
15, 2020 
92120219 / 
Ver F 
2. Protocol 
Synopsis 
4.2 Study 
Rationale 
5. Device 
Description 
7. Study Design 
8. Subject 
Selection 
10. Study 
Methods 
11.3.1 Other 
Endpoints 
15.2 
Investigator 
Responsibilities 
18. Safety 
Reporting  
20. Committees 
22. Study 
Registration 
Estimated number of devices used throughout the 
trial added. 
Minimum number of procedure subjects specified 
as 120. 
Canada was removed throughout the protocol.  
Adverse Event collection will be limited to device 
and procedure related events.  
All Follow-up visits may be completed as remote 
or in clinic visits. 
Inclusion Criteria #6 was updated to allow subjects 
with continuous incontinence to participate.  
Physical Assessment including height and weight 
may be self reported if the visit is conducted 
remotely.  
Extended visit windows. 
Removal of requirement for physicians to have 
previously implanted 10 AMS 800 devices. 
ISO14155 definitions updated to 2020 revision.  
Protocol template updates for 
Version D, E and F. 
 
Number of sites increased due to 
COVID-19 enrollment 
challenges.  
 
Adverse Event collection reduced 
as appropriate for a non-
mandated post-market study of 
this nature.  
 
Clinical Events Committee 
reduced to an Independent 
Medical Reviewer following the 
adverse event collection changes. 
Remote visits are allowed for all 
follow-up visits due to COVID-
19 pandemic and the nature of 
the study does not require in 
person clinic visits.  
 
The requirement for a physician 
to have implanted 10 AMS800 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 4 of 62 
  
 
 
 
Revision Version 
Protocol 
Date 
Template 
number 
and version 
Protocol 
Section 
Modified 
Summary of Changes 
Justification for Modification 
devices prior to implanting in the 
study was removed as this is a 
post-market study.  
 
Revision C 
November 
10, 2021 
 
2. Protocol 
Synopsis 
 
 
 
8.3. Exclusion 
Criteria 
 
 
15.2 
Investigator 
Responsibilities 
 
18. Safety 
Reporting 
 
Exclusion criteria updated. Removal of criteria 
pertaining to radiation, modification of criteria 
regarding bleeding and modification to criteria 
concerning genitourinary mechanical prosthesis. 
 
 
Updated Exclusion criteria.  See comment above 
regarding Synopsis.   
 
Clarifying language added to reporting of device 
deficiencies and potential SADE  
 
 
Revised to align with updated European 
Regulations 
Updated criteria will more 
accurately reflect real world 
patient population for the AMS 
800 
 
 
See justification above for 
Synopsis. 
 
 
Align with ISO 14155 
 
 
European sites planned in the 
study 
 
 
 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 5 of 62 
  
2. Protocol Synopsis 
Artificial Urinary Sphincter Clinical Outcomes  
AUSCO 
Study 
Objective(s) 
To evaluate the AMS 800 Artificial Urinary Sphincter™ (AUS) in men 
with primary stress urinary incontinence as measured by pad weight 
tests. 
Indication(s) for 
Use  
The AMS 800 Artificial Urinary Sphincter is used to treat urinary 
incontinence due to reduced outlet resistance (intrinsic sphincter 
deficiency) following prostate surgery.    
Device applied 
as Standard of 
Care and sizes 
The AMS 800 Artificial Urinary SphincterTM is available with cuff sizes 
of 3.5cm-11cm, and three (3) pressure regulating balloon ranges of 51-
60cm, 61-70cm, and 71-80cm. The device is available both with and 
without InhibiZone. It is estimated that 120-140 devices will be used for 
this study. 
Study Design 
Single-arm, prospective, multi-center study with 12-month follow-up.  
Note: All follow-up visits may be completed as clinic or remote visits.  
  
Figure 7.1-1: AUSCO Study Design 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 6 of 62 
  
Artificial Urinary Sphincter Clinical Outcomes  
AUSCO 
Planned 
Number of 
Subjects 
Approximately 175 subjects will be enrolled in total to treat a minimum 
of 120 procedure subjects.  
Planned 
Number of Sites 
/ Countries 
Up to 30 sites will be activated in regions where the AMS 800 is 
commercially available, including but not limited to the United States, 
Europe, and Australia.  
Primary 
Endpoint 
Treatment success defined as ≥ 50% reduction in 24-hour pad weight 
test from baseline at 12 months post device activation. 
Secondary 
Endpoints 
Incidence of safety parameters at 3 months, 6 months, and 12 months. 
Safety parameters include device and/or procedure related adverse 
events, revision rates, and serious adverse events     
≥ 50% reduction in urinary incontinence as measured by 24-hour pad 
weight test at device activation and 6 months post device activation 
compared to baseline  
≥ 75% reduction in urinary incontinence as measured by 24-hour pad 
weight test at device activation, 6 months, and 12 months post device 
activation compared to baseline  
Reduction in # of pads per day at 3 months, 6 months and 12 months 
post-device activation compared to baseline   
Additional 
Endpoints 
Comparison of Pressure Regulating Balloons by subgroup analysis 
Change in numbers of stress urinary incontinence episodes, fluid intake, 
urgency urinary incontinence episodes, and frequency of urination based 
on 3-day electronic diary at 6 months and 12 months post device 
activation compared to baseline 
Change in quality of life at 3 months, 6 months, and 12 months post 
device activation compared to baseline, as measured by the following 
questionnaires:  
• IQoL 
• IIQ-7 
• EQ5D (12 Month)  
• Subject Ease of Use (6 and 12 Month)   

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 7 of 62 
  
Artificial Urinary Sphincter Clinical Outcomes  
AUSCO 
Method of 
Assigning 
Patients to 
Treatment 
Patients are considered enrolled once they sign the informed consent 
form. Subjects will then undergo baseline data collection to confirm 
eligibility. All eligible subjects are treated with the AMS 800. 
Follow-up 
Schedule 
Follow-up visits will occur at 3, 6, and 12 months after device 
activation. The study will be considered complete after all subjects have 
completed the 12-month follow-up visit. All follow-up visits may be 
conducted remotely or in clinic. 
Study Duration Enrollment is expected to be completed in approximately 24 months; 
therefore, the total study duration is estimated to be approximately 44 
months. 
Participant 
Duration 
The study duration for each subject is expected to be approximately 12 
months from time of device activation. If the subject is seen at the end of 
their visit window, participant duration would be 13.5 months.  
Inclusion 
Criteria 
1. Male  
2. ≥ 18 years of age  
3. Has undergone either a radical prostatectomy, transurethral 
resection of the prostate or other invasive prostate surgery   
4. Demonstrates primary stress urinary incontinence   
5. Positive screening 24-hour pad weight test (≥100 grams)  
6. Experiences at least 3 incontinence episodes per day during 
baseline diary or presents with continuous incontinence 
7. Negative urine culture   
8. Willing and able to undergo surgical implantation of the AUS 
device   
9. Willing and able to comply with the follow-up requirements   
10. Willing and able to forego any other surgical urinary 
incontinence treatments while participating in the study   
11. Willing and able to sign the informed consent 
Exclusion 
Criteria 
1. Previously had or currently has a device implanted (AUS/Sling, 
or otherwise) for treatment of SUI or urge incontinence  
2. Primary urgency incontinence     
3. Postvoid residual volume greater that 150 ml or a history of 
difficulty emptying the bladder  

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 8 of 62 
  
Artificial Urinary Sphincter Clinical Outcomes  
AUSCO 
4. Recurrent vesicourethral anastomotic stricture or urethral 
stricture disease within the past 6 months  
5. Known urogenital malignancy other than previously treated 
prostate cancer   
6. Recurrent prostate cancer that is expected to require intervention 
during the study follow-up period   
7. History of recurrent bladder stones within the past 12 months 
prior to signing the informed consent 
8. Neurogenic bladder     
9. Need for intermittent catheterization   
10. Known history of untreated/uncontrolled bleeding diathesis or 
coagulopathy     
11. Immunosuppressed or on medical therapy which would impact 
the immune system   
12. Uncontrolled diabetes, defined as (HbA1c>10) 
13. Has a genitourinary mechanical prosthesis that was implanted 
within 3 months from the date of consent  
14. Had a post-implantation infection associated with the device 
after genitourinary mechanical prosthesis was implanted  
15. Undergone bulking procedure within 6 months of the baseline 
assessment   
16. Poor candidate for surgical procedures and/or anesthesia due to 
physical or mental conditions 
17. Urinary incontinence due to or complicated by an irreversibly 
obstructed lower urinary tract 
18. Irresolvable detrusor hyperreflexia or bladder instability 
19. Currently enrolled or plans to enroll in another device or drug 
clinical trial   
20. Currently using an indwelling catheter or condom catheter for 
treatment of incontinence and is not willing to discontinue use at 
least 4 weeks prior to baseline assessment   
21. Known allergy or sensitivity to rifampin or to minocycline HCl 
or other tetracyclines (only applicable when implanting with 
InhibiZone version of this device) 
22. Systemic lupus erythematosus because minocycline HCl has 
been reported to aggravate this condition (only applicable when 
implanting with InhibiZone version of this device) 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 9 of 62 
  
Artificial Urinary Sphincter Clinical Outcomes  
AUSCO 
Statistical Methods  
Primary 
Statistical 
Hypothesis 
The primary endpoint is treatment success based on the 24-hour pad-
weight test on a per-subject basis. A 50% or greater reduction in pad-
weight from baseline to 12 months post device activation is considered a 
treatment success.  
Hypotheses:  
H0: p ≤ 0.65 
H1: p > 0.65 
where p = the proportion of subjects who are a treatment success. 
Statistical Test 
Method 
The hypotheses will be evaluated using a one-sided exact binomial test. 
No interim analyses are planned. 
Sample Size 
Parameters 
The statistical power calculation is based on an assumption that the 
treatment success rate is 80%.  
With a one-sided type I error of 0.025 and a type II error of 0.10 (90% 
power), a sample size of 96 subjects are needed to demonstrate the 
proportion of subjects who are a treatment success exceeds 65%. To 
account for a potential 20% attrition rate, 120 subjects with study 
procedure are anticipated.  
 
 
 
 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 10 of 62 
  
 
3. Table of Contents 
1. 
TITLE PAGE  .......................................................................................................................1 
2. 
PROTOCOL SYNOPSIS .........................................................................................................5 
3. 
TABLE OF CONTENTS .......................................................................................................10 
3.1. Table of Figures .....................................................................................................13 
3.2. Table of Tables ......................................................................................................14 
4. 
INTRODUCTION.................................................................................................................15 
4.1. Background ............................................................................................................15 
4.2. Study Rationale .....................................................................................................16 
5. 
DEVICE DESCRIPTION (PART OF STANDARD OF CARE) ..................................................16 
5.1. Commercial Device ...............................................................................................16 
6. 
STUDY OBJECTIVES AND ENDPOINTS ..............................................................................19 
7. 
STUDY DESIGN .................................................................................................................20 
7.1. Scale and Duration ................................................................................................21 
7.2. Treatment Assignment ..........................................................................................22 
7.3. Justification for the Study Design ........................................................................23 
8. 
SUBJECT SELECTION ........................................................................................................23 
8.1. Study Population and Eligibility ..........................................................................23 
8.2. Inclusion Criteria ..................................................................................................23 
8.3. Exclusion Criteria .................................................................................................24 
9. 
SUBJECT ACCOUNTABILITY .............................................................................................26 
9.1. Point of Enrollment ...............................................................................................26 
9.2. Withdrawal ............................................................................................................26 
9.2.1. 
Voluntary Withdrawal ..............................................................................26 
9.2.2. 
Involuntary Withdrawal ............................................................................26 
9.3. Lost to Follow-Up ..................................................................................................26 
9.4. Subject Status and Classification .........................................................................27 
9.5. End-of-Study Definition........................................................................................27 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 11 of 62 
  
10. STUDY METHODS .............................................................................................................28 
10.1. Data Collection ......................................................................................................28 
10.2. Study Candidate Screening ..................................................................................30 
10.2.1. Strategies for Recruitment and Retention .................................................30 
10.3. Informed Consent..................................................................................................30 
10.4. Screening/Enrollment Visit ..................................................................................30 
10.5. Pre-Operative/Baseline Visit [≤90 calendar days before Index Procedure] ....31 
10.6. Index Procedure [≤90 calendar days from Baseline] .........................................31 
10.7. Device Activation [Approximately 30-45 days post index procedure] and 
Follow-up Procedures ...........................................................................................31 
10.8. Month 3 Follow-up Visit [± 6 weeks post device activation] .............................32 
10.9. Months 6 [± 3 Months] and 12 Visit [± 3 Months] .............................................32 
10.10. 
Study Completion ...................................................................................33 
10.11. 
Revision Surgery .....................................................................................33 
10.12. 
Source Documents ..................................................................................33 
11. STATISTICAL CONSIDERATIONS ......................................................................................34 
11.1. Endpoints ...............................................................................................................34 
11.1.1. Primary Endpoint ......................................................................................34 
11.1.1.1. Hypotheses ...............................................................................34 
11.1.1.2. Sample Size ..............................................................................34 
11.1.1.3. Statistical Methods ...................................................................34 
11.1.2. Secondary Endpoints ................................................................................34 
11.1.2.1. Secondary Endpoint 1 –Serious Adverse Events .....................34 
11.1.2.2. Secondary Endpoint 2 - Revision ............................................35 
11.1.2.3. Secondary Endpoint 3 – 50% Reduction in pad weight ..........35 
11.1.2.4. Secondary Endpoint 4 – 75% Reduction in pad weight ..........35 
11.1.2.5. Secondary Endpoint 5 – number of pads per day ....................35 
11.2. General Statistical Methods .................................................................................36 
11.2.1. Control of Systematic Error/Bias ..............................................................36 
11.2.2. Number of Subjects per Investigative Site ...............................................36 
11.3. Data Analyses ........................................................................................................36 
11.3.1. Other Endpoints/Measurements ................................................................36 
11.3.1.1. Additional Endpoint 1 – stress urinary incontinence episodes 
per day ......................................................................................36 
11.3.1.2. Additional Endpoint 2 - IQoL ..................................................37 
11.3.1.3. Additional Endpoint 3 – IIQ-7 .................................................37 
11.3.1.4. Additional Endpoint 4 – EQ-5D ..............................................38 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 12 of 62 
  
11.3.1.5. Additional Endpoint 5 – Patient Ease of Use ...........................38 
11.3.2. Interim Analyses .......................................................................................38 
11.3.3. Subgroup Analyses ...................................................................................38 
11.3.4. Justification of Pooling .............................................................................38 
11.3.5. Multivariable Analyses .............................................................................38 
11.3.6. Changes to Planned Analyses ...................................................................39 
12. HEALTH ECONOMICS OUTCOMES ...................................................................................39 
13. DATA MANAGEMENT .......................................................................................................39 
13.1. Data Collection, Processing, and Review ............................................................39 
13.2. Data Retention .......................................................................................................40 
14. DEVIATIONS......................................................................................................................40 
15. COMPLIANCE ....................................................................................................................41 
15.1. Statement of Compliance ......................................................................................41 
15.2. Investigator Responsibilities ................................................................................41 
15.2.1. Delegation of Responsibility ....................................................................43 
15.3. Institutional Review Board/ Ethics Committee ..................................................43 
15.4. Sponsor Responsibilities .......................................................................................44 
15.5. General Data Protection Regulations ..................................................................44 
15.5.1. Transparency .............................................................................................45 
15.5.2. Rights to Data Subjects .............................................................................45 
15.6. Insurance ................................................................................................................46 
16. MONITORING ....................................................................................................................46 
17. POTENTIAL RISKS AND BENEFITS ...................................................................................46 
17.1. Instructions for Use ...............................................................................................46 
17.2. Risks associated with Participation in the Clinical Study .................................46 
17.3. Risk Minimization Actions ...................................................................................46 
17.4. Anticipated Benefits ..............................................................................................47 
18. SAFETY REPORTING .........................................................................................................47 
18.1. Reportable Events by investigational site to Boston Scientific .........................47 
18.2. Definitions and Classification...............................................................................48 
18.3. Relationship to Study Deviceand/or Study Procedure ......................................49 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 13 of 62 
  
18.4. Investigator Reporting Requirements .................................................................51 
18.5. Device Deficiencies ................................................................................................52 
18.6. Reporting to Regulatory Authorities / IRBs / ECs / REBs/ Investigators .......53 
18.7. Subject Death Reporting ......................................................................................53 
19. INFORMED CONSENT ........................................................................................................54 
20. COMMITTEES ...................................................................................................................55 
20.1. Safety Monitoring Process ....................................................................................55 
20.2. Independent Medical Reviewer ...........................................................................55 
21. SUSPENSION OR TERMINATION........................................................................................55 
21.1 Premature Termination of the Study ..................................................................55 
21.1.1 
Criteria for Premature Termination of the Study ......................................56 
21.2 Termination of Study Participation by the Investigator or Withdrawal of 
IRB/ EC/REB Approval .......................................................................................56 
21.3 Requirements for Documentation and Subject Follow-up ................................56 
21.4 Criteria for Suspending/Terminating a Study Site ............................................56 
22. STUDY REGISTRATION AND RESULTS .............................................................................57 
22.1. Study Registration .................................................................................................57 
22.2. Clinical Investigation Report ...............................................................................57 
23. PUBLICATION POLICY ......................................................................................................57 
24. REIMBURSEMENT AND COMPENSATION FOR SUBJECTS .................................................58 
24.1. Subject Reimbursement ........................................................................................58 
24.2. Compensation for Subject’s Health Injury.........................................................58 
25. BIBLIOGRAPHY .................................................................................................................58 
26. ABBREVIATIONS AND DEFINITIONS .................................................................................59 
26.1. Abbreviations.........................................................................................................59 
26.2. Definitions ..............................................................................................................60 
 
 
3.1. Table of Figures 
Figure 5.1-1: AMS 800 Artificial Urinary Sphincter .............................................................. 17 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 14 of 62 
  
Figure 7.1-1: AUSCO Study Design ...................................................................................... 22 
 
3.2. Table of Tables 
Table 5.1-1: AMS 800 Product line with and without InhibiZone Treatment ........................ 17 
Table 6.1-1: Overview of objectives and endpoints ............................................................... 19 
Table 8.2-1: Inclusion Criteria ................................................................................................ 23 
Table 8.3-1: Exclusion Criteria ............................................................................................... 25 
Table 10.1-1: Data Collection Schedule ................................................................................. 29 
Table 18.2-1: Safety Definitions ............................................................................................. 48 
Table 18.3-1: Criteria for Assessing Relationship of Study Device or Procedure to Adverse 
Event .................................................................................................................... 50 
Table 18.4-1: Reporting Timelines ......................................................................................... 51 
Table 26.1-1: Abbreviations ................................................................................................... 59 
Table 26.2-1: Definitions ........................................................................................................ 60 
 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 15 of 62 
  
4. Introduction 
4.1. Background 
Urinary incontinence (UI) remains a prevalent condition of major impact on a global scale.  
A major type of UI is stress urinary incontinence (SUI), defined as the complaint of 
involuntary loss of urine on effort or physical exertion including sporting activities, or on 
sneezing or coughing.  SUI is primarily due to weakness of the components of the urethral 
sphincter mechanism.   
 
Male SUI is usually iatrogenic in origin, resulting from sphincter insufficiency after surgery 
or prostatic radiotherapy, referred to as incontinence after prostate treatment (IPT).1 IPT is 
not rare following radical prostatectomy, mainly due to damage sustained to the distal 
urethral sphincter, which results in development of SUI. Post-prostatectomy incontinence 
(PPI) occurs at rates ranging from 3.0% to 87%, depending on the definition of incontinence 
applied.2,3 Moderate to severe SUI constitutes a significant burden to quality of life and 
carries substantial psychological impact on individuals and their families.2  
 
Several treatments are available for male SUI. SUI interventions include observation, 
behavioral modification (e.g., fluid restriction, limiting caffeine and alcohol, smoking 
cessation, timed voiding or double voiding, avoiding bladder irritants), pelvic floor training 
with or without biofeedback, urethral bulking agents, male urethral slings (MUS), adjustable 
continence balloons, and artificial urinary sphincter (AUS).4 Of these options, AUS, which 
includes the AMS 800, remains the gold standard for the treatment of severe IPT due to SUI 
because of its high success rates, with approximately 80% of patients achieving 
continence.4,5,2,6   
 
Numerous clinical trials have been conducted with the AMS 800 device.  Four studies 
conducted by American Medical Systems (AMS) demonstrated the safety and efficacy of the 
AMS 800.  These studies included 569 patients and include safety and performance data up 
to 10 years post-implant. Included within the analysis were continence rates, patient 
satisfaction data, revision rates, and adverse events. 
 
Results from these prospective clinical studies were combined with a Bayesian analysis of 
data collected from Patient Information Forms (PIFs) to further support the post market 
application for AMS 800 and included 12,713 patients.  This analysis defined the 5-year 
revision free rate for subjects implanted with the AMS 800 device as equivalent to the 75% 
predicted by the Bayesian analysis.  
 
In addition, a post market PIF study was completed and reported to the FDA in January 2013 
to evaluate the impact of the InhibiZone antibiotic surface treatment on the AMS 800 device.  
This post market study included 17,063 patients who were followed for up to 5.8 years. This 
analysis was designed to compare infection rates, mechanical malfunction, and surgical 
revision rates for InhibiZone treated versus non InhibiZone treated AMS 800s.  This study 
included all patients implanted with the AMS 800 or the AMS 800 with InhibiZone for 
whom a Patient Information Form (PIF) was collected by AMS from October 2006 to July 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 16 of 62 
  
2012.  The results demonstrated no statistically significant difference in the infection rates 
between IZ and Non-IZ treated AMS 800 patients. 
 
Overall, the AMS 800 has been studied in over 30,000 patients to support its performance 
and safety for up to 10 years post-implant. Based on current treatment recommendations, the 
artificial urinary sphincter, which includes the AMS 800, is the established standard for the 
treatment of persistent moderate to severe male stress urinary incontinence (SUI).7,8 
 
4.2. Study Rationale 
The AMS 800 has been on the market for several decades. Though the device does predate 
the Medical Device Amendment to the Food Drug and Cosmetics Act of 1976, the AUS 
received FDA clearance to market through the 510k process on November 30, 1982 and 
approval via the PMA process on June 14, 2001. As time has progressed, incremental 
technological advancements have been implemented to the device, along with the creation of 
additional tools to assist with the implantation procedure.  The study results will provide 
contemporary data on both the AMS 800 and the AMS tools. 
5. Device Description (part of Standard of Care) 
5.1. Commercial Device  
The AMS 800 Artificial Urinary Sphincter (AUS) is an implantable, fluid filled, solid 
silicone elastomer device used to treat stress urinary incontinence due to reduced 
urethral/bladder outlet resistance (intrinsic sphincter deficiency). It is designed to restore the 
natural process of urinary control. The device simulates normal sphincter function by 
opening and closing the urethra under the control of the patient. 
 
The AUS consists of three interconnected components: a cuff, a pump, and a pressure-
regulating balloon (PRB).  The three components are connected with kink-resistant tubing.  
The AMS 800 can be implanted at either the bulbous urethra or the bladder neck. When the 
cuff is inflated, the urethra is closed, and urine stays in the bladder. When the patient wishes 
to void, he cycles the device by squeezing and releasing the pump several times, moving the 
fluid from the cuff to the PRB. The cuff deflates, and urine passes through the open urethra. 
Pressure from the PRB pushes fluid back into the cuff, occluding the urethra and restoring 
continence. Figure 5.1-1 depicts the AMS 800 device.  
 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 17 of 62 
  
z 
 
Figure 5.1-1: AMS 800 Artificial Urinary Sphincter  
 
The major components of the device include: 
• An occlusive cuff, which is placed around the urethra and applies compression; 
• A pressure regulating balloon, which stores filling solution and maintains the system 
at constant pressure; 
• A control pump with a deactivation feature, which is used to fill and empty the cuff;  
• Accessory tools, which are used to aid in the implantation of the device; 
• Accessory Kit, which contains accessory materials necessary for one implant 
procedure; 
• Insertion Package, which contains two curved tubing passers used to route the tubing 
of the components through the appropriate tissue planes; 
• Deactivation Package, which contains three stainless steel plugs and one suture-tie 
connector.  
Table 5.1-1 provides the product line available for the AMS 800 as of June 19, 2019.  
 
Table 5.1-1: AMS 800 Product line with and without InhibiZone Treatment 
Part Number 
Description 
72400023 
BALLOON FGS, 51-60 CM 
72400024 
BALLOON FGS, 61-70 CM 
72400025 
BALLOON FGS, 71-80 CM 
72400160 
BELT CUFF FGS, 4.0 CM 
72400161 
BELT CUFF FGS, 4.5 CM 
72400162 
BELT CUFF FGS, 5.0 CM 
72400163 
BELT CUFF FGS, 5.5 CM 
72400164 
BELT CUFF FGS, 6.0 CM 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 18 of 62 
  
72400165 
BELT CUFF FGS, 6.5 CM 
72400166 
BELT CUFF FGS, 7.0 CM 
72400167 
BELT CUFF FGS, 7.5 CM 
72400168 
BELT CUFF FGS, 8.0 CM 
72400170 
BELT CUFF FGS, 9.0 CM 
72400172 
BELT CUFF FGS, 10.0 CM 
72400174 
BELT CUFF FGS, 11.0 CM 
72404130 
BELT CUFF FGS, 4.0 CM, IZ 
72404131 
BELT CUFF FGS, 4.5 CM, IZ 
72404132 
BELT CUFF FGS, 5.0 CM, IZ 
72404133 
BELT CUFF FGS, 5.5 CM, IZ 
72404134 
BELT CUFF FGS, 6.0 CM, IZ 
72404135 
BELT CUFF FGS, 6.5 CM, IZ 
72404136 
BELT CUFF FGS, 7.0 CM, IZ 
72404137 
BELT CUFF FGS, 7.5 CM, IZ 
72404138 
BELT CUFF FGS, 8.0 CM, IZ 
72404140 
BELT CUFF FGS, 9.0 CM, IZ 
72404142 
BELT CUFF FGS, 10.0 CM, IZ 
72404144 
BELT CUFF FGS, 11.0 CM, IZ 
720133-01 
CUFF FGS, 3.5 CM, AUS 
720157-01 
CUFF FGS, 3.5 CM, INHIBIZONE 
72400098 
CONTROL PUMP FGS 
72404127 
CONTROL PUMP FGS, IZ 
72100005 
INSERTION PACKAGE FG 
72400271 
CONNECTOR ASSEMBLY TOOL 
PKG 
72400095 
DEACTIVATION PKG FGS 
72401685 
AMS 800 ACCESSORY KIT, OUS 
 
The AMS 800 cuff and pump components are available with and without the InhibiZone 
treatment, an antibiotic coating of rifampin (also known as rifampicin) and minocycline HCl. 
The InhibiZone version of AMS 800 is identical to the non-InhibiZone AMS 800 in all 
technical ways except for the InhibiZone surface treatment. The InhibiZone antibiotic 
treatment process is intended to elute antibiotics from AMS 800 AUS component surfaces 
when they are exposed to a warm, moist environment.  
 
A copy of the Instructions for Use (IFU) will be provided in local language(s) as required per 
national regulations.  
 
Boston Scientific will not conduct investigational study device accountability as required per 
ISO 14155 as all study devices are commercially available products. The study devices shall 
be maintained per each institution’s standard practice and are being used within their 
approved indication.  
 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 19 of 62 
  
5.2  Accessory Medical Equipment   
Utilization, adverse event, and performance data may be collected on any AMS /BSC-
manufactured tool or accessory used during artificial urinary sphincter surgical procedures. 
Tools will be assessed once by means of a physician survey (or similar) at the end of 
enrollment. Examples of tools or accessories may include:  
  
• Connector Assembly Tool (Quick Connect) 
• Tubing Passer 
6. Study Objectives and Endpoints 
The primary objective of the study is to demonstrate that more than 65% of the subjects 
achieve a clinically meaningful level of dryness, i.e. treatment success. Treatment success is 
defined as a 50% reduction or greater in baseline urinary incontinence as measured by 24-
hour pad weight test at 12 months.9  
Table 6.1-1 lists the primary endpoint and all secondary and additional endpoints. The 
objectives and justifications for each endpoint are also provided.  
Table 6.1-1: Overview of objectives and endpoints 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION 
FOR ENDPOINTS 
Primary 
 
 
To evaluate the AMS 800 
AUS in men with SUI 
Treatment success:  achieving 
50% reduction or greater in 
baseline urinary incontinence as 
measured by 24-hour pad 
weight test at 12 months post 
device activation 
FDA guidance 
documentation for 
50% reduction9; 65% 
based on expected 
80% treatment success 
rate with a 15% 
margin   
Secondary 
 
 
To further confirm the safety 
of the AMS 800 AUS  
Incidence of safety parameters 
at 3 months, 6 months, and 12 
months. Safety parameters 
include device and/or procedure 
related adverse events, revision 
rates, and serious adverse events 
Common research 
endpoint  
To evaluate the AMS 800 
AUS  
≥ 50% reduction in urinary 
incontinence as measured by 24-
hour pad weight test at device 
activation and 6 months post 
device activation compared to 
baseline 
Assess level of 
improvement in 
continence at time 
points other than 
primary endpoint   
To evaluate the AMS 800 
AUS 
≥ 75% reduction in urinary 
incontinence as measured by 24-
Determine level of 
improvement in 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 20 of 62 
  
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION 
FOR ENDPOINTS 
hour pad weight test at device 
activation, 6 months, and 12 
months post device activation 
compared to baseline  
continence with a 
more stringent 
measurement than 
primary endpoint    
To evaluate the AMS 800 
AUS 
Reduction in # of pads per day 
at 3 months, 6 months and 12 
months post-device activation 
compared to baseline  
Objective 
measurement of 
number of 
incontinence episodes 
per day. Common 
endpoint to assess 
urinary 
incontinence9,10 
Additional 
 
 
To compare the functionality 
of the offered pressure 
regulating balloons 
Comparison of Pressure 
Regulating Balloons by 
subgroup analysis 
Compare  different 
pressure regulated 
balloons 
To evaluate the incontinence 
episodes and changes in 
voiding function following 
AMS 800 implantation 
Change in numbers of stress 
urinary incontinence episodes, 
fluid intake, urgency urinary 
incontinence episodes, and 
frequency of urination based on 
3-day electronic diary at 6 
months and 12 months post 
device activation compared to 
baseline 
Gather patient 
reported outcomes on 
device9, 10  
To evaluate the quality of life 
following AMS 800 
implantation 
Change in quality of life at 3 
months, 6 months, and 12 
months compared to baseline, as 
measured by the following 
questionnaires – IQoL, IIQ-7, 
EQ5D 
Gain information on 
patient satisfaction 
and improvement in 
quality of life using 
validated 
questionnaires10 
To evaluate the quality of life 
following AMS 800 
implantation 
Subject Ease of Use 
questionnaire  
Gain information 
specific to the 
patient’s use of the 
device 
 
7. Study Design 
The study is a single arm, prospective, multi-center study with 12-month follow-up following 
device activation.  

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 21 of 62 
  
The primary endpoint will be evaluated once all Intent-To-Treat (ITT) subjects have 
completed the 12-month study visit. All subjects will be followed to month 12, until study 
completion, or until discontinuation prior to month 12. All study procedures will be 
standardized for uniformity. 
Physician specialty and site procedure location (such as private-practice, hospital, academic 
medical center, etc.) will be recorded in the site selection questionnaire. 
7.1. Scale and Duration 
The study will be conducted at up to 30sites. Study sites will be considered in regions where 
the AMS 800 device is commercially available, including but not limited to the United 
States, Europe, and Australia. Sites will be encouraged to enroll a minimum of 5 subjects and 
up to a maximum of 25 subjects. The enrollment period is expected to be approximately 24 
months after the final study center has been activated to enroll subjects.  
 
It is anticipated that approximately 175 subjects will be enrolled in total to treat 
approximately 120 procedure subjects.  The number of enrolled subjects allows for subjects 
to screen fail after signing the informed consent based on collected baseline data.   
 
Figure 7.1-1 below depicts a high-level flow diagram, which visualizes the study design, 
enrollment process, and follow-up schedule.   Note: All follow-up visits may be completed 
either remote or in clinic. 
 
  

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 22 of 62 
  
  
Figure 7.1-1: AUSCO Study Design 
 
7.2. Treatment Assignment 
This study is a single-arm trial for a post market device. Subjects will serve as their own 
controls; follow-up assessments will be compared to values obtained at baseline. Subjects 
will be enrolled into the study after providing informed consent.  
Treatment will occur after all baseline procedures have been completed and the subject has 
been deemed eligible for the study. Baseline procedures may be combined with the screening 
visit and may occur within 90 days prior to the study procedure. Due to the allowable 
window of up to 90 days between baseline and study procedure, the study staff will confirm 
that subjects are still electing to undergo the study surgery prior to implantation and note the 
subject’s approval in their medical records and on the procedure CRF. 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 23 of 62 
  
7.3. Justification for the Study Design 
Artificial urinary sphincters are considered the gold standard for the treatment of moderate to 
severe post-prostatectomy SUI.4,5,2,6 With a single arm study design, all subjects receive the 
standard of care procedure.  
8. Subject Selection  
8.1. Study Population and Eligibility  
This study will enroll adult males with moderate to severe primary stress urinary 
incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications 
for surgical correction of urinary incontinence. 
To assess for eligibility for this study, inclusion and exclusion criteria are included in 
Sections 8.2 and 8.3 below. 
8.2. Inclusion Criteria 
Subjects who meet all of the following criteria (see Table 8.2-1) may be given consideration 
for inclusion in this clinical investigation, provided no exclusion criterion (see Section 8.3) is 
met.  
The inclusion criteria below are based on clinical standards for AUS surgery and the 
Instructions for Use.  
Table 8.2-1: Inclusion Criteria 
Inclusion 
Criteria 
1. Male  
2. ≥ 18 years of age  
3. Has undergone either a radical prostatectomy, transurethral resection of the 
prostate or other invasive prostate surgery   
4. Demonstrates primary stress urinary incontinence   
5. Positive screening 24-hour pad weight test (≥100 grams)  
6. Experiences at least 3 incontinence episodes per day during baseline diary or 
presents with continuous incontinence 
7. Negative urine culture   
8. Willing and able to undergo surgical implantation of the AUS device   
9. Willing and able to comply with the follow-up requirements   
10. Willing and able to forego any other surgical urinary incontinence treatments 
while participating in the study   
11. Willing and able to sign the informed consent 
 
 
 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 24 of 62 
  
8.3. Exclusion Criteria 
Subjects who meet any one of the following criteria (Error! Reference source not found.) 
cannot be included in this study and will be excluded from this clinical study. 
 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 25 of 62 
  
Table 8.3-1: Exclusion Criteria 
 
Exclusion 
Criteria 
1. Previously had or currently has a device implanted (AUS/Sling, or otherwise) for 
treatment of SUI or urge incontinence  
2. Primary urgency incontinence     
3. Postvoid residual volume greater that 150 ml or a history of difficulty emptying 
the bladder  
4. Recurrent vesicourethral anastomotic stricture or urethral stricture disease within 
the past 6 months  
5. Known urogenital malignancy other than previously treated prostate cancer   
6. Recurrent prostate cancer that is expected to require intervention during the study 
follow-up period   
7. History of recurrent bladder stones within the past 12 months prior to signing the 
informed consent 
8. Neurogenic bladder     
9. Need for intermittent catheterization   
10. Known history of untreated/uncontrolled bleeding diathesis or coagulopathy     
11. Immunosuppressed or on medical therapy which would impact the immune 
system   
12. Uncontrolled diabetes, defined as (HbA1c>10) 
13. Has a genitourinary mechanical prosthesis that was implanted within 3 months 
from the date of consent  
14. Had a post-implantation infection associated with the device after genitourinary 
mechanical prosthesis was implanted  
 
15. Undergone bulking procedure within 6 months of the baseline assessment   
16. Poor candidate for surgical procedures and/or anesthesia due to physical or mental 
conditions 
17. Urinary incontinence due to or complicated by an irreversibly obstructed lower 
urinary tract 
18. Irresolvable detrusor hyperreflexia or bladder instability 
19. Currently enrolled or plans to enroll in another device or drug clinical trial   
20. Currently using an indwelling catheter or condom catheter for treatment of 
incontinence and is not willing to discontinue use at least 4 weeks prior to baseline 
assessment   
21. Known allergy or sensitivity to rifampin or to minocycline HCl or other 
tetracyclines (only applicable when implanting with InhibiZone version of this 
device) 
22. Systemic lupus erythematosus because minocycline HCl has been reported to 
aggravate this condition (only applicable when implanting with InhibiZone version 
of this device) 
 
 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 26 of 62 
  
9. Subject Accountability 
9.1. Point of Enrollment 
Subjects will be considered enrolled in the study once they sign the informed consent. All 
enrolled subjects will have been consented prior to the procedure. All enrolled subjects with 
a surgery initiated (i.e. first incision) will be considered part of the Intent-to-Treat (ITT) 
population.  
9.2. Withdrawal 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study) 
shall be accounted for and documented. If a subject withdraws from the clinical 
investigation, the reason(s) shall be reported. If such withdrawal is due to problems related to 
device safety or performance, the investigator shall ask for the subject’s permission to follow 
his/her status/condition outside of the clinical study. 
 
Reasons for withdrawal include but are not limited to physician discretion and subject choice 
to withdraw consent. While study withdrawal is discouraged, subjects may withdraw from 
the study at any time, with or without reason, and without prejudice to further treatment. All 
applicable electronic Case Report Forms (eCRFs) up to the point of subject withdrawal and 
an End of Study eCRF must be completed.  Additional data may no longer be collected after 
the point at which a subject has been withdrawn from the study or withdraws his/her consent.  
Data collected up to the point of subject withdrawal may be used for study analysis, unless 
local regulations specify differently. 
9.2.1. Voluntary Withdrawal 
Subjects may withdraw from the study at any time. At the time of withdrawal, the 
Investigator shall document the reason for the withdrawal. For subjects who withdraw from 
the study and decide to revoke their authorization to use and disclose their medical 
information, the information that has already been collected in the study record may continue 
to be used; however, no new information will be obtained or added. 
9.2.2. Involuntary Withdrawal  
Subjects may be involuntarily withdrawn from the study if the Investigator determines it is in 
the subject’s best interest. If the subject is withdrawn at the investigator’s discretion, the 
reason for withdrawal must be documented in the subject’s medical records.  
9.3. Lost to Follow-Up 
If a participant fails to contact the clinic for a required study visit, the site will attempt to 
contact the participant and reschedule the missed visit prior to the next visit window, and are 
encouraged to remind the participant on the importance of maintaining the assigned visit 
schedule and ascertain if the participant wishes to and/or should continue in the study. 
 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 27 of 62 
  
Before the subject may be considered lost to follow-up, the investigator must make the 
following attempts to contact the subject: 
• Three documented telephone attempts 
• One certified letter 
 
If the subject can be reached and no longer wishes to participate in the study, the Investigator 
shall document the reason for the withdrawal and complete the End of Study eCRF.   
 
If subject is not able to be reached after the required attempts to contact the subject have been 
made and the subject has missed two consecutive follow-up visits within the 12-month 
follow-up schedule, or the subject has missed the final 12-month follow-up visit, the subject 
may be considered lost to follow-up.  The Investigator should document in the subject’s 
medical record the attempts to contact the subject and the reason for withdrawal. 
9.4. Subject Status and Classification 
Subjects are enrolled once they complete the informed consent process. However, some 
subjects may not meet all inclusion/exclusion criteria and subsequently are not counted 
toward the enrollment ceiling. The following definitions are intended to classify subjects 
based on their study eligibility:  
• Consent Ineligible: A subject who has signed the ICF but is found to not meet 
eligibility criteria. The subjects will be exited and will not undergo any study 
related procedures once their ineligibility has been determined. These subjects do 
not count toward enrollment. 
• Exited Prior to Procedure: A subject who signs the informed consent, meets 
eligibility criteria, but then does not have the study procedure initiated (first 
incision). The original ICF and screening documentation for these patients should 
be maintained in the site’s files. There are no follow-up requirements and any data 
collected prior to procedure is not included in statistical analyses.   
• 
Intent to Treat: A subject who signs the informed consent, and for whom the 
index procedure is initiated (first incision). The original ICF and screening 
documentation for intent to treat patients should be maintained in the site’s files. 
These patients are followed in accordance with the study follow-up schedule and 
count toward enrollment.  
9.5. End-of-Study Definition  
The clinical trial is considered completed when participants are no longer being examined or 
the last participant’s last study visit has occurred.  
A participant is considered to have completed the study if he has completed the Month 12 
visit as shown in the Data Collection Schedule (see Section 10 for details). 
The end of the study is defined as completion of the final Clinical Study Report.  

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 28 of 62 
  
10. Study Methods 
10.1. Data Collection 
The data collection schedule is shown in Table 10.1-1. All study data will be recorded on 
source documentation and captured within Case Report Forms (CRFs) for the purposes of 
this study. Study data will be monitored by Boston Scientific or representatives and as 
applicable on a regular basis as outlined in the study Monitoring Plan. 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCOS, 92406268, Rev/Ver C 
Page 29 of 62 
  
 
 
Table 10.1-1: Data Collection Schedule 
Procedure/Assessment 
Screening / 
Enrollment 
Visit2 
Pre-Operative / 
Baseline Visit 
(≤90 calendar 
days before index 
procedure) 
Index Procedure 
(≤90 calendar 
days from 
screening visit) 
Device Activation 
(30-45 calendar 
days post index 
procedure) 
Follow-up Visits4 
3 Month Visit5 
(±6 Weeks) 
6 Month Visit5 
(± 3 Months) 
12 Month Visit5 
(± 3 Months) 
Informed consent process, including informed 
consent signature and date 
X 
 
 
 
 
 
 
Inclusion/Exclusion Criteria Review 
X 
X 
 
 
 
 
 
Demographics 
 
X 
 
 
 
 
 
Physical assessment, including weight and 
height 
 
X 
 
 
 
X6  
X6  
Medical history1 
X 
X 
 
 
 
 
 
3-day eDiary   
 
X 
 
 
 
X 
X 
24-hour Pad Weight Test 
 
X 
 
X 
 
X 
X 
# Pads per Day 
 
X 
 
 
X 
X 
X 
IQoL (Urinary Incontinence Quality of Life) 
 
X 
 
 
X 
X 
X 
IIQ-7 (Incontinence Impact Questionnaire) 
 
X 
 
 
X 
X 
X 
EQ-5D (Health Status)  
 
X 
 
 
 
 
X 
Patient Ease of Use Questionnaire 
 
 
 
 
 
X 
X 
Index Procedure 
 
 
X 
 
 
 
 
Assessment of Adverse Events and Device 
Deficiencies3 
 
 
X 
X 
X 
X 
X 
End of Study 
 
 
 
 
 
 
X 
 
1Medical History at baseline includes documented absence of urine culture. 
2The Screening/Enrollment Visit and Pre-Operative/Baseline Visit may be combined and occur up to 90 calendar days prior to the study procedure with confirmed absence of 
infection. 
3Reportable events include (procedure related) AEs, SAEs,  SADEs, ADEs and device deficiencies. Adverse events that are not related to the device and not related to the 
procedure will not be collected; however, these assessments should be noted in the subject’s medical records.  
4Every effort should be made to do the follow-up visit within the window; however, if this is not possible, the site should attempt to complete the visit as soon as possible, but 
before the next visit window opens. Follow-up visits will be considered missed once the visit window for the next follow-up visit opens. For the Month 12 visit, the visit is not 
considered missed until the last day of the visit window. All follow-up visit windows start from the day of device activation. 
5Visits may be conducted in clinic or remote. 
6Optional assessment.  Height and weight may be patient reported. 
 
 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 30 of 62 
  
10.2. Study Candidate Screening 
Subjects will be screened against the inclusion/exclusion criteria and if confirmed to meet all 
the requirements attainable per standard of care, will be eligible to be consented for 
enrollment into the study. Any non-standard of care assessments that must be conducted in 
order to complete the inclusion/exclusion criteria review will be completed after the subject 
has completed the informed consent process. 
Subjects who do not meet the inclusion/exclusion criteria and were not enrolled into the 
study are considered screen failures.  Information on screen failures will be captured in the 
source documentation and screening logs and should include reasons for screen failure. 
These screen failures will not count toward the enrollment ceiling.  
If the subject has completed the informed consent process and met all inclusion/exclusion 
criteria, the subject will progress to the index procedure and follow-up phases of the study. 
10.2.1. Strategies for Recruitment and Retention 
Subjects will be recruited from clinician practice.  
Subjects will be compensated for visit related expenses. The compensation will be modest in 
nature and approved by the reviewing IRB/EC.  
10.3. Informed Consent 
Prior to any study-related assessments, each subject must complete the informed consent 
process and sign an IRB/EC-approved informed consent document to participate in the study 
as described in the Declaration of Helsinki and ISO 14155:2020 (Clinical Investigation of 
Medical Devices for Human Subjects- Good Clinical Practice) and will be in accordance 
with all applicable laws and regulations.  The informed consent form will describe the 
planned and permitted uses, transfers and disclosures of the subject’s personal health 
information.   
The subject or legally authorized representative (if approved by IRB/EC) will be given ample 
opportunity to inquire about details of the study to decide whether to participate in the study.  
Copies of the informed consent form will be provided to the subject and original documents 
filed at each study center as per regulatory requirements. 
Once the subject voluntarily agrees to participate in the study, then the Study Visit Schedule 
will be followed per below and as outlined in Table 10.1-1. 
10.4. Screening/Enrollment Visit 
The Screening/Enrollment may occur prior to the Pre-Operative/Baseline Visit. At this visit, 
the assessments below must be completed: 
• Informed Consent Process, including informed consent signature  
• Review of Inclusion/Exclusion Criteria 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 31 of 62 
  
• Medical History 
10.5. Pre-Operative/Baseline Visit [≤90 calendar days before Index Procedure] 
The Pre-operative/Baseline Visit will occur prior to the subject having surgery. The 
assessments below must be completed prior to index procedure. This visit may be combined 
with the Screening/Enrollment Visit and may occur up to 90 calendar days prior to surgery.  
• Demographics and physical examination 
• Medical History 
• 3-day eDiary  
• 24-hour pad weight test  
• Number of pads per day  
• IQoL 
• IIQ-7 
• EQ-5D 
10.6. Index Procedure [≤90 calendar days from Baseline] 
All procedures are to be performed with the AMS 800 Artificial Urinary Sphincter. 
Concomitant procedures are not allowed. Physicians should follow the IFU during the 
procedure. The following data must be collected during the index procedure: 
• Study device component information 
• Estimated blood loss  
• Anesthesia type  
• Duration of procedure, defined as time of first incision to time of closure 
• Assessment of adverse events and device deficiencies 
Once enrollment is complete, each study site investigator will be sent one AMS tools 
questionnaire to complete based on the AMS tools used during the index procedures. 
10.7. Device Activation [Approximately 30-45 days post index procedure] and 
Follow-up Procedures 
Subjects will be scheduled for follow-up visits as outlined in Table 10.1-1 (Data Collection 
Study Schedule).  
 
Every effort should be made to complete the follow-up visit within the window; however, if 
this is not possible, the site should attempt to complete the visit as soon as possible but before 
the next visit window opens. Follow-up visits will be considered missed once the visit 
window for the next follow-up visit opens. For the Month 12 visit, the visit is not considered 
missed until the last day of the visit window. 
 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 32 of 62 
  
Subjects will be scheduled for device activation approximately 4-6 weeks following the 
index procedure per standard of care. The following assessments will be attained 24 to 48 
hours after the device activation:  
• 24-hour pad weight test 
• Adverse event and device deficiency collection  
10.8. Month 3 Follow-up Visit [± 6 weeks post device activation] 
The 3-month follow-up visit occurs 90 calendar days after the day of device activation, ± 6 
weeks.  
Subjects can be contacted via a remote visit for their 3-month follow-up visit. A clinic visit is 
also allowed, though not required. Remote contacts must be documented in the subject’s 
medical records.  
Questionnaires cannot be completed over the phone. The site must mail the questionnaires to 
the subjects and the subjects should return the questionnaires to the site as soon as possible.  
The following data will be collected at the 3-month visit:  
• Number of pads per day 
• IQoL 
• IIQ-7 
• Assessment of adverse events and device deficiencies 
10.9. Months 6 [± 3 Months] and 12 Visit [± 3 Months] 
The 6-month follow-up visit occurs 180 calendar days after the day of device activation, ± 3 
months. The 12-month follow-up visit occurs 365 calendar days after the day of device 
activation, ± 3 months. These visits may occur either remotely or in clinic.   
Questionnaires cannot be completed over the phone. The site must mail the questionnaires to 
the subjects and the subjects should return the questionnaires to the site as soon as possible. 
Pads can be mailed to subjects and returned per the pad weight protocol or dropped off by the 
subject.  
The following data will be collected at the 6-month and 12-month visits:  
• Physical examination including height and weight (Note: If a remote visit is 
completed, the subject may self report his height and weight.) 
• 3-day eDiary 
• 24-hour pad weight test 
• Number of pads per day 
• IQoL 
• IIQ-7 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 33 of 62 
  
• EQ-5D (Month 12 only) 
• Patient Ease of Use 
• Assessment of adverse events and device deficiencies  
• Study completion (12-month follow-up only) 
10.10. 
Study Completion 
All subjects completing the 12-month follow-up visit will be considered to have completed 
the study. 
 
Upon completion of the study, all adverse events indicated as “ongoing” should be changed 
to one of the following outcomes:  
• Not Recovered/Not Resolved  
• Resolved 
• Resolved with sequelae 
• Unknown  
The outcome of “unknown” should only be used for subjects who are lost to follow-up. 
Whenever possible, sites should enter a reason for each ongoing/unresolved adverse event at 
time of study exit.  
10.11. 
Revision Surgery 
It is recognized that during the course of the study, there is a possibility subjects may require 
a medical revision of the implant for events including but not limited to infection, erosion, 
and mechanical malfunction.  
 
A medical revision is defined as a secondary surgery to modify or replace the initially 
implanted device. A replacement is a subset of medical revision, defined as removal of one 
or more components of the AMS 800 and/or implantation of a new component. Components 
include the cuff, pump, and PRB.    
 
Any subject who receives a medical revision should return to the clinic for the next regular 
study visit as per his original schedule.   
10.12. 
Source Documents 
It is preferable that original source documents are maintained, when available. In lieu of 
original source documents, certified copies are required to be maintained.  A certified copy is 
a copy (irrespective of the type of media used) of the original record that has been verified 
(i.e., by a dated signature or by generation through a validated process) to have the same 
information, including data that describe the context, content, and structure, as the original.  

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 34 of 62 
  
11. Statistical Considerations 
11.1. Endpoints 
11.1.1. Primary Endpoint 
The primary endpoint is defined as treatment success based on the 24-hour pad-weight test. 
A 50% or greater reduction in pad-weight from baseline to 12 months post-device activation 
is considered a treatment success. 
11.1.1.1. Hypotheses 
The study will evaluate whether the proportion of subjects experiencing a treatment success 
exceeds 65% at 12 months. The null and alternative hypotheses for this evaluation are 
 
H0:  p ≤ 65% 
 
H1: p > 65% 
where p is the proportion of subjects who are a treatment success at 12 months. 
11.1.1.2. Sample Size  
The sample size calculation is based on an assumption that the treatment success rate is 
80%4. With a one-sided type I error of 0.025 and a type II error of 0.10 (90% power), a 
sample size of 96 subjects are needed to demonstrate the proportion of subjects who are a 
treatment success exceeds 65%. Assuming a 20% attrition rate, at least 120 subjects with 
AMS 800 AUS procedure are required. 
11.1.1.3. Statistical Methods 
The hypotheses will be evaluated using a one-sided exact binomial test. In addition, a two-
sided 95% exact (Clopper-Pearson) confidence interval will be presented. Sensitivity analysis 
to missing data will be performed using tipping-point analysis. If a medical revision is 
performed due to efficacy reasons at or prior to the 12 month visit, then the subject is 
considered as experiencing a treatment failure. 
11.1.2. Secondary Endpoints 
The secondary endpoints are explanatory in nature; descriptive statistics including 95% 
confidence intervals will be used to summarize all these endpoints unless specified 
otherwise. 
11.1.2.1. Secondary Endpoint 1 –Serious Adverse Events 
The endpoint is a serious adverse event. 
11.1.2.1.1 Statistical Methods 
Serious adverse events will be summarized using descriptive statistics (event counts, 
proportion of subjects with a serious adverse event), and by relatedness to procedure and/or 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 35 of 62 
  
device. The serious adverse event rates will be summarized by the Kaplan-Meier estimate at 
3 months (90 days), 6 months (180 days) and 12 months (365 days) post device activation.   
11.1.2.2. Secondary Endpoint 2 - Revision 
The endpoint is a medical revision of the implant for events including but not limited to 
infection, erosion, and mechanical malfunction. 
11.1.2.2.1 Statistical Methods 
The proportion of subjects with a revision will be summarized by the Kaplan-Meier estimate 
at 3 months (90 days), 6 months (180 days) and 12 months (365 days) post device activation. 
The revision rate will be summarized by a revision reason, e.g. infection, erosion, and 
mechanical malfunction if applicable.  
11.1.2.3. Secondary Endpoint 3 – 50% Reduction in pad weight 
The endpoint is the proportion of subjects with at least 50% reduction from baseline in 
urinary incontinence as measured by 24-hour pad weight test at device activation, and 6 
months post device activation. 
11.1.2.3.1 Statistical Methods 
Descriptive statistics including 95% two-sided confidence intervals will be used to 
summarize the percentage of subjects with at least 50% reduction from baseline in 24-hour 
pad weight at device activation, and 6 months post device activation.   
11.1.2.4. Secondary Endpoint 4 – 75% Reduction in pad weight  
The endpoint is the proportion of subjects with at least 75% reduction from baseline in 
urinary incontinence as measured by 24-hour pad weight test at device activation, 6 months 
and 12 months post device activation. 
11.1.2.4.1 Statistical Methods 
Descriptive statistics including 95% two-sided confidence intervals will be used to 
summarize the percentage of subjects with at least 75% reduction from baseline in 24-hour 
pad weight at device activation, 6 months and 12 months post device activation.  
11.1.2.5. Secondary Endpoint 5 – number of pads per day 
The endpoint is change in number of pads per day at 3 months, 6 months and 12 months post 
device activation compared to baseline. 
11.1.2.5.1 Statistical Methods 
Descriptive statistics (N, mean, standard deviation, minimum, Q1, median, Q3 and 
maximum) will be used to summarize the number of pads per day at Baseline, 3 months, 6 
months and 12 months post device activation along with change and percent change from 
baseline when applicable.  

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 36 of 62 
  
11.2. General Statistical Methods 
The Intent-to-Treat (ITT) subject population includes all subjects who provide written 
informed consent to be enrolled into the study, and have a surgery initiated (defined as the 
first incision).  
 
The As Treated (AT) Population includes all subjects for whom implantation of the device is 
successful. 
 
The Per Protocol (PP) population includes all subjects in the AT Population who meet all 
eligibility criteria and have no major protocol deviations.  
The endpoint analyses will be performed for the ITT population. The AT and PP populations 
will be evaluated as sensitivity analyses for the primary endpoint, and the safety outcomes 
will also be assessed using AT population.  
11.2.1. Control of Systematic Error/Bias 
All subjects will be treated according to the directions in the Operating Manual and 
Instructions for Use.  
The primary endpoint analysis based on the exact binomial test is specified to be 
conservative in order to avoid bias toward demonstrating the primary hypothesis (i.e., 
achieving the performance goal) of the study. Furthermore, the potential of bias from missing 
data for the primary endpoint will be assessed through tipping point analysis.  
11.2.2. Number of Subjects per Investigative Site 
The study will be conducted at up to 30 sites. Sites will be encouraged to enroll a minimum 
of 5 subjects; a maximum of 25 subjects may be enrolled at a site, unless the site has received 
prior approval from the sponsor to enroll additional subjects. 
11.3. Data Analyses 
The analyses will include only the available cases unless specified otherwise. Presentation of 
summary statistics for continuous variables will include N, mean, median, standard 
deviation, minimum, and maximum values. For categorical variables, the number and 
percentage under each category will be presented. 
11.3.1. Other Endpoints/Measurements  
11.3.1.1. Additional Endpoint 1 – stress urinary incontinence episodes per day 
The endpoint is change in number of stress urinary incontinence episodes per day at 6 
months and 12 months post device activation compared to baseline. The stress urinary 
incontinence episodes are collected in the three day electronic diary.  

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 37 of 62 
  
11.3.1.1.1 Statistical Methods 
For those patients without the continuous leakage at baseline, descriptive statistics (N, mean, 
standard deviation, minimum, Q1, median, Q3 and maximum) will be used to summarize the 
stress urinary incontinence episodes per day at baseline, 6 months and 12 months post device 
activation along with change and percent change from baseline when applicable. 
For those patients with the continuous leakage at baseline, descriptive statistics (N, mean, 
standard deviation, minimum, Q1, median, Q3 and maximum) will be used to summarize the 
stress urinary incontinence episodes per day at 6 months and 12 months post device 
activation. If a subject experiences continuous leakage at a follow up visit, the number of 
stress urinary incontinence episodes will not be imputed.  
Number and percentage of patients with continuous leakage will be reported separately at 
baseline, 6 months and 12 months post device activation.  
Similar analyses will be performed for the other parameters collected in the three day 
electronic diary (urgency urinary incontinence episodes, fluid intake, and frequency of 
urination) when applicable.  
11.3.1.2. Additional Endpoint 2 - IQoL 
To evaluate the change in quality of life as measured by Incontinence Quality of Life (IQoL) 
at 3 months, 6 months and 12 months post device activation compared to baseline. 
The endpoints are the IQoL total score and each of the three subscales of the IQoL, a 22 
items tool quantifying the quality of life. The three subscales are the Avoidance & Limiting 
Behaviors (ALB), Psychosocial Impact (PS) and the Social Embarrassment (SE). 
11.3.1.2.1 Statistical Methods 
Descriptive statistics including 95% confidence intervals will be used to summarize the IQoL 
total scores and the three subscale scores at baseline, 3 months, 6 months and 12 months post 
device activation along with change from baseline.  
11.3.1.3. Additional Endpoint 3 – IIQ-7 
To evaluate the life impact of UI as measured by Incontinence Impact Questionnaire (IIQ-7) 
at 3 months, 6 months and 12 months post device activation compared to baseline. 
The endpoint is the IIQ-7 score. 
11.3.1.3.1 Statistical Methods 
Descriptive statistics including 95% confidence intervals will be used to summarize the IIQ-7 
score at baseline, 3 months, 6 months and 12 months post device activation along with 
change from baseline. 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 38 of 62 
  
11.3.1.4. Additional Endpoint 4 – EQ-5D 
To quantify the health states as measured by Health Status (EQ-5D) at 12 months post device 
activation compared to baseline. 
The endpoints are EQ-5D descriptive system and EQ VAS, and it may be converted into a 
single index value.   
11.3.1.4.1 Statistical Methods 
For a categorical variable, the frequency or the proportion of a category will be calculated at 
baseline and 12 months post device implantation. For a continuous variable, descriptive 
statistics including 95% confidence intervals will be used to summarize the value at baseline, 
and 12 months post device activation. 
11.3.1.5. Additional Endpoint 5 – Patient Ease of Use 
To evaluate the patient use of device as measured by Patient Ease of Use Questionnaire at 6 
months and 12 months post device activation. 
The endpoint is the patient ease of use of the device.  
11.3.1.5.1 Statistical Methods 
The frequency and the proportion of a category will be calculated at 6 months and 12 months 
post device activation. 
11.3.2. Interim Analyses  
No formal interim analyses are planned for the purpose of stopping the study early for 
declaring effectiveness or for futility. 
11.3.3. Subgroup Analyses 
Treatment success rates will be calculated by three Pressure Regulating Balloon subgroups 
(Balloon FGS 51-60 cm, 61-70 cm, 71-80 cm), and Fisher’s Exact test or Chi-squared test 
will be applied to evaluate if there is a correlation between treatment success and Pressure 
Regulating Balloons. 
11.3.4. Justification of Pooling 
Fisher’s Exact test or Chi-squared test will be applied to evaluate the homogeneity of the 
treatment success rates across the study centers.  
11.3.5. Multivariable Analyses 
There are no planned multivariable analyses.  

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 39 of 62 
  
11.3.6. Changes to Planned Analyses 
Any changes to the planned statistical analyses made prior to performing the analyses will be 
documented in an amended Statistical Analysis Plan approved prior to performing the 
analyses. Changes from the planned statistical methods after performing the analyses will be 
documented in the clinical study report along with a reason for the deviation. 
12. Health Economics Outcomes 
A formal health economics analysis may be conducted after the trial is completed, given 
meaningful clinical results are obtained. In addition to the primary clinical endpoints, the 
EQ-5D-5L questionnaire, a standardized instrument, will be collected prospectively in all 
subjects at baseline and 12-month follow up as a measure of non-disease-specific health-
related quality of life and used to obtain health utility scores. The health economics analysis 
may take into consideration any differences in clinical endpoints, complication rates, quality 
of life, and resource utilization. 
13. Data Management 
13.1. Data Collection, Processing, and Review 
Subject data will be recorded in a limited access secure electronic data capture (EDC) 
system.  
The clinical database will reside on a production server hosted by Medidata EDC System. All 
changes made to the clinical data will be captured in an electronic audit trail and available for 
review by the sponsor or its representative. The associated Rave software and database have 
been designed to meet regulatory compliance for deployment as part of a validated system 
compliant with laws and regulations applicable to the conduct of clinical studies pertaining to 
the use of electronic records and signatures. Database backups are performed regularly. 
The Investigator provides his/her electronic signature on the appropriate electronic case 
report forms (eCRFs) in compliance with local regulations. A written signature on printouts 
of the eCRFs must also be provided if required by local regulation. Changes to data 
previously submitted to the sponsor require a new electronic signature by the Investigator 
acknowledging and approving the changes. 
Visual and/or electronic data review will be performed to identify possible data 
discrepancies. Manual and/or automatic queries will be created in the Medidata EDC system 
and will be issued to the site for appropriate response. Site staff will be responsible for 
resolving all queries in the database. 
All access to the clinical database will be changed to “Read only” after all data is either 
“Hard Locked” or “Entry Locked”. Once acceptance of the final report or finalization of 
publications (as applicable) is received, final database storage and archiving activities can 
begin. Once all of the closeout activities are completed a request to IT is submitted to have 
the “Database Locked” or Decommissioned and all database access revoked. 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 40 of 62 
  
 
13.1.1. Subject Diaries  
This study will capture subject diary data electronically via a secure application (Medidata 
Rave Patient Cloud) directly integrated with the 21 CFR Part 11-compliant Rave EDC 
system or on a paper version of the diary.  The subject can utilize their own device (i.e. 
smartphone or tablet) to access the application, or the subject will be provided with an off-the 
shelf, commercially available device. The subject will use the Patient Cloud Application to 
respond to diary questions and/or questionnaires. Data will be automatically uploaded into 
the EDC system via the Internet or cellular signal. Entries on the paper version of the diary 
will be manually entered by site staff. 
13.1.2. Questionnaires 
Paper questionnaires that are completed by the subject are transcribed into the EDC database 
by the site staff. The Patient Ease of Use questionnaire will be provided in electronic form 
directly within the subject diaries’ secure application or on a paper version. Data will be 
uploaded automatically into the EDC system via the Internet (Wi-Fi) or cellular signal. 
Completed paper versions of the Patient Ease of Use questionnaire will be manually entered 
by site staff.  
13.2. Data Retention 
The Principal Investigator or his/her designee or investigational site will maintain all 
essential study documents and source documentation that support the data collected on the 
study subjects in compliance with applicable regulatory requirements.   
The Principal Investigator or his/her designee will take measures to prevent accidental or 
premature destruction of these documents. If for any reason the Principal Investigator or 
his/her designee withdraws responsibility for maintaining these essential documents, custody 
must be transferred to an individual who will assume responsibility and Boston Scientific  
must receive written notification of this custodial change. Sites are required to inform BSC in 
writing where paper or electronic files are maintained in case files are stored off site and are 
not readily available. 
14. Deviations 
An Investigator must not make any changes or deviate from this protocol, except to protect 
the life and physical well-being of a subject in an emergency. An investigator shall notify the 
sponsor and the reviewing IRB/EC/REB, and the regulatory authority if applicable of any 
deviation from the investigational plan to protect the life or physical well-being of a subject 
in an emergency, and those deviations which affect the scientific integrity of the clinical 
investigation. Such notice shall be given as soon as possible, but no later than 5 working days 
after the emergency occurred, or per prevailing local requirements, if sooner than 5 working 
days.  

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 41 of 62 
  
All deviations from the investigational plan, with the reason for the deviation and the date of 
occurrence, must be documented and reported to the sponsor by completing the Protocol 
Deviation eCRF in Rave EDC. Sites may also be required to report deviations to the 
IRB/EC/REB, and the regulatory authority, per local guidelines and national/government 
regulations.  
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including IRB/EC/REB/Regulatory Authority/, site re-
training, or site discontinuation/termination) will be put into place by the sponsor. 
The sponsor will not approve protocol waivers. 
15. Compliance 
15.1. Statement of Compliance 
This clinical investigation is financed by the study sponsor. Before the investigational site 
can be “Authorized to Enroll,” the investigational site must enter into a Clinical Study 
Agreement with the sponsor that details the financing of the study as well as the rights and 
obligations of the investigational site and the investigator. This study will be conducted in 
accordance with applicable FDA regulations (21 CFR 50, 54, 56), European Medical Device 
Regulation, the spirit of EN ISO 14155: Clinical Investigation of Medical Devices for 
Human Subjects, ICH Good Clinical Practice, ethical principles that have their origins in the 
Declaration of Helsinki, and applicable individual country laws and regulations.  
Applicability of the above principles have been reviewed for this post-market observational 
clinical investigation and justifications for ISO 14155 exemptions are noted in the 
appropriate sections. 
The study shall not begin until the required approval/favorable opinion from the 
IRB/EC/REB and/or regulatory authority has been obtained, if appropriate. Also, the study 
shall not begin prior to issuance of the site Authorization to Enroll, as provided by the 
sponsor. Any additional requirements imposed by the IRB/EC/REB or regulatory authority 
shall be followed, if appropriate.  
15.2. Investigator Responsibilities 
The Principal Investigator of an investigational site is responsible for ensuring that the study 
is conducted in accordance with the Clinical Study Agreement, the clinical investigation 
plan, the spirit of ISO 14155, ethical principles that have their origins in the Declaration of 
Helsinki, any conditions of approval imposed by the reviewing IRB/EC/REB, and prevailing 
local and/or country laws and/or regulations, whichever affords the greater protection to the 
subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following.  
• Prior to beginning the study, sign the Clinical Study Agreement and comply with the 
Investigator responsibilities as described in such Agreement.   

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 42 of 62 
  
• Provide his/her qualifications and experience to assume responsibility for the proper 
conduct of the study and that of key members of the site team through up-to-date 
curriculum vitae or other relevant documentation and disclose potential conflicts of 
interest, including financial, that may interfere with the conduct of the clinical study or 
interpretation of results. 
• Make no changes in or deviate from this protocol, except to protect the life and physical 
well-being of a subject in an emergency; document and explain any deviation from the 
approved protocol that occurred during the course of the clinical investigation. 
• Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all clinical-
investigation-related records are retained per requirements. 
• Ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
sponsor in the CRFs and in all required reports. 
• Record, report, and assess (seriousness and relationship to the device/procedure) every 
adverse event as applicable per the protocol and observed device deficiency. 
• Report to sponsor, per the protocol requirements, all reportable events. 
• Report to the IRB/EC/REB and regulatory authorities any SAEs and device deficiencies 
that could have led to a SADE  if required by applicable laws or regulations or this 
protocol or by the IRB/EC/REB, and supply BSC with any additional requested 
information related to the safety reporting of a particular event. 
• Allow the sponsor to perform monitoring and auditing activities and be accessible to the 
clinical research monitor or auditor and respond to questions during monitoring visits or 
audit(s). 
• Allow and support regulatory authorities and the IRB/EC/REB when performing auditing 
activities. 
• Ensure that informed consent is obtained in accordance with applicable laws, this 
protocol and local IRB/EC/REB requirements. 
• Provide adequate medical care to a subject during and after a subject’s participation in a 
clinical study in the case of adverse events, as described in the Informed Consent Form 
(ICF). 
• Inform the subject of the nature and possible cause of any adverse events experienced. 
• As applicable, provide the subject with necessary instructions on proper use, handling, 
storage, and return of the device when it is used/operated by the subject. 
• Inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required. 
• Provide the subject with well-defined procedures for possible emergency situations 
related to the clinical study, and make the necessary arrangements for emergency 
treatment, including decoding procedures for blinded/masked clinical investigations, as 
needed. 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 43 of 62 
  
• Ensure that clinical medical records are clearly marked to indicate that the subject is 
enrolled in this clinical study. 
• Ensure that, if appropriate, subjects enrolled in the clinical investigation are provided 
with some means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided). 
• Inform, with the subject’s approval or when required by national regulations, the 
subject’s personal physician about the subject’s participation in the clinical investigation. 
• Make all reasonable efforts to ascertain the reason(s) for a subject’s premature 
withdrawal from clinical investigation while fully respecting the subject’s rights. 
• Ensure that an adequate investigation site team and facilities exist and are maintained and 
documented during the clinical investigation. 
• Discuss questionnaire responses with subjects and subsequently report adverse event(s) if 
warranted. 
All investigators will provide their qualifications and experience to assume responsibility for 
their delegated tasks through up-to-date curriculum vitae or other relevant documentation and 
disclose potential conflicts of interest, including financial, that may interfere with the conduct 
of the clinical study or interpretation of results. 
 
15.2.1. Delegation of Responsibility 
When specific tasks are delegated by an investigator, including but not limited to conducting 
the informed consent process, the Principal Investigator is responsible for ensuring 
competency of those to whom tasks are delegated as well as for providing appropriate 
training to,  and adequate supervision of them. The Principal Investigator will provide both 
the training documents and a signed training log to BSC. Where there is a sub investigator at 
a site, the sub investigator should not be delegated the primary supervisory responsibility for 
the site. The investigator is accountable for regulatory violations resulting from failure to 
adequately supervise the conduct of the clinical study.  
15.3. Institutional Review Board/ Ethics Committee 
The investigational site will obtain the written and dated approval/favorable opinion of the 
IRB/EC/REB for the clinical investigation before recruiting subjects and implementing all 
subsequent amendments, if required. 
A copy of the written IRB/EC/REB and/or competent authority (CA) approval of the 
protocol (or permission to conduct the study) and ICF, must be received by the sponsor 
before recruitment of subjects into the trial. Prior approval must also be obtained for other 
materials related to subject recruitment or which will be provided to the subject. 
Any amendment to the protocol will require review and approval by the IRB/EC/REB before 
the changes are implemented to the study.  All changes to the ICF will be IRB/EC/REB 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 44 of 62 
  
approved; a determination will be made regarding whether a new ICF needs to be obtained 
from participants who provided consent, using a previously approved ICF.  
Annual IRB/EC/REB approval and renewals will be obtained throughout the duration of the 
study as required by applicable local/country laws or regulations or IRB/EC/REB 
requirements. Copies of the study reports and the IRB/EC/REB continuance of approval must 
be provided to the sponsor.  
15.4. Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this study 
will be considered confidential by BSC and will be kept confidential in accordance with all 
applicable laws and regulations. Only authorized BSC personnel and/or a BSC representative 
including, but not limited to Contract Research Organization (CRO), will have access to this 
information. Authorized regulatory personnel have the right to inspect and copy all records 
pertinent to this study. Study data collected during this study may be used by BSC for the 
purposes of this study, publication, and to support future research and/or other business 
purposes, such as overseeing and improving the performance of its device, new medical 
research and proposals for developing new medical products and procedures. All data used in 
the analysis and reporting of this study or shared with a third-party researcher will be without 
identifiable reference to specific subjects. 
Information received during the study will not be used to market to subjects; subject names 
will not be placed on any mailing lists or sold to anyone for marketing purposes.  
15.5. General Data Protection Regulations  
Data collected from clinical trial data subjects are considered “personal data” (including 
sensitive personal data in some cases). The protection of clinical trial subject personal data and 
compliance with privacy, data protection laws and regulations is of critical importance to BSC. 
Data collection has been carefully considered for this study and has been restricted to the strict 
essentials with a clear, specific and detailed purpose to mitigate the risk and the impact of data 
breach and to comply with data privacy laws (including but not limited to HIPAA and GDPR). 
Section 10 of the protocol defines the data that need to be collected to fulfill the objectives of 
the clinical study. 
 
Personal data collected by Boston Scientific includes, but is not limited to:  
• Geographic data (site name)  
• Important Dates  
o Informed consent date  
o Date of birth  
o Procedure date  
o Adverse event start/end date  
o Hospitalization admission/discharge date  
o Subject visit dates  
 
The purposes of the personal data processing will be carefully defined within the informed 
consent form. Personal data will not be used for a purpose other than the one stated in the 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 45 of 62 
  
informed consent provided to the subjects. Personal data shall not be disclosed, made available, 
or otherwise used, processed, transferred, or stored for purposes other than those specified in 
the informed consent form, except: 
• with the consent of the data subject; or 
• processing is necessary for compliance with a legal obligation.  
  
15.5.1. Transparency 
BSC must only collect personal data by fair and lawful means. BSC must be transparent and 
open with individuals about how BSC collects and uses personal data, with whom BSC 
shares it, and where it may be processed. 
For this transparency principle, BSC must provide information to our health care providers 
and their study subjects about the purpose for collecting their personal data; who will have 
access to the data and to whom it may be shared, if it will be accessed or transferred to 
another country; and who to contact with questions or requests. 
15.5.2. Rights to Data Subjects 
In GDPR, a data subject is any living individual to whom the personal data relates. A data 
subject includes study subjects. Data subjects shall have the right to:  
• obtain from BSC confirmation of whether BSC has data relating to the individual; 
• have data relating to them communicated: 
o within a reasonable time (within 30 days from receipt of request, extendable if 
complicated or unclear request); 
o at a charge, if any, that is not excessive; 
o in a reasonable manner; and 
o in a form that is readily intelligible to the individual; 
• be given reasons if a request made under subparagraphs (a) and (b) is denied, and to be 
able to challenge such denial; 
• challenge data relating to the individual and, if the challenge is successful, to have the 
data erased, rectified, completed, or amended. During the period of such challenge, the 
individual can require that access to the data be restricted; 
• "opt out"/oppose that their personal data are used for marketing purposes; and, 
• when requested, BSC must also communicate any rectification or erasure of personal 
data or restriction of processing to each recipient to whom the personal data have been 
disclosed, unless this proves impossible or involves disproportionate effort. 
These rights will also be listed in the subject informed consent form.  
Physicians are also data subjects in this study. As data subjects, they have the same rights as 
study subjects, listed above. For the purposes of this study, data collected on physicians 
includes but is not limited to:  
• Documentation such as:  
o Curriculum Vitaes 
o Medical Licenses  

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 46 of 62 
  
• Identifying information such as:  
o Medical license number  
o Place of work  
o Telephone numbers  
o Email addresses  
15.6. Insurance  
Where required by local/country regulation, proof and type of insurance coverage, by BSC 
for subjects in the study will be obtained. 
16. Monitoring 
Monitoring will be performed during the study to assess continued compliance with the 
protocol and applicable regulations. In addition, the clinical research monitor verifies that 
study records are adequately maintained, that data are reported in a satisfactory manner with 
respect to timeliness, adequacy, and accuracy, and that the Principal Investigator continues to 
have sufficient staff and facilities to conduct the study safely and effectively. The Principal 
Investigator/institution guarantees direct access to original source documents by BSC 
personnel, their designees, and appropriate regulatory authorities. 
The sponsor will put a plan in place to document the specific monitoring requirements. 
The study may also be subject to a quality assurance audit by BSC or its designees, as well as 
inspection by appropriate regulatory authorities. It is important that the Principal Investigator 
and relevant study personnel are available during on-site monitoring visits or audits and that 
sufficient time is devoted to the process. 
17. Potential Risks and Benefits 
17.1. Instructions for Use 
Please refer to the Instructions for Use for an overview of anticipated adverse device effects, 
as well as anticipated adverse events, and risks associated to the commercial device(s).   
17.2. Risks associated with Participation in the Clinical Study 
The AMS 800 AUS is a commercially available device. None of the procedures associated 
with this study fall outside of standard of care procedure. Therefore, there are no foreseen 
additional risks associated with the study follow-up schedules, study procedures, testing, or 
withdrawal from the study. 
17.3. Risk Minimization Actions 
Additional risks may exist. Risks can be minimized through compliance with this protocol, 
performing procedures in the appropriate hospital environment, adherence to subject 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 47 of 62 
  
selection criteria, close monitoring of the subject's physiologic status during research 
procedures and/or follow-ups and by promptly supplying BSC with all pertinent information 
required by this protocol. 
17.4. Anticipated Benefits 
There are no guaranteed benefits from participation in this study. The AMS 800 AUS is a 
commercially available device, and can be implanted with or without enrollment in this 
study. However, information gained from the conduct of this study may be of benefit to 
others with the same medical conditions.  
 
Refer to the Instructions for Use for further information on benefists and risks associated 
with the use of the AMS 800.   
18. Safety Reporting 
18.1. Reportable Events by investigational site to Boston Scientific 
It is the responsibility of the investigator to assess and report the following events to BSC if 
they occurred from the time of index procedure through the end of the subject’s participation 
in the study: 
• Serious Adverse Events 
• Serious Adverse Device Effects 
• Adverse Device Effects 
• Procedure Related Adverse Events  
• Device Deficiencies 
Events to be reported include both anticipated and expected post procedural events, in 
addition to any other unanticipated and unexpected events.  
When possible, the medical diagnosis should be reported as the Event Term instead of 
individual symptoms. 
If it is unclear whether or not an event fits one of the above categories, or if the event cannot 
be isolated from the device or procedure, it should be submitted as an adverse event and/or 
device deficiency. 
Reportable events must be recorded in the eCRF. The Investigator or designee is responsible 
for updating the eCRF with new or updated information in relation to the already reported 
event as soon as he/she becomes aware.  
Underlying diseases and chronic conditions are not reported as AEs unless there is an 
increase in severity or frequency during the course of the investigation. Death should not be 
recorded as an AE but should only be reflected as an outcome of one (1) specific SAE (see 
Table 18.2-1 for Safety definitions). 
Refer to Instructions for Use for the known risks associated with the commercial device(s). 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 48 of 62 
  
18.2. Definitions and Classification 
Safety definitions are provided in Table 18.2-1. Administrative edits were made on the safety 
definitions from applicable regulations and guidance including (but not limited to) 21 CFR 
Part 812, ISO 14155 and EU MDR 2017/745/MDCG 2020-10/1 Guidance on Safety 
Reporting in Clinical Investigations for clarification purposes. 
 
Table 18.2-1: Safety Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1  
 
 
 
 
Any untoward medical occurrence, unintended disease or injury, or any 
untoward clinical signs (including an abnormal laboratory finding) in 
subjects, users or other persons, in the context of a clinical investigation, 
whether or not related to the study medical device and whether anticipated 
or unanticipated.  
NOTE 1: This includes events related to the study medical device or 
comparator. 
NOTE 2: This definition includes events related to the procedures 
involved. 
NOTE 3: For users or other persons, this definition is restricted to events 
related to the study medical device.  
Adverse Device Effect (ADE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
Adverse event related to the use of the study medical device 
NOTE 1: This includes any adverse event resulting from insufficiencies or 
inadequacies in the instructions for use, the deployment, the implantation, 
the installation, the operation, or any malfunction of the study medical 
device. 
NOTE 2: This definition includes any event resulting from use error or 
from intentional misuseof the study medical device. 
Note 3: This includes ‘comparator’ if the comparator is a medical device. 
Serious Adverse Event (SAE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
Adverse event that led to any of the following: 
a) death, 
b) serious deterioration in the health of the subject, user or other persons 
as defined by either: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, 
including chronic diseases, or 
3) in-patient hospitalization or prolongation of existing 
hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness 
or injury or permanent impairment to a body structure or a body 
function 
c) foetal distress, foetal death, or a congenital abnormality or birth defect 
including physical or mental impairement. 
NOTE 1: Planned hospitalization for a pre-existing condition, or a 
procedure required by the clinical investigational plan, without a serious 
deterioration in health, is not considered a serious adverse event.  
Serious Adverse Device Effect 
(SADE) 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 49 of 62 
  
Table 18.2-1: Safety Definitions 
Term 
Definition 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
 
Serious Health Threat 
 
Ref: ISO 14155 
 
Signal from any adverse event or device deficiency that indicates an  
imminent risk of death or a serious deterioration in the health in subjects, 
users or other persons, and that requires prompt remedial action 
for other subjects, users or other persons. 
NOTE 1: This would include events that are of significant and unexpected 
nature such that they become alarming as a potential serious health hazard 
or possibility of multiple deaths occurring at short intervals. 
Device Deficiency 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
An inadequacy of a medical device related to its identity, quality, 
durability, reliability, usability, safety or performance.  
NOTE 1: Device deficiencies include malfunctions, use errors, and 
inadequacy in the information supplied by the manufacturer including 
labelling. 
NOTE 2: This definition includes device deficiencies related to the device 
under study.  
The following definitions will be used for defining hospitalization or prolongation of hospitalization for SAE 
classification purposes: 
Hospitalizations 
Hospitalization does not include: 
• 
emergency room visit that does not result in in-patient admission  
Note: although an emergency room visit does not itself meet the 
definition for hospitalization, it may meet other serious criteria 
(e.g. medical or surgical intervention to prevent permanent 
impairment or damage) 
• 
elective and pre-planned treatment/surgery for a pre-existing 
condition that is documented in the subject’s record at the time of 
consent/enrollment 
• 
admission for social reasons and/or respite care in the absence of 
any deterioration in the subject’s general condition (e.g. subject is 
homeless, caregiver relief) 
• 
pre-planned, protocol-specified admission related to the clinical 
study (e.g. procedure required by protocol) 
Prolongation of hospitalization  
In-patient admission to the hospital that is prolonged beyond the expected 
standard duration for the condition under treatment. 
Note: new adverse events occurring during the hospitalization are 
evaluated to determine if they prolonged hospitalization or meet another 
SAE criteria. 
 
18.3. Relationship to Study Deviceand/or Study Procedure 
The Investigator must assess the relationship of the reportable event to the study device 
and/or study procedure. See criteria in Table 18.3-1: . 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 50 of 62 
  
Table 18.3-1: Criteria for Assessing Relationship of Study Device or Procedure to 
Adverse Event 
Classification 
Description 
Not Related 
Ref: MDCG 2020-10/1 
Relationship to the device or procedures can be excluded when: 
- the event has no temporal relationship with the use of the study device or the 
procedures related to the use of the study device; 
- the serious event does not follow a known response pattern to the medical device 
(if the response pattern is previously known) and is biologically implausible; 
- the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible – and reintroduction of its use (or 
increase of the level of activation/exposure), do not impact on the serious event; 
- the event involves a body-site or an organ that cannot be affected by the device or 
procedure;  
- the serious event can be attributed to another cause (e.g. an underlying 
or concurrent illness/ clinical condition, an effect of another device, drug, treatment 
or other risk factors); 
- the event does not depend on a false result given by the study device used for 
diagnosis, when applicable; 
In order to establish the non-relatedness, not all the criteria listed above might be 
met at the same time, depending on the type of device/procedures and the serious 
event. 
Possibly Related 
Ref: MDCG 2020-10/1 
The relationship with the use of the study device or the relationship with 
procedures is weak but cannot be ruled out completely. Alternative causes are also 
possible (e.g. an underlying or concurrent illness/ clinical condition or/and an effect 
of another device, drug or treatment). Cases where relatedness cannot be assessed 
or no information has been obtained should also be classified as possible. 
Probably Related 
Ref: MDCG 2020-10/1 
The relationship with the use of the study device or the relationship with 
procedures seems relevant and/or the event cannot be reasonably explained by 
another cause. 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 51 of 62 
  
Table 18.3-1: Criteria for Assessing Relationship of Study Device or Procedure to 
Adverse Event 
Classification 
Description 
Causal Relationship 
Ref: MDCG 2020-10/1 
The serious event is associated with the study device or with procedures beyond 
reasonable doubt when: 
- the event is a known side effect of the product category the device belongs to or 
of similar devices and procedures; 
- the event has a temporal relationship with the study device use/application or 
procedures; 
- the event involves a body-site or organ that 
-the study device or procedures are applied to; 
-the study device or procedures have an effect on; 
- the serious event follows a known response pattern to the medical device (if the 
response pattern is previously known); 
- the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious event (when clinically feasible); 
- other possible causes (e.g. an underlying or concurrent illness/ clinical condition 
or/and an effect of another device, drug or treatment) have been adequately ruled 
out; 
- harm to the subject is due to error in use; 
- the event depends on a false result given by the study device used for diagnosis, 
when applicable; 
In order to establish the relatedness, not all the criteria listed above might be met at 
the same time, depending on the type of device/procedures and the serious event. 
 
18.4. Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Table 18.4-1. 
 
Table 18.4-1: Reporting Timelines 
Event Classification 
Communication Method  
Communication Timeline post-market 
studies*  
(EU MDR 2017/745, MDCG 2020-10/1 
MEDDEV 2.12/1:  
GUIDELINES ON A MEDICAL DEVICE 
VIGILANCE SYSTEM) 
Serious Adverse Event  
Complete AE eCRF page 
with all available new and 
updated information.  
• 
Within 10 calendar days after becoming 
aware of the event or as per local/regional 
regulations. 
• 
Reporting required through the end of the 
study. 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 52 of 62 
  
Event Classification 
Communication Method  
Communication Timeline post-market 
studies*  
(EU MDR 2017/745, MDCG 2020-10/1 
MEDDEV 2.12/1:  
GUIDELINES ON A MEDICAL DEVICE 
VIGILANCE SYSTEM) 
Provide all relevant source 
documentation (de-
identified/ pseudonymized) 
for reported event.  
• 
When documentation is available 
(recommend within 60 calendar days) 
• 
Upon request of sponsor 
Serious Adverse Device 
Effects 
Complete AE eCRF page 
with all available new and 
updated information. 
• 
Within 3 calendar days of first becoming 
aware of the event or as per local/regional 
regulations. 
• 
Reporting required through the end of the 
study. 
Provide all relevant source 
documentation (de-
identified/ pseudonymized) 
for reported event.  
• 
When documentation is available 
(recommend within 30 calendar days) 
• 
Upon request of sponsor 
Device Deficiencies 
(including but not limited to 
malfunctions, use errors, and 
inadequacy in information 
supplied by the manufacturer, 
including labelling) 
Note:  Any Device Deficiency 
that might have led to a 
serious adverse event if 
appropriate action had not 
been taken intervention had 
not occurred if circumstances 
had been less fortunate is 
considered a reportable event. 
Complete Device Event 
CRF with all available new 
and updated information.  
• 
Within 3 calendar days of first becoming 
aware of the event.  
• 
Reporting required through the end of the 
study. 
Provide all relevant source 
documentation (de-
identified/ pseudonymized) 
for reported event. 
• 
Upon request of sponsor.  
Procedure-Related Adverse 
Events and Adverse Device 
Effects 
Complete AE eCRF page, 
which contains such 
information as date of AE, 
treatment of AE resolution, 
assessment of seriousness 
and relationship to the 
device.  
• 
Adverse Device Effects: In a timely 
manner but not later than 30 business 
days after becoming aware of the 
information. 
• 
Procedure-Related Adverse Events: In a 
timely manner but recommend within 30 
business days after becoming aware of the 
information 
• 
Reporting required through the end of the 
study. 
Provide all relevant source 
documentation (de-
identified/ pseudonymized) 
for reported event as 
required. 
 
18.5. Device Deficiencies 
Device deficiencies (including but not limited to failures, malfunctions, use errors, product 
nonconformities, and inadequacy in the information supplied by the manufacturer) for BSC 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 53 of 62 
  
devices will be documented and reported to BSC. If possible, the device(s) under study 
should be returned to BSC for analysis. Instructions for returning the device(s) will be 
provided by the Clinical Project Manager and will be filed in the investigator site file. If it is 
not possible to return the device, the investigator should document why the device was not 
returned and the final disposition of the device. Device deficiencies should also be 
documented in the subject’s source records. 
Device deficiencies are not adverse events. However, an adverse event that results from a 
device deficiency, would be recorded as an adverse event on the appropriate eCRF. 
18.6. Reporting to Regulatory Authorities / IRBs / ECs / REBs/ Investigators 
BSC is responsible for reporting adverse event information to all participating Principal 
Investigators, IRBs/ECs/REBs and regulatory authorities, as applicable.  
The Principal Investigator is responsible for informing the IRB/EC/REB, and regulatory 
authorities of SAEs as required by local/regional regulations. 
18.7. Subject Death Reporting  
A subject death that occurs during the study should be reported to Boston Scientific as soon 
as possible and, in any event, within three (3) calendar days of site notification. The site’s 
IRB/EC/REB must be notified of any deaths in accordance with that site’s IRB/EC/REB 
policies and procedures.  
Notification of death should include a narrative that provides detailed information describing 
the circumstances surrounding the death. The details listed below should be addressed in the 
death narrative, in order for BSC to understand the circumstance surrounding the death: 
• Date of death 
• Immediate cause of death  
• Whether the death was related to the study device or procedure 
• Any other circumstances surrounding the death  
• Investigator or sub-investigator signature and date  
Also submit the following documentation:  
• If the patient expired in the hospital:  
o A copy of the medical records for that admission (e.g., H & P, consults, test 
results, operative reports, and/or progress notes from the hospital chart)  
o Death certificate (if available)  
o Autopsy report (if applicable)  
• If the patient expired outside of the hospital (e.g., home):  
o A copy of the most recent clinic visit (if not already submitted to Boston 
Scientific)  

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 54 of 62 
  
o Death certificate (if available)   
19. Informed Consent 
Subject participation in this clinical study is voluntary.  Informed Consent is required from 
each subject or his/her legally authorized representative. The Investigator is responsible for 
ensuring that Informed Consent is obtained prior to the use of any study devices, study-
required procedures and/or testing, or data collection.  
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and 
local Ethics Committee and/or Regulatory authority, as applicable. The ICF must be accepted 
by BSC or its delegate (e.g. CRO) and approved by the site’s IRB/EC/REB, or central IRB, if 
applicable. 
Boston Scientific will provide a study-specific template of the ICF to investigators 
participating in this study. The ICF template may be modified to meet the requirements of the 
investigative site’s IRB/EC/REB.  Any modification requires acceptance from BSC prior to 
use of the form.  The ICF must be in a language understandable to the subject and if needed, 
BSC will assist the site in obtaining a written consent translation. Translated consent forms 
must also have IRB/EC/REB approval prior to their use.  Privacy language shall be included 
in the body of the form or as a separate form as applicable.   
The process of obtaining Informed Consent shall at a minimum include the following steps, 
as well as any other steps required by applicable laws, rules, regulations and guidelines: 
• be conducted by the Principal Investigator or designee authorized to conduct the process,  
• include a description of all aspects of the clinical study that are relevant to the subject’s 
decision to participate throughout the clinical study, 
• avoid any coercion of or undue influence of subjects to participate, 
• not waive or appear to waive subject’s legal rights, 
• use native language that is non-technical and understandable to the subject or his/her 
legal representative, 
• provide ample time for the subject to consider participation and ask questions if 
necessary, 
• ensure important new information is provided to new and existing subjects throughout the 
clinical study.  
The ICF shall always be signed and personally dated by the subject or legal representative 
competent to sign the ICF under the applicable laws, rules, regulations and guidelines and by 
the investigator and/or an authorized designee responsible for conducting the informed 
consent process. If a legal representative signs, the subject shall be asked to provide informed 
consent for continued participation as soon as his/her medical condition allows. The original 
signed ICF will be retained by the site and a copy of the signed and dated document and any 
other written information must be given to the person signing the form.  

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 55 of 62 
  
Failure to obtain subject consent must be reported to BSC. Any violations of the informed 
consent process must be reported as deviations to the sponsor and local regulatory authorities 
(e.g. IRB/EC/REB), as appropriate. 
If new information becomes available that can significantly affect a subject's future health 
and medical care, that information shall be provided to the affected subject(s) in written form 
via a revised ICF or, in some situations, enrolled subjects may be requested to sign and date 
an addendum to the ICF. In addition to new significant information during the course of a 
study, other situations may necessitate revision of the ICF, such as if there are amendments 
to the applicable laws, protocol, a change in Principal Investigator, administrative changes, or 
following annual review by the IRB/EC/REB. The new version of the ICF must be approved 
by the IRB/EC/REB. Acceptance by Boston Scientific is required if changes to the revised 
ICF are requested by the site’s IRB/EC/REB. The IRB/EC/REB will determine the subject 
population to be re-consented. 
A Screening/Enrollment Log will be maintained to document select information about 
candidates who fail to meet the general or "other specific" entry criteria. 
20. Committees 
20.1. Safety Monitoring Process 
The BSC personnel from the Medical Safety and Safety Trial Operations group review safety 
data as it is reported by the sites throughout the duration of the study. During scheduled 
monitoring activities, clinical research monitors further support this review through their 
review of source document and other data information. The BSC Medical Safety and Safety 
Trial Operations team include health care providers with the necessary therapeutic and 
subject matter expertise to evaluate and classify the events into the categories outlined above. 
20.2. Independent Medical Reviewer 
An Independent Medical Reviewer (IMR) is an independent practitioner with trial relevant 
therapeutic expertise that reviews and adjudicates important endpoints and relevant adverse 
events reported by study investigators. The IMR will review a safety event dossier, which 
may include copies of subject source documents provided by study sites, for all reportable  
events, excluding device deficiencies. IMR responsibilities, qualifications, membership, and 
procedures are outlined in the IMR Charter.  
21. Suspension or Termination 
21.1 Premature Termination of the Study 
Boston Scientific reserves the right to terminate the study at any stage but intends to exercise 
this right only for valid scientific or business reasons and reasons related to protection of 
subjects.  Investigators, associated IRBs/ECs/REBs, and regulatory authorities, as applicable, 
will be notified in writing in the event of study termination. 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 56 of 62 
  
21.1.1 Criteria for Premature Termination of the Study 
Possible reasons for premature study termination include, but are not limited to, the 
following: 
• Suspicion of an unacceptable risk, including serious health threat. In this case, the 
sponsor shall suspend the clinical investigation while the risk is assessed. The sponsor 
shall terminate the clinical investigation if an unacceptable risk which cannot be 
controlled is confirmed. 
• Instructions by the IRB/EC/REB or regulatory authorities to suspend or terminate the 
clinical investigation. 
• An enrollment rate far below expectation that prejudices the conclusion of the study.  
• A decision on the part of Boston Scientific to suspend or discontinue 
development/marketing of the device. 
21.2 Termination of Study Participation by the Investigator or Withdrawal of IRB/ 
EC/REB Approval 
Any investigator, or associated IRB/EC/REB or regulatory authority may discontinue 
participation in the study or withdraw approval of the study, respectively, with suitable 
written notice to Boston Scientific. Investigators, associated IRBs/ECs/REBs, and regulatory 
authorities, as applicable, will be notified in writing in the event of these occurrences. 
21.3 Requirements for Documentation and Subject Follow-up 
In the event of premature study termination, a written statement as to why the premature 
termination has occurred will be provided to all participating sites by Boston Scientific. The 
IRB/EC/REB and regulatory authorities, as applicable, will be notified. Detailed information 
on how enrolled subjects will be managed thereafter will be provided.  
In the event an IRB/EC/REB terminates participation in the study, participating investigators, 
associated IRBs/ECs/REBs, and regulatory authorities, as applicable, will be notified in 
writing. Detailed information on how enrolled subjects will be managed thereafter will be 
provided by Boston Scientific. 
In the event a Principal Investigator terminates participation in the study, study responsibility 
will be transferred to another investigator, if possible. In the event there are no opportunities 
to transfer Principal Investigator responsibility, detailed information on how enrolled 
subjects will be managed thereafter will be provided by Boston Scientific. 
The Principal Investigator or his/her designee must return all study-related documents and 
devices, if supplied by Boston Scientific, unless this action would jeopardize the rights, 
safety, or welfare of the subjects. 
21.4 Criteria for Suspending/Terminating a Study Site 
Boston Scientific reserves the right to stop the inclusion of subjects at a study site at any time 
after the study initiation visit if no subjects have been enrolled for a period beyond 6 months 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 57 of 62 
  
after site initiation, or if the site has multiple or severe protocol violations/noncompliance 
without justification and/or fails to follow remedial actions. 
In the event of termination of site participation, all devices and testing equipment, as 
applicable, will be returned to BSC unless this action would jeopardize the rights, safety or 
well-being of the subjects. The IRB/EC/REB and regulatory authorities, as applicable, will 
be notified. Study participants will be contacted, as applicable, and be informed of changes to 
study visit schedule. 
 
22. Study Registration and Results 
22.1. Study Registration 
To comply with applicable laws and regulations, the study will be registered on a publicly 
accessible database. 
22.2. Clinical Investigation Report 
Study results will be made available in accordance with the legal requirements and the 
recognized ethical principles, in accordance with the Boston Scientific Policy. A Clinical 
Investigation Report will be made available to all investigators, IRB/EC/REB and regulatory 
authorities, as applicable in accordance with the Boston Scientific Policy and local 
requirements.  As applicable an abbreviated Clinical Investigation Report will be made 
available on a publicly accessible database. 
 
23. Publication Policy 
BSC requires disclosure of its involvement as a sponsor or financial supporter in any 
publication or presentation relating to a BSC study or its results. BSC may submit study 
results for publication (regardless of study outcome) following the conclusion or termination 
of the study. Boston Scientific adheres to the Contributorship Criteria set forth in the 
Uniform Requirements of the International Committee of Medical Journal Editors (ICMJE; 
http://www.icmje.org). In order to ensure the public disclosure of study results in a timely 
manner, while maintaining an unbiased presentation of study outcomes, BSC personnel may 
assist authors and investigators in publication preparation provided the following guidelines 
are followed:  
• All authorship and contributorship requirements as described above must be followed. 
• BSC involvement in the publication preparation and the BSC Publication Policy should 
be discussed with the Coordinating Principal Investigator(s) and/or Executive/Steering 
Committee at the onset of the project. 
• The First and Senior authors are the primary drivers of decisions regarding publication 
content, review, approval, and submission.  

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 58 of 62 
  
The data, analytic methods, and study materials for this clinical trial may be made available 
to other researchers in accordance with the Boston Scientific Data Sharing Policy 
(https://www.bostonscientific.com/).  
24. Reimbursement and Compensation for Subjects 
24.1. Subject Reimbursement 
Travel and other expenses incurred by subjects as a result of participation in the study will be 
reimbursed in accordance with pertinent country laws and regulations and per the study site’s 
regulations.   
24.2. Compensation for Subject’s Health Injury 
Boston Scientific will purchase an insurance policy to cover the cost of potential health 
injury for study subjects, if required by applicable law.  
25. Bibliography 
1. Ravier E, Fassi-Fehri H, Crouzet S, Gelet A, Abid N, Martin X. Complications after 
artificial urinary sphincter implantation in patients with or without prior radiotherapy. 
BJU Int. 2015;115(2):300-307. 
2. Bates AS, Martin RM, Terry TR. Complications following artificial urinary sphincter 
placement after radical prostatectomy and radiotherapy: a meta-analysis. BJU Int. 
2015;116(4):623-633. 
3. Yafi FA, DeLay KJ, Stewart C, Chiang J, Sangkum P, Hellstrom WJ. Device 
Survival after Primary Implantation of an Artificial Urinary Sphincter for Male Stress 
Urinary Incontinence. J Urol. 2017;197(3 Pt 1):759-765. 
4. Radadia KD, Farber NJ, Shinder B, Polotti CF, Milas LJ, Tunuguntla H. Management 
of Postradical Prostatectomy Urinary Incontinence: A Review. Urology. 
2018;113:13-19. 
5. Ziegelmann MJ, Linder BJ, Rivera ME, Viers BR, Rangel LJ, Elliott DS. Outcomes 
of artificial urinary sphincter placement in octogenarians. Int J Urol. 2016;23(5):419-
423. 
6. Sacomani CAR, Zequi SC, Costa WHD, et al. Long-term results of the implantation 
of the AMS 800 artificial sphincter for post-prostatectomy incontinence: a single-
center experience. Int Braz J Urol. 2018;44(1):114-120. 
7. Husch T, Kretschmer A, Thomsen F, et al. Antibiotic Coating of the Artificial 
Urinary Sphincter (AMS 800): Is it Worthwhile? Urology. 2017;103:179-184. 
8. Kretschmer A, Husch T, Thomsen F, et al. Targeting Moderate and Severe Male 
Stress Urinary Incontinence with Adjustable Male Slings and the Perineal Artificial 
Urinary Sphincter: Focus on Perioperative Complications and Device Explantations. 
Int Neurourol J. 2017;21(2):109-115. 
9. Clinical Investigations of Devices Indicated for the Treatment of Urinary 
Incontinence - Guidance for Industry and FDA Staff [Internet]. Fda.gov. 2011 Mar 08 
[cited 2019 Apr 18]. Available from: 
https://www.fda.gov/RegulatoryInformation/Guidances/ucm070852.htm  

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 59 of 62 
  
10. Burkhard FC, Lucas MG, Berghmans LC, Bosch JLHR, Cruz F, Lemack GE, 
Nambiar AK, Nilsson CG, Pickard R, Tubaro A. EAU Guidelines on Urinary 
Incontinence in Adults [Internet]. Uroweb.org. 2016 [cited 2019 Apr 18]. Available 
from: https://uroweb.org/wp-content/uploads/EAU-Guidelines-Urinary-Incontinence-
2016.pdf  
26. Abbreviations and Definitions  
26.1. Abbreviations 
Abbreviations are shown in Table 26.1-1-1.   
Table 26.1-1: Abbreviations 
Abbreviation/Acronym 
Term 
AE 
Adverse Event 
AT 
As Treated 
AMS 
American Medical Systems 
AUS 
Artificial Urinary Sphincter 
BSC 
Boston Scientific Corporation 
CA 
Competent Authority 
CCGs 
Case Report Form Completion Guidelines 
CRO 
Contract Research Organization 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture  
GDPR 
Global Data Protection  
HIPAA 
Health Information Portability and Accountability Act 
ICF 
Informed Consent Form 
IFU 
Instructions for Use 
IMR 
Independent Medical Reviewer 
IPT 
Incontinence after Prostate Treatment 
IRB 
Institutional Review Board 
ISD 
Intrinsic Sphincteric Deficiency 
ITT 
Intent to Treat 
IZ 
InhibiZone 
MUS 
Male Urethral Sling 
PIF 
Patient Information Forms  
PP 
Per Protocol  
PPI 
Post Prostatectomy Incontinence 
PRB 
Pressure Regulating Balloon 
REB 
Research Ethics Board 
SAE 
Serious Adverse Event 
SUI 
Stress Urinary Incontinence 
UI 
Urinary Incontinence  

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 60 of 62 
  
26.2. Definitions 
Terms are defined in Table 26.2-1-1.  
Table 26.2-1: Definitions 
Term 
Definition 
Adverse Device Effect  
See Table 18.2-1, Safety Definitions 
Adverse Event 
See Table 18.2-1, Safety Definitions 
As Treated 
All subjects for whom implantation of the device is attempted. 
Consent Ineligible 
A subject who has signed the ICF but is found to not meet eligibility criteria. 
These subjects can still receive the AMS 800 per standard of care treatment, but 
do not count toward enrollment. The subjects will be exited and will not 
undergo any study related procedures once their ineligibility has been 
determined.   These subjects do not count toward enrollment. 
Data Controller 
In GDPR: The entity which determines the purposes (why the entity needs to 
process data) and means (database managed through a software, hard copy files, 
centralized database) of personal information processing. 
Data Processor 
In GDPR: The person or entity processing the data on behalf and according to 
the instructions of the data controller. An entity which uses an external data 
processor must ensure that, in the contract, its data processor offers adequate 
guarantees to ensure the security and confidentiality of the data communicated. 
Data Subject 
In GDPR: Any living individual to whom the personal data relates. Examples of 
data subjects in this study are physicians and subjects. 
Deviation (Clinical 
Protocol) 
A departure from the requirements established in the clinical trial protocol (e.g., 
inclusion/exclusion criteria; visit windows, required procedures, and any 
specified consenting process requirements). 
Exited Prior to Procedure 
A subject who signs the informed consent, meets eligibility criteria but then 
does not undergo having the index study procedure initiated (first incision) or 
receive the study device. The original ICF and screening documentation for 
these patients should be maintained in the site’s files. There are no follow-up 
requirements and these subjects do not count toward enrollment. Any data 
collected prior to procedure is not included in statistical analyses. These 
subjects do not count toward enrollment. 
General Data Protection 
Regulation (GDPR) 
The General Data Protection Regulation (GDPR) is a European law that will 
govern how companies (whether EU-based or not) use personal data. 
Hospitalization 
See Table 18.2-1 Safety Definitions 
Identifiers 
“Identifiers” are personal data that can be used alone or in combination with 
other identifiers to identify an individual.  
Independent Medical 
Reviewer 
An independent practitioner with trial relevant therapeutic expertise that 
reviews and adjudicates important endpoints and relevant adverse events 
reported by study investigators. 
Index Procedure 
The primary procedure for treatment with the study device (test and/or control 
device). 
Intent-To-Treat 
A subject who signs the informed consent, meets eligibility criteria, and for 
whom the index procedure is initiated but not completed (first incision). The 
original ICF and screening documentation for intent to treat patients should be 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 61 of 62 
  
Table 26.2-1: Definitions 
Term 
Definition 
maintained in the site’s files. These patients are followed in accordance with the 
study follow up schedule for safety and count toward enrollment.   
Intrinsic Sphincter 
Deficiency 
Stress incontinence caused by weakness of the urinary sphincter. 
Medical Revision 
A medical revision is defined as a secondary surgery to modify or replace the 
initially implanted device. See section 10.11.  
Minimal Risk 
The probability and magnitude of harm or discomfort anticipated in the 
research are not greater in and of themselves than those ordinarily encountered 
in daily life or during the performance of routine physical or psychological 
examinations or tests. 
Monitoring 
EN ISO 14155:2020-3.29 - Act of overseeing the progress of a clinical 
investigation to ensure that it is conducted, recorded, and 
reported in accordance with the CIP, written procedures, this document, and the 
applicable regulatory 
requirements 
ICH E6 1.38 - The act of overseeing the progress of a clinical study and of 
ensuring that it is conducted, recorded, and reported in accordance with the 
protocol, Standard Operating Procedures (SOPs), GCP, and the applicable 
regulatory requirement(s). 
FDA Guidance - Generally refers to the methods used by sponsors of 
investigational studies, or CROs delegated responsibilities for the conduct of 
such studies, to oversee the conduct of and reporting of data from clinical 
investigations, including appropriate investigator supervision of study site staff 
and third-party contractors. 
Multi-center study 
A clinical trial conducted according to a single protocol but at more than one 
site, and therefore carried out by more than one investigator. 
Patient-Reported Outcome 
(PRO) 
A measurement based on a report that comes directly from the patient (i.e., 
study subject) about the status of a patient’s health condition without 
amendment or interpretation of the patient’s response by a clinician or anyone 
else. A PRO can be measured by self-report or by interview provided that the 
interviewer records only the patient’s response. 
Per Protocol 
All subjects in the As Treated Population who have no major protocol 
deviations. 
Personal Data  
GDPR defines “Personal data” to be any information relating to an identified or 
identifiable natural person (‘data subject’); an identifiable natural person is one 
who can be identified, directly or indirectly, in particular by reference to an 
identifier such as a name, an identification number, location data, an online 
identifier or to one or more factors specific to the physical, physiological, 
genetic, mental, economic, cultural or social identity of that natural person. 
Point of Enrollment 
Time at which, following recruitment, a subject signs and dates the informed 
consent form 
Processing 
Any use of personal data by BSC (or a third party on behalf of BSC), including 
data collection, data sharing, anonymization, and data storage (note the mere 
storage of data is considered as processing). 

Confidential 
 
Form/Template 92120219_Rev/Ver G 
Protocol U0669 – AUSCO, 92406268, Rev/Ver C 
Page 62 of 62 
  
Table 26.2-1: Definitions 
Term 
Definition 
RAVE 
Proprietary electronic data capture system for capturing, managing and 
reporting clinical study data. 
Recruitment 
Active efforts to identify subjects who may be suitable for enrollment in the 
clinical investigation. 
Replacement 
Removal of one or more components of the AMS 800 and implantation of a 
new component. See section 10.11. 
Sensitive Personal Data 
GDPR defines “Sensitive personal” data as a subset of Personal Data, which, 
due to their nature have been classified as deserving additional privacy and 
security protections because their processing may create a risk for an 
individual’s fundamental right and freedom. 
Serious Adverse Device 
Effect (SADE) 
See Table 18.2-1, Safety Definitions 
Serious Adverse Event 
(SAE) 
See Table 18.2-1, Safety Definitions 
Site Noncompliance 
A departure from the regulations established by the relevant regulatory 
authorities. Includes all clinical site noncompliance that does not represent a 
direct deviation from the clinical trial protocol, e.g. IRB/IEC and sponsor 
reporting, device storage and accountability, staff qualifications and training, 
facilities, and equipment required to conduct the clinical trial, collection and 
documentation of data in source documents and CRFs, investigator oversight, 
etc. 
Source Data 
All information in original records, certified copies of original records of 
clinical findings, observations, or other activities in a clinical investigation, 
necessary for the reconstruction and evaluation of the clinical investigation 
(Ref. ISO 14155-2020) 
Source Document 
Original or certified copy of printed, optical or electronic document containing 
source data (Ref. ISO 14155-2020) 
Stress Urinary Incontinence  Urinary incontinence is the unintentional loss of urine. Stress incontinence is 
defined as the complaint of involuntary loss of urine on effort or physical 
exertion including sporting activities, or on sneezing or coughing.