Prospective Registry of Outcomes With Penile Prosthesis for Erectile Restoration (PROPPER)
Conditions: Erectile Dysfunction, Impotence
Sponsor: Boston Scientific Corporation

 
Confidential: Contains Proprietary Information 
                                                              D009530 
                                                        Rev03 
                                     
 
 
 
Prospective Registry of Outcomes with Penile Prostheses for 
Erectile Restoration (PROPPER) ER1005 
 
 
BSC Study U0552 (also known as AMS Study ER1005)* Version #: 3 
Version Date: March 17, 2016 
 
Version Number                Date of Version 
1 (Initial Release)         March 16, 2011 
2 (Amended)     May 12, 2014 
3 (Amended)     March 17, 2016 
 
 
 
Registry Sponsor 
Boston Scientific Corporation (BSC) 
10700 Bren Road West 
Minnetonka, MN 55343, USA 
 
Registry Sponsor Contact 
Meaghan Wilk 
Senior Clinical Project Manager 
Urology and Pelvic Health 
100 Boston Scientific Way 
Marlborough, MA 01752 
Direct Phone: 508-683-4113     
E-mail: Meaghan.Wilk@bsci.com 
 
Ethical Conduct 
This registry will be conducted in compliance with this document, the principles of Good Clinical Practices 
and other applicable regulatory requirements or standards. 
 
Confidential Information 
No use of disclosure of this document outside Boston Scientific Corporation is permitted without prior 
written authorization from American Medical Systems.  
 
 
*AMS was acquired by Boston Scientific in August 2015. Due to the fact that the PROPPER Registry was ongoing at 
time of acquisition, study documents may refer to the study as BSC Study U0552 and/or AMS Study ER1005. 
 
 
 
 
 
 

 
 
 
 
BSC Study: U0552 
V3 March 17, 2016 
 
Protocol Signature Page 
 
Prospective Registry of Outcomes with Penile Prosthesis for 
Erectile Restoration (PROPPER) ER1005 
BSC Study #:  ER1005 
Version #: 3 
Version Date: March 17, 2016 
 
Version Number                Date of Version 
1 (Initial Release)         March 16, 2011 
2 (Amended)              May 12, 2014 
3 (Amended)              March 17, 2016 
 
I have read this protocol and agree to conduct the investigation in accordance with the above 
named protocol, Data Registry Agreement, the principles of Good Clinical Practices, any 
conditions of approval imposed by the Institutional Review Board/Ethics Committee 
(IRB/EC), and any other applicable regulatory requirements or standards. I will provide 
copies of this protocol and all pertinent information to the study personnel under my 
supervision and to my IRB/EC.  I will ensure they are fully informed regarding the conduct 
of the study according to this protocol and applicable laws and regulatory requirements.  
 
_____________________  
Clinical Site Name 
 
____________________________________               ________________ 
Site Principal Investigator Signature                             Date 
 
____________________________________ 
Site Principal Investigator Printed Name 
 
Please complete this page and return to the Registry sponsor: 
Boston Scientific Corporation (BSC) 
10700 Bren Road West 
Minnetonka, MN 55343, USA 
Attn:  Curtis Blackwell, Clinical Urology 
Phone:  952-930-6607  Fax:  952-930-5178 
 
 
 
 
 
 

 
 
 
 
BSC Study: U0552 
V3 March 17, 2016 
 
 
Table of Contents  
PROTOCOL SIGNATURE PAGE ................................................................................................................ 2 
1 
PROPPER REGISTRY STUDY SYNOPSIS ....................................................................................... 1 
2 
BACKGROUND AND REGISTRY RATIONALE.............................................................................. 12 
2.1 
BACKGROUND ..................................................................................................................................... 12 
2.2 
REGISTRY DESIGN RATIONALE ................................................................................................................ 13 
2.3 
DEVICE DESCRIPTION ....................................................................................................................... 14 
2.4 
DEVICE ACCOUNTABILITY ................................................................................................................ 14 
3 
REGISTRY OBJECTIVES ................................................................................................................ 15 
3.1 
MAIN OBJECTIVE ................................................................................................................................. 15 
4 
REGISTRY DESIGN SUMMARY...................................................................................................... 15 
5 
PATIENT ELIGIBILITY ..................................................................................................................... 16 
5.1 
INCLUSION CRITERIA ......................................................................................................................... 16 
5.2 
EXCLUSION CRITERIA ........................................................................................................................ 16 
6 
PATIENT ENROLLMENT ................................................................................................................. 16 
7 
DATA COLLECTION ........................................................................................................................ 16 
7.1 
DEVICE USE AND SATISFACTION QUESTIONS ........................................................................... 17 
7.2 
DEPRESSION HISTORY QUESTIONS ............................................................................................. 18 
7.3 
PATIENT QUESTIONNAIRES ............................................................................................................. 18 
7.3.1 
International Index of Erectile Function-5 / Sexual Health Inventory for Men (IIEF-5/SHIM) 19 
7.3.2 
EHS Erection Hardness Questionnaire ................................................................................. 19 
7.3.3 
SF-12 Health-related Quality of Life (HRQOL) Questionnaire .............................................. 19 
7.3.4 
American Urological Association – Symptom Index (AUA-SI) .............................................. 19 
7.3.5 
UCLA-Prostate Cancer Index (UCLA-PCI) Questionnaire .................................................... 20 
7.4 
SAFETY ASSESSMENTS .................................................................................................................... 20 
7.4.1 
CLINICAL STUDY EVENTS .................................................................................................. 20 
7.4.2 
DEVICE COMPLAINT REPORTING..................................................................................... 21 
7.4.3 
SAFETY REPORTING .......................................................................................................... 21 
8 
STATISTICAL METHODS AND DATA ANALYSIS ......................................................................... 24 
8.1 
SAMPLE SIZE ........................................................................................................................................ 24 
8.2 
SAFETY OBJECTIVES ......................................................................................................................... 24 
8.3 
EFFECTIVENESS OBJECTIVES ........................................................................................................ 25 
8.3.1 
EFFECTIVENESS OBJECTIVE 1 – DEVICE USE AND SATISFACTION ........................... 25 
8.3.2 
EFFECTIVENESS OBJECTIVE 2 – IIEF-5/SHIM QUESTIONNAIRES ............................... 26 
8.3.3 
EFFECTIVENESS OBJECTIVE 3 – EHS QUESTIONNAIRES ............................................ 27 
8.3.4 
EFFECTIVENESS OBJECTIVE 4 – SF-12 HRQOL QUESTIONNAIRES............................ 28 
8.3.5 
EFFECTIVENESS OBJECTIVE 5 – AUA-SI/IPSS QUESTIONNAIRES .............................. 28 
8.3.6 
EFFECTIVENSS OBJECTIVE 6 – UCLA-PCI QUESTIONNAIRES ..................................... 29 
8.3.7 
ADDITIONAL EFFECTIVNESS OBJECTIVES ..................................................................... 30 
8.4 
ADDITIONAL DATA ANALYSIS .......................................................................................................... 31 
8.4.1 
SUBGROUP ANALYSIS ....................................................................................................... 31 
8.4.2 
PHYSICIAN DATA ................................................................................................................ 31 
8.4.3 
BASELINE/ PRE-OPERATIVE DATA ................................................................................... 31 
8.5 
IMPLANTATION DATA ......................................................................................................................... 33 
9 
PROTOCOL DEVIATIONS ............................................................................................................... 34 
10 
DATA ANALYSIS ............................................................................................................................. 34 
11 
DATA SECURITY ............................................................................................................................. 35 
12 
DATA QUALITY ASSURANCE ........................................................................................................ 35 

 
 
 
 
BSC Study: U0552 
V3 March 17, 2016 
 
13 
MONITORING PLAN ........................................................................................................................ 35 
14 
INSTITUTIONAL REVIEW BOARD (IRB)/ETHICS COMMITTEE (EC) REVIEW ........................... 35 
15 
INFORMED CONSENT AND PATIENT PRIVACY .......................................................................... 36 
16 
STUDY RECORDS AND REPORTS ................................................................................................ 36 
16.1 
PHYSICIAN REPORTS ........................................................................................................................ 37 
16.2 
BSC REPORTS ...................................................................................................................................... 38 
17 
PHYSICIAN NON-COMPLIANCE AND STUDY TERMINATION .................................................... 38 
18 
PUBLICATION PLAN ....................................................................................................................... 38 
19 
REFERENCES .................................................................................................................................. 40 
APPENDIX 1 - QUESTIONNAIRES ........................................................................................................... 47 
International Index of Erectile Function-5 / Sexual Health Inventory for Men (IIEF-5/SHIM)............. 47 
EHS Erection Hardness Questionnaire .............................................................................................. 48 
SF-12 Health-related Quality of Life (HRQOL) Questionnaire ........................................................... 48 
American Urological Association – Symptom Index (AUA-SI) ........................................................... 50 
UCLA-Prostate Cancer Index (UCLA-PCI) Questionnaire ................................................................. 52 
 
Table of Tables 
Table 1: Electronic data collection schedule ................................................................... 9 
Table 2: Description and Submission Requirements of Physician Reports ................... 37 
Table 3: Description and Submission Requirements of BSC Reports ........................... 38 
 
Table of Figures 
Figure 1: Study Flow Diagram ....................................................................................... 11 

D009530 
Rev02 
 
BSC Study: U0552-181050 
March 17, 2016 
Page 1 of 55 
 
1 
PROPPER REGISTRY STUDY SYNOPSIS 
 
Sponsor: 
Boston Scientific Corporation (BSC)  
Protocol Title (BSC 
Study Number): 
Prospective Registry of Outcomes with Penile Prostheses for 
Erectile Restoration (PROPPER) (ER1005) 
Clinical Phase and 
Regulatory Status 
Post-Market Registry 
Study Sites: 
Up to 16 sites throughout the USA and Canada  
 
Principal Investigators: 
 
Anthony J. Bella, MD, FRCSC 
University of Ottawa Ontario, Ontario, Canada 
 
Rafael E. Carrion, MD 
University of South Florida, Tampa, FL, USA 
  
Brian S. Christine, MD 
Urology Centers of Alabama, Birmingham, AL, USA 
  
Gerard D. Henry, MD 
Regional Urology; Shreveport, LA, USA 
 
Additional investigators are expected.  The names and 
addresses of all participating Principal Investigators will be 
maintained in a separate document.    
 
Objectives: 
To understand “real-world” outcomes for men implanted with 
BSC penile prostheses,  including the following: 
 Safety 
 Durability 
 Patient satisfaction 
 Effectiveness/Quality of Life 
 
Study Design: 
Prospective, multi-center, post-market, observational registry, 
up to 5 year follow-up 
Planned Sample Size: 
Approximately 500-1500 
Inclusion Criteria: 
Men diagnosed with erectile dysfunction (ED) for whom a 
BSC penile prosthesis is recommended by their physician 
are eligible for inclusion.  Potentially eligible men should also 
meet the following inclusion criteria for study enrollment: 
 Willing and able to provide written informed consent prior to 
enrollment (if applicable).  

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 2 of 55 
 Willing to be seen or contacted by phone by the investigator 
and answer at least 2 questions related to treatment 
satisfaction and device use 1 year following implantation of 
an BSC penile prosthesis  
 
Exclusion Criteria: 
Men who are deemed by their physician to be not suitable 
for a penile implant are excluded from eligibility.  
 
Device Description(s): 
Men to be enrolled and followed in this study include those 
implanted with one of the following marketed BSC penile 
prostheses: 
 3-piece inflatable penile prosthesis (e.g., AMS 700®) 
 2-piece inflatable penile prosthesis (e.g., AMS Ambicor®) 
 Malleable or concealable penile prosthesis (e.g., 
Spectra™) 
 
Implantation 
Description: 
BSC recommends that all devices are implanted according 
to the device specific Instruction for Use (IFU) and/or 
Operating Room (OR) manual and the site or investigator’s 
standard of care.  
Concomitant Surgical 
Procedures: 
Concomitant urological procedures are allowed and will be 
captured; however, outcomes data on these procedures will 
not be collected, unless an AMS 800 artificial urinary 
sphincter or AdVance male sling is implanted concomitantly 
with the BSC penile prostheses. Optional questionnaires will 
be available to use for assessment. 
Implantation Success 
Measures: 
Success will be measured post-operatively by querying 
patients about treatment satisfaction and device use. Any 
reported intra-operative and post-treatment complications 
will be collected in the registry database.  
Event Schedule: 
Patient data will be collected from the baseline/pre-operative 
visit, the implantation procedure, and follow-up evaluations 
which will occur according to each physician’s standard of 
care, up to 5 years post-implantation. A 1-year follow-up 
evaluation will be required, and a 2-year follow-up evaluation 
will be strongly encouraged.  
Duration of Study: 
1-2 year enrollment period 
Up to 5 year patient follow-up 
Measurements: 
The registry database will include required measures for all 
participating investigators to complete and optional 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 3 of 55 
measures (listed below in italics) for investigators to 
complete if they coincide with their standard of care.  
 
Each investigator will be asked basic practice information 
including:  
• Practice type (private, academic)  
• Main setting for procedures (Hospital or ASC)  
• Do you provide standard device cycling instructions to 
patients receiving IPPs? If yes, please describe your 
protocol 
 
Data for each patient for whom a BSC penile implant is 
recommended will be entered into the registry database at 
baseline/procedure and at post-implant follow-ups to occur 
at a minimum 1 year after implantation, and through up to 5 
years after implantation. 
 
The baseline/pre-operative data will include:  
• Age 
• Race/Ethnicity 
• Primary etiology of ED 
o Organic 
 Diabetes  
 Cardiovascular disease 
 Neurologic disorder 
 Peyronie’s disease 
 Other organic (specify) 
o Acute 
 Radical prostatectomy (RP) (robotic, 
open or laparoscopic) 
 Radical pelvic surgery (other than RP) 
 Pelvic radiation therapy 
 Pelvic trauma or injury 
 Spinal cord injury 
 Venous Leak 
 Priapism 
 Other acute (specify) 
• Relevant concomitant medical conditions and 
concomitant medications that might impact ED 
(premature or rapid ejaculation/PE, climacturia, 
cardiovascular disease, diabetes, Peyronie’s disease, 
stress urinary incontinence/SUI, steroid use, 
anticoagulant use, anti-depressant use, venous leak, 
and Other, please specify) – with the following sub-

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 4 of 55 
assessments if SUI checked: 
o Etiology of incontinence (radical 
prostatectomy, pelvic irradiation, and other – 
please specify) 
o Previous treatment(s) for incontinence 
(behavior modification, pelvic floor muscle 
training, transobturator male sling - specify 
model and implant date, artificial urinary 
sphincter/AUS – specify implant model date, 
other - specify)  
o Number of pads used daily 
o Pad weight (24-hour test) 
o Urodynamics:  Post-void residual (PVR) 
volume (ml), maximum flow rate (ml/sec), any 
detrusor overactivity (DO) or detruser sphincter 
dyssynergia (DSD) 
o Cystoscopy findings (bladder neck contracture, 
other – specify) 
• Pre-op flaccid penile length (measured from 
suprapubic fat pad to tip) 
• Pre-op stretched penile length (measure from 
suprapubic fat pad to tip) 
• Pre-op flaccid girth (circumference measured 1cm 
proximal to the proximal end of the corona) 
• Duration of ED (years or months) 
• Previous ED Treatments [ PDE-5 inhibitors (PDE-5s), 
vacuum erection device (VED), intracavernosal 
injection (ICI), Combination therapies, previous/failed 
penile implants), other, specify] 
• Patient query - any office visits in past year for 
treatment of depression Y/N 
o If Yes: approximately how many visits 
o If Yes: taking any depression medication 
• Was VED and/or penile traction therapy prescribed 
pre-operatively? (Y/N) 
o If Yes:  specify Duration (weeks) and 
Frequency (times/day) 
• Baseline effectiveness/quality of life assessments 
 
Implantation surgery data will include: 
• Date of procedure 
• Original (virgin), revision, salvage or replacement 
implant  
o If revision or salvage, washout (Y/N) 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 5 of 55 
• Surgical approach (Penoscrotal (PS), Infrapubic (IP), 
Subcoronal (SC) or “Other, please specify”)  
• Implant model type: 
o Spectra™ Concealable Penile Prosthesis  
 Cylinder diameter (9.5, 12, 14 mm) 
 Cylinder length (12, 16, 20 cm) 
 Total number of RTEs per cylinder (0, 1, 
2) 
 Total length of RTEs per cylinder 
(specify: 0.5 to 7.5 cm)  
o AMS Ambicor® Penile Prosthesis (2-piece 
inflatable)  
 Cylinder diameter (12.5, 14, 15.5 mm) 
 Cylinder length (14, 16, 18, 20, 22 cm) 
 Total number of RTEs per cylinder (0, 1, 
2, 3, 4) 
 Total length of RTEs per cylinder 
(specify: 0.5 to 6.5 cm)  
o AMS 700® Penile Prosthesis (3–piece 
inflatable) 
 InhibiZone®-impregnated (Y/N) 
 Cylinder type (CX, LGX, CXR, Ultrex, 
CXM) 
 Cylinder length (10, 12, 14, 15, 16, 18, 
21, 24 cm) 
 Total number of RTEs per cylinder (0, 1, 
2, 3, 4) 
 Total length of RTEs per cylinder 
(specify: 0.5 to 7.5 cm) 
 Pump type (MS Pump, Tactile pump, 
Inflate/Deflate) 
 Preconnect (Y/N)  
 Reservoir (Spherical 65 ml, Spherical 
100 ml, Conceal 100 ml)  
 Reservoir placement (space of Retzius, 
Sub-muscular, Sub-Scarpa’s fascia, 
other – specify) 
 Reservoir separate incision (Y/N) 
• Drain (Y/N) 
o If Yes, Type 
• Dressing 
o None, compression/mummy wrap, non-
compressive dressing 
• Concurrent procedures (Y/N) 
o If Yes, specify procedure(s): ventral 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 6 of 55 
phalloplasty, ligament release, circumcision, 
suprapubic fat pad reduction, spermatic 
cord/testicular procedure, AMS 800 (single or 
multiple incision), sling (specify sling type and 
single or multiple incision), other - specify  
• Significant corporal fibrosis or scarring noted (Y/N) 
• Curvature correction procedure(s) (e.g., for 
Peyronie’s Disease)(Y/N) 
o If Yes: Initial intraoperative curvature 
measurement (angle of curvature with inflated 
device using a goniometer or protractor) 
o If Yes: Correction technique (Wilson/Delk 
remodeling, tunical incision, incision and 
grafting, or plication) 
o Curvature measurement after correction 
o Second correction? If Yes, same set of 
questions as above.  
• Patient status post-op: Admitted/inpatient/≥24 hours 
or same day discharge/outpatient/<24 hours  
o If admitted/inpatient/≥24 hours is chosen, 
include: number of days in the hospital 
• Length of procedure (measured from time of first 
incision to time of closure) 
• Intra-operative penile length measurement with 
device inflated (measured from suprapubic fat pad to 
tip) 
• Intra-op penile girth measurement with device inflated 
(circumference measured 1cm proximal to the 
proximal end of the corona) 
• Intra-op stretched penile length measurement with 
device deflated (measured from suprapubic fat pad to 
tip) 
• Foley in place at discharge? (Y/N) 
 
Follow-up is required 1 year post-operatively. Additional 
follow-ups will be determined per the physician’s standard 
practice up to 5 years. Follow-up data will include:  
• Query for any device related complications and their 
outcomes by asking patients if they have had any 
surgery on their penis or problems with the device 
since their penile prosthesis was implanted (Y/N)   
• Patients will be asked: 
o How satisfied they are with the device(s) 
(using a 5-point scale)  

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 7 of 55 
o If they are using the device (Y/N) 
 If yes, how often they are using the 
device (less than once per month or 
more than once per month) 
o How many times per month? 
 If no, why aren’t you using the device 
(loss of partner, partner disinterest, 
device problem, device dissatisfaction, 
health decline, other – describe, other 
device use reason). 
 If yes, and not using the device as often 
as desired, or if dissatisfied with the 
device, indicate why ((loss of partner, 
partner disinterest, device problem, 
device dissatisfaction, health decline, 
other – describe, other device use 
reason). 
• Number of pads used daily (if incontinence indicated 
pre-operatively) 
• Pad weight (24-hour test) (if incontinence indicated 
pre-operatively) 
• Penile length measurement with device fully inflated 
(measured from suprapubic fat pad to tip) 
• Penile girth measurement with device fully inflated 
(circumference measured 1cm proximal to the 
proximal end of the corona) 
• Stretched penile length measurement with device 
deflated (measured from suprapubic fat pad to tip) 
• Patient query - any office visits in past year for 
treatment of depression Y/N 
o If Yes: approximately how many visits 
o If Yes: taking any depression medication 
 
• Effectiveness/quality of life assessments 
 
 
Effectiveness 
Assessments: 
Patient questionnaires to measure effectiveness will be 
optional at baseline and at all follow-up visits. Included are 
the following validated, patient-reported outcome 
questionnaires: 
Strongly recommended for all:  
• IIEF-5/SHIM erectile function questionnaire  
• EHS erection hardness questionnaire 
• SF-12 health-related quality of life questionnaire 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 8 of 55 
Recommended for all patients with post-prostatectomy 
ED or incontinence:  
• AUA-SI/IPSS urinary symptom questionnaire  
• UCLA-PCI urinary, sexual and bowel function and 
bother questionnaire  
Safety/Device 
Malfunction 
Assessments: 
Any reported intra-operative or post-operative device or 
surgery related complications will be recorded throughout 
study follow-up (for BSC products only). This information will 
include:  
• Complication 
• Treatment 
• Location of treatment 
• Resolution (Resolved or Continuing)  
Potential device or surgery related complications are 
described in the device specific IFU and OR manuals. 
Statistical Analyses, 
Including Determination 
of Sample Size: 
Up to 1500 patients with erectile dysfunction (ED) electing to 
receive a BSC penile prosthesis implant will be included in 
this registry. 
 
Analyses of multi-center data for initial publication(s) may be 
performed after approximately 500 patients complete 1 year 
follow-up. Additional individual and multi-center data 
analyses may be performed as warranted throughout the 
study for publication(s). Analysis for multi-center 
publication(s) is planned after the study enrollment is 
complete and all the enrolled patients have completed their 
one-year and five-year follow-up evaluations, consistent with 
each physician’s standard of care. 
 
Continuous variables will be presented as mean +/- SD; 
ordinal variables will be summarized using median with 
interquartile ranges; categorical variables will be presented 
as count and proportion. 
 
Kaplan-Meier method will be used to estimate the event rate 
over time by device type for major complications. 
 
For within-patient change at 1 year follow up compared to 
the baseline visit, signed rank test or paired t-test may be 
used for continuous variables and McNemar’s test may be 
used for binary variables when applicable. Mixed effects 
model or Generalized Estimating Equation model may be 
used to estimate the change from baseline across follow up 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 9 of 55 
visits when appropriate.  
 
 The data to be collected in electronic data forms will include the following: 
 
 
Table 1: Electronic data collection schedule 
Data  
Baseline/ 
Procedure 
Interim 
Follow-Up* 
1 Year 
Follow-Up* 
2 - 5 Year 
(Annual) 
Follow-Up* 
Date of Informed 
Consent/first data record 
R 
 
 
 
Demographics and 
Characteristics 
R 
 
 
 
ED History 
R 
 
 
 
Depression History 
O 
N/A 
O 
O 
Implantation Procedure 
Details 
R 
 
 
 
Device Use and 
Satisfaction 
N/A 
O 
R 
SE 
Penile Measurements 
O 
O 
O 
O 
Incontinence Data 
O 
O 
O 
O 
Patient Questionnaires 
SE 
SE 
SE 
SE 
Clinical Study 
Events/Complications 
R† 
R† 
R† 
R† 
* The same assessments, evaluations, questionnaires that were completed at baseline should be completed at follow-up 
R = Required, O = Optional, SE = Strongly Encouraged, N/A = Not Applicable. 
† = if applicable 
 
o Demographics and Characteristics – age, race/ethnicity, concomitant medical 
conditions and medications 
o ED History – primary etiology of ED, previous ED treatments (optional) 
o Depression History – query for any treatment of depression in past year – 
optional at baseline and at annual follow-up 
o Implantation Procedure Details – surgical procedure details and implant model 
information, patient status post-op 
o Device Use and Satisfaction – query for device use and device satisfaction 
o Penile Measurements – pre-op flaccid and stretched length and girth, intra-op 
inflated penile length and girth and deflated stretched length, and post-operative 
inflated length and girth measurements, by physician 
o Incontinence Data –  Daily pad use, pad weight tests, urodynamics, post-void 
residual (PVR) volume maximum flow rate  

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 10 of 55 
o Patient Questionnaires – IIEF-5/SHIM erectile function questionnaire; EHS 
erection hardness question; SF-12 health-related quality of life questionnaire; 
AUA-SI symptom questionnaire; UCLA-PCI urinary, sexual and bowel function 
and bother questionnaire 
o Clinical study events – device or procedure related complications (adverse 
device effects/events), device malfunctions, revision procedures related to the 
device or implantation procedure 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 11 of 55 
 
Figure 1: Study Flow Diagram 
Baseline/prosthesis 
implantation data 
Enrollment
Informed Consent Form and/or 
HIPAA Authorization signed by 
patient as necessary per site 
requirements prior to entry of first 
data records in database
Follow-up Assessments
Required 1 year follow-up
 
Other assessments and visits  
according to standard of care 
(approximately yearly up to 5 years)

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 12 of 55 
 
2 
BACKGROUND AND REGISTRY RATIONALE 
2.1 
BACKGROUND 
Erectile dysfunction (ED), or impotence, is defined as a persistent failure to develop and 
maintain erections sufficient for penetrative sexual intercourse. 1   The total prevalence 
of erectile dysfunction of varying degrees in the United States is estimated to be 
approximately 30 million. According to the Massachusetts Male Aging Study, an 
estimated 52% of men over 40 are affected by ED. 2   Prevalence is expected to 
increase by one-third due to the aging of the population and factors such as increases 
in weight, dietary changes, smoking behavior, and an emerging increase in diabetes by 
2020. 3  Erectile dysfunction is associated with many risk factors or precursors including 
surgical trauma, diabetes, hypertension, dyslipidemia, and smoking, and has been 
associated with depression, as well as increased mortality primarily through its 
association with cardiovascular disease. 4-8 Following a radical prostatectomy or other 
acute pelvic surgery or trauma, vascular, neurologic and other tissue injury contributes 
to ED that is often persistent. 9 
 
Every man undergoing surgery for prostate cancer will experience some impact on 
sexual function after prostatectomy, even if erectile function is eventually restored. 10-15  
Erectile dysfunction also occurs in up to 86% of patients after androgen deprivation 
therapy, as well as after external beam radiation therapy for prostate cancer. 16-18 
Restoration of the same degree of potency enjoyed prior to radical prostatectomy (RP) 
occurs only rarely, and older men and those with decreased pre-operative function 
generally recover erections less fully than pre-potent and younger men. Nerve sparing 
surgeries have increased the recovery of post-prostatectomy erectile function by 
approximately 20%  1-2 years after surgery to over 50% for unilateral and over 75% for 
bilateral nerve sparing procedures performed by some specialists. However, even with 
early penile rehabilitation using PDE-5 drug therapy or vacuum erection devices to aid 
in the restoration of function, only approximately 50-60% of patients will have 
unassisted functional erections restored by 2 years after prostate cancer treatment. 19-23 
With almost 200,000 new prostate cancer diagnoses forecast each year in the United 
States alone, the impact of persistent, prostatectomy-associated ED is great.24  
      
Regardless of the cause of ED, the surgical implantation of a penile prosthesis can 
provide a high level of satisfaction along with durable and reliable restoration of erectile 
function. 25-37 Restoration of erectile function and rigidity can be related to or predictive 
of improvement in other areas of health that impact quality of life and psychosocial 
status, as sexual health is integral to overall well-being. 38, 39  
 
Although there is a large body of scientific literature describing outcomes associated 
with penile implants, articles reporting prospectively collected, validated outcomes in 
large numbers of patients implanted with modern BSC penile implant models are 
limited.      

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 13 of 55 
2.2 
Registry Design Rationale 
The selection of specific effectiveness data measurements in this Registry study was 
based on outcomes reported in published literature for a range of current ED treatment 
options, to allow for generalized comparisons between modern, prospective penile 
prosthesis outcomes and historical data for a variety of ED treatments.  
 
Current recommendations for ED diagnosis, management and research from 
international evidence-based consensus panels were also consulted to determine which 
patient-reported outcomes (PROs) are measured as part of the standard of care for 
clinical evaluation and treatment of ED.40-43  
 
In both clinical practice and research, it has been recommended that ED severity be 
categorized using the International Index for Erectile Function EF domain (IIEF-EF).  
The IIEF-5 (also identified as the Sexual Health Inventory for Men or SHIM) is a 
validated and well established erectile function measure comprised of 5 of the 15 IIEF 
items, including 4 of the 6 IIEF-EF questions and one question from the intercourse 
satisfaction domain. 44-49 A single-item, validated erection hardness scale/score (EHS) is 
also commonly recommended and used. 50- 53 These tools have been successfully 
employed to measure baseline and post-treatment erectile function and penile rigidity in 
many clinical trials of ED pharmacotherapy and devices as well as in clinical practice.   
 
For patients with ED due to treatment of prostate cancer, the UCLA Prostate Cancer 
Index (UCLA-PCI) is a validated 20-item tool for measurement of health-related quality 
of life specific to sexual, urinary, and bowel function and bother; and has been 
employed in numerous published studies to demonstrate serial improvements or 
declines in the six domains commonly affected by prostate cancer treatment. 49, 54-58 
Each UCLA-PCI domain scale is scored on a scale of 0–100 points with higher values 
representing better outcomes. A difference of 5–10 points has been considered a 
clinically important change in a given domain. 59  
 
Incontinence or urinary leakage and obstruction often accompanies ED after prostate 
cancer treatment, at least transiently, and is measured in clinical practice and research 
using pad counts and weights and validated PROs. 47-48, 60-63 The American Urological 
Association Symptom Index (AUA-SI) is comprised of 7 of the 8 items of the 
International Prostate Symptom Score (IPSS), and has been widely used to report 
baseline and post-treatment clinical urinary symptom outcomes. 56, 64-67 
 
General health-related quality of life (HRQOL) has been evaluated in many different 
disease state settings with serial assessments using the Short Form Health Survey (SF-
12), which is a 12-item adaptation of the RAND 36-Item Health Survey (SF-36) that 
takes only two to three minutes to complete.  The SF-12 (v2) is a practical, reliable, and 
valid measure of physical and mental health widely used in large population 
applications.  The SF-12v2 is available in multiple modes of administration and in both 
standard four week and acute one week recall periods. The SF-12 quantifies HRQOL 
into two composite scores: the Physical Component Summary (PCS) and Mental 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 14 of 55 
Component Summary (MCS) scales.  This survey also quantifies HRQOL into the same 
eight multi-item subscale domains used in the SF-36 with one or two questions in each 
domain:  physical functioning, emotional well-being, general health, pain, energy, social 
functioning, and role limitations (problems with work or other daily activities) as a result 
of physical or emotional health.49, 57-58, 67- 71 Because this survey uses norm-based 
scoring, comparisons can be made between published outcomes from the broader SF-
36 survey.   
 
Additional measurements were identified for required and optional data collection in the 
Registry database based on interviews with physician Principal Investigators and their 
standard of care for management of patients with ED before and after implantation of a 
penile prosthesis.  The two, simple, individual questions about device use and 
satisfaction with the device were selected based on this feedback and the published 
studies using similar single-item assessments, since there is no validated tool available 
at present to measure the outcomes associated with penile implants as a treatment for 
ED.      
 
The required 1-year follow-up time frame was chosen based on a large body of 
literature reporting clinical outcomes of this duration or longer after ED treatment, and 
the recommendations in the labeling for BSC penile prostheses for evaluating long-term 
device function [AMS 700® with MS Pump Operating Room Manual, 06/10].  The 
overall 5-year follow-up time frame is the minimum duration that is generally considered 
long-term follow-up after penile implantation. 40  
2.3 
DEVICE DESCRIPTION 
Devices included in this registry are the AMS 700® Series Inflatable Penile Prosthesis, 
AMS Ambicor® Penile Prosthesis, and the Spectra™ Concealable Penile Prosthesis. 
These devices have been approved for marketing and are manufactured by Boston 
Scientific Corporation (Marlborough, MA, USA).  The penile prostheses are intended for 
use in the treatment of chronic, organic, male erectile dysfunction (impotence). These 
devices are for men who, after appropriate patient history and diagnostic evaluation as 
well as discussions with the urologist about other alternative treatment methods, are 
determined to be suitable candidates for implantation surgery.  For specific device 
descriptions and information about their use and implantation refer to each device’s 
Instructions for Use (IFU) and Operating Room (OR) Manual. 
 
2.4 
DEVICE ACCOUNTABILITY 
All of the BSC devices for which data are being collected in this registry have been 
approved for marketing, and will be obtained by participating physician investigators 
through normal purchasing processes.  A BSC Patient Information Form (PIF) related to 
each surgical implant procedure may be completed as per standard practice in addition 
to entering implant data into the study database.  Individual device unit or lot numbers 
will not be tracked or accounted for in this study. 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 15 of 55 
3 
REGISTRY OBJECTIVES 
3.1 
MAIN OBJECTIVE 
The objective of this registry study is to prospectively collect data prior to and after BSC 
penile prosthesis implantation in order to document and evaluate ‘real-world’ penile 
prosthetic outcomes including safety, durability, patient satisfaction and 
effectiveness/Quality of Life. 
4 
REGISTRY DESIGN SUMMARY 
The PROPPER Registry is a post-market, multi-center, non-interventional, 
observational collection of clinical outcomes for patients implanted with a BSC penile 
prosthesis for the treatment of erectile dysfunction. 
 
As an observational collection, the registry does not dictate patient selection for 
implantation of BSC devices, and does not direct physicians in the medical and surgical 
management of patients. Physicians are free to select and manage their patients 
according to their usual practice. Concomitant urological procedures are allowed and 
will be recorded.  However, outcomes data on these procedures will not be collected, 
with the exception of select data for any concomitantly implanted AMS 800 Artificial 
Urinary Sphincters or AdVance slings for the treatment of incontinence.  
 
BSC recommends that all devices are implanted according to the device specific 
Instruction for Use (IFU) and/or Operating Room (OR) manuals and the site or 
physician’s standard of care.  
 
Patient data will be collected from the baseline/pre-operative visit, the procedure, and 
follow up evaluations which will occur according to each physician’s standard of care, 
up to 5 years post-operatively. A 1=year follow up evaluation will be required, and a 2-
year follow-up evaluation will be strongly encouraged. Follow-up evaluations may occur 
during visits with the physician and/or by telephone or mail.   
 
Each physician will determine if the device implantation procedure was successful 
based on his/her standard of care. Any reported intra-operative complications will be 
collected in the registry database. Success will be measured post-operatively by 
querying patients about device use.  
 
The PROPPER Registry is designed to obtain post market safety and effectiveness 
information as well as to serve as an active surveillance system for collecting device 
related events or complications and malfunctions in patients implanted with BSC penile 
prostheses and reporting product complaints to BSC. This will provide a robust 
database of clinical information from which a number of analyses can be performed.  

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 16 of 55 
5 
PATIENT ELIGIBILITY 
The PROPPER Registry is expected to enroll approximately 500 to 1500 patients at up 
to 16 sites throughout the US and Canada. Enrollment is expected to be over a one to 
two year period with up to five year patient follow-up. 
5.1 
INCLUSION CRITERIA 
Men diagnosed with erectile dysfunction (ED) for whom a BSC penile prosthesis is 
recommended by their physician are eligible for inclusion.  Potentially eligible men 
should also meet the following inclusion criteria for study enrollment: 
• Willing and able to provide written informed consent prior to enrollment (if 
applicable)  
• Willing to be seen or contacted by phone by the physician and answer at least 2 
questions related to satisfaction, device use, and potential issues with the device 
1 year following implantation of an BSC penile prosthesis, as well as standard 
physician assessments throughout the study  
5.2 
EXCLUSION CRITERIA 
Men who are deemed by their physician to be not suitable for a penile implant will be 
excluded.  
6 
PATIENT ENROLLMENT 
All patients who meet eligibility criteria should be encouraged to enroll in the registry. 
Patients will be considered enrolled once they have signed an informed consent. If a 
site has a waiver of informed consent each patient from that site will be considered 
enrolled once the first data records are entered into the database. A unique patient 
identifier will be assigned to each patient at enrollment (upon signing an ICF or 
database entry). The PROPPER Registry is expected to enroll approximately 500 to 
1500 patients at up to 16 sites throughout the US and Canada. Enrollment is expected 
to be over a one to two year period with up to five year patient follow-up.  A total of more 
than 500 patients are anticipated to be implanted and entered into the registry database 
per year of enrollment. Based on historical estimates and assuming 10 to 15 
participating physicians, the following number of each BSC penile prosthesis type will 
be implanted each year of enrollment: 500 AMS 700® Inflatable Penile Prostheses, 15 
AMS Ambicor® Penile Prostheses, and 20Spectra™ Concealable Penile Prostheses.  
 
7 
DATA COLLECTION 
Data will be collected via internet-based electronic data capture (EDC) with paper based 
questionnaires for collection of patient-reported outcomes (PRO) data. The PRO data 
will be entered into the registry database by the physician, physician staff or BSC staff. 
The EDC module will be developed and maintained by BSC. 
 
Physicians are not required to complete all data fields in the database. Each will be 
asked to enter the required data at baseline/procedure and one-year follow-up for each 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 17 of 55 
patient and optional data based on the information that they collect per their own 
standard of care.  
 
Additional outcomes will be collected at whatever time frames are deemed appropriate 
by the physician, based on their standard of care for treatment of ED. 
 
This is an observational collection of prospective patient data, with the following data 
required for each enrolled physician and patient: 
• basic practice information for each physician 
• baseline/pre-operative patient information:  age, race/ethnicity, primary etiology 
of ED, relevant concomitant medical conditions and concomitant medications that 
might impact ED  
• implantation surgery data:  date of procedure, surgical approach, implant model 
type, drain, dressing, concurrent procedures, significant corporal fibrosis or 
scarring noted, curvature correction procedure(s) (e.g., for Peyronie’s disease), 
and patient status post-op  
• 1-year post-operative follow-up (at a minimum):  each patient is asked 3 
standardized questions during a visit or by phone to record any potential device 
related complications and their outcomes, patient satisfaction with implanted 
device(s) and use of device. 
 
Refer to Table 1 for the study data collection schedule. 
7.1 
DEVICE USE AND SATISFACTION QUESTIONS 
The following two standardized, non-validated questions will be used to assess post-
implantation patient satisfaction with the device and use of the device: 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 18 of 55 
• How satisfied are you with the device(s)? (5-point scale) 
1 – Very Dissatisfied 
2 – Dissatisfied  
3 – Neither Satisfied nor Dissatisfied 
4 – Satisfied   
5 – Very Satisfied  
• Are you using the device?  (Y/N) 
o (If yes)  How often are you using the device? (less than once per month, 
or more than once per month)  
o How many times per month? 
o If no, why aren’t you using the device? (Loss of partner, partner 
disinterest, device problem, device dissatisfaction, health decline, other, 
other device use reason) 
o If yes, and not using the device as often as desired, or if dissatisfied with 
the device, indicate why (Loss of partner, partner disinterest, device 
problem, device dissatisfaction, health decline, other, other device use 
reason) 
 
7.2 
DEPRESSION HISTORY QUESTIONS 
The following patient questions used to assess depression will be optional at baseline 
and at each annual follow-up. 
• Have you had any office visits in past year for treatment of depression? (Y/N) 
o If Yes: Approximately how many visits? 
o If Yes: Are you taking any medication for treatment of depression?  
 If Yes:  How many months have you taken the medication? 
 
7.3 
PATIENT QUESTIONNAIRES 
Patient questionnaires to measure effectiveness will be optional at baseline and at all 
follow-ups. The following validated, patient-reported outcome questionnaires are 
strongly recommended for all patients at baseline and follow-up: 
• IIEF-5/SHIM erectile function questionnaire  
• EHS erection hardness questionnaire  
• SF-12 health-related quality of life (HRQOL) questionnaire  
 
The following validated, patient-reported outcome questionnaires are recommended for 
all patients with post-prostatectomy ED or incontinence: 
• AUA-SI/IPSS urinary symptom questionnaires  
• UCLA-PCl urinary, sexual and bowel function and bother questionnaire 
 
The questions for each individual questionnaire are provided in the Appendix. 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 19 of 55 
7.3.1 International Index of Erectile Function-5 / Sexual Health Inventory for 
Men (IIEF-5/SHIM)  
The IIEF-5 (also known as the SHIM) is a validated, self-report questionnaire with a 25-
point maximum score, summed from responses to four questions derived from the 
erectile function domain (items 2, 4, 5, and 15) and one question from the intercourse 
satisfaction domain (item 7) of the broader validated 15-item IIEF questionnaire used to 
assess sexual function in multiple domains.  Severity of ED is categorized based on the 
following IIEF-5 domain scores established and validated in previous studies: 
Severe—5 to 7 
Moderate—8 to 11 
Mild-Moderate—12 to16  
Mild—17 to 21 
No ED—22 to 25 
 
7.3.2 EHS Erection Hardness Questionnaire 
Patients will be asked to respond to the Erection Hardness Score (EHS) questionnaire 
once per year or at each follow-up visit to assess erection hardness based on their most 
recent sexual encounter(s).  The EHS has a range of responses from 0 to 4 with higher 
scores corresponding to a more firm or rigid erection. 
 
7.3.3 SF-12 Health-related Quality of Life (HRQOL) Questionnaire 
The SF-12v.2 Health Survey is a generic measure and does not target a specific age or 
disease group. It is a shorter version of the SF-36V2 Health Survey that uses 12 
questions to measure function health and well-being from the patient’s point of view.  
The SF-12 quantifies HRQOL into two composite scores, the Physical Component 
Summary (PCS) and Mental Component Summary (MCS) scales.  This survey also 
quantifies HRQOL into the same eight multi-item subscale domains used in the SF-36 
with one or two questions in each domain:  physical functioning, emotional well-being, 
general health, pain, energy, social functioning, and role limitations (problems with work 
or other daily activities) as a result of physical or emotional health.  Each individual 
domain and the component summary scores (PCS and MCS) are calculated and 
converted to a standardized 0-100 scale, with higher scores indicating better HRQOL.  
 
 
7.3.4 American Urological Association – Symptom Index (AUA-SI)  
THE AUA-SI (comprised of 7 of the 8 questions of the International Prostate Symptom 
Score, or IPSS) is used to quantify urinary irritative/obstructive symptom frequency and 
severity and is scored on a scale of 0–35 based on the summary of the values for each 
item, with higher scores corresponding to worse outcomes. Classification of urinary 
irritative/obstructive symptoms based on these scores are as follows: 
Mild – 0 to 7 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 20 of 55 
Moderate – 8 to 19 
Severe – 20 to 35 
 
7.3.5 UCLA-Prostate Cancer Index (UCLA-PCI) Questionnaire 
The UCLA-PCI assesses disease-specific, organ targeted health related quality of life 
(HRQOL) in six scales or domains that are of special concern to men treated for 
prostate cancer. Each UCLA PCI domain is scored on a scale of 0–100 points with 
higher values representing better outcomes.  
 
7.4 SAFETY ASSESSMENTS  
Prior to enrollment in the study, patients should be informed by the physician of all 
known potential risks and discomforts that may be associated with the implantation of a 
BSC penile prosthesis, or with the study evaluations and data collection.  The 
implantation of a BSC penile prosthesis is a standard medical treatment for ED, and no 
experimental interventions, tests or procedures are included in this observational 
Registry study.  A complete list of potential adverse device effects and surgery or device 
related complications that may occur during or after the implantation of the BSC devices 
can be found in the device specific IFU and/or OR and Patient Manuals.   
 
As per the OR Manual for the penile prosthesis, after penile prosthesis implantation, the 
Principal Physician is responsible for checking with the patient for any signs of 
complications, and for reporting device complications in compliance with local 
regulations (e.g. IRB/EC, country) for a market-released device.  The physician should 
continue to have contact with the patient at least on an annual basis to ask if he has 
noticed any changes in device functioning (e.g., cylinders losing rigidity), and to check 
for signs of complications such as infection or erosion.  Patients should be instructed to 
discuss any changes noticed in the function of their prosthesis or problems that may 
develop after implantation surgery with their physician.   
       
7.4.1 CLINICAL STUDY EVENTS  
 
Clinical study events to be collected for assessment of safety include complications 
(adverse device effects/events), device malfunctions, and revision procedures related to 
the device or implantation procedure.  At follow-up, including the required 1-year post-
operative visit or telephone call, the following standardized, non-validated question will 
be used to determine whether any complications with the device have occurred: 
•  Have you had any surgery on your penis or problems with the device since your 
penile prosthesis was implanted? (Y/N)  
  
A clinical study event data form will be provided to record any events that occur during 
or after surgical implantation of a BSC penile prosthesis device.  Any reported intra-
operative or post-operative device or surgery related complications should be recorded 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 21 of 55 
at the time of procedure and any follow-up visits (for BSC products only). The 
information recorded will include the following:  
• Complication 
• Treatment 
• Location of treatment 
• Resolution (Resolved or Continuing)  
 
BSC personnel will follow up with the physician to obtain additional available details, if 
needed, related to any reported complication that results in a serious adverse device 
effect, or device deficiency that could have led to a serious adverse device effect, or is 
severe and may pose unreasonable risk, or potential for death, or serious injury to the 
patient.   
 
7.4.2 DEVICE COMPLAINT REPORTING  
 
Product complaints are any communication relative to the identity, quality, durability, 
reliability, safety, effectiveness, or performance of a device, or any report of a failure of 
a device to meet its performance.  Entering a clinical study event into the database   
during this study will automatically result in an event that might be considered a product 
complaint associated with a BSC device being reported directly to BSC Consumer 
Affairs and any appropriate regulatory authority without any additional action required by 
the physician.  If a reportable event is identified, BSC Consumer Affairs will seek to 
obtain as much of the following information as possible: name of the product, lot series 
number (if known), source of data/physician, event description, event start date, date of 
BSC notification, medical action taken, patient outcome (if known), investigation results, 
corrective action taken (if any), and regulatory reports (if any).  These additional details 
for any device complaint will not be recorded in the Registry study database.   
 
The Principal Physician will be responsible for reporting events to the IRB/EC based on 
local requirements.  The Principal Physician will also be responsible for reporting any 
device complications that occur after the time of study exit and all updates to device 
complications that are unresolved at the time of study exit using the usual process 
applicable to market-released devices.   
 
7.4.3 SAFETY REPORTING 
Definitions and Classification 
Adverse event definitions are provided in Table 2. Administrative edits were made to combine 
definitions from ISO 14155-2011 and MEDDEV 2.7/3 (2015). 
 
 
 
 
 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 22 of 55 
Table 2: Safety Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 
(2015) 
 
 
Any untoward medical occurrence, unintended disease or 
injury, or any untoward clinical signs (including an abnormal 
laboratory finding) in subjects, users or other persons, 
whether or not related to the investigational medical device.  
Serious Adverse Device 
Effect (SADE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 
(2015) 
Adverse event that: 
a.            Led to death, 
b.            Led to serious deterioration in the health of the 
subject, that either resulted in as defined by either: 
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body 
function, or 
3. in-patient or prolonged 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.            Led to fetal distress, distress death or a congenital 
abnormality or birth defect. 
 
NOTE: Planned hospitalization for a pre-existing condition, 
or a procedure required by the Clinical Investigational Plan, 
without serious deterioration in health, is not considered a 
serious adverse event. 
Unanticipated Adverse 
Device Effect (UADE) 
 
Ref: 21 CFR Part 812 
 
 
Any serious adverse effect on health or safety or any life-
threatening problem or death caused by, or associated with, 
a device, if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a 
supplementary plan or application), or any other 
unanticipated serious problem associated with a device that 
relates to the rights, safety, or welfare of subjects.   
Unanticipated Serious 
Adverse Device Effect 
(USADE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 
(2015) 
 
Serious adverse device effect which by its nature, 
incidence, severity, or outcome has not been identified in 
the current version of the risk analysis report. 
 
 
NOTE 1: Anticipated serious adverse device effect (ASADE) 
is an effect which by its nature, incidence, severity or 
outcome has been identified in the risk analysis report. 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 23 of 55 
Table 2: Safety Definitions 
Term 
Definition 
 
Device Deficiency 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 
(2015) 
An inadequacy of an investigational medical device related 
to its identity, quality, durability, reliability, safety or 
performance. This may include malfunctions, use error, or 
inadequacy in the information supplied by the manufacturer. 
 
 
 
 
Relationship to Study Device(s) 
The investigator must assess the relationship of the AE to the study device as related or 
unrelated. See criteria in Table 3:  
 
Table 3: Criteria for Assessing Relationship of Study Device to Adverse Event 
Classification 
Description 
Unrelated 
• The adverse event is determined to be due to a concurrent 
illness or effect of another device/drug and is not related to 
the investigational product. 
Related 
• The adverse event is determined to be potentially related to 
the investigational product, and an alternative etiology is 
equally or less likely compared to the potential relationship 
to investigational product, or 
• There is a strong relationship to investigational product, or 
recurs on re-challenge, and another etiology is unlikely, or 
• There is no other reasonable medical explanation for the 
event. 
 
Relationship to Study Procedure 
The investigator must assess the relationship of the AE to the study procedure as unrelated, 
possibly related, or probably related. See criteria in Table 4:  
 
Table 4: Criteria for Assessing Relationship to Study Procedure 
Classification 
Description 
Unrelated 
• No evidence that the timing of the adverse event has a 
relationship to the procedure performed. 
Related 
• The adverse event has a timely relationship to procedure 
performed.   
However, a potential alternative etiology may be responsible for the 
adverse event. 
 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 24 of 55 
8 
STATISTICAL METHODS AND DATA ANALYSIS  
Analyses of multi-center data for initial publication(s) may be performed after 
approximately 500 patients complete 1 year follow-up.  Additional individual and multi-
center data analyses may be performed as warranted throughout the study for 
publication(s). Analysis for study publications is planned after the study enrollment is 
complete and all the enrolled patients have completed their 1-year and 5-year follow-up 
evaluations. 
 
8.1  SAMPLE SIZE   
Up to 1500 patients with erectile dysfunction (ED) electing to receive a BSC penile 
prosthesis implant will be included in this registry over a 1- to 2-year enrollment period.  
A total of more than 500 patients are anticipated to be implanted and entered into the 
registry database per year of enrollment, based on the following BSC historical 
estimates of the number of each BSC penile prosthesis type implanted, and assuming 
10 to 15 participating physicians: 
• 500 AMS 700®  
• 15 AMS Ambicor® 
• 20 Spectra™  
 
The minimum sample size for multi-center data analysis will depend on the total number 
of patients, or the number of patients with each type of penile prosthesis implanted for 
whom sufficient follow-up data on multiple endpoints of interest are available.  
Generally, a minimum follow-up of at least one year after implantation is desired for 
analysis of data for the device subsets with previous clinical outcomes reported in the 
literature (e.g., AMS 700®, AMS Ambicor®).  Because clinical data has been published 
from multiple studies including more than 100 patients implanted with AMS 700® 
devices in the past decade (since the introduction of the InhibiZone antibiotic-
impregnated devices and the current MS Pump), analysis of less than 100 patients 
implanted with these devices with at least one1 year of follow-up is not planned.  
However, an analysis sample size as small as 10 to 25 patients implanted with the 
newer Spectra™ or AMS 700® Series devices with the Conceal Low Profile reservoir, 
with 6 to 12 months of post-implant follow-up, may be of value for publication in the 
scientific literature due to the lack of any prospective clinical outcomes published to date 
for these products.   
8.2  SAFETY OBJECTIVES 
Safety will be assessed by collection and review of all reported intra-operative and post-
operative device or surgery related clinical study events recorded during the 
implantation or any follow-up visits (for BSC products only).   
 
Endpoint: 
• Complications (adverse device effects/events) 
o Intra-operative device or surgery related complications - reported during 
Implantation visit (e.g., cylinder crossover) 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 25 of 55 
o Post-operative device or surgery related complications - reported during 
follow-up (e.g., mechanical malfunction, infection) 
o Unanticipated and serious adverse device effects (per ISO 14155:2011) 
o Deaths (related to the device or implantation procedure) 
 
• Device Malfunctions 
o Device deficiencies or malfunctions (per ISO 14155:2011)   
 
• Revision procedures related to the device or implantation procedure 
 
Statistical Analysis: 
Descriptive statistics (number of events, number and proportion of patients) will be 
summarized by complication category by device type and for the full group.  Kaplan-
Meier method will be used to estimate the major complication event rate at 1 year post-
operative follow up by device type and overall for all BSC penile prostheses recipients. 
 
Descriptions will also be prepared of the following details associated with device related 
complications in each category, and will include the following as available for each: 
• Treatment for complication 
• Location of treatment 
• Resolution (resolved or continuing) 
 
Additional analyses may be prepared for other follow-up time such as 6 month, 2, 3, 4, 
and 5 years. 
      
Determination of Patients for Analysis: 
All enrolled patients that received a BSC penile prosthesis with data available will be 
included.  
8.3  EFFECTIVENESS OBJECTIVES 
Effectiveness of the BSC penile prostheses will be assessed in all patients with data 
available at the required 1-year (± 4 months) post-operative follow-up, and any of the 
following additional follow-up time points with data available: 
• 3 months (± 1 month) 
• 6 months (± 1 month) 
• 18 months (± 1 month) 
• 2 years (± 4 months) 
• 3 years (± 6 months) 
• 4 years (± 6 months) 
• 5 years(± 6 months) 
 
8.3.1 EFFECTIVENESS OBJECTIVE 1 – DEVICE USE AND SATISFACTION 
To assess post-implantation patient satisfaction with the device and use of the device. 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 26 of 55 
 
Endpoint: 
• How satisfied are you with the device(s)? (5-point scale) 
1 – Very Dissatisfied 
2 – Dissatisfied  
3 – Equally Satisfied and Dissatisfied 
4 – Satisfied   
5 – Very Satisfied  
• Are you using the device?  (Y/N) 
o (If yes)  How often are you using the device? (less than once per month, 
or more than once per month)  
o How many times per month? 
o If no, why aren’t you using the device? (Loss of partner, partner 
disinterest, device problem, device dissatisfaction, health decline, other, 
other device use reason) 
o If yes, and not using the device as often as desired, or if dissatisfied with 
the device, indicate why (Loss of partner, partner disinterest, device 
problem, device dissatisfaction, health decline, other, other device use 
reason) 
 
Statistical Analysis: 
The number and percentage of patients with responses in each category for the 
satisfaction and the device use questions at 1-year visit and any of the additional follow-
up time points with data available will be summarized for each device type and overall 
for all BSC penile prostheses recipients. 
 
Determination of Patients for Analysis: 
All enrolled patients that received a BSC penile prosthesis with data available will be 
included.  
8.3.2 EFFECTIVENESS OBJECTIVE 2 – IIEF-5/SHIM QUESTIONNAIRES  
To assess sexual function in IIEF-5 scores. 
 
Endpoint: 
The endpoint is the change in IIEF-5 total scores from baseline to 1-year post-operative 
follow-up.  
 
Statistical Analysis: 
The IIEF-5 total scores will be computed for each patient at baseline and 1-year follow 
up, and the change from baseline to 1-year follow up will be calculated.  Descriptive 
summary statistics including mean, median, standard deviation (SD), and range will be 
generated by each device type and overall for all BSC penile prostheses recipients. For 
within patient change at 1-year follow up compared to baseline, signed rank sum test or 
paired t-test may be used when applicable.   
 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 27 of 55 
Additional analyses may also be used to summarize the values at the other follow-up 
time points with data available along with changes from baseline for each device type 
and overall for all BSC penile prostheses recipients. Mixed effects model may be used 
to estimate the change from baseline across follow up visits when appropriate.  
 
In addition, the number and percentage of patients with IIEF-5 scores meeting the 
following criteria will be calculated at baseline and at each post-treatment time point for 
each device type and overall: 
o ≤ 7 points (severe ED) 
o 8 to 11 points (moderate ED) 
o 12 to16 points (mild-moderate ED) 
o 17 to 21 points (mild ED) 
o ≥ 22 points (no ED) 
 
Determination of Patients for Analysis: 
All enrolled patients that received a BSC penile prosthesis with data available will be 
included. 
 
8.3.3 EFFECTIVENESS OBJECTIVE 3 – EHS QUESTIONNAIRES   
To assess erection hardness based on patients’ most recent sexual encounters.  
 
Endpoint: 
The endpoint is the change in the single-item EHS scores from baseline to 1-year 
 post-operative follow-up.  
 
Statistical Analysis: 
The EHS scores will be computed for each patient at baseline and 1-year follow up, and 
the change from baseline to 1-year follow up will be calculated.  Descriptive summary 
statistics including mean, median, SD, and range will be generated by each device type 
and overall for all BSC penile prostheses recipients. For within patient change at 1-year 
follow up compared to baseline, signed rank sum test or paired t-test may be used when 
applicable.   
 
Additional analyses may also be used to summarize the values at the other follow-up 
time points with data available along with changes from baseline for each device type 
and overall for all BSC penile prostheses recipients. Mixed effects model may be used 
to estimate the change from baseline across follow up visits when appropriate.  
 
In addition, the number and percentage of patients who meet the following criteria will 
be calculated at baseline and each follow up visit for each device type and overall: 
• Patients with an EHS score ≥ 3 (penis hard enough for penetration but not 
completely hard) 
• Patients with an EHS score =  4 (penis completely hard and fully rigid) 
 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 28 of 55 
Determination of Patients for Analysis: 
All enrolled patients that received a BSC penile prosthesis with data available will be 
included. 
 
8.3.4 EFFECTIVENESS OBJECTIVE 4 – SF-12 HRQOL QUESTIONNAIRES  
To measure function health and well-being from the patient’s point of view.  
 
Endpoint: 
The endpoint is the change in each of the following SF-12 scales from baseline to 1-
year post-operative follow-up.  
 
Two component summary scales: 
• PCS (physical component summary) 
• MCS (mental component summary) 
Eight individual domain scales: 
• Physical functioning 
• Role physical 
• Emotional well-being 
• Role emotional 
• Social functioning 
• Energy 
• Pain 
• General health 
 
Statistical Analysis: 
The PCS, MCS and individual domain scores will be computed for each patient at 
baseline and 1-year follow up, and the change from baseline to 1-year follow up will be 
calculated. Descriptive summary statistics including mean, median, SD, and range will 
be generated for each device type and overall for all BSC penile prostheses recipients. 
For within patient change at 1-year follow up compared to baseline, signed rank sum 
test or paired t-test may be used when applicable.   
 
Additional analyses may also be used to summarize the values at the other follow-up 
time points with data available along with changes from baseline for each device type 
and overall for all BSC penile prostheses recipients. Mixed effects model may be used 
to estimate the change from baseline across follow up visits when appropriate.  
 
Determination of Patients for Analysis: 
All enrolled patients that received a BSC penile prosthesis with data available will be 
included. 
 
8.3.5 EFFECTIVENESS OBJECTIVE 5 – AUA-SI/IPSS QUESTIONNAIRES   
To quantify urinary irritative/obstructive symptom frequency and severity. 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 29 of 55 
 
Endpoint: 
The endpoint is the change in the AUA-SI total scores from baseline to 1-year 
 post-operative follow-up.  
 
Statistical Analysis: 
The AUA-SI total scores will be computed for each patient at baseline and 1-year follow 
up, and the change from baseline to 1-year follow up will be calculated. Descriptive 
summary statistics including mean, median, SD, and range will be generated for each 
device type and overall for all BSC penile prostheses recipients. For within patient 
change at 1-year follow up compared to baseline, signed rank sum test or paired t-test 
may be used when applicable.   
 
Additional analyses may also be used to summarize the values at the other follow up 
time points with data available along with changes from baseline for each device type 
and overall for all BSC penile prostheses recipients. Mixed effects model may be used 
to estimate the change from baseline across follow up visits when appropriate.  
 
In addition, the number and percentage of patients who meet the following criteria will 
be calculated at baseline and each follow up visit: 
• Mild (0 to 7) 
• Moderate (8 to 19) 
• Severe ( 20 to 35) 
 
Determination of Patients for Analysis: 
All enrolled patients that received a BSC penile prosthesis with data available will be 
included. 
 
8.3.6 EFFECTIVENSS OBJECTIVE 6 – UCLA-PCI QUESTIONNAIRES   
To assess disease-specific, organ targeted health related quality of life in six scales or 
domains that are of special concern to men treated for prostate cancer.  
 
Endpoint: 
The endpoint is the change in each of the following UCLA-PCI domains from baseline to 
1-year post-operative follow up.  
 
• Sexual Function 
• Sexual Bother 
• Urinary Function 
• Urinary Bother 
• Bowel Function 
• Bowel Bother 
 
Statistical Analysis: 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 30 of 55 
The individual domain scores will be computed for each patient at baseline and 1-year 
follow up, and the change from baseline to 1-year follow up will be calculated.  
Descriptive summary statistics including mean, median, SD, and range will be 
generated for each device type and overall for all BSC penile prostheses recipients. For 
within patient change at 1-year follow up compared to baseline, signed rank sum test or 
paired t-test may be used when applicable.   
 
Additional analyses may also be used to summarize the values at the other follow-up 
time points with data available along with changes from baseline for each device type 
and overall for all BSC penile prostheses recipients. Mixed effects model may be used 
to estimate the change from baseline across follow up visits when appropriate.  
 
Determination of Patients for Analysis: 
All enrolled patients that received a BSC penile prosthesis with data available will be 
included. 
 
8.3.7 ADDITIONAL EFFECTIVNESS OBJECTIVES   
To assess the penile length and girth, number of pads used daily and pad weight (24-
hour test). 
 
Endpoint: 
The endpoint is the change in each of the following measurements from baseline to 1 
year post-operative follow-up.  
 
• Inflated penile length measurement (measured from suprapubic fat pad to tip) 
• Inflated penile girth measurement (circumference measured 1cm proximal to the 
proximal end of the corona) 
• Number of pads used daily (if incontinence indicated pre-operatively) 
• Pad weight (24-hour test) (if incontinence indicated pre-operatively) 
 
Statistical Analysis: 
Descriptive summary statistics for penile length and girth, number of pads used daily 
and pad weight at baseline and 1-year follow up, and the change from baseline and 1-
year follow up will be calculated and summarized for each device type and overall for all 
BSC penile prostheses recipients. For within patient change at 1-year follow up 
compared to baseline, signed rank sum test or paired t-test may be used when 
applicable.   
 
Additional analyses may also be used to summarize the values at the other follow up 
time points with data available along with changes from baseline for each device type 
and overall for all BSC penile prostheses recipients.  
 
Determination of Patients for Analysis: 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 31 of 55 
All enrolled patients that received a BSC penile prosthesis with data available will be 
included. 
8.4  ADDITIONAL DATA ANALYSIS  
8.4.1 SUBGROUP ANALYSIS  
Subgroups of patients for which analyses of safety and effectiveness outcomes may be 
performed based on relevant available data include, but are not limited to, the following: 
 
• Implant type and model (AMS 700®, Ambicor®, Spectra™) 
o AMS 700® LGX  
o AMS 700® Series with Conceal 
o AMS 700® MS Pump  
o AMS 700® with InhibiZone 
• Original (virgin) and revision implants (if revision – with or without washout) 
• Primary etiology of ED (e.g., Diabetes, Cardiovascular disease, Radical 
prostatectomy, Peyronie’s disease) 
 
8.4.2 PHYSICIAN DATA   
Recorded data from each practice will be summarized in the following categories:  
• Practice type (private or academic)  
• Main setting for procedures (Hospital or ASC)  
• Standard device cycling instructions to patients receiving IPPs (number and 
percentage) – a description of each physician’s recorded device cycling 
protocol will also be prepared. 
8.4.3 BASELINE/ PRE-OPERATIVE DATA  
The following demographic and patient characteristics will be summarized (including 
mean, median, and standard deviations) for patient groups based on the type of BSC 
device implanted and overall for all BSC penile prostheses recipients: 
• Age 
• Duration of ED (years or months) 
• Pre-op flaccid penile length (measured from suprapubic fat pad to tip) 
• Pre-op stretched penile length (measure from suprapubic fat pad to tip) 
• Pre-op flaccid girth (circumference measured 1cm proximal to the proximal 
end of the corona) 
• Number of office visits in past year for treatment of depression  
• Duration (weeks) and Frequency (times/day) of VED use prescribed pre-
operatively  
• Number of pads used daily (for SUI) 
• Pad weight (24-hour test) (for SUI) 
• Urodynamics (for SUI):  Post-void residual (PVR) volume (ml), maximum flow 
rate (ml/sec) 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 32 of 55 
 
The number and percentage of patients with recorded baseline data will also be 
summarized within each device type and the full patient group in the following 
categories: 
• Race/Ethnicity 
• Primary etiology of ED 
o  Organic 
 Diabetes  
 Cardiovascular disease 
 Neurologic disorder 
 Peyronie’s disease 
 Other organic (specify) 
o Acute 
 Radical prostatectomy (RP) (robotic, open or laparoscopic) 
 Radical pelvic surgery (other than RP) 
 Pelvic radiation therapy 
 Pelvic trauma or injury 
 Spinal cord injury 
 Venous Leak 
 Priapism 
 Other acute (specify) 
 
• Concomitant medical conditions and concomitant medications:  
o premature or rapid ejaculation/PE  
o climacturia  
o cardiovascular disease  
o diabetes  
o Peyronie’s disease  
o steroid use  
o anticoagulant use  
o anti-depressant use 
o Venous Leak 
o stress urinary incontinence/SUI  
 Etiology of incontinence (radical prostatectomy, pelvic irradiation, 
and other) 
 Previous treatment(s) for incontinence (behavior modification, 
pelvic floor muscle training, transobturator male sling, artificial 
urinary sphincter/AUS, and other)  
 Cystoscopy findings (bladder neck contracture, other) (for SUI) 
 Any detrusor overactivity (DO) or detruser sphincter dyssynergia 
(DSD) (for SUI) 
o any others recorded  
• Previous treatments used for ED (PDE-5 inhibitor, VED, ICI, combination 
therapies, previous/failed penile implants) 
• Patients with any office visits in past year for treatment of depression  

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 33 of 55 
• Patients taking any depression medication in past year 
• Patients with VED and/or penile traction therapy prescribed pre-operatively  
8.5 IMPLANTATION DATA  
Descriptive summaries of all available implantation data collected in the registry 
database will be prepared, to include the number of patients (and percentage or range 
of values, as applicable) with recorded data within each device type and the full patient 
group in the following categories: 
 
• Date of procedure (range) 
• Original (virgin), revision, salvage, or replacement implant (if revision or salvage, 
with or without washout) 
• Surgical approach (percentage of patients by category:  Penoscrotal (PS), 
Infrapubic (IP), Subcoronal (SC) and Other)  
• Implant model type 
o Spectra™ Concealable Penile Prosthesis  
 Cylinder diameter (9.5, 12, 14 mm) 
 Cylinder length (12, 16, 20 cm) 
 Total number of RTEs per cylinder (0, 1, 2) 
 Total length of RTEs per cylinder (specify: 0.5 to 7.5 cm)  
o AMS Ambicor® Penile Prosthesis (2-piece inflatable)  
 Cylinder diameter (12.5, 14, 15.5 mm) 
 Cylinder length (14, 16, 18, 20, 22 cm) 
 Total number of RTEs per cylinder (0, 1, 2, 3, 4) 
 Total length of RTEs per cylinder (specify: 0.5 to 6.5 cm)  
o AMS 700® Penile Prosthesis (3–piece inflatable) 
 InhibiZone-impregnated  
 Cylinder type (CX, LGX, CXR, Ultrex, CXM) 
 Cylinder length (10, 12, 14, 15, 16, 18, 21, 24 cm) 
 Total number of RTEs per cylinder (0, 1, 2, 3, 4) 
 Total length of RTEs per cylinder (specify: 0.5 to 7.5 cm) 
 Pump type (MS Pump, Tactile pump, Inflate/Deflate) 
 Preconnect  
 Reservoir (Spherical 65 ml, Spherical 100 ml, Conceal 100 ml)  
 Reservoir placement (space of Retzius, Sub-muscular, Sub 
Scarpas’s fascia, other) 
 Reservoir separate incision  
• Drain (None or Type) 
• Dressing (None, compression/mummy wrap, non-compressive dressing) 
• Concurrent procedures (ventral phalloplasty, ligament release, circumcision, 
suprapubic fat pad reduction, spermatic cord/testicular procedure, AUS (including 
single or multiple incision), sling – (including sling type and single or multiple 
incision) 
• Significant corporal fibrosis or scarring noted  
• Peyronie’s Disease  

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 34 of 55 
o Initial intraoperative curvature measurement (angle of curvature with 
inflated device using a goniometer or protractor) 
o Any curvature correction procedure(s) performed (including correction 
technique (Wilson/Delk remodeling, tunical incision, incision and grafting, 
or plication) 
 Curvature measurement after correction 
 Second correction procedure(s) (including summary details as 
above)  
• Patient status post-op (Admitted/inpatient/≥24 hours, same day 
discharge/outpatient/<24 hours)  
o Number of days in the hospital for admitted patients (mean, median, 
standard deviation) 
• Length of procedure (mean, median, standard deviation) 
• Intra-operative penile length measurement with device fully inflated (mean, 
median, standard deviation) 
• Intra-op penile girth measurement with device fully inflated (mean, median, 
standard deviation) 
• Intra-op stretched penile length with device deflated (mean, median, standard 
deviation) 
• Foley in place at discharge 
 
9 
PROTOCOL DEVIATIONS 
All attempts should be made not to deviate from the clinical protocol. If, however, a 
Protocol Deviation occurs a Protocol Deviation data form should be recorded for each 
study protocol deviation (e.g., failure to obtain written informed consent if required, 
enrolling a patient who does not meet inclusion criteria, not obtaining minimum required 
follow-up data).  This form will include a description of the deviation, reason for 
deviation, and corrective and/or preventative action, if necessary. The Principal 
Physician is responsible for reporting protocol deviations in compliance with their 
IRB/EC regulations. BSC will determine and document whether the data obtained from 
patient(s) with one or more protocol deviations are sufficient to be included in the study 
outcomes analyses prior to locking the data for the analyses.  
 
10 
DATA ANALYSIS 
Sites will be able to access their own data via ad hoc reporting at any time. Through 
BSC, sites will also be able to request some summary data.  Aggregate data from more 
than one site will be made available to Principal Physician(s) only upon approval of a 
request by the PROPPER Publication Review Committee. To preserve anonymity, 
aggregate data may not be made available until a minimum of 50 patients have been 
enrolled into the Registry.   
 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 35 of 55 
11 
DATA SECURITY 
The EDC system to be used for this study by Boston Scientific Corporation is in full 
compliance with 21 CFR 11, Guidance on Computerized Systems used in Clinical 
Trials, and ICH and ISO GCP guidelines for electronic clinical data systems. 
 
Electronic access to the EDC system will be carefully controlled by Boston Scientific 
Corporation. System entry will be limited via unique usernames and password-protected 
logon procedures. Physicians will have access only to data from their own sites; they 
will not have access to data from other sites.  
12 
DATA QUALITY ASSURANCE 
The EDC system will include edit checks that will inform physicians as soon as they 
enter inappropriate data. There are 2 levels of edit checks: soft and hard. ‘Soft’ errors 
result in a pop-up message that notes the nature of the error and a confirmation request 
of the value in question. ‘Hard’ errors generate similar error messages, but also prevent 
the form from further data entry until the error is corrected. An example of a soft error 
generation is entering an out of range value, for example a dry pad weight value of 20g 
and a pad weight after test value of 10g, would be outside the expected value of pad 
weight difference. An example of a hard error is failing to respond ‘yes’ to the question: 
‘Was Informed Consent/HIPAA waiver obtained (per your IRB/EC requirements)?’. 
Validation tests of this edit check system have been performed by BSC and selected 
physicians.  
 
13 MONITORING PLAN 
 BSC will conduct pre-study telephone calls, and site initiation visits to ensure 
appropriate physician training.  Interim monitoring visits will be completed by a CRO 
after patients have been enrolled at each site to ensure that records related to the study 
and patient informed consent documentation are maintained at each site as needed.  
Sites are required to grant access to source documentation for the purposes of 
monitoring visits including patient Informed Consent Forms. All Informed Consent 
Forms will be monitored, with additional monitoring to be conducted as necessary 
throughout the study and per the monitoring plan.  
 
14 
INSTITUTIONAL REVIEW BOARD (IRB)/ETHICS COMMITTEE (EC) REVIEW 
This registry will be performed in accordance with all applicable requirements set forth 
in the ICH Good Clinical Practices (GCPs), the World Medical Association Declaration 
of Helsinki, ISO 14155 Good Clinical Practice standards, and any other applicable local 
laws and regulations. 
The PROPPER Registry is an observational collection of data and as such physicians 
are free to manage their patients according to their usual practices. BSC devices for 
which clinical outcomes will be collected in the registry have all been cleared for 
marketing by the FDA or other local responsible regulatory agency. Physicians are 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 36 of 55 
encouraged to use these devices according to the labeled indication and product use 
instructions. Therefore, participation in the Registry study poses no additional risk to the 
patient in relation to the device implantation for the treatment of ED or related standard-
of-care testing or assessments. BSC will ensure adequate provisions are in place to 
protect the privacy of patients and to maintain the confidentiality of study data as 
required by regulations, including limiting electronic database system access to 
authorized individuals. This study protocol will be subject to an IRB/EC for review and 
approval if required prior to patient enrollment at each site. All physicians must comply 
with the requirements of their IRB/EC. 
15 
INFORMED CONSENT AND PATIENT PRIVACY 
BSC will provide a template Informed Consent Form describing this study for physicians 
at each participating site to submit to their IRB/ECs.  All physicians must comply with 
the requirements of their IRB/EC. If an IRB/EC requires patients to provide informed 
consent to participate in this study, a site-specific Informed Consent Form will be 
submitted for IRB/EC review and approval prior to patient enrollment at the site.  
Because this registry study is non-interventional and physicians are using standard-of-
care treatment and assessments in this study, the IRB/EC at some sites may not 
require written informed consent from patients prior to their participation in this study.  If 
study-specific informed consent is not required at a site, a waiver from informed consent 
must be documented from the site’s IRB/EC prior to study patient enrollment.  A site’s 
IRB/EC may require that an approved HIPAA authorization be signed instead of, or in 
addition to, informed consent prior to enrollment of study patients. 
 
16 
STUDY RECORDS AND REPORTS 
Data from this study related to the safety or performance of the BSC penile prostheses 
may be submitted to regulatory authorities.  Study records will be maintained by the 
Principal Physician and by BSC consistent with FDA/ICH and ISO ICH Good Clinical 
Practice (GCP) guidance and standards [FDA/ICH E6 Guidance, April 1996; ISO 
14155:2011(E)].  The physician is responsible for maintaining accurate, complete, and 
current records and documents relating to the conduct of this study as outlined in the 
GCP standards, including the following:   
• Clinical investigational plan (CIP/protocol) and any amendments 
• Signed Investigator agreement and clinical study reimbursement agreement 
• Physician curriculum vitae (CV) (current by address) 
• Physician medical license (current by date) 
• Physician financial disclosure information 
• Study personnel training records (BSC to provide) 
• IRB/EC composition, approvals, renewals and correspondence (as applicable) 
• Delegation of Authority Log (BSC to provide) 
• Study related correspondence with another physician, an IRB/EC, BSC, 
monitors, patients, or responsible regulatory authority, including required reports 
that relate to this study 
• Patient’s medical records 
• Signed study Informed Consent Form for each patient (ICF, if required) 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 37 of 55 
• Patient questionnaires (if used) 
 
All records pertaining to this clinical study will be maintained for at least 2 years after the 
conclusion of the study, or until the physician is informed by BSC that the records are 
no longer required to support a regulatory application, whichever occurs later. These 
records should be retained for a longer period, however, if required by the applicable 
regulatory requirements. If records are stored or transferred to a location other than the 
site where the study was conducted a pointer will be placed in the site file explaining 
where the records are located and BSC should be notified.  If the physician wishes to 
withdraw from the responsibility of maintaining these study records, a transfer of 
responsibility to a person willing to accept the responsibility must occur and be reported 
to BSC not more than 30 days after the transfer occurs. 
 
16.1 PHYSICIAN REPORTS  
 
Physician is responsible for preparation and submission of the following reports as 
identified in Table 5 below. 
 
Table 5: Description and Submission Requirements of Physician Reports 
Report 
Submit to 
Description 
Clinical Study Events  
Sponsor/IRB/EC 
Unanticipated adverse device Effect (UADE), 
and Serious Adverse Device Effect (SADE) 
need to be submitted to the Sponsor and may 
need to be submitted to the IRB/EC in 
accordance with the IRB/EC requirements at the 
study site, as soon as possible but no later than 
10 working days after the physician learns of the 
event 
Study Patient Death 
Sponsor/IRB/EC 
Death must be reported to the sponsor and may 
need to be submitted to the IRB/EC in 
accordance with local requirements, no later 
than 10 working days after the physician learns 
of the death 
Withdrawal of IRB/EC 
approval 
Sponsor 
The physician must report a withdrawal of 
approval by the reviewing EC/ IRB of the 
physician’s part of the study, within 5 working 
days of the physician learning of the withdrawal 
of approval 
Progress Report 
Sponsor/IRB/EC 
The physician must submit this report to the 
sponsor and the IRB/EC at regular intervals in 
accordance with the IRB/ EC requirements at 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 38 of 55 
the study site 
Study Deviations 
Sponsor/IRB/EC 
Notice of deviations from the plan will be 
submitted to the sponsor and may need to be 
submitted to the IRB/EC in accordance with 
IRB/EC requirements  
Final Report 
Sponsor/IRB/EC 
Notification of clinical investigation close-out to 
the IRB/EC by physicians, where required.  
 
16.2 BSC REPORTS  
BSC is responsible for preparation and submission of the following reports as identified 
in Table 6 below. 
 
Table 6: Description and Submission Requirements of BSC Reports 
Report 
Submit to 
Description 
Unanticipated Adverse 
Device Effects  
Physicians, 
FDA/CA, IRB/EC, 
(where required) 
Notification within 10 working days after the 
Sponsor learns of the event 
Withdrawal of IRB/EC 
approval 
Physicians, 
IRB/EC, (where 
required) 
Notification within 5 working days  of the 
Sponsor learning of the withdrawal of approval 
Recall  
Physicians, 
FDA/CA, IRB/EC 
(where required) 
Notification within 30 working days and will 
include the reasons for any request that a 
physician return, repair or otherwise dispose of 
any devices  
Final report 
IRB/EC, 
Physicians (if 
required) 
BSC will notify physicians and IRBs/ECs within 
6 months after completion or termination of this 
study.  
 
17 
PHYSICIAN NON-COMPLIANCE AND STUDY TERMINATION  
Protocol deviations will be closely monitored by BSC and analyzed for trends that may 
be occurring at each site or more than one site.  If excessive deviations or a failure to 
reduce deviations are noted, BSC reserves the right to suspend study enrollment until a 
sufficient system is in place at the site to reduce further deviations.  BSC may also 
terminate study activities at the site as required by GCPs or local regulations for issues 
of non-compliance that cannot be resolved.  A physician may elect to withdraw from 
study participation at any time during the study.   
18 
PUBLICATION PLAN 
 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 39 of 55 
Results of this study are intended to be submitted for publication in scientific journals 
and at scientific meetings.  Study data acquisition, analyses and interpretation of 
aggregate multi-center study data for all enrolled patients after completion of 1-year 
follow-up and final study follow-up for publication will be overseen by BSC, in 
collaboration with actively participating physician(s) and study Publication Review 
Committee members.  Additional statistical analysis or aggregate data publications 
describing study outcomes authored by one or more physicians will be considered by 
this committee comprised of physicians and BSC representatives.   
 
The PROPPER Publication Review Committee will develop a charter describing its 
membership and the details of the schedule and procedures for requesting data, 
analyses or other support related to publications for submission to scientific 
organizations.  This charter will be distributed to all participating physicians by BSC. A 
BSC Clinical Project Leader or designee will be the coordinator for facilitating the 
submission of analysis or publication support requests by interested physician authors 
to the committee for consideration.   
 
Physicians will have access to the data from their own patients throughout the study 
and may perform independent analyses for publication(s). However, BSC requires that 
the author furnish a copy of any proposed publication to BSC for Publication Review 
Committee review prior to submission to the publisher.  
 
Generally accepted criteria for publication authorship will be considered appropriate for 
all study-related publications72:   
 
1) substantial contributions to conception and design, acquisition of data, or analysis 
and interpretation of data;  
2) drafting the manuscript or revising it critically for important intellectual content; and  
3) final approval of the version of the manuscript to be submitted for publication.  
 
Each individual author should qualify for authorship, and all authors who qualify should 
be listed either as individual authors or as part of an authors’ group on study 
publications.  Each author should have participated sufficiently in the work to take public 
responsibility for appropriate portions of the content.  Although BSC representatives 
may in some cases co-author publications, acquisition of data or general supervision of 
the study alone does not qualify one for authorship.  

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 40 of 55 
 
19 
REFERENCES 
1. Carson C, Kirby R, Goldstein. Textbook of Erectile Dysfunction. Oxford 1999. 
 
2. Feldman HA, Goldstein I, Hatzichristou DG. Impotence and its medical and 
psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 
1994;151(1):54–61. 
 
3. McKinlay JB, Digruttolo L, Glasser D. International differences in the epidemiology of 
male erectile dysfunction. Int J Clin Pract Suppl. 1999;102:35. 
 
4. Nelson CJ, Mulhall JP, Roth AJ. The association between erectile dysfunction and 
depressive symptoms in men treated for prostate cancer. J Sex Med. 2011 
Feb;8(2):560-6. 
 
5. Rosen R, Shabsigh R, Berber M, Assalian P, Menza M, Rodriguez-Vela L, Porto R, 
Bangerter K, Seger M, Montorsi F; Vardenafil Study Site Investigators. Efficacy and 
tolerability of vardenafil in men with mild depression and erectile dysfunction: the 
depression-related improvement with vardenafil for erectile response study. Am J 
Psychiatry. 2006 Jan;163(1):79-87. PubMed PMID: 16390893. 
 
6. Araujo AB, Travison TG, Ganz P, Chiu GR, Kupelian V, Rosen RC, Hall SA, 
McKinlay JB. Erectile dysfunction and mortality. J Sex Med. 2009 Sep;6(9):2445-54. 
Epub 2009 Jun 15. 
 
7. Schouten B, Bohnen AM, Thomas S. Erectile dysfunction and incidence of 
cardiovascular disease. JAMA. 2006 May 3;295(17):1999. 
 
8. Schouten BW, Bohnen AM, Bosch JL, Bernsen RM, Deckers JW, Dohle GR, Thomas 
S. Erectile dysfunction prospectively associated with cardiovascular disease in the 
Dutch general population: results from the Krimpen Study. Int J Impot Res. 2008 Jan-
Feb;20(1):92-9. Epub 2007 Aug 30. 
 
9. McVary KT. Clinical practice. Erectile dysfunction. N Engl J Med. 2007 Dec 
13;357(24):2472-81. 
 
10. Stanford JL, Feng Z, Hamilton AS, Gilliland FD, Stephenson RA, Eley JW, Albertsen 
PC, Harlan LC, Potosky AL: Urinary and sexual function after radical prostatectomy for 
clinically localized prostate cancer: the Prostate Cancer Outcomes Study. JAMA 2000, 
283(3):354-60. 
 
11. Kundo SD, Roehl KA, Effener SE, et al. Potency, continence and complications in 
3,477 consecutive radical retropubic prostatectomies. J Urol. 2004; 172:2227-2231 
 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 41 of 55 
12. Catalona, W. J., Carvalhal, G. F., Mager, D. E. and Smith, D. S.: Potency, 
continence and complication rates in 1,870 consecutive radical retropubic 
prostatectomies. J Urol, 162: 433, 1999. 
 
13. Gore JL, Kwan L, Lee SP, Reiter RE, Litwin MS. Survivorship beyond 
convalescence: 48-month quality-of-life outcomes after treatment for localized prostate 
cancer. J Natl Cancer Inst. 2009 Jun 16;101(12):888-92. Epub 2009 Jun 9. 
 
14. Wilt TJ, MacDonald R, Rutks I, Shamliyan TA, Taylor BC, Kane RL. Systematic 
review: comparative effectiveness and harms of treatments for clinically localized 
prostate cancer. Ann Intern Med. 2008 Mar 18;148(6):435-48. Epub 2008 Feb 4. 
Review. Erratum in: Ann Intern Med. 2008 Jun 3;148(11):888.  
 
15. Bergman J, Gore JL, Penson DF, Kwan L, Litwin MS. Erectile aid use by men 
treated for localized prostate cancer. J Urol. 2009 Aug;182(2):649-54. Epub 2009 Jun 
17. 
 
16. Potosky AL, Reeve BB, Clegg LX, et al. Quality of life following localized prostate 
cancer treated initially with androgen deprivation therapy or no therapy. J Natl Cancer 
Inst 2002;94:430–437. 
 
17. D’Amico AV, Manola J, Loffredo M, Renshaw AA, DellaCroce A, Kantoff PW. 6-
month androgen suppression plus radiation therapy vs radiation therapy alone for 
patients with clinically localized prostate cancer: a randomized controlled trial. JAMA. 
2004;292:821-7. 
 
18. Gleave ME, Goldenberg SL, Chin JL, Warner J, Saad F, Klotz LH, et al. Canadian 
Uro-Oncology Group. Randomized comparative study of 3 versus 8-month neoadjuvant 
hormonal therapy before radical prostatectomy: biochemical and pathological effects. J 
Urol. 2001;166:500-6; discussion 506-7. 
 
19. Padma-Nathan H, McCullough AR, Levine LA, Lipshultz LI, Siegel R, Montorsi F, 
Giuliano F, Brock G; Study Group. Randomized, double-blind, placebo-controlled study 
of postoperative nightly sildenafil citrate for the prevention of erectile dysfunction after 
bilateral nerve-sparing radical prostatectomy. Int J Impot Res. 2008 Sep-Oct;20(5):479-
86. Epub 2008 Jul 24. 
 
20. Montorsi F, Brock G, Lee J, Shapiro J, Van Poppel H, Graefen M, Stief C. Effect of 
nightly versus on-demand vardenafil on recovery of erectile function in men following 
bilateral nerve-sparing radical prostatectomy. Eur Urol. 2008 Oct;54(4):924-31. Epub 
2008 Jul 9. 
 
21. Mulhall JP, Parker M, Waters BW, Flanigan R. The timing of penile rehabilitation 
after bilateral nerve-sparing radical prostatectomy affects the recovery of erectile 
function. BJU Int. 2010 Jan 1;105(1):37-41. Epub 2009 Jul 31. 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 42 of 55 
 
22. Ohebshalom M, Parker M, Guhring P, Mulhall JP. The efficacy of sildenafil citrate 
following radiation therapy for prostate cancer: temporal considerations. J Urol. 2005 
Jul;174(1):258-62; discussion 262. 
 
23. Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, Lin X, 
Greenfield TK, Litwin MS, Saigal CS, Mahadevan A, Klein E, Kibel A, Pisters LL, Kuban 
D, Kaplan I, Wood D, Ciezki J, Shah N, Wei JT. Quality of life and satisfaction with 
outcome among prostate-cancer survivors. N Engl J Med. 2008 Mar 20;358(12):1250-
61. 
 
24. Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. 
CA Cancer J Clin. 2011 Feb 4. [Epub ahead of print]. 
 
25. Stephenson RA, Mori M, Hsieh YC, Beer TM, Stanford JL, Gilliland FD, Hoffman 
RM, Potosky AL. Treatment of erectile dysfunction following therapy for clinically 
localized prostate cancer: patient reported use and outcomes from the Surveillance, 
Epidemiology, and End Results Prostate Cancer Outcomes Study. J Urol. 2005 
Aug;174(2):646-50; discussion 650. 
 
26. Jarow JP, Nana-Sinkam P, Sabbagh M, Eskew A. Outcome analysis of goal 
directed therapy for impotence. J Urol. 1996 May;155(5):1609-12. 
 
27. Mulhall JP, Ahmed A, Branch J, Parker M. Serial assessment of efficacy and 
satisfaction profiles following penile prosthesis surgery. J Urol. 2003 Apr;169(4):1429-
33. 
 
28. Rajpurkar A, Dhabuwala CB. Comparison of satisfaction rates and erectile function 
in patients treated with sildenafil, intracavernous prostaglandin E1 and penile implant 
surgery for erectile dysfunction in urology practice. J Urol. 2003 Jul;170(1):159-63. 
 
29. Bae JH, Song PH, Kim HT, Moon KH. Assessment of erectile and ejaculatory 
function after penile prosthesis implantation. Korean J Urol. 2010 Mar;51(3):202-7. 
Epub 2010 Mar 19. 
 
30. Montorsi F, Rigatti P, Carmignani G, Corbu C, Campo B, Ordesi G, Breda G, 
Silvestre P, Giammusso B, Morgia G, Graziottin A. AMS three-piece inflatable implants 
for erectile dysfunction: a long-term multi-institutional study in 200 consecutive patients. 
Eur Urol. 2000 Jan;37(1):50-5. 
 
31. Carson CC, Mulcahy JJ, Govier FE. Efficacy, safety and patient satisfaction 
outcomes of the AMS 700CX inflatable penile prosthesis: results of a long-term 
multicenter study. AMS 700CX Study Group. J Urol. 2000; Aug;164(2):376-80. 
 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 43 of 55 
32. Dhar NB, Angermeier KW, Montague DK. Long-term mechanical reliability of AMS 
700CX/CXM inflatable penile prosthesis. J Urol. 2006 Dec;176(6 Pt 1):2599-601; 
discussion 2601. 
 
33. Levine LA, Estrada CR, Morgentaler A. Mechanical reliability and safety of, and 
patient satisfaction with the Ambicor inflatable penile prosthesis: results of a 2 center 
study. J Urol. 2001 Sep;166(3):932-7. 
 
34. Lux M, Reyes-Vallejo L, Morgentaler A, Levine LA. Outcomes and satisfaction rates 
for the redesigned 2-piece penile prosthesis. J Urol. 2007 Jan;177(1):262-6. 
 
35. Natali A, Olianas R, Fisch M. Penile implantation in Europe: successes and 
complications with 253 implants in Italy and Germany. J Sex Med. 2008 Jun;5(6):1503-
12. Epub 2008 Apr 10. 
 
36. Levine LA, Benson J, Hoover C. Inflatable penile prosthesis placement in men with 
Peyronie's disease and drug-resistant erectile dysfunction: A single-center study. J Sex 
Med. 2010 Nov;7(11):3775-83. 
 
37. Burnett AL. Erectile dysfunction following radical prostatectomy. JAMA. 2005 Jun 
1;293(21):2648-53. 
 
38. Montorsi F, Adaikan G, Becher E, Giuliano F, Khoury S, Lue TF, Sharlip I, Althof 
SE, Andersson KE, Brock G, Broderick G, Burnett A, Buvat J, Dean J, Donatucci C, 
Eardley I, Fugl-Meyer KS, Goldstein I, Hackett G, Hatzichristou D, Hellstrom W, Incrocci 
L, Jackson G, Kadioglu A, Levine L, Lewis RW, Maggi M, McCabe M, McMahon CG, 
Montague D, Montorsi P, Mulhall J, Pfaus J, Porst H, Ralph D, Rosen R, Rowland D, 
Sadeghi-Nejad H, Shabsigh R, Stief C, Vardi Y, Wallen K, Wasserman M. Summary of 
the recommendations on sexual dysfunctions in men. J Sex Med. 2010 Nov;7(11):3572-
88. 
 
39. Kaminetsky JC, Depko AJ, Ströberg P, Buvat J, Tseng LJ, Stecher VJ. In men with 
erectile dysfunction, satisfaction with quality of erections correlates with erection 
hardness, treatment satisfaction, and emotional well-being. J Sex Med. 2009 
Mar;6(3):800-8. Epub 2009 Jan 7. 
 
40. Porst H, Vardi Y, Akkus E, Melman A, Park NC, Seftel AD, Teloken C, Wyllie M. 
Standards for clinical trials in male sexual dysfunctions. J Sex Med. 2010 Jan;7(1 Pt 
2):414-44. 
 
41. Hellstrom WJ, Montague DK, Moncada I, Carson C, Minhas S, Faria G, 
Krishnamurti S. Implants, mechanical devices, and vascular surgery for erectile 
dysfunction. J Sex Med. 2010 Jan;7(1 Pt 2):501-23. 
 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 44 of 55 
42. Montague DK, Jarow JP, Broderick GA, Dmochowski RR, Heaton JP, Lue TF, 
Milbank AJ, Nehra A, Sharlip ID; Erectile Dysfunction Guideline Update Panel. Chapter 
1: The management of erectile dysfunction: an AUA update. J Urol. 2005 
Jul;174(1):230-9. 
 
43. Mulhall J, Althof S, Brock G, Goldstein I, Jünemann K-P, Kirby M. Erectile 
dysfunction: Monitoring response to treatment in clinical practice—recommendations of 
an international consensus panel. J Sex Med 2007;4:448–64. 
 
44. Cappelleri JC, Rosen RC. The Sexual Health Inventory for Men (SHIM): a 5-year 
review of research and clinical experience. Int J Impot Res. 2005 Jul-Aug;17(4):307-19. 
 
45. Köhler TS, Pedro R, Hendlin K, Utz W, Ugarte R, Reddy P, Makhlouf A, Ryndin I, 
Canales BK, Weiland D, Nakib N, Ramani A, Anderson JK, Monga M. A pilot study on 
the early use of the vacuum erection device after radical retropubic prostatectomy. BJU 
Int. 2007 Oct;100(4):858-62. 
 
46. Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Peña BM. Development and 
evaluation of an abridged, 5-item version of the International Index of Erectile Function 
(IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 
Dec;11(6):319-26. 
 
47. Gorbatiy V, Westney OL, Romero C, Wang R. Outcomes of simultaneous 
placement of an inflatable penile prosthesis and a male urethral sling through a single 
perineal incision. J Sex Med. 2010 Feb;7(2 Pt 1):832-8. Epub 2009 Sep 29. 
 
48. Bauer RM, Soljanik I, Füllhase C, Karl A, Becker A, Stief CG, Gozzi C. Mid-term 
results for the retroluminar transobturator sling suspension for stress urinary 
incontinence after prostatectomy. BJU Int. 2010 Sep 30. 
 
49. Imbimbo C, Creta M, Gacci M, Simonato A, Gontero P, de Cobelli O, Briganti A,  
Fulcoli V, Martorana G, Nicita G, Mirone V, Carmignani G. Patients' Desire to Preserve 
Sexual Activity and Final Decision for a Nerve-Sparing Approach: Results from the 
MIRROR (Multicenter Italian Report on Radical Prostatectomy Outcomes and 
Research) Study. J Sex Med. 2011 Feb 16. 
 
50. Mulhall JP, Goldstein I, Bushmakin AG, Cappelleri JC, Hvidsten K. Validation of the 
erection hardness score. J Sex Med. 2007 Nov;4(6):1626-34. Epub 2007 Sep 21. 
 
51. King R, Juenemann KP, Levinson IP, Stecher VJ, Creanga DL. Correlations 
between increased erection hardness and improvements in emotional well-being and 
satisfaction outcomes in men treated with sildenafil citrate for erectile dysfunction. Int J 
Impot Res. 2007 Jul-Aug;19(4):398-406. Epub 2007 Mar 15. 
 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 45 of 55 
52. Goldstein I, Mulhall JP, Bushmakin AG, Cappelleri JC, Hvidsten K, Symonds T: The 
Erection Hardness Score and its relationship to successful sexual intercourse. J Sex 
Med 2008; Epub ahead of print. 
 
53. Hsiao W, Bennett N, Guhring P, Narus J, Mulhall JP. Satisfaction profiles in men 
using intracavernosal injection therapy. J Sex Med. 2011 Feb;8(2):512-7. 
 
54. Litwin, M. S., Hays, R. D., Fink, A., Ganz, P. A., Leake, B., Leach, G. E. et al: 
Quality-of-life outcomes in men treated for localized prostate cancer. JAMA, 273: 129, 
1995. 
 
55. Lepor H, Kaci L. The impact of open radical retropubic prostatectomy on continence 
and lower urinary tract symptoms: a prospective assessment using validated self-
administered outcome instruments. J Urol. 2004 Mar;171(3):1216-9. 
 
56. Reynolds WS, Shikanov SA, Katz MH, Zagaja GP, Shalhav AL, Zorn KC. Analysis 
of continence rates following robot-assisted radical prostatectomy: strict leak-free and 
pad-free continence. Urology. 2010 Feb;75(2):431-6. Epub 2009 Oct 24. 
 
57. Lebeau T, Perrotte P, Valiquette L, Bénard F, McCormack M, Saad F, Karakiewicz 
PI. Validation of prostate cancer index and SF-12 short forms. Can J Urol. 2005 
Dec;12(6):2873-9. 
 
58. Anger JT, Maliski SL, Krupski TL, Kwan L, Gore JL, Fink A, Connor SE, Orecklin 
JR, Litwin MS. Outcomes in men denied access to a California public assistance 
program for prostate cancer. Public Health Rep. 2007 Mar-Apr;122(2):217-23. 
 
59. Litwin MS, McGuican KA, Shpall AI, Dhanani N (1999) Recovery of health related 
QoL in the year after radical prostatectomy: early experience. J Urol 161: 515. 
 
60. Penson DF, McLerran D, Feng Z, Li L, Albertsen PC, Gilliland FD, Hamilton A, 
Hoffman RM, Stephenson RA, Potosky AL, Stanford JL. 5-year urinary and sexual 
outcomes after radical prostatectomy: results from the prostate cancer outcomes study. 
J Urol. 2005 May;173(5):1701-5. 
 
61. Rogers CG, Su LM, Link RE, Sullivan W, Wagner A, Pavlovich CP. Age stratified 
functional outcomes after laparoscopic radical prostatectomy. J Urol. 2006 Dec;176(6 Pt 
1):2448-52. 
 
62. Cornu JN, Sèbe P, Ciofu C, Peyrat L, Cussenot O, Haab F. Mid-term evaluation of 
the transobturator male sling for post-prostatectomy incontinence: focus on prognostic 
factors. BJU Int. 2010 Oct 18. 
 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 46 of 55 
63. Christine B, Knoll LD. Treatment of recurrent urinary incontinence after artificial 
urinary sphincter placement using the AdVance male sling. Urology. 2010 
Dec;76(6):1321-4. Epub 2010 Aug 14. 
 
64. Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, 
Cockett AT. The American Urological Association symptom index for benign prostatic 
hyperplasia. The Measurement Committee of the American Urological Association. J 
Urol. 1992 Nov;148(5):1549-57; discussion 1564. 
 
65. Deliveliotis C, Liakouras C, Delis A, Skolarikos A, Varkarakis J, Protogerou V. 
Prostate operations: long-term effects on sexual and urinary function and quality of life. 
Comparison with an age-matched control population. Urol Res. 2004 Aug;32(4):283-9. 
Epub 2004 Mar 31. 
 
66. Shikanov S, Desai V, Razmaria A, Zagaja GP, Shalhav AL. Robotic radical 
prostatectomy for elderly patients: probability of achieving continence and potency 1 
year after surgery. J Urol. 2010 May;183(5):1803-7. Epub 2010 Mar 17. 
 
67. Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation 
of the expanded prostate cancer index composite (EPIC) for comprehensive 
assessment of health-related quality of life in men with prostate cancer. Urology. 2000 
Dec 20;56(6):899-905. 
 
68. Ware J Jr, Kosinski M, Keller SD. A 12-item short-form health survey: construction 
of scales and preliminary tests of reliability and validity. Med Care 1996;34:220-33. 
 
69. Ware J Jr, Kosinski M, Keller SD. SF-12: how to score the SF-12 physical and 
mental health summary scales. Boston: The Health Institute, New England Medical 
Center; 1995. 
 
70. Clark JA, Inui TS, Silliman RA, Bokhour BG, Krasnow SH, Robinson RA, Spaulding 
M, Talcott JA. Patients' perceptions of quality of life after treatment for early prostate 
cancer. J Clin Oncol. 2003 Oct 15;21(20):3777-84. 
 
71. Liu H, Hays RD, Adams JL, Chen WP, Tisnado D, Mangione CM, Damberg CL, 
Kahn KL. Imputation of SF-12 health scores for respondents with partially missing data. 
Health Serv Res. 2005 Jun;40(3):905-21. 
 
72. International Committee of Medical Journal Editors (ICMJE).  Uniform Requirements 
for Manuscripts Submitted to Biomedical Journals:  Ethical Considerations in the 
Conduct and Reporting of Research: Authorship and Contributorship.  Available at:  
http://www.icmje.org/ethical_1author.html.   Accessed 10 May 2010. 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 47 of 55 
 
APPENDIX 1 - QUESTIONNAIRES 
International Index of Erectile Function-5 / Sexual Health Inventory for Men 
(IIEF-5/SHIM)  
 
The 5 specific questions comprising the IIEF-5/SHIM are shown below.  Each question 
is preceded by the phrase, “Over the past 6 months,”: 
 
1. How do you rate your confidence that you could get and keep an erection? 
1 - Very low 
2 - Low 
3 - Moderate 
4 - High 
5 - Very high 
2. When you had erections with sexual stimulation, how often were your 
erections hard enough for penetration? 
1 - Almost never/never 
2 - A few times (much less than half the time) 
3 - Sometimes (about half the time) 
4 - Most times (much more than half the time) 
5 - Almost always/always 
3. During sexual intercourse, how often were you able to maintain your erection 
after you had penetrated (entered) your partner? 
1 - Almost never/never 
2 - A few times (much less than half the time) 
3 - Sometimes (about half the time) 
4 - Most times (much more than half the time) 
5 - Almost always/always 
4. During sexual intercourse, how difficult was it to maintain your erection to 
completion of intercourse? 
1 - Extremely difficult 
2 - Very difficult 
3 - Difficult 
4 - Slightly difficult 
5 - Not difficult 
5. When you attempted sexual intercourse, how often was it satisfactory for you? 
1 - Almost never/never 
2 - A few times (much less than half the time) 
3 - Sometimes (about half the time) 
4 - Most times (much more than half the time) 
5 - Almost always/always 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 48 of 55 
EHS Erection Hardness Questionnaire 
The specific question comprising the EHS is shown below. 
 
EHS: “How would you rate the hardness of your erection?” 
0: Penis does not enlarge. 
1: Penis is larger but not hard. 
2: Penis is hard but not hard enough for penetration. 
3: Penis is hard enough for penetration but not completely hard. 
4: Penis is completely hard and fully rigid. 
 
SF-12 Health-related Quality of Life (HRQOL) Questionnaire 
 
The 7 specific questions comprising the SF-12 are shown below.   
 
1. In general, would you say your health is: 
1 - Excellent 
2 - Very good 
3 - Good 
4 - Fair 
5 - Poor 
 
2. The following questions are about activities you might do during a typical day. 
Does your health now limit you in these activities? If so, how much? 
 
Moderate activities, such as moving a table, pushing a vacuum cleaner, 
bowling or playing golf 
1 – Yes, limited a lot 
2 – Yes, limited a little 
3 – No, not limited at all 
 
Climbing several flights of stairs 
 1 – Yes, limited a lot 
2 – Yes, limited a little 
3 – No, not limited at all 
 
 3. During the past 4 weeks how much of the time have you had any of the 
following problems with your work or other regular daily activities as a result of 
your physical health 
 
 
Accomplished less than you would like 
1 – All of the time 
2 – Most of the time 
3 – Some of the time 
4 – A little of the time 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 49 of 55 
5 – None of the time 
 
Were limited in the kind of work or other activities 
1 – All of the time 
2 – Most of the time 
3 – Some of the time 
4 – A little of the time 
5 – None of the time 
 
4. During the past 4 weeks, how much of the time have you had any of the 
following problems with your work or other regular daily activities as a result of 
any emotional problems (such as feeling depressed or anxious)? 
 
 Accomplished less than you would like 
1 – All of the time 
2 – Most of the time 
3 – Some of the time 
4 – A little of the time 
5 – None of the time 
 
Did work or other activities less carefully than usual 
1 – All of the time 
2 – Most of the time 
3 – Some of the time 
4 – A little of the time 
5 – None of the time 
 
5. During the past 4 weeks, how much did pain interfere with your normal work 
(including both work outside the home and housework)? 
1- Not at all 
2 – A little bit 
3 – Moderately 
4 – Quite a bit 
5 – Extremely 
 
6. These questions are about how you feel and how things have been with you 
during the past 4 weeks. For each question, please five  the one answer that 
comes closet to the way you have been feeling. How much of the time during the 
past 4 weeks… 
 
Have you felt calm and peaceful? 
1 – All of the time 
2 – Most of the time 
3 – Some of the time 
4 – A little of the time 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 50 of 55 
5 – None of the time 
 
Did you have a lot of energy? 
1 – All of the time 
2 – Most of the time 
3 – Some of the time 
4 – A little of the time 
5 – None of the time 
 
Have you felt downhearted and depressed? 
1 – All of the time 
2 – Most of the time 
3 – Some of the time 
4 – A little of the time 
5 – None of the time 
 
7. During the past 4 weeks, how much of the time has your physical health or 
emotional problems interfered with your social activities (like visiting friends, 
relatives, etc.)? 
1 – All of the time 
2 – Most of the time 
3 – Some of the time 
4 – A little of the time 
5 – None of the time 
 
American Urological Association – Symptom Index (AUA-SI)  
The 7 specific questions comprising the AUA-SI are shown below. 
 
Over the past month, how often have you had a sensation of not emptying your 
bladder completely after you finished urinating? 
 0 – Not at all 
1 – Less than 1 time in 5 
2 – Less than half the time 
3 – About half the time 
4 – More than half the time 
5 – Almost always 
 
Over the past month, how often have you had to urinate again less than two 
hours after you finished urinating? 
0 – Not at all 
1 – Less than 1 time in 5 
2 – Less than half the time 
3 – About half the time 
4 – More than half the time 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 51 of 55 
5 – Almost always 
 
Over the past month, how often have you found you stopped and started again 
several times when you urinated? 
0 – Not at all 
1 – Less than 1 time in 5 
2 – Less than half the time 
3 – About half the time 
4 – More than half the time 
5 – Almost always 
 
Over the past month, how often have you found it difficult to postpone urination? 
0 – Not at all 
1 – Less than 1 time in 5 
2 – Less than half the time 
3 – About half the time 
4 – More than half the time 
5 – Almost always 
 
Over the past month, how often have you had a weak urinary stream? 
0 – Not at all 
1 – Less than 1 time in 5 
2 – Less than half the time 
3 – About half the time 
4 – More than half the time 
5 – Almost always 
 
Over the past month, how often have you had to push or strain to begin 
urination? 
0 – Not at all 
1 – Less than 1 time in 5 
2 – Less than half the time 
3 – About half the time 
4 – More than half the time 
5 – Almost always 
 
Over the past month, how many times did you most typically get up to urinate 
from the time you went to bed at night until the time you got up in the morning? 
0 – None 
1 – 1 time 
2 – 2 times 
3 – 3 times 
4 – 4 times 
5 – 5 times 
 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 52 of 55 
UCLA-Prostate Cancer Index (UCLA-PCI) Questionnaire 
The 20 specific questions comprising the 6 scales of the UCLA-PCI are shown below. 
 
Sexual Function 
How would you rate each of the following during the last 4 weeks? 
1. Your level of sexual desire? 
1 - Very poor 
2 - Poor  
3 – Fair 
4 – Good 
5 - Very Good 
2. Your ability to have an erection? 
1 - Very poor 
2 – Poor 
3 – Fair 
4 – Good 
5 - Very Good 
3. Your ability to reach orgasm (climax)? 
1- Very poor 
2- Poor 
3 – Fair 
4- Good 
5 - Very Good 
4. How would you describe the usual QUALITY of your erection? 
1 - None at all 
2 - Not firm enough for any sexual activity 
3 - Firm enough for masturbation and foreplay only 
4 - Firm enough for intercourse 
5. How would you describe the FREQUENCY of your erections? 
1 - I NEVER had an erection when I wanted one  
2 - I had an erection LESS THAN HALF the time I wanted one  
3 - I had an erection ABOUT HALF the time I wanted one  
4 -I had an erection MORE THAN HALF the time I wanted one  
5 -I had an erection WHENEVER I wanted one 
6. How often have you awakened in the morning or night with an erection? 
1 –Never 
2 - Seldom (less than 25% of the time) 
3 - Not often (less than half the time) 
4 - Often (more than half the time) 
5 - Very often (more than 75% of the time) 
7. During the last 4 weeks, did you have vaginal or anal intercourse? 
1 –No 
2 - Yes, Once 
3 - Yes, More than once 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 53 of 55 
8. Overall, how would you rate your ability to function sexually during the last 4 
weeks? 
1 - Very poor 
2 – Poor 
3 - Fair  
4 – Good 
5 - Very Good 
 
Sexual Bother 
1. Overall, how big a problem has getting and maintaining an erection been for 
you during the last 4 weeks? 
1 - No problem 
2 - Very small problem 
3 - Small problem 
4 - Moderate problem 
5 - Big problem 
 
Urinary function 
1. Over the past 4 weeks, how often have you leaked urine? 
1 - Every day 
2 - About once a week 
3 - Less than once a week 
4 - Not at all 
2. Which of the following best describes your urinary control during the last 4 
weeks? 
1 - No control whatsoever 
2 - Frequent dribbling 
3 - Occasional dribbling 
4 - Total control 
3. How many pads or adult diapers per day did you usually use to control 
leakage during the last 4 weeks? 
1- 3 or more pads per day 
2 - 1-2 pads per day 
3 - No pads 
 
4. How big a problem, if any, has each of the following been for you during the 
last 4 weeks? 
 
Dripping urine or wetting your pants 
0 - No problem 
1 - Very small problem 
2 - Small problem 
3 - Moderate problem 
4 - Big problem 
Urine leakage interfering with your sexual activity 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 54 of 55 
0 - No problem 
1 - Very small problem 
2 - Small problem 
3 - Moderate problem 
4 - Big problem 
 
Urinary Bother 
1. Overall, how big a problem has your urinary function been for you during the 
last 4 weeks? 
1- No problem 
2-  Very small problem 
3-  Small problem 
4-  Moderate problem 
5-  Big problem 
 
Bowel Function 
1. How often have you had rectal urgency (felt like I had to pass stool, but did 
not) during the last 4 weeks? 
1 - More than once a day 
2 - About once a day 
3 - More than once a week 
4 - About once a week 
5 - Rarely or never 
2. How often have you had stools (bowel movements) that were loose or liquid 
(no form, watery, mushy) during the last 4 weeks? 
1 - Never 
2 - Rarely 
3 - About half the time 
4 - Usually 
5 - Always 
3. How much distress have your bowel movements cause you during the last 4 
weeks? 
1- Severe distress 
2-  Moderate distress 
3-  Little distress 
4-  No distress 
4. How often have you had crampy pain in your abdomen or pelvis during the 
last 4 weeks? 
1- Several times a day 
2-  About once a day 
3-  Several times a week 
4-  About once a week 
5-  About once this month 
6-  Rarely or never 
 

D009530 
Rev03 
 
 
BSC Study: U0552 
March 17, 2016 
Page 55 of 55 
Bowel Bother 
1. Overall, how big a problem have your bowel habits been for you during the 
last 4 weeks? 
1- No problem 
2-  Very small problem 
3- Small problem 
4-  Moderate problem 
5-  Big problem