A Real World Study to Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China (Rezūm RWS Study)
Conditions: Benign Prostatic Hyperplasia (BPH)
Sponsor: Boston Scientific Corporation

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Medical Device Clinical Trial Protocol 
 
 
Protocol Title：A real world study to evaluate the feasibility, 
preliminary safety and performance of Rezūm system in BPH 
treatment in China (Rezūm RWS study) 
 
 
Investigational Device 
Rezūm Generator (G2200-0032) 
Rezūm Delivery Device Kit(M006D2201-0032) 
Class of device 
Class 3 medical device requiring clinical trials 
Yes□  No☒ 
Same class device within China   
Yes□  No☒ 
Protocol version and 
date 
Rev/Ver B，March 22，2021 
 
Clinical trial sites 
Boao Yiling Life Care Center 
Principal Investigator 
LIU Ming  
Sponsor 
BSC International Medical Trading (Shanghai) 
Co., Ltd, (“BSC China”) 
 
 
 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. It should be held 
confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 
 
 
 

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A real world study to evaluate the feasibility, preliminary safety 
and performance of Rezūm system in BPH treatment in China 
Rezūm RWS study 
 
U0719 
CLINICAL INVESTIGATION PLAN 
 
 
 
 
Sponsored By 
BSC International Medical Trading (Shanghai) Co., Ltd, (“BSC 
China”)  
Part A, 2nd Floor, No.68, Rijing Road,  
Free Trade Zone,  
Shanghai, China 200131 
 
 
 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. The protocol should be 
held confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 
 
 
 
 
 
 
 
 

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Contact Information 
Role 
Contact  
Clinical Contact 
LIN Hui  
Clinical Trial Manager/Medical affairs  
Boston Scientific China 
Part A, 2nd Floor, No.68, Rijing Road,  
Free Trade Zone,  
Shanghai, 200131, P.R .China 
Email：Hui.Lin@bsci.com 
Tele：+86 10 61412942 
Meidical Writer  
CHENG Huanlian 
Medical affairs manager 
Boston Scientific China 
Part A, 2nd Floor, No.68, Rijing Road,  
Free Trade Zone,  
Shanghai, 200131, P.R .China 
Email：Huanlian.Cheng@bsci.com 
Tele：+86 10 85216472 
Coordinating Principal 
Investigator(s) 
LIU Ming 
Chief physician 
Boao Yiling Life Care Center 
No.13 Hainan Boao Lecheng International Medical Tourism Pilot 
Zone, Qiong Hai, Hainan, P.R .China 
 
 
 

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Original Release: Dec 21, 2020 
Current Version: Mar 22, 2021 
 
 
 
Revision Version 
Protocol Date 
Template 
number and 
version 
Protocol 
Section 
Modified 
Summary of Changes 
 
Justification for 
Modification 
 
Rev/Ver A 
Dec 21,2020 
92120219_R
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NA 
NA 
First release 
Rev/Ver B 
Mar 22, 2021 
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Synopsis and 
6.2.1 
Clarify the definition of primary end point:
‘ …… Complications from Rezūm procedure to 
3-6M post Rezūm procedure ’ 
Based on EC comments 
Rev/Ver B 
Mar 22, 2021 
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Synopsis  
‘Study 
Duration’ 
Added : ‘it will takes about 3 months to 
complete data collection’ 
Modified per plan 
Rev/Ver B 
Mar 22, 2021 
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7 
Modified ‘1 invstigation site, Boao Yiling Life 
Care Center’ 
Based on EC comments 
Rev/Ver B 
Mar 22, 2021 
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8.2 
1 criteria was added.  
‘ The subjects will provide written informed 
consent form and agree to data collection.’ 
Based on EC comments 
Rev/Ver B 
Mar 22, 2021 
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8.3 
Delete ‘the subjects who were diagnosed as 
BPH, ……Hainan medical pilot zone should be 
enrolled.’ 
Based on EC comments 
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9.1 
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Based on EC comments 
Rev/Ver B 
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9.3 
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informed consent 
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Rev/Ver B 
Mar 22, 2021 
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9.6 
Modify the wording 
Modified per plan 

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Revision Version 
Protocol Date 
Template 
number and 
version 
Protocol 
Section 
Modified 
Summary of Changes 
 
Justification for 
Modification 
 
Rev/Ver B 
Mar 22, 2021 
92120219_R
ev/Ver F 
13.3 
Add the ICF approval by EC/IRB, delete  waiver 
of ICF. Make a minor change in wording. 
Based on EC comments 
Rev/Ver B 
Mar 22, 2021 
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13.4 
Specify  copy the recored of study per regulation  
Based on EC comments 
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Add  ‘signed ICF ’ 
Based on EC comments 
Rev/Ver B 
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15.2 
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detail. 
Based on EC comments 
Rev/Ver B 
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15.3 
Risk minimization actions 
Based on EC comments 
Rev/Ver B 
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Add informed consent in detail. 
Based on EC comments 
Rev/Ver B 
Mar 22, 2021 
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20.3 
Please contact Boston Scientific staff for further 
information: LinHui, 010-61412942 
update 
Rev/Ver B 
Mar 22, 2021 
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Contact 
Information 
Update the adress 
update 
 
 
 

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2. Protocol Synopsis 
A real world study to evaluate the feasibility, preliminary safety and performance of 
Rezūm system in BPH treatment in China（Rezūm RWS study） 
Study 
Objective(s) 
This RWS study is to evaluate the feasibility, preliminary safety and 
performance of Rezūm system in BPH treatment in China, to generate 
local real world data from a Chinese BPH population. 
Indication(s) for 
Use  
The Rezūm System is intended to relieve symptoms, obstructions, and 
reduce prostate tissue associated with BPH. It is indicated for men ≥50 
years of age with a prostate volume ≥ 30cm3 and ≤80cm3. The Rezūm 
System is also indicated for treatment of prostate with hyperplasia of the 
central zone and/or a median lobe.  
(Commercial) 
Device/System 
applied  
Rezūm Generator （Model #G2200-0032） 
Rezūm Delivery Device Kit（Model # M006D2201-0032） 
Study Design 
Retrospective, single arm, RWS study 
Planned 
Number of 
Subjects 
Up to 30 subjects who were diagnosed as BPH and treated with Rezūm 
system will be collected to get 22 treated subjects with valid data.   
Planned 
Number of Sites  
1 investigation site, Boao Yiling Life Care Center 
Primary 
Endpoint 
Primary Efficacy Endpoint: IPSS change at 3-6M post Rezūm 
procedure. 
Primary Safety Endpoint: Device Related Serious Complications from 
Rezūm procedure to 3-6M post Rezūm procedure.  
Composite device related serious complications for this endpoint are 
defined as: 
1. Device perforation of the rectum or GI tract; 
2. Device related formation of fistula between the rectum and 
urethra; 
3. De novo severe urinary retention lasting more than 21 
consecutive days post treatment. 

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A real world study to evaluate the feasibility, preliminary safety and performance of 
Rezūm system in BPH treatment in China（Rezūm RWS study） 
Secondary 
Endpoint 
1. Anesthesia method 
2. Rezūm procedure time 
3. Qmax and Post void residual (PVR） 
4. Catheterization time 
5. Quality of Life (if available) 
6. Ejective function（MSHQ-EjD and IIEF (if available) 
7. Surgical retreatment post Rezūm procedure (if available)  
8. Medication retreatment post Rezūm procedure (if available) 
9. All SAEs 
Method of 
Assigning 
Patients to 
Treatment 
Not applicable, this is a single-arm study. 
Follow-up 
Schedule 
Not applicable, this is a retrospective study with no follow-up visit.  
Study Duration This is a retrospective study, it will takes about 3 months to complete 
data collection. 
Participant 
Duration 
Not applicable, this is a retrospective study. 
Inclusion 
Criteria 
• The subjects will provide written informed consent form and agree to 
data collection. 
• The subjects who were diagnosed as BPH and treated by Rezūm 
procedure in Hainan medical pilot zone will be enrolled in this study. 
Exclusion 
Criteria 
This is a retrospective study without any formal exclusion criteria. 
Statistical Methods  

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A real world study to evaluate the feasibility, preliminary safety and performance of 
Rezūm system in BPH treatment in China（Rezūm RWS study） 
Primary 
Statistical 
Hypothesis 
The primary endpoint is IPSS change at 3-6M post Rezūm procedure. In 
Rezūm Pivotal II study, IPSS score represents a 11.2±7.6 point reduction 
at 3M post Rezūm procedure in treatment arm, while 4.3±6.9 point 
reduction in sham control. In Pivotal trial, IPSS score in treatment group 
decreased 25%(5.375) compared to sham control group is recognized as 
meaningful.  
As this is a retrospective RWS study, the inclusion/exclusion criteria is 
not strict, we set up performance goal for score change as 5.5, the 
expected score change is 10 at 3-6M post Rezūm procedure. A 
performance goal (PG) testing for the primary endpoint is planned. The 
decision rule is to calculate the 95% Lower Confidence Interval (LCI) of 
score change and compare it to the PG, meet PG if LCI is greater than PG. 
Statistical Test 
Method 
Study endpoints will be summarized descriptively,when it comes to 
primary endpoint-IPSS score, last IPSS score during 3-6 moth post 
procedure of subjects will be used, if they had several IPSS score. 
Categorical variables will be tabulated with frequencies, percentages and 
95% confidence intervals. Continuous variables will be tabulated with 
mean, median, standard deviation, minimum, maximum, and 95% 
confidence interval of the mean. This study allows exploratory analysis, 
eg.the change tendency of IPSS score and variables, sub-group analysis 
based on IPSS score. 
Sample Size 
Parameters 
The sample size is calculated according to below formula: 
 n =
(𝑍𝛼+ 𝑍𝛽)
2𝜎2
𝛿2
 
n is sample size, we designed 5.5 as performance value, 10 is expected 
IPSS change, α=0.05，β=0.20（power=80%）Considering the small 
sample size needs to be iterative distribution, 22 subjects will provide 
more than 85% power. As this is retrospective study, there are chances of 
missing data in the study. So the final sample size will be up to 30, to 
satisfy 22 treated subjects. 
 
 
 
 

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3. Table of Contents 
1. 
TITLE PAGE  .........................................................................................................................1 
2. 
PROTOCOL SYNOPSIS ...........................................................................................................6 
3. 
TABLE OF CONTENTS ...........................................................................................................9 
3.1. Table of Tables ........................................................................................................11 
4. 
INTRODUCTION ..................................................................................................................12 
4.1. Background .............................................................................................................12 
4.2. Study Rationale .......................................................................................................13 
5. 
(COMMERCIAL) DEVICE DESCRIPTION...............................................................................13 
5.1. Commercial Device .................................................................................................13 
5.2. Rationale and principle ...........................................................................................14 
5.3. Indication .................................................................................................................14 
5.4. Required Procedures ...............................................................................................15 
6. 
STUDY OBJECTIVES AND ENDPOINTS .................................................................................15 
6.1. Study objectives ......................................................................................................15 
6.2. Study endpoints .......................................................................................................15 
7. 
STUDY DESIGN ..................................................................................................................16 
7.1. Scale and Duration ..................................................................................................16 
7.2. Treatment Assignment ............................................................................................16 
7.3. Justification for the Study Design ...........................................................................16 
8. 
SUBJECT SELECTION ..........................................................................................................17 
8.1. Study Population and Eligibility .............................................................................17 
8.2. Inclusion Criteria .....................................................................................................17 
8.3. Exclusion Criteria ....................................................................................................17 
9. 
STUDY METHODS ..............................................................................................................17 
9.1. Data Collection ........................................................................................................17 
9.2. Study Candidate Screening/enrolling ......................................................................19 
9.3. Informed consent .....................................................................................................19 
9.4. Data collection: Baseline-procedure-discharge .......................................................19 

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9.5. Data collection: visits ..............................................................................................19 
9.6. Study Completion....................................................................................................20 
9.7. Source Documents ..................................................................................................20 
10. STATISTICAL CONSIDERATIONS .........................................................................................20 
10.1. Primary Endpoints ...................................................................................................20 
10.2. General Statistical Methods ....................................................................................21 
11. DATA MANAGEMENT ........................................................................................................22 
11.1. Data Collection, Processing, and Review ...............................................................22 
11.2. Data Retention .........................................................................................................22 
12. AMENDMENT .....................................................................................................................23 
13. COMPLIANCE .....................................................................................................................23 
13.1. Statement of Compliance ........................................................................................23 
13.2. Investigator Responsibilities ...................................................................................23 
13.3. Institutional Review Board/ Ethics Committee .......................................................24 
13.4. Sponsor Responsibilities .........................................................................................25 
14. MONITORING .....................................................................................................................25 
15. POTENTIAL RISKS AND BENEFITS ......................................................................................26 
15.1. Instructions for Use .................................................................................................26 
15.2. Risks associated with Participation in the Clinical Study .......................................26 
15.3. Risk minimization actions .......................................................................................26 
15.4. Anticipated Benefits ................................................................................................26 
16. SAFETY REPORTING ...........................................................................................................26 
16.1. Reportable Events by investigational site to Boston Scientific ..............................26 
16.2. Definitions and Classification .................................................................................27 
16.3. Relationship to Device(s) and/or Study Procedure .................................................29 
16.4. Investigator Reporting Requirements .....................................................................31 
16.5. Boston Scientific Device Deficiencies ....................................................................33 
16.6. Reporting to Regulatory Authorities / IRBs / ECs / Investigators ..........................33 
17. INFORMED CONSENT .........................................................................................................33 
18. COMMITTEES .....................................................................................................................34 

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18.1. Safety Monitoring Process ......................................................................................34 
19. SUSPENSION OR TERMINATION ..........................................................................................35 
19.1 Premature Termination of the Study .......................................................................35 
19.2 Termination of Study Participation by the Investigator or Withdrawal of IRB/ EC 
Approval ..................................................................................................................35 
19.3 Requirements for Documentation and Subject Follow-up ......................................35 
19.4 Criteria for Suspending/Terminating a Study Site ..................................................36 
20. STUDY REGISTRATION AND RESULTS ................................................................................36 
20.1. Study Registration ...................................................................................................36 
20.2. Clinical Investigation Report ..................................................................................36 
20.3. Publication Policy ...................................................................................................36 
21. BIBLIOGRAPHY ..................................................................................................................37 
22. ABBREVIATIONS AND DEFINITIONS ...................................................................................37 
22.1. Abbreviations ..........................................................................................................37 
 
3.1. Table of Tables 
Table 9.1-1:The data collection schedule ............................................................................... 18 
Table 16.2-1: Safety Definitions ............................................................................................. 27 
Table 16.3-1: Criteria for Assessing Relationship of Study Device or Procedure to Adverse 
Event .................................................................................................................... 30 
Table 16.4-1:Requirements for reporting ............................................................................... 31 
Table 22.1-1: Abbreviations ................................................................................................... 38 
 

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4. Introduction 
4.1. Background 
Benign prostatic hyperplasia (BPH) with associated lower urinary tract symptoms (LUTS) is 
a common medical condition in the aging male. The incidence has been estimated to increase 
from 40% among male between the age of 50 and 60 years to 90% among male older than 80 
years of age, as cited by Ackerman et al[1]. In 2007, the prevalence of BPH in the U.S. was 
estimated to be 10.7 million men[2].  In China, the morbidity of BPH in male over 60 years old 
is more than 50%, and is as high as 83% in male over 80 years[3]. 
 
Initially, active surveillance (observing without treatment) is often employed. Treatment  
initiation usually occurs once symptoms of bladder outlet obstruction and bladder irritability 
interfere with the subject’s quality of life. The American Urological Association Symptom 
Index (AUASI)/International Prostate Symptom Score (IPSS) is considered the gold standard 
measurement tool for the assessment of BPH symptoms and response to treatment, both in a 
clinical practice setting and as an outcome measure in randomized controlled studies[4]. (The 
AUASI is identical to the seven symptom questions of the IPSS while the IPSS has one more 
question dealing with how these symptoms affect a patient’s quality of life (QoL). Results from 
the AUASI are referred to as the IPSS; the acronym IPSS is also used as a substitute for 
AUASI.) 
 
For many men, medications are the most common way to control mild to moderate  symptoms 
of BPH to reduce its major symptoms. However, BPH medications have several systemic side 
effects, are costly if used for long periods of time, and some subjects have difficulty with 
complying with medications, particularly in the older population. For severe BPH symptoms, 
transurethral resection of the prostate (TURP), laser vaporization, or thermal ablation are 
common treatments of choice. 
 
The Rezūm System is a minimally invasive thermal ablation treatment that may mitigate the 
symptoms of BPH. The Rezūm System treatment is rapid, preserves the urethra, and subjects 
may potentially have relief from the symptoms of BPH as soon as 1 week after treatment. The 
Rezūm System has got CE mark and FDA approval in 2013 and 2015 respectivly, and a series 
of clinical studies have been conducted worldwide.  
 
The pivotal study of Rezūm System demonstrated  its efficacy and safety. 197 males subjects 
were enrolled in pivotal study,  with  a prostate size > 30 cm3 but < 80 cm3 and IPSS > 13.  All 
eligible subjects  were randomized in a 2:1 ratio to receive either the Rezūm vapor ablation 
treatment , or a control sham procedure. The primary endpiont, the change in IPSS at 3 months 
post-procedure were 11.2, 4.3 respectively in  the Treatment Arm and  the Control Arm. The 
treatment arm’s IPSS was 22 at baseline, which improved at 2 weeks after procedure, and the 
improvement of IPSS were more than 50% at 3, 6, 12 months post- procedure, Qmax at 3 
months post-procedure was improved by 6.2ml/s, and remained  consistently durable at 12 
months post- procedure; There was no de novo ED,  with just mild, moderate AE occurred[5]; 
At 2 years post procedure, convective radiofrequency thermal therapy improved urinary 
symptoms significantly over controls at 3 months procedure (86.9% (53/61) subjects in the 

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Control Arm had qualified and elected to cross over to receive the Rezūm treatment following 
their 3-month postprocedure visit. ), and provided a sustained 51% reduction from baseline; 
This produced a 5- and 8-point or greater score decrease in 84% and 74% of subjects , 
respectively [6]; There were a more than 50% improvement in the IPSS, quality of life, Qmax, 
BPH impact index at 3 years post procedure, which were maintained during 3 years after 
procedure, without late AE, surgical retreatment rate was 4.4% at 3, 4,5 years after water vapor 
thermal therapy[7,8,9]. As a a minimally invasive medical divice, Rezūm System provides 
effective early onset, as well as enduring relief of LUTS associated with BPH, with an 
acceptable side effect profile, and can be performed in an outpatient treatment setting with 
short procedure time. 
 
4.2. Study Rationale 
Benign prostatic hyperplasia (BPH) is a disease of aging, whose morbidity  increases with age. 
Progressive prostate enlargement causes bladder outflow obstruction and lower urinary tract 
symptoms, which have a significant impact on patients' quality of life.In view of the 
aggravation of the aging process in China and the high incidence rate of male patients over 50 
years old , there is a considerable socioeconomic burden to patients and society as it represents 
the most commonly presenting urological complaint.   
BPH medications could relieve LUTS  symptoms,  but some get unsatisfactory symptom relief, 
Furthermore, it can be associated with systemic side effects such as postural hypotension, is 
costly when used for a long time; and some subjects have difficulty complying with the 
medication regime, particularly among the older population. 
Transurethral resection of the prostate (TURP), which is considered the gold standard 
intervention, have a hgih complication rate, such as TRUS, retrograde ejaculation, erectile 
dysfunction, urethral stricture; and its surgical retreatment rate was 1–2% per year. 
Furthermore, it requires the use of general or spinal anaesthesia, which may cause more risks 
for elderly.  
The Rezūm System is a minimally invasive thermal ablation treatment. The treatment with 
Rezūm System is rapid under local anesthesia and sedation, with the urethra preserved, which 
may mitigate the symptoms of BPH. The Rezūm System have been on the market for many 
years with consistently durable efficacy and mild AE. This retrospective study will collect the 
data of treated subjects in the hospitals in BOAO medical pilot zone, to evaluate it safety and 
performance in Chinese patients, which will provide real world evidence for extensive use in 
China. 
5. (Commercial) Device Description  
5.1. Commercial Device  
The Rezūm System includes the following major components: 
• Rezūm Generator (reusable)/Model # G2200-0032  
✓ Generator 
✓ One Power Cord 

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✓ Rezūm Operators Manual 
• Rezūm Delivery Device Kit (disposable)/ Model # M006D2201-0032  
✓ One sterile Delivery Device with cable and tubing 
✓ One sterile Syringe 
✓ One sterile Spike Adaptor 
 
 
Figure 1  Rezūm System 
5.2. Rationale and principle  
The basic principle of the Rezūm System is to deliver a controlled amount of sterile water 
vapor directly into the hyperplastic tissue in the transition zone of the prostate using a 
transurethral approach .The stored thermal energy in the vapor is transferred directly onto the 
cell membranes as the vapor condenses and releases the heat of condensation, causing cell 
death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment 
zone, resulting in a bloodless procedure. During procedure the water vapor is created by a 
heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and 
preserves the urethra.  
Please refer to IFU for more detailed information. 
5.3. Indication  
The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue 
associated with BPH. It is indicated for men ≥50 years of age with a prostate volume ≥ 30cm3 
and ≤80cm3.The Rezūm System is also indicated for treatment of prostate with hyperplasia 
of the central zone and/or a median lobe. 
 
 
Rezūm Delivery 
Device Kit 
Rezūm 
Generator 

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5.4. Required Procedures 
A standard 4mm, 30°, rigid cystoscopic lens is inserted into the Delivery Device, thereby 
allowing the Delivery Device to be advanced and positioned under direct visualization within 
the prostatic urethra. 
6. Study Objectives and Endpoints 
6.1. Study objectives  
This retrospective RWS study is to evaluate the safety and efficacy  of Rezūm system in BPH 
treatment, to generate local real world data from a Chinese BPH population for  Rezūm 
System’s approval in china. 
6.2. Study endpoints  
6.2.1. Primary endpoints 
6.2.1.1. Primary Efficacy Endpoint 
Primary efficacy endpoint: IPSS change at 3-6M post Rezūm procedure. 
International prostate symptom score (IPSS) is a questionnaire used to indicate the severity of 
LUTS symptoms, There are 7 questions relating to different symptoms subjects be 
experiencing and one question relating to overall quality of life.  
IPSS at baseline and post procedure will be collected. If several IPSS scores are collectedy, the 
last IPSS score during 3-6 months post procedure will be used to assess the primary efficacy 
endpoint. 
6.2.1.2. Primary Safety Endpoint 
Primary safety endpoint: Device Related Serious Complications from Rezūm procedure to 3-
6M post Rezūm procedure.  
Composite device related serious complications for this endpoint are defined as: 
1. Device perforation of the rectum or GI tract; 
2. Device related formation of fistula between the rectum and urethra; 
3. De novo severe urinary retention lasting more than 21 consecutive days post 
treatment. 
AEs will be collected and relationship to device will be assessed by investigators, it will be 
assessed whether meet the pre-specific device related serious complications . It’s uncertain that 
when subject’s data of the last follow up get in this retrospective study, so serious 
complications in up to 6 months post procedure will be used for primary safety endpoint. 
6.2.2. Secondery  endpoints 
1. Anesthesia method 

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2. Rezūm operation time 
3. Qmax and Post Void Residual Urine Volume (PVR） 
4. Length of Catheterization 
5. Quality of Life (if available) 
6. Ejective function（MSHQ-EjD and IIEF (if available)） 
7. Surgical retreatment post Rezūm procedure (if available)  
8. Medication retreatment post Rezūm procedure (if available) 
9. All SAEs 
7. Study Design 
This is a retrospective, single arm, RWS study, which will be performed in Boao Yiling Life 
Care Center in Hainan BOAO mecial pilot zone. 
7.1. Scale and Duration 
This RWS study aims to gather no more than 30 BPH subjects datas at basline, procedure and 
follow-up visits from the medical records, who recerived the thermal ablation treatment via 
Rezūm System in Boao Yiling Life Care Center in Hainan BOAO mediacl pilot zone, about 
22 subjects with valid data will be analysed  finally. 
This RWS study is based on the medical practices without intervention. All subjects enrolled  
have been treated by Rezūm System, so participation duration is not applicable, only data 
generatated in medical practices will be gathered. 
7.2. Treatment Assignment 
Treatment Assignment is not applicable in this retrospective study. 
7.3. Justification for the Study Design 
The Rezūm System has got CE mark and FDA approval in 2013 and 2015 respectivly, and a 
series of clinical studies have been conducted worldwide, such as FIM, Rezūm I, Rezūm II 
RCT, and demonstrated its safety and efficacy from histopathology and clinical medicine. 
Furthermore, It have been on the market for many years with consistently durable effeacy and 
mild AE. This retrospective study use the data produced in hospitals in BOAO medical pilot 
zone, to evaluate it safety and performance in Chinese BPH patients, which will provide real 
world evidence for extensive use in China and approval as well. 
 

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8. Subject Selection  
8.1. Study Population and Eligibility  
Target poputions are BPHs who were treated with Rezūm system in hospitals in Hainan 
medical pilot zone, To be eligible for enrollment in the study, subjects must meet all of the 
inclusion criteria. 
8.2. Inclusion Criteria 
Subjects  who meet all inclusion criteria, and don’t meet exclusion criteria will be eligible for 
enrollment. 
• The subjects will provide written informed consent form and agree to data collection. 
• The subjects who were diagnosed as BPH and treated by Rezūm procedure in Hainan 
medical pilot zone with complete procedure recored . 
8.3. Exclusion Criteria 
This is a retrospective study without any formal exclusion criteria. 
9. Study Methods 
9.1. Data Collection 
The data collection schedule is shown in Table 9.1-1. 

 
 
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Table 9.1-1:The data collection schedule  
 
 
Procedure/Assessment 
Baseline/pre-
procedure 
Index 
Procedure 
Post 
procedure/ 
Prehospital 
Discharge 
follow-up 
post-
precedure # 
 
Informed consent 
 
 
 
X& 
Demographics 
X 
 
 
 
Medical history 
X 
 
 
 
Physical examination (height, weight, 
etc) 
X 
 
 
X 
Prostate volume (MRI, DUS)* 
X 
 
 
X 
Uroflowmetry(Qmax, Urinary volume  ) 
X 
 
 
X 
PVR 
X 
 
 
X 
IPSS 
X 
 
 
X 
QoL 
X 
 
 
X 
IIEF 
X 
 
 
X 
MSHQ-EjD 
X 
 
 
X 
Procedure information 
 
X 
 
 
Length of catheterization 
 
 
X 
 
Surgical retreatment 
 
 
 
X 
Medication(s) used(LUTS /BPH) 
X 
 
X 
X 
Device Defect (if available) 
 
X 
 
 
Adverse events assessment 
 
X 
X 
X 
 
Note: # All information of subjects available before the defined end of study will be collected in this 
retrospectively study, data missing will be allowed. 
*Prostate volume -data form MRI and DUS are collected, MRI data will be preferred to used for statistic, DUS 
data will be used ONLY MRI data unavailable. 
&Only written  informed consent  form  is provided  after initiation , data will be  collected.

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9.2. Study Candidate Screening/enrolling 
Subjects with BPH will be screened form the medical recored database in Boao Yiling Life 
Care Center in BOAO medical pilot zone, and  these have been treated with Rezūm system 
will be enrolled in this study. 
9.3. Informed consent 
Data won’t be collected before the informed consent form is signed. Once subjects provide 
informed consent, he will be enrolled in this study, then medical data will be retrospectively 
collected. 
9.4. Data collection: Baseline-procedure-discharge 
The pre-procedure examination, procedure and information at discharge of the selected 
subjects will be collected from the electronic medical record database or paper medical records 
of hospitals in Hainan Boao Medical Pilot zone. 
• Baseline/pre-procedure: Demographics, medical history, physical examination, prostate 
volume (MRI, DUS), PVR, Uroflowmetry(Qmax, Urinary volume ), IPSS and quality of 
Life questionnaire, sexual function (IIEF and MSHQ-EjD , if available), Medication(s) 
used(LUTS /BPH). 
• Procedure : anesthesia method,  Rezūm operation time, key points of operation of Rezūm 
system,  Device Defect (if available),adverse events, etc. Rezūm Operation time is from 
the time of insertion to the time the Rezūm Delivery Device  removed. 
• Discharge: Length of catheterization, Medication(s) used(LUTS /BPH), adverse events, 
etc. Length of Catheterization is form the time of insertion to time the catheter removed. 
9.5. Data collection: visits 
This study is a retrospective study with no formal visit plan. Data post-procedure will be 
collected form the medical recored database and health examination in Hainan medical pilot 
zone. All available follow up data before the end of study is suggested to be collected. The 
pages of follow up visits in CRF will be filled according the time. 
 Data below will be collected and recored in CRF, if available: 
Prostate volume(MRI, DUS), PVR, Uroflowmetry(Qmax, Urinary volume ),  IPSS score and 
QoL, sexual function (IIEF and MSHQ-EjD), surguical retreatment and medication for 
BPH/LUTS, adverse events. 
Note: the enrolled subjects must be treated with Rezūm system in hospitals in Hainan Boao 
Medical Pilot zone, the follow-up visits could be preformed in local hospital. the data can be 
collected and recorded in CRF, if available.  

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9.6. Study Completion 
This study is a retrospective real world study with no formal visit plan, no visit must be 
performed. The end of study will be scheduled at 4 months post Rezūm procedure of last 
subject enrolled. 
9.7. Source Documents 
It is preferable that original source documents are maintained, when available. In lieu of 
original source documents, certified copies are required to be maintained.  A certified copy is 
a copy (irrespective of the type of media used) of the original record that has been verified (i.e., 
by a dated signature or by generation through a validated process) to have the same information, 
including data that describe the context, content, and structure, as the original.  
10. Statistical Considerations 
10.1. Primary Endpoints 
Primary Efficacy Endpoint: IPSS change at 3-6M post Rezūm procedure. 
Primary Safety Endpoint: Device Related Serious Complications from Rezūm procedure to 3-
6M post Rezūm procedure.  
Composite device related serious complications for this endpoint are defined as: 
1. Device perforation of the rectum or GI tract; 
2. Device related formation of fistula between the rectum and urethra; 
3. De novo severe urinary retention lasting more than 21 consecutive days post treatment. 
10.1.1. Hypothsis 
The primary endpoint is IPSS change at 3-6M post Rezūm procedure.  
In Rezūm Pivotal II study, IPSS score represents a 11.2±7.6 point reduction at 3M post Rezūm 
procedure in treatment arm, while 4.3±6.9 point reduction in sham control. In Pivotal trial, 
IPSS score in treatment group decreased 25%(5.375) compared to sham control group is 
recognized as meaningful.  
As this is a retrospective RWS study, the inclusion/exclusion criteria is not strict, we set up 
performance goal for score change as 5.5, the expected score change is 10 at 3-6M post Rezūm 
procedure. A performance goal (PG) testing for the primary endpoint is planned. The decision 
rule is to calculate the Lower Confidence Interval (LCI) of score change and compare it to the 
PG, meet PG if LCI is greater than PG. 
10.1.2. Sample size 
The sample size is calculated according to below formula: 

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 n =
(𝑍𝛼+ 𝑍𝛽)
2𝜎2
𝛿2
 
n is sample size, we designed 5.5 as performance value, 10 is expected IPSS change, α=0.05，
β=0.20（power=80%）Considering the small sample size needs to be iterative distribution, 
22 subjects will provide more than 85% power. As this is retrospective study, there are chances 
of missing data in the study. So the final sample size will be up to 30, to satisfy 22 treated 
subjects. 
10.2. General Statistical Methods 
10.2.1. Analysis Sets 
This real world study plans to collect medial data of BPH patients who has been treated with 
Rezūm system in Hainan BOAO medical pilot zone.  
The efficacy analysis set includes subjects with IPSS scores at baseline and at 3-6 months  post- 
procedure. 
The safety analysis set includes all subjects who has been treated with Rezūm system in 
hospitals in Hainan BOAO medical pilot zone. 
10.2.2. Control of Systematic Error/Bias 
All subjects treated with treated with Rezūm system in Hainan BOAO medical pilot zone will 
be enrolled to reduce select bias duing given time. The data will be collected completely and 
accurately, stratified analysis or Multivariate analysis may be used to find and control the bias. 
10.2.3. The method of handling missing, incorrect data( including subjects withdrawal 
and lost to follow-up) and unreasonable data 
Missing data will be excluded for primary analysis in this small sample size study. Imputation 
with mean or median where applicable for continuous variable, and tipping point analysis for 
categorical variable might be conducted for sensitivity analysis. Incorrect and unreasonable 
data will be clarified before database lock. 
10.2.4. Data Analyses 
Study endpoints will be summarized descriptively, when it comes to primary endpoint-IPSS 
score, last IPSS socre during 3-6 moth post procedure of subjects will be used, if they had 
several IPSS questionares. Continuous variables will be tabulated with mean, median, standard 
deviation, minimum, maximum, and 95% confidence interval of the mean. Categorical 
variables will be tabulated with frequencies, percentages and 95% confidence intervals. 
This study may allow explorative statistics based on collected data, which may include, but is 
not limited to, the change tendency of IPSS score and variables, sub-group analysis based on 
IPSS score. All the analysis details will be added in statistical analysis plan. 

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11. Data Management 
11.1. Data Collection, Processing, and Review 
Subject data will be recorded in a limited access secure electronic data capture (EDC) system.  
The clinical database will reside on a production server hosted by Medidata EDC System. All 
changes made to the clinical data will be captured in an electronic audit trail and available for 
review by the sponsor or its representative. The associated Rave software and database have 
been designed to meet regulatory compliance for deployment as part of a validated system 
compliant with laws and regulations applicable to the conduct of clinical studies pertaining to 
the use of electronic records and signatures. Database backups are performed regularly. 
The Investigator provides his/her electronic signature on the appropriate electronic case report 
forms (eCRFs) in compliance with local regulations. A written signature on printouts of the 
eCRFs must also be provided if required by local regulation. Changes to data previously 
submitted to the sponsor require a new electronic signature by the Investigator acknowledging 
and approving the changes. 
Visual and/or electronic data review will be performed to identify possible data discrepancies. 
Manual and/or automatic queries will be created in the Medidata EDC system and will be 
issued to the site for appropriate response. Site staff will be responsible for resolving all queries 
in the database. 
All access to the clinical database will be changed to “Read only” after all data is either “Hard 
Locked” or “Entry Locked”. Once acceptance of the final report or finalization of publications 
(as applicable) is received, final database storage and archiving activities can begin. Once all 
of the closeout activities are completed a request to IT is submitted to have the “Database 
Locked” or Decommissioned and all database access revoked. 
11.2. Data Retention 
The Principal Investigator or his/her designee or Investigational site will maintain all essential 
study documents and source documentation that support the data collected on the study 
subjects in compliance with applicable regulatory requirements.  Documents must be retained 
for 10 years after the formal discontinuation of the clinical investigation of the product. These 
documents will be retained by BSC until the product/device is no longer in use in compliance with 
local regulations. 
The Principal Investigator or his/her designee will take measures to prevent accidental or 
premature destruction of these documents. If for any reason the Principal Investigator or his/her 
designee withdraws responsibility for maintaining these essential documents, custody must be 
transferred to an individual who will assume responsibility and BSC must receive written 
notification of this custodial change. Sites are required to inform Boston Scientific in writing 
where paper or electronic files are maintained in case files are stored off site and are not readily 
available. 

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12. Amendment 
The investigator should adhere to the approved protocol.Any modification to the protocol 
(management information or alterations of the study , etc.) during the study implementation 
shall be submitted to the EC for approval or recored by the investigator  upon approved by the 
sponsor. Appropriate approvals (e.g., EC) of the revised protocol must be obtained prior to 
implementation. 
13. Compliance 
13.1. Statement of Compliance 
This real world study is financed by the study sponsor. Before the investigational site can be 
“Authorized to Enroll,” the investigational site must enter into a Clinical Study Agreement 
with the sponsor that details the financing of the study as well as the rights and obligations of 
the investigational site and the investigator. This study will be conducted in accordance with 
ISO14155、ICH-GCP, ethical principles that have their origins in the Declaration of Helsinki, 
and applicable Chinese laws and regulations. The study shall not begin until the required 
approval/favorable opinion from the IRB/EC and/or regulatory authority has been obtained, if 
appropriate. Also, the study shall not begin prior to issuance of the site Authorization to Enroll, 
as provided by the sponsor. Any additional requirements imposed by the IRB/EC or regulatory 
authority shall be followed, if appropriate.  
13.2. Investigator Responsibilities 
The Principal Investigator of an investigational site is responsible for ensuring that the study 
is conducted in accordance with the Clinical Study Agreement, the clinical investigation plan, 
the spirit of ISO 14155, ethical principles that have their origins in the Declaration of Helsinki, 
any conditions of approval imposed by the reviewing IRB/EC, and prevailing local and/or 
country laws and/or regulations, whichever affords the greater protection to the subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following.  
• Prior to beginning the study, sign the Clinical Study Agreement and comply with the 
Investigator responsibilities as described in such Agreement.   
• Prior to beginning the study, sign the IB（if available）and protocol, and comply with 
study schedule in protocol. 
• Provide his/her qualifications and experience to assume responsibility for the proper 
conduct of the study and that of key members of the site team through up-to-date 
curriculum vitae or other relevant documentation and disclose potential conflicts of interest, 
including financial, that may interfere with the conduct of the clinical study or 
interpretation of results. 
• Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all clinical-
investigation-related records are retained per requirements. 

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• Ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
sponsor in the CRFs and in all required reports. 
• Record, report, and assess (seriousness and relationship to the device/procedure) every 
adverse event as applicable per the protocol and observed device deficiency. 
• Report to sponsor, per the protocol requirements, all reportable events. 
• Report to the IRB/EC and regulatory authorities any SAEs and device deficiencies that 
could have led to a SADE and potential/USADE or UADE, if required by applicable laws 
or regulations or this protocol or by the IRB/EC, and supply BSC with any additional 
requested information related to the safety reporting of a particular event. 
• Allow the sponsor to perform monitoring and auditing activities, and be accessible to the 
clinical research monitor or auditor and respond to questions during monitoring visits or 
audit(s). 
• Allow and support regulatory authorities and the IRB/EC when performing auditing 
activities. 
• Ensure that an adequate investigation site team and facilities exist and are maintained and 
documented during the clinical investigation. 
 
All investigators will provide their qualifications and experience to assume responsibility for 
their delegated tasks through up-to-date curriculum vitae or other relevant documentation and 
disclose potential conflicts of interest, including financial, that may interfere with the conduct 
of the clinical study or interpretation of results. 
Delegation of Responsibility 
When specific tasks are delegated by an investigator, including but not limited to conducting 
data collection process, the Principal Investigator is responsible for providing appropriate 
training, are competent to perform the tasks they have been delegated and adequate supervision 
of those to whom tasks are delegated. Where there is a sub investigator at a site, the sub 
investigator should not be delegated the primary supervisory responsibility for the site. The 
investigator is accountable for regulatory violations resulting from failure to adequately 
supervise the conduct of the clinical study.  
13.3. Institutional Review Board/ Ethics Committee 
The investigational site will obtain the written and dated approval/favorable opinion of the 
IRB/EC for the clinical investigation and ICF before recruiting subjects. 
A copy of the written IRB/EC and/or competent authority (CA) approval of the protocol (or 
permission to conduct the study) and ICF, must be received by the sponsor before recruitment 
of subjects.  
 
Any amendment to the protocol will require review and approval by the IRB/EC before the 
changes are implemented to the study.  Any amendment to ICF will require review and 
approval by  IRB/EC.Annual IRB/EC approval and renewals will be obtained throughout the 

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duration of the study as required by applicable local/country laws or regulations or IRB/EC 
requirements. Copies of the study reports and the IRB/EC continuance of approval must be 
provided to the sponsor.  
13.4. Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this study 
will be considered confidential by BSC and will be kept confidential in accordance with all 
applicable laws and regulations. Only authorized BSC personnel and/or a BSC representative 
including, but not limited to Contract Research Organization (CRO), will have access to this 
information. Authorized regulatory personnel have the right to inspect and copy all records 
pertinent to this study per guidelines issued by NMPA. Study data collected during this study 
may be used by BSC for the purposes of this study and publication, All data used in the analysis 
and reporting of this study or shared with a third-party researcher will be without identifiable 
reference to specific subjects. 
BSC adhere to all applicable regulations and laws. Information received during the study will 
not be used to market to subjects; subject names will not be placed on any mailing lists or sold 
to anyone for marketing purposes.  
 
Role of Boston Scientific Representatives 
BSC personnel may perform certain activities to ensure study quality. These activities may 
include the following. 
• Observing testing or medical procedures to provide information relevant to protocol 
compliance 
• Reviewing collected data and study documentation for completeness and accuracy 
 
Boston Scientific personnel will not do the following.  
• Practice medicine 
• Provide medical diagnosis or treatment to subjects 
• Discuss a subject’s condition or treatment with a subject  
• Independently collect critical study data (defined as primary or secondary endpoint data) 
• Enter data in electronic data capture systems or on paper case report forms 
14. Monitoring 
Monitoring will be performed during the study to assess continued compliance with the 
protocol and applicable regulations. In addition, the clinical research monitor verifies that 
study records are adequately maintained, that data are reported in a satisfactory manner with 
respect to timeliness, adequacy, and accuracy, and that the Principal Investigator continues to 
have sufficient staff and facilities to conduct the study safely and effectively. The source 
documents include but not limit to signed ICF, mdical recoredsy, image(if any), lab tests (if 

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any) and SAE. The Device deficiencies, relationships of AE and medical device/ procedure 
recored in the CRF will be considered as souce documents in this study. The sponsor will put 
a plan in place to document the specific monitoring requirements.  
The Principal Investigator/institution guarantees direct access to original or electronical source 
documents by BSC personnel, their designees, and appropriate regulatory authorities. If the 
souce docment can’t be acquired for subjects went to non-investigation hospital, the certified 
copies should be got and maintained. Source document related to SAE should be copied ( if 
applicable ) and sent to BSC safety. 
The study may also be subject to a quality assurance audit by BSC or its designees, as well as 
inspection by appropriate regulatory authorities. It is important that the Principal Investigator 
and relevant study personnel are available during on-site monitoring visits or audits and that 
sufficient time is devoted to the process. 
15. Potential Risks and Benefits 
15.1. Instructions for Use 
Please refer to the Instructions for Use for an overview of anticipated adverse (device) effects, 
and risks associated to the commercial device(s).   
15.2. Risks associated with Participation in the Clinical Study 
This study is retrocpective real world study, that the medical data generated in the previous 
clinical practice will be used, no new or additional intervention will be imposed on the subjects 
without additional risks, and there was no impacts on the health and right of the subjects. 
During the data collection in the study, no private information that can identify the subject will 
be collected, such as, name, ID number, hospital number, telephone number, address etc. 
15.3. Risk minimization actions 
There may be other unkonown risk. Risk related the data collection will be minimized via 
protecting subject privacy, abiding by the protocol and regulations of clinical study.   
15.4. Anticipated Benefits 
There is No anticipated benefits for subjects enrolled in this estrospective study.  
16. Safety Reporting 
16.1. Reportable Events by investigational site to Boston Scientific 
It is the responsibility of the investigator to assess and report to BSC any event which occurs 
in any of following categories: 
• All adverse events 
• All Serious Adverse Events 

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• All device related adverse events 
• All device related Serious Adverse Events 
• All procedure related adverse events 
• All procedure related Serious Adverse Events 
• All Device Deficiencies  
• Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects 
• New findings/updates in relation to already reported events 
When possible, the medical diagnosis should be reported as the Event Term instead of 
individual symptoms. 
If it is unclear whether or not an event fits one of the above categories, or if the event cannot 
be isolated from the device or procedure, it should be submitted as an adverse event and/or 
device deficiency. 
Any reportable event, whether prior to, during or subsequent to the procedure, must be 
recorded in the CRF. 
Underlying diseases and chronic conditions are not reported as AEs unless there is an increase 
in severity or frequency during the course of the investigation. Death should not be recorded 
as an AE, but should only be reflected as an outcome of one (1) specific SAE (see Table 16.2-
1 for AE definitions). 
Refer to Instructions for Use for the known risks associated with the commercial device(s). 
16.2. Definitions and Classification 
Adverse event definitions are provided in Table 16.2-1. Administrative edits were made on the 
safety definitions from ISO 14155 and EU 2017/745 for clarification purposes. 
 
Table 16.2-1: Safety Definitions  
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
 
 
 
 
Any untoward medical occurrence, unintended disease or injury, or any 
untoward clinical signs (including an abnormal laboratory finding) in 
subjects, users or other persons, in the context of a clinical investigation, 
whether or not related to the study medical device and whether anticipated 
or unanticipated.  
NOTE 1: This includes events related to the study medical device or 
comparator. 
NOTE 2: This definition includes events related to the procedures 
involved. 
NOTE 3: For users or other persons, this definition is restricted to events 
related to the study medical device.  
Adverse Device Effect (ADE) 
 
Ref: ISO 14155 
Adverse event related to the use of the study medical device 
NOTE 1: This includes any adverse event resulting from insufficiencies 
or inadequacies in the instructions for use, the deployment, the 

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Table 16.2-1: Safety Definitions  
Term 
Definition 
 
Ref: MEDDEV 2.7/3  
implantation, the installation, the operation, or any malfunction of the 
study medical device. 
NOTE 2: This definition includes any event resulting from use error or 
from intentional misuse of the study medical device. 
NOTE 3: This includes ‘comparator’ if the comparator is a medical 
device. 
Serious Adverse Event (SAE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
Adverse event that led to any of the following: 
a) death, 
b) serious deterioration in the health of the subject, users or other persons 
as defined by either: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, 
including chronic diseases, or  
3) in-patient hospitalization or prolongation of existing 
hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness 
or injury or permanent impairment to a body structure or a body 
function 
c) foetal distress, foetal death, or a congenital abnormality or birth defect 
including physical or mental impairment. 
NOTE 1: Planned hospitalization for a pre-existing condition, or a 
procedure required by the clinical investigational plan, without a serious 
deterioration in health, is not considered a serious adverse event.  
Serious Adverse Device Effect 
(SADE) 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
Adverse device effect that has resulted in any of the consequences 
characteristic of 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 
 
Ref: MEDDEV 2.7/3  
 
Serious adverse device effect which by its nature, incidence, severity, or 
outcome has not been identified in the current risk assessment. 
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 assessment. 

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Table 16.2-1: Safety Definitions  
Term 
Definition 
Serious Health Threat 
 
Ref: ISO 14155 
 
Signal from any adverse event or device deficiency that indicates an  
imminent risk of death or a serious deterioration in the health in subjects, 
users or other persons, and that requires prompt remedial action 
for other subjects, users or other persons. 
Note 1 to entry: This would include events that are of significant 
and unexpected nature such that they become alarming as a 
potential serious health hazard or possibility of multiple deaths 
occurring at short intervals. 
Device Deficiency 
 
Ref: ISO 14155 
 
Ref: MEDDEV 2.7/3  
An inadequacy of a medical device related to its identity, quality, 
durability, reliability, usability, safety or performance.  
NOTE 1: Device deficiencies include malfunctions, use errors, and 
inadequacy in the information supplied by the manufacturer including 
labelling. 
NOTE 2: This definition includes device deficiencies related to the 
investigational medical device or the comparator. 
The following definitions will be used for defining hospitalization or prolongation of hospitalization for SAE 
classification purposes: 
Hospitalizations  
Hospitalization does not include: 
• 
emergency room visit that does not result in in-patient admission  
Note: although an emergency room visit does not itself meet the 
definition for hospitalization, it may meet other serious criteria 
(e.g. medical or surgical intervention to prevent permanent 
impairment or damage) 
• 
elective and pre-planned treatment/surgery for a pre-existing 
condition that is documented in the subject’s record at the time of 
consent/enrollment 
• 
admission for social reasons and/or respite care in the absence of 
any deterioration in the subject’s general condition (e.g. subject is 
homeless, caregiver relief) 
• 
pre-planned, protocol-specified admission related to the clinical 
study (e.g. procedure required by protocol) 
Prolongation of hospitalization  
In-patient admission to the hospital that is prolonged beyond the expected 
standard duration for the condition under treatment. 
Note: new adverse events occurring during the hospitalization are 
evaluated to determine if they prolonged hospitalization or meet another 
SAE criteria. 
 
16.3. Relationship to Device(s) and/or Study Procedure 
The Investigator must assess the relationship of the reportable AE to the device, and/or study 
procedure. See criteria in Table 16.3-1.Table 16.3-1:  

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Table 16.3-1: Criteria for Assessing Relationship of Study Device or Procedure to 
Adverse Event 
Classification 
Description 
Not Related 
Ref: MEDDEV 2.7/3 
Relationship to the device, comparator or procedures can be excluded when: 
- the event is not a known side effect of the product category the device belongs to 
or of similar devices and procedures; 
- the event has no temporal relationship with the use of the study device or the 
procedures; 
- the serious event does not follow a known response pattern to the medical device 
(if the response pattern is previously known) and is biologically implausible; 
- the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible – and reintroduction of its use (or 
increase of the level of activation/exposure), do not impact on the serious event; 
- the event involves a body-site or an organ not expected to be affected by the 
device or procedure;  
- the serious event can be attributed to another cause (e.g. an underlying 
or concurrent illness/ clinical condition, an effect of another device, drug, treatment 
or other risk factors); 
- the event does not depend on a false result given by the study device used for 
diagnosis, when applicable; harms to the subject are not clearly due to use error; 
- In order to establish the non-relatedness, not all the criteria listed above might be 
met at the same time, depending on the type of device/procedures and the serious 
event. 
Possibly Related 
Ref: MEDDEV 2.7/3 
The relationship with the use of the study device or comparator, or the relationship 
with procedures is weak but cannot be ruled out completely. Alternative causes are 
also possible (e.g. an underlying or concurrent illness/ clinical condition or/and an 
effect of another device, drug or treatment). Cases were relatedness cannot be 
assessed or no information has been obtained should also be classified as possible. 
Probably Related 
Ref: MEDDEV 2.7/3 
The relationship with the use of the study device, comparator, or the relationship 
with procedures seems relevant and/or the event cannot be reasonably explained by 
another cause, but additional information may be obtained. 

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Table 16.3-1: Criteria for Assessing Relationship of Study Device or Procedure to 
Adverse Event 
Classification 
Description 
Causal Relationship 
Ref: MEDDEV 2.7/3 
The serious event is associated with the study device or comparator or with 
procedures beyond reasonable doubt when: 
- the event is a known side effect of the product category the device belongs to or 
of similar devices and procedures; 
- the event has a temporal relationship with the study device use/application or 
procedures; 
- the event involves a body-site or organ that 
-the study device or procedures are applied to; 
-the study device or procedures have an effect on; 
- the serious event follows a known response pattern to the medical device (if the 
response pattern is previously known); 
- the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious event (when clinically feasible); 
- other possible causes (e.g. an underlying or concurrent illness/ clinical condition 
or/and an effect of another device, drug or treatment) have been adequately ruled 
out; 
- harm to the subject is due to error in use; 
- the event depends on a false result given by the study device used for diagnosis, 
when applicable; 
- In order to establish the relatedness, not all the criteria listed above might be met 
at the same time, depending on the type of device/procedures and the serious event. 
 
16.4. Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Table 16.4-1. 
NOTE: Considering that this is a retrospective study base on licensed device used in BOAO 
pilot medical zone , the Requirements for reporting is not provided in current regulations. The 
enents will be reported as below, which is defined according to retrospective study and 
operation. 
Table 16.4-1:Requirements for reporting 
Event Classification 
Communication Method  
Communication Timeline post-market 
studies*  
(MEDDEV 2.12/1:  
GUIDELINES ON A MEDICAL DEVICE 
VIGILANCE SYSTEM) 
Unanticipated Adverse 
Device Effect / Unanticipated 
Serious Adverse Device 
Effect  
 
Complete AE eCRF page 
with all available new and 
updated information.  
• 
In period of data collection，within 5 
business day of the event identified for 
applicable study*. 
• 
Terminating at the end of the study. 
 

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Event Classification 
Communication Method  
Communication Timeline post-market 
studies*  
(MEDDEV 2.12/1:  
GUIDELINES ON A MEDICAL DEVICE 
VIGILANCE SYSTEM) 
*Applicable study= post market interventional 
study non-standard of care 
Provide all relevant source 
documentation (de-
identified/ pseudonymized) 
for reported event.  
• 
Upon request of sponsor.  
Serious Adverse 
Event,include Serious 
Adverse Device Effect 
Complete AE eCRF page 
with all available new and 
updated information.  
• 
In period of data collection，within 5 
business day of the event identified or as 
per local/regional regulations.  
• 
Reporting required through the end of 
study 
Provide all relevant source 
documentation (de-
identified/ pseudonymized) 
for reported event.  
• 
When documentation is available 
• 
Upon request of sponsor 
Device Deficiencies 
(including but not limited to 
failures, malfunctions, and 
product nonconformities) 
Note:  Any Device Deficiency 
that might have led to a 
serious adverse event if a) 
suitable action had not been 
taken or b) intervention had 
not been made or c) if 
circumstances had been less 
fortunate is considered a 
reportable event. 
Complete eCRFwith all 
available new and updated 
information.  
• 
In period of data collection，within 5 
business day of the event identified. 
Reporting required through the end of the 
study 
Provide all relevant source 
documentation (de-
identified/ pseudonymized) 
for reported event. 
• 
Upon request of sponsor  
Adverse Event including 
Adverse Device Effects 
Complete AE eCRF page, 
which contains such 
information as date of AE, 
treatment of AE resolution, 
assessment of seriousness 
and relationship to the 
device.  
• 
In period of data collection，within 10 
business day of the event identified  
• 
Reporting required through the end of 
study 
• 
Upon request of sponsor 
Provide all relevant source 
documentation (de-
identified/ pseudonymized) 
for reported event.  
 

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16.5. Boston Scientific Device Deficiencies 
Device deficiencies (including but not limit to malfunction, faulty production, etc) will be 
documented and reported to BSC. If possible, the device(s) should be returned to BSC for 
analysis.  
Device deficiencies are not adverse events. However, an adverse event that results from a 
device deficiency, would be recorded as an adverse event on the appropriate eCRF. 
16.6. Reporting to Regulatory Authorities / IRBs / ECs / Investigators 
BSC is responsible for reporting all adverse event and device deficiency information to 
IRB/EC, as applicable.  
The Principal Investigator is responsible for informing the IRB/EC, and regulatory authorities 
of U(S)ADEs and SAEs as required by China regulations. 
BSC will report all serious adverce events and device deficiencies which may lead to SAE to 
regulatory authorities in Hainan and Shanghai Within 10 business day of first becoming aware 
of the even duing data collection, and notify IRB/IEC in a timely manner. 
17. Informed Consent 
Subject participation in this clinical study is voluntary.  Informed Consent is required from 
each subject or his/her legally authorized representative. The Investigator is responsible for 
ensuring that Informed Consent is obtained prior to data collection.  
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155,  and china NMPA regulations, any 
applicable national regulations, and local Ethics Committee and/or Regulatory authority, as 
applicable. The ICF must be accepted by BSC or its delegate (e.g. CRO), and approved by 
the site’s IRB/EC, or central IRB, if applicable. 
Boston Scientific will provide a study-specific template of the ICF to investigators 
participating in this study. The ICF template may be modified to meet the requirements of the 
investigative site’s IRB/EC.  Any modification requires acceptance from BSC prior to use of 
the form.  The ICF must be in a language understandable to the subject and if needed, BSC 
will assist the site in obtaining a written consent translation. Translated consent forms must 
also have IRB/EC approval prior to their use.     
The process of obtaining Informed Consent shall at a minimum include the following steps, 
as well as any other steps required by applicable laws, rules, regulations and guidelines: 
• be conducted by the Principal Investigator or designee authorized to conduct the process,  
• include a description of all aspects of the clinical study that are relevant to the subject’s 
decision to participate throughout the clinical study, 
• avoid any coercion of or undue influence of subjects to participate, 
• not waive or appear to waive subject’s legal rights, 

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• use native language that is non-technical and understandable to the subject or his/her 
legal representative, 
• provide ample time for the subject to consider participation and ask questions if 
necessary, 
• ensure important new information is provided to new and existing subjects throughout the 
clinical study.  
The ICF shall always be signed and personally dated by the subject or legal representative 
competent to sign the ICF under the applicable laws, rules, regulations and guidelines and by 
the investigator and/or an authorized designee responsible for conducting the informed 
consent process. If a legal representative signs, the subject shall be asked to provide informed 
consent for continued participation as soon as his/her medical condition allows. The original 
signed ICF will be retained by the site and a copy of the signed and dated document and any 
other written information must be given to the person signing the form.  
Failure to obtain subject consent will be reported by BSC to the applicable regulatory 
authority according to their requirements (e.g., FDA requirement is within 5 working days of 
learning of such an event). Any violations of the informed consent process must be reported 
as deviations to the sponsor and local regulatory authorities (e.g. IRB/EC), as appropriate. 
If new information becomes available that can significantly affect a subject's future health 
and medical care, that information shall be provided to the affected subject(s) in written form 
via a revised ICF or, in some situations, enrolled subjects may be requested to sign and date 
an addendum to the ICF. In addition to new significant information during the course of a 
study, other situations may necessitate revision of the ICF, such as if there are amendments 
to the applicable laws, protocol, a change in Principal Investigator, administrative changes, or 
following annual review by the IRB/EC. The new version of the ICF must be approved by 
the IRB/EC. Acceptance by Boston Scientific is required if changes to the revised ICF are 
requested by the site’s IRB/EC. The IRB/EC will determine the subject population to be re-
consented. 
18. Committees 
18.1. Safety Monitoring Process 
The BSC personnel from the Medical Safety and Safety Trial Operation group review safety 
data as it is reported by the sites throughout the duration of the study. During scheduled 
monitoring activities, clinical research monitors further support this review through their 
review of source documents and other data information. The BSC Medical Safety and Safety 
Trial Operations team include health care providers with expertise in urology and with the 
necessary therapeutic and subject matter expertise to evaluate and classify the events into the 
categories outlined above.  
No committee will be included in this study ,such as clinical event committee, data monitoring 
committee, independent reviewer, etc. 

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19. Suspension or Termination 
19.1 Premature Termination of the Study 
Boston Scientific reserves the right to terminate the study at any stage but intends to exercise 
this right only for valid scientific or business reasons and reasons related to protection of 
subjects.  Investigators, associated IRBs/ECs, and regulatory authorities, as applicable, will be 
notified in writing in the event of study termination. 
19.1.1 Criteria for Premature Termination of the Study 
Possible reasons for premature study termination include, but are not limited to, the following: 
• Suspicion of an unacceptable risk, including serious health threat. In this case, the sponsor 
shall suspend the clinical investigation while the risk is assessed. The sponsor shall 
terminate the clinical investigation if an unacceptable risk which cannot be controlled is 
confirmed. 
• Instructions by the IRB/EC or regulatory authorities to suspend or terminate the clinical 
investigation. 
• An enrollment rate far below expectation that prejudices the conclusion of the study.  
19.2 Termination of Study Participation by the Investigator or Withdrawal of IRB/ 
EC Approval 
Any investigator, or associated IRB/EC or regulatory authority may discontinue participation 
in the study or withdraw approval of the study, respectively, with suitable written notice to 
Boston Scientific. Investigators, associated IRBs/ECs, and regulatory authorities, as applicable, 
will be notified in writing in the event of these occurrences. 
19.3 Requirements for Documentation and Subject Follow-up 
In the event of premature study termination a written statement as to why the premature 
termination has occurred will be provided to all participating sites by Boston Scientific. The 
IRB/EC and regulatory authorities, as applicable, will be notified.  
In the event an IRB/EC terminates participation in the study, participating investigators, 
associated IRBs/ECs, and regulatory authorities, as applicable, will be notified in writing. 
Detailed information on how enrolled subjects will be managed thereafter will be provided by 
Boston Scientific. 
In the event a Principal Investigator terminates participation in the study, study responsibility 
will be transferred to another investigator, if possible. In the event there are no opportunities 
to transfer Principal Investigator responsibility; detailed information on how enrolled subjects 
will be managed thereafter will be provided by Boston Scientific. 
The Principal Investigator or his/her designee must return all study-related documents and , if 
supplied by Boston Scientific, unless this action would jeopardize the rights, safety, or welfare 
of the subjects. 

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19.4 Criteria for Suspending/Terminating a Study Site 
Boston Scientific reserves the right to stop the inclusion of subjects at a study site at any time 
after the study initiation visit if no subjects have been enrolled  for a period beyond 6 months 
after site initiation, or if the site has multiple or severe protocol violations/noncompliance 
without justification and/or fails to follow remedial actions. 
The IRB/EC and regulatory authorities, as applicable, will be notified.  
 
20. Study Registration and Results 
20.1. Study Registration 
To comply with applicable laws and regulations, the study will be registered on a publicly 
accessible database. 
20.2. Clinical Investigation Report 
Study results will be made available in accordance with the legal requirements and the 
recognized ethical principles, in accordance with the Boston Scientific Policy. A Clinical 
Investigation Report will be made available to all investigators, IRB/EC and regulatory 
authorities, as applicable in accordance with the Boston Scientific Policy and local 
requirements.  As applicable an abbreviated Clinical Investigation Report will be made 
available on a publicly accessible database. 
20.3. Publication Policy 
BSC requires disclosure of its involvement as a sponsor or financial supporter in any 
publication or presentation relating to a BSC study or its results. BSC may submit study results 
for publication (regardless of study outcome) following the conclusion or termination of the 
study. Boston Scientific adheres to the Contributorship Criteria set forth in the Uniform 
Requirements of the International Committee of Medical Journal Editors (ICMJE; 
http://www.icmje.org). In order to ensure the public disclosure of study results in a timely 
manner, while maintaining an unbiased presentation of study outcomes, BSC personnel may 
assist authors and investigators in publication preparation provided the following guidelines 
are followed:  
• All authorship and contributorship requirements as described above must be followed. 
• BSC involvement in the publication preparation and the BSC Publication Policy should be 
discussed with the Coordinating Principal Investigator(s) and/or Executive/Steering 
Committee at the onset of the project. 
• The First and Senior authors are the primary drivers of decisions regarding publication 
content, review, approval, and submission.  

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The data, analytic methods, and study materials for this clinical trial may be made available to 
other researchers in accordance with the Boston Scientific Data Sharing Policy (Please contact 
Boston Scientific staff for further information: Lin Hui，010-61412942). 
21. Bibliography 
1. Ackerman SJ, Rein AL, Blute M, Beusterien K, Sullivan EM, Tanio CP, Manyak MJ, 
Strauss MJ. Cost effectiveness of microwave thermotherapy in patients with BPH: Part 
I – Methods. Urology, 2000;56:972-980.  
2. 2008 MedTech Insight BPH Report.  
3. 良性前列腺增生诊断治疗指南-中华泌尿外科协会诊疗指南系列2014 
4. AUA Practice Guidelines Committee. AUA Guideline on Management of Benign 
Prostatic Hyperplasia (2003). Chapter 1: Diagnosis and treatment recommendations. J 
Urol. 2003;170:530-547 . 
5. McVary KT, Gange SN, Gittelman MC, et al. Minimally Invasive Prostate Convective 
Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the 
Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. 
J Urol. 2016;195(5):1529-1538. doi:10.1016/j.juro.2015.10.181 
6. Roehrborn CG, Gange SN, Gittelman MC, et al. Convective Thermal Therapy: Durable 
2-Year Results of Randomized Controlled and Prospective Crossover Studies for 
Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. J 
Urol. 2017;197(6):1507-1516. doi:10.1016/j.juro.2016.12.045 
7. McVary KT, Roehrborn CG. Three-Year Outcomes of the Prospective, Randomized 
Controlled Rezūm System Study: Convective Radiofrequency Thermal Therapy for 
Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. 
Urology. 2018;111:1-9. doi:10.1016/j.urology.2017.10.023 
8. McVary KT, Rogers T, Roehrborn CG. Rezūm Water Vapor Thermal Therapy for Lower 
Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results 
From 
Randomized 
Controlled 
Study. 
Urology. 
2019;126:171-179. 
doi:10.1016/j.urology.2018.12.041 
9. McVary KT, Roehrborn C. Five year results of the prospective, randomized controlled 
trial of water vapor thermal therapy for treatment of lower urinary tract symptoms due 
to benign prostatic hyperplasia. Late-Breaking Abstract 01-06. J Urol. 2020 
Apr;203(4):e1021 
22. Abbreviations and Definitions  
22.1. Abbreviations 
Abbreviations are shown in Table22.1-1.   

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Table 22.1-1: Abbreviations 
Abbreviation/Acronym 
Term 
AE 
Adverse event 
AUASI 
The American Urological Association Symptom Index 
BPH 
Benign prostatic hyperplasia 
CRF 
case report form 
DUS 
Doppler ultrasound 
eCRF 
Electronical case report form 
FDA 
Food and drug administration  
GCP 
Good clinical practice  
ICH 
International Conference on Harmonization 
IIEF 
The International Index of Erectile Function 
IPSS 
International Prostate Symptom Score 
IRB 
Institutional Review Board 
LCI 
Lower confidence interval 
LUTS 
lower urinary tract symptoms 
MSHQ-EjD 
Male Sexual Health Questionnaire Short Form- Ejaculation dysfunction 
MRI 
Magnetic Resonance Imaging 
PVR 
Post Void Residual Urine Volume 
Qmax 
Peak Flow Rate  
QoL 
quality of life 
SADE  
serious adverse device effect 
SAE 
serious adverse event 
TURP 
transurethral resection of the prostate 
UADE 
unanticipated adverse device effect 
USADE 
unanticipated serious adverse device effect