A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of the Solyx™ Single Incision Sling System vs. the Obtryx™ II Sling System for the Treatment of Women With Stress Urinary Incontinence
Phase: NA
Conditions: Stress Urinary Incontinence
Sponsor: Boston Scientific Corporation

Solyx Protocol (U9915) 
Cover Page 
NCT01784588 
A prospective, Non-randomized, Parallel Cohort, Multi-Center Study of the Solyx™ Single Incision Sling 
System Vs. The Obtryx II™ Sling System for the Treatment of Women with Stress Urinary Incontinence 
Date Last Updated: August 22, 2018 

Boston Scientific 
Protocol U9915 – Solyx vs. Obtryx 
  
 
 
 
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Postmarket Study PS120093 
Solyx™ Study 
 
CLINICAL PROTOCOL 
 
 
A Prospective, Non-Randomized, Parallel Cohort, Multi-center Study of the Solyx™ Single 
Incision Sling System vs. the Obtryx™ II Sling System for the Treatment of Women with 
Stress Urinary Incontinence 
 
Sponsored By 
Boston Scientific Corporation 
 
 
 
 
 
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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Postmarket Solyx™ Study PS120093:  A Prospective, Non-Randomized, 
Parallel Cohort, Multi-center Study of the Solyx™ Single Incision Sling 
System vs. the Obtryx™ II Sling System for the Treatment of Women with 
Stress Urinary Incontinence 
• Week 2 Visit  
• Week 6 Visit 
• Month 6 Visit 
• Month 12 Visit 
• Month 18 Visit 
• Month 24 Visit 
• Month 36 Visit (End of study) 
Study 
Duration 
Approximately 3 years from last subject enrolled 
Key 
Inclusion 
Criteria 
1. Female ≥ 18 years of age 
2. Willing and able to comply with the study procedures and provide 
written informed consent to participate in the study (subject or legal 
representative) 
3. Diagnosed with predominant SUI confirmed by positive cough stress 
test during  the protocol required bladder fill procedure (see manual of 
operations) 
4. Confirmed SUI is greater than urge incontinence with MESA 
5. Cystometric capacity ≥ 300 cc 
6. Post-void residual (PVR) of < 150 cc  
7. Medically approved for general, regional or monitored anesthesia 
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PS120093 
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Postmarket Solyx™ Study PS120093:  A Prospective, Non-Randomized, 
Parallel Cohort, Multi-center Study of the Solyx™ Single Incision Sling 
System vs. the Obtryx™ II Sling System for the Treatment of Women with 
Stress Urinary Incontinence 
Key 
Exclusion 
Criteria 
1. Subjects who are pregnant, lactating, or planning future pregnancies  
2. Subjects with a chief complaint of overactive bladder  
3. Subjects with a pattern of recurrent urinary tract infections, defined as ≥ 2 
culture-proven urinary tract infections during a 6-month period prior to 
surgery or ≥ 3 in a 12-month period 
4. Subjects with previous surgical procedures for SUI including bulking, 
urethral sling, bone anchor, Burch procedure, pubo-vaginal sling, and 
MMK procedure. Previous surgical procedures for SUI does not include 
Kelly plication, Botox, anterior repair, or Inter-Stim.  
5. Subjects with prior pelvic organ prolapse surgery who experienced mesh 
complications 
6. Subjects with previous radiation therapy to the pelvis 
7. Subjects with known or suspected hypersensitivity to polypropylene mesh  
8. Subjects with any of the following confounding conditions: 
a. Neurogenic bladder 
b. Urethral stricture and bladder neck contracture 
c. Bladder stones or tumors 
d. Urinary tract fistula or diverticula 
e. Pathology which would compromise implant placement including 
subjects  currently taking anticoagulation therapy 
f. Pathology that would limit blood supply or infections that would 
compromise healing including chemotherapy, systemic steroids 
and systemic immunosuppressants 
9. Subjects with diabetes and an A1c ≥ 7% 
10. Non-English speaking subjects 
11. Subjects who have participated in an investigational study (medical 
device or drug) within 30 days of study entry that may impact analysis of 
this device or have previously participated in the current study 
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PS120093 
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Postmarket Solyx™ Study PS120093:  A Prospective, Non-Randomized, 
Parallel Cohort, Multi-center Study of the Solyx™ Single Incision Sling 
System vs. the Obtryx™ II Sling System for the Treatment of Women with 
Stress Urinary Incontinence 
Primary 
Statistical 
Hypothesis 
The single incision sling will be non-inferior to the standard outside-in 
transobturator sling for the treatment of female stress urinary incontinence in 
safety and effectiveness at 36 months as compared to Baseline.  
Statistical testing will be performed to determine if success rate of 
improvement in stress urinary incontinence at 36 months of single incision 
sling (treatment) group will be non-inferior to transobturator device (control) 
group. The null hypothesis is that the success rate in treatment group is less 
than or equal to the success rate in control group minus margin: 
 
𝐻𝐻𝐻𝐻: 𝜋𝜋𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡−𝜋𝜋𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑟𝑟𝑟𝑟𝑟𝑟 ≤ − ∆   
 
 
The alternative hypothesis is:  
 
𝐻𝐻𝐻𝐻: 𝜋𝜋𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡− 𝜋𝜋𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐> − ∆     
 
where 𝜋𝜋𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡 
 and 𝜋𝜋𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐 are the success rate of improvement in stress 
urinary incontinence at 36 months in treatment group and control group 
respectively, and ∆ is defined as the non-inferiority margin. 
 
 
 
 
 
 
 
 
 
 
 
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3. Table of Contents 
1. 
TITLE PAGE  ........................................................................................................................ 1 
2. 
PROTOCOL SYNOPSIS .......................................................................................................... 4 
3. 
TABLE OF CONTENTS ........................................................................................................ 10 
 
3.2. Table of Tables ....................................................................................................... 14 
4. 
INTRODUCTION ................................................................................................................. 15 
5. 
DEVICE DESCRIPTION ....................................................................................................... 16 
6. 
OBJECTIVES ...................................................................................................................... 16 
7. 
ENDPOINTS ........................................................................................................................ 16 
8. 
DESIGN .............................................................................................................................. 17 
8.1. Scale and Duration ................................................................................................. 17 
8.2. Treatment Assignment .......................................................................................... 20 
8.2.1. 
Treatment and Control ............................................................................... 20 
9. 
SUBJECT SELECTION ......................................................................................................... 20 
9.1. Study Population and Eligibility ........................................................................... 20 
9.2. Inclusion Criteria ................................................................................................... 21 
9.3. Exclusion Criteria .................................................................................................. 21 
10. SUBJECT ACCOUNTABILITY .............................................................................................. 22 
10.1. Point of Enrollment ................................................................................................ 22 
10.2. Withdrawal ............................................................................................................. 22 
11. STUDY METHODS .............................................................................................................. 23 
 
11.2. Study Candidate Screening ................................................................................... 27 
11.3. Informed Consent .................................................................................................. 27 
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12.3.5. Changes to Planned Analyses .................................................................... 40 
13. DATA MANAGEMENT ........................................................................................................ 40 
13.1. Data Collection, Processing, and Review ............................................................. 40 
13.2. Data Retention ........................................................................................................ 40 
14. AMENDMENTS ................................................................................................................... 41 
15. DEVIATIONS ...................................................................................................................... 41 
16. DEVICE/EQUIPMENT ACCOUNTABILITY .......................................................................... 41 
17. COMPLIANCE ..................................................................................................................... 42 
17.1. Statement of Compliance ....................................................................................... 42 
17.2. Investigator Responsibilities ................................................................................. 42 
17.2.1. Delegation of Responsibility ..................................................................... 43 
17.3. Institutional Review Board/ Ethics Committee ................................................... 44 
17.4. Sponsor Responsibilities ........................................................................................ 44 
17.5. Insurance ................................................................................................................. 44 
18. MONITORING ..................................................................................................................... 44 
19. POTENTIAL RISKS AND BENEFITS .................................................................................... 45 
19.1. General .................................................................................................................... 45 
19.2. Anticipated Adverse Events .................................................................................. 45 
19.2.1. Mesh Exposure and Erosion Event Classification ..................................... 46 
19.3. Risks associated with Participation in the Clinical Study .................................. 47 
19.4. Risk Minimization Actions .................................................................................... 47 
19.5. Anticipated Benefits ............................................................................................... 47 
 
20. INFORMED CONSENT ......................................................................................................... 47 
21. SAFETY REPORTING .......................................................................................................... 49 
21.1. Definitions and Classification ............................................................................... 49 
21.2. Relationship to Study Device(s) ............................................................................ 50 
21.3. Relationship to Study Procedure .......................................................................... 50 
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21.4. Investigator Reporting Requirements .................................................................. 51 
 
21.6. Reporting to Regulatory Authorities / IRBs / ECs / Investigators .................... 52 
 
 
23. SUSPENSION OR TERMINATION ......................................................................................... 53 
23.1 Premature Termination of the Study ................................................................... 53 
23.1.1 
Criteria for Premature Termination of the Study ....................................... 53 
23.2 Termination of Study Participation by the Investigator or Withdrawal of 
IRB/ EC Approval .................................................................................................. 53 
23.3 Requirements for Documentation and Subject Follow-up ................................. 53 
23.4 Criteria for Suspending/Terminating a Study Center ........................................ 54 
 
 
26. ABBREVIATIONS AND DEFINITIONS .................................................................................. 57 
26.1. Abbreviations ......................................................................................................... 57 
26.2. Definitions ............................................................................................................... 57 
 
 
 
 
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Once enrolled into the study, subjects will be followed to 36 months post-surgery to be 
evaluated for the primary endpoint analysis.  The total duration of each subject’s 
participation in the study is 36 months from study procedure.  
Subjects who undergo a medical intervention (surgical or non-surgical) to treat recurrence, 
persistence of SUI, or a mesh complication will be followed to 36 months, post the initial 
study procedure.  
 
 
 
 
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who will undergo the surgical placement of a sling as treatment, who may or may not also 
undergo a concomitant procedure (such as pelvic floor prolapse repair).  
To assess for eligibility for this study, inclusion and exclusion criteria are included in 
Sections 9.2 and 9.3 below.  
9.2. Inclusion Criteria 
Subjects who meet all of the following criteria may be given consideration for inclusion in 
this clinical investigation, provided no exclusion criterion (see Section 9.3) is met. 
1. Female ≥ 18 years of age 
2. Willing and able to comply with the study procedures and provide written informed 
consent to participate in the study (subject or legal representative) 
3. Diagnosed with predominant SUI confirmed by positive cough stress test during  the 
protocol required bladder fill procedure (see manual of operations) 
4. Confirmed SUI is greater than urge incontinence with MESA 
5. Cystometric capacity ≥ 300 cc 
6. Post-void residual (PVR) of ≤ 150 cc 
7. Medically approved for general, regional or monitored anesthesia 
9.3. Exclusion Criteria 
Subjects who meet any one of the following criteria will be excluded from this clinical study. 
1. Subjects who are pregnant, lactating, or planning future pregnancies 
2. Subjects with a chief complaint of overactive bladder  
3. Subjects with a pattern of recurrent urinary tract infections, defined as ≥ 2 culture-
proven urinary tract infections during a 6-month period prior to surgery or ≥ 3 in a 
12-month period 
4. Subjects with previous surgical  procedures for SUI including bulking, urethral sling, 
bone anchor, Burch procedure, pubo-vaginal sling, and MMK procedure. Excluding 
Kelly plication, Botox, anterior repair, or Inter-Stim 
5. Subjects with prior pelvic organ prolapse surgery who experienced mesh 
complications 
6. Subjects with previous radiation therapy to the pelvis 
7. Subjects with known or suspected hypersensitivity to polypropylene mesh 
8. Subjects with any of the following confounding conditions: 
a. Neurogenic bladder 
b. Urethral stricture and bladder neck contracture 
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c. Bladder stones or tumors 
d. Urinary tract fistula or diverticula 
e. Pathology which would compromise implant placement including subjects  
currently taking anticoagulation therapy 
f. Pathology that would limit blood supply or infections that would compromise 
healing including chemotherapy, systemic steroids and systemic 
immunosuppressants 
9. Subjects with diabetes and an A1c ≥ 7% 
10. Non-English speaking subjects 
11. Subjects who have participated in an investigational study (medical device or drug) 
within 30 days of study entry that may impact analysis of this device or have 
previously participated in the current study 
10. Subject Accountability 
10.1. Point of Enrollment 
Subjects will be considered enrolled once they have been determined to be eligible against all 
inclusion and exclusion criteria and have signed Informed Consent. Subjects will be 
considered Intent-to-Treat (ITT) once the sling procedure has been initiated (i.e. anesthesia 
administered).  All enrolled subjects will be assigned to receive either the treatment or 
control device by the Investigator prior to the site initiation as sites will be device-specific 
centers.  All ITT subjects who receive the assigned device and have no major protocol 
deviations will be considered part of the Per Protocol analysis.      
10.2. Withdrawal 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study 
or lost to follow-up) will be accounted for and documented. If a subject withdraws from the 
clinical investigation, the reason(s) will be recorded.  
Reasons for study withdrawal may include, withdrawn consent, lost to follow-up, subject 
death or other reasons to be documented on the Case Report Form.  
Once a subject withdraws from the study, the Case Report Form will be completed as 
appropriate up to the point of withdrawal and all Adverse Events shall be closed or 
documented as appropriate.  Withdrawn subjects will be included in the ITT analysis and will 
not be replaced.  
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11.5. Study Completion 
All subjects who have completed the study surgery and discharge will proceed to follow-up 
through the above-outlined study visits to Month 36 where the primary endpoint analysis will 
be assessed.  The study will be considered complete when the last  subject completes this 
visit.  All subjects completing the Month 36 visit will be considered complete.   
11.6. Re-Intervention 
It is the intention of this study to demonstrate an improvement in stress urinary incontinence 
through clinical effectiveness of a single incision sling.  However, it is recognized that during 
the course of the study, there is a possibility subjects may require a re-intervention for events 
including but not limited to failed sling repair, persistence of SUI symptoms, or a mesh-
related complication.  A re-intervention may include surgical or non-surgical treatments 
(medical). For the purpose of this study surgical interventions shall be classified as “re-
surgery” and non-surgical interventions shall be classified as “re-interventions”.   
Non-surgical interventions (re-interventions) are defined as office-based procedures and do 
not involve an operating room procedure.  Examples of non-surgical interventions may 
include but are not limited to an office visit to trim exposed mesh in the vagina or physical 
therapy to treat procedural complications or persistent SUI symptoms.  Data on non-surgical 
interventions will be captured in the CRFs.  Subjects will continue to be followed per the 
regular study visit schedule.   
Surgical interventions (re-surgery) are surgical operations or procedures performed to correct 
recurring SUI symptoms or a mesh-related complication.  These surgical events typically 
may occur on an outpatient basis yet can require admission to a hospital.  Surgical events 
may include a re-operation to remove mesh material or to loosen the sling as well as a 
bulking agent application to treat recurrence. The decision to perform a re-surgery will be per 
physician and subject discretion and all re-surgery data will be captured in the Case Report 
Forms.  Subjects undergoing re-surgery to treat recurrence or persistence of SUI symptoms 
are considered treatment failures. 
Subjects undergoing a re-surgery will be followed to 36 months post their initial study 
procedure as indicated in 
  The subject should return to the clinic for the next 
regular study visit as per the adjusted schedule.  If the subject elects to not undergo re-
surgery, then the subject will be followed to the Month 36 visit unless the subject chooses to 
withdraw consent from the study.  No subject will be followed for more than 36 months 
beyond their initial study procedure.  
11.7. Subject Death 
In the event of a subject death, results are to be documented in the source documentation and 
Case Report Form and reported to the Sponsor within the timeframe noted in Table 21.4-1: 
Investigator Reporting Requirements.  If an autopsy is conducted, a copy of the final autopsy 
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12.3.5. Changes to Planned Analyses 
Any changes to the planned statistical analyses made will be documented in an amended 
Statistical Analysis Plan.  Changes from the planned statistical methods will be documented 
in the clinical study report along with a reason for the deviation. 
13. Data Management 
13.1. Data Collection, Processing, and Review 
Good Clinical Practice Guidelines require that investigators maintain information in the 
subject’s medical records, laboratory reports, clinic charts that correspond to data recorded 
on the Case Report Forms. In order to comply with these requirements, the following 
information should be maintained as source documentation, including but not limited to: 
• Medical history/physical condition of the subject before enrollment 
• Protocol entry criteria 
• Dated and signed notes for specific results of procedures and exams 
• Laboratory reports 
• Information related to adverse events 
• Re-interventions (including physical therapy, bulking, mesh trimming) 
• Surgical notes, including subject condition and re-surgery if applicable 
• Quality of life assessments and VAS pain scales 
• Discharge Summaries/Procedure reports 
• Autopsy reports 
Subject data will be recorded on Case Report Forms which will be provided by the Sponsor 
or designated vendor. The data reported on the Case Report Forms shall be derived from 
source documentation and shall be consistent with these source documents.  Any 
discrepancies shall be explained and documented. Any change or correction made to the 
clinical data will be dated, initialed, and explained, if necessary, and shall not obscure the 
original entry. An audit trail shall be maintained which will be made available for review by 
the Sponsor or its representative.  Any queries to the data will be addressed by the study 
center staff in a timely manner.  
13.2. Data Retention 
The investigator will maintain, at the investigative site, in original format all essential study 
documents and source documentation that support the data collected on study subjects in 
compliance with ICH/GCP guidelines.  Documents must be retained for at least 2 years after 
the last approval of a marketing application or until at least 2 years have elapsed since the 
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formal discontinuation of the clinical investigation of the product. These documents will be 
retained for a longer period of time by agreement with the Sponsor or in compliance with 
other local regulations. It is BSC’s responsibility to inform the investigator when these 
documents no longer need to be maintained. The investigator will take measures to ensure 
that these essential documents are not accidentally damaged or destroyed. If for any reason 
the investigator 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.  
14. Amendments  
If a protocol revision is necessary for reasons including but not limited to, the rights, safety 
or welfare of the subject, or scientific integrity of the data, an amendment is required. 
Appropriate approvals (e.g., IRB/EC/FDA/CA) of the revised protocol must be obtained 
prior to implementation. 
15. Deviations 
An Investigator must not make any changes or deviate from this protocol, except to protect 
the life and physical well-being of a subject in an emergency. An investigator shall notify the 
sponsor and the reviewing IRB/EC of any deviation from the investigational plan to protect 
the life or physical well-being of a subject in an emergency, and those deviations which 
affect the scientific integrity of the clinical investigation. Such notice shall be given as soon 
as possible, but no later than 5 working days after the emergency occurred, or per prevailing 
local requirements, if sooner than 5 working days.  
All deviations from the investigational plan, with the reason for the deviation and the date of 
occurrence, must be documented and reported to the Sponsor.  Study centers may also be 
required to report deviations to their IRB/EC, per local guidelines and government 
regulations.  
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including notification, center re-training, or 
discontinuation) will be put into place by the Sponsor. 
16. Device/Equipment Accountability 
This is a post-market study and therefore no investigational devices are being used.  All 
commercial and institutional policies regarding but not limited to device use, purchase and/or 
storage will be followed.   
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17. Compliance 
17.1. Statement of Compliance 
This study will be conducted in accordance with ICH/GCP Guidelines, ethical principles that 
have their origins in the Declaration of Helsinki, and pertinent individual country 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, as appropriate. Any additional 
requirements imposed by the IRB/EC or regulatory authority shall be followed, if 
appropriate. 
17.2. Investigator Responsibilities 
The Principal Investigator of an investigational center is responsible for ensuring that the 
study is conducted in accordance with the Clinical Study Agreement, the investigational 
plan/protocol, 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 Investigator Agreement and Protocol Signature 
page documenting his/her agreement to conduct the study in accordance with the 
protocol. 
• Provide his/her qualifications and experience to assume responsibility for the proper 
conduct of the study and that of key members of the center team through up-to-date 
curriculum vitae or other relevant documentation and disclose potential conflicts of 
interest, including financial, that may interfere with the conduct of the clinical study or 
interpretation of results. 
• Make no changes in or deviate from this protocol, except to protect the life and physical 
well-being of a subject in an emergency; document and explain any deviation from the 
approved protocol that occurred during the course of the clinical investigation. 
• Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all clinical-
investigation-related records are retained per requirements. 
• Ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
sponsor in the CRFs and in all required reports. 
• Record, report, and assess (seriousness and relationship to the device/procedure) every 
adverse event and observed device deficiency. 
• Report to BSC, per the protocol requirements, all SAEs and device deficiencies that 
could have led to a SADE. 
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• Report to the IRB/EC and regulatory authorities any SAEs and device deficiencies that 
could have led to a SADE, if required by the national 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 
monitor and respond to questions during monitoring visits. 
• Allow and support regulatory authorities and the IRB/EC when performing auditing 
activities. 
• Ensure that informed consent is obtained in accordance with this protocol and local 
IRB/EC requirements. 
• Provide adequate medical care to a subject during and after a subject’s participation in a 
clinical study in the case of adverse events, as described in the Informed Consent Form 
(ICF). 
• Inform the subject of the nature and possible cause of any adverse events experienced. 
• Inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required. 
• Ensure that clinical medical records are clearly marked to indicate that the subject is 
enrolled in this clinical study. 
• Ensure that, if appropriate, subjects enrolled in the clinical investigation are provided 
with some means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided). 
• Inform, with the subject’s approval or when required by national regulations, the 
subject’s personal physician about the subject’s participation in the clinical investigation. 
• Make all reasonable efforts to ascertain the reason(s) for a subject’s premature 
withdrawal from clinical investigation while fully respecting the subject’s rights. 
• Ensure that an adequate investigation site team and facilities exist and are maintained and 
documented during the clinical investigation. 
• Ensure that maintenance and calibration of the equipment relevant for the assessment of 
the clinical investigation is appropriately performed and documented, where applicable. 
17.2.1. Delegation of Responsibility 
When specific tasks are delegated by an investigator, included but not limited to conducting 
the informed consent process, the investigator is responsible for providing appropriate 
training and adequate supervision of those to whom tasks are delegated. The investigator is 
accountable for regulatory violations resulting from failure to adequately supervise the 
conduct of the clinical study.  
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17.3. Institutional Review Board/ Ethics Committee 
Prior to gaining Approval-to-Enroll status, the investigational center will provide to the 
sponsor documentation verifying that their IRB/EC is registered or that registration has been 
submitted to the appropriate agency, as applicable according to national/regulatory 
requirements.   
A copy of the written IRB/EC and/or competent authority approval of the protocol (or 
permission to conduct the study) and Informed Consent Form, must be received by the 
sponsor before recruitment of subjects into the. Prior approval must also be obtained for 
other materials related to subject recruitment or which will be provided to the subject. 
Annual IRB/EC approval and renewals will be obtained throughout the duration of the study 
as required by local/country or IRB/EC requirements. Copies of the Investigator’s reports 
and the IRB/EC continuance of approval must be provided to the sponsor.  
17.4. Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this study 
will be considered confidential by BSC. Only authorized BSC personnel or a BSC 
representative will have access to these confidential records. Authorized regulatory personnel 
have the right to inspect and copy all records pertinent to this study. Study data collected 
during this study may be used by BSC for the purposes of this study, publication, and to 
support future research and/or other business purposes. All data used in the analysis and 
reporting of this study will be without identifiable reference to specific subject name. 
BSC will keep subjects’ health information confidential in accordance with all applicable 
laws and regulations.  BSC may use subjects’ health information to conduct this research, as 
well as for additional purposes, such as overseeing and improving the performance of its 
device, new medical research and proposals for developing new medical products or 
procedures, and other business purposes. 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.  
17.5. Insurance  
Where required by local/country regulation, proof and type of insurance coverage, by BSC 
for subjects in the study will be obtained. 
18. Monitoring 
Monitoring will be performed during the study to assess continued compliance with the 
protocol and applicable regulations. In addition, the 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 investigator continues to have sufficient 
staff and facilities to conduct the study safely and effectively. The investigator/institution 
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guarantees direct access to original source documents by BSC personnel, their designees, and 
appropriate regulatory authorities. 
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 investigator and 
relevant study personnel are available during on-site monitoring visits or audits and that 
sufficient time is devoted to the process. 
19. Potential Risks and Benefits 
19.1. General   
The risks and benefits of performing a suburethral sling procedure in the following subjects 
should be carefully considered due to additional risks associated with their conditions: 
• Women planning future pregnancies 
• Overweight women (weight parameters to be determined by the physician) 
• Subjects with blood coagulation disorder 
• Subjects with a compromised immune system or any other condition that would 
compromise healing 
• Subjects with renal insufficiency or upper urinary tract obstruction 
19.2. Anticipated Adverse Events  
The following anticipated adverse events (AE) have been reported due to suburethral sling 
placement, but are not limited to: 
• Abscess 
• Allergic reaction 
• Bleeding 
• Bruising/Hematoma 
• Dehiscence of vaginal incision 
• Detrusor Instability 
• De Novo Dyspareunia 
• Edema/Erythema 
• Exposure 
• Erosion 
• Extrusion 
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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 center’s IRB/EC.  Any modification requires approval 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 center in obtaining a written consent translation. Translated consent forms 
must also have IRB/EC approval prior to their use.  Privacy language shall be included in the 
body of the form or as a separate form as applicable.   
The process of obtaining Informed Consent shall: 
• be conducted by the Principal Investigator or designee authorized to conduct the process,  
• include a description of all aspects of the clinical study that are relevant to the subject’s 
decision to participate throughout the clinical study, 
• avoid any coercion of or undue influence of subjects to participate, 
• not waive or appear to waive subject’s legal rights, 
• use native language that is non-technical and understandable to the subject or his/her 
legal representative, 
• provide ample time for the subject to consider participation and ask questions if 
necessary, 
• ensure important new information is provided to new and existing subjects throughout the 
clinical study. 
The ICF shall always be signed and personally dated by the subject or legal representative 
and by the investigator 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 center 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 body 
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 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. 
Boston Scientific approval is required if changes to the revised ICF are requested by the 
center’s IRB/EC. The IRB/EC will determine the subject population to be re-consented. 
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A Screening/Enrollment Log will be maintained to document select information about 
candidates who fail to meet the general or “other specific” entry criteria.  
21. Safety Reporting 
21.1. Definitions and Classification 
Adverse event definitions are provided in Table 21.1-1. Administrative edits were made to 
combine definitions from ISO 14155-2011 and MEDDEV 2.7/3 12/2010. 
 
Table 21.1-1: Adverse Event Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
 
 
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.  
NOTE 1: This includes events related to the investigational medical device 
or comparator. 
NOTE 2: This definition includes events related to the procedures involved 
(any procedure in the clinical investigation plan). 
NOTE 3: For users or other persons, this definition is restricted to events 
related to the investigational medical device.  
Serious Adverse Event (SAE) 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
Adverse event that: 
• Led to death, 
• Led to  serious deterioration in the health of the subject, that either 
resulted in: 
o a life-threatening illness or injury, or 
o a permanent impairment of a body structure or a body function, or 
o in-subject  or prolonged hospitalization of existing hospitalization, or 
o medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function 
• Led to fetal distress, fetal death, or a congenital abnormality or birth 
defect. 
NOTE 1: 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.  
Device Deficiency 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
A device deficiency is any inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety or performance. 
NOTE 1: Device deficiencies include malfunctions, misuse or use errors, 
and inadequate labeling. 
 
Abbreviations: EC=Ethics Committee; IRB=Institutional Review Board 
 
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Underlying diseases 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 a specific SAE (see Table 21.1-1 for AE 
definitions).  
Any device related or study procedure related AE experienced by the study subject after 
informed consent, whether during or subsequent to the procedure, must be recorded in the 
CRF.  Only device and procedure-related AE’s are captured in this study.   
Refer to Section 19 for the known risks associated with the study device(s). 
21.2. 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 21.2-1:  
Table 21.2-1: 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. 
21.3. 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 21.2-1:  
Table 21.3-2: 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. 
Possibly Related 
• The adverse event has a timely relationship to procedure performed.   
However, a potential alternative etiology may be responsible for the adverse 
event. 
Probably Related 
• The adverse event has a timely relationship to the study procedure performed and 
the causative relationship can be clearly established. No potential alternative 
etiology is apparent.  
 
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21.4. Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Table 21.4-1. 
Table 21.4-1: Investigator Reporting Requirements 
Event Classification 
Communication Method  
Communication Timeline  
Adverse device Effects and 
Serious Adverse Device 
Effects. 
Events assessed for reporting 
shall include but are not 
limited to: 
• 
Mesh exposure in the 
vagina 
• 
Mesh erosion into the 
bladder 
Complete AE CRF page with all 
available new and updated information 
• Within 2 business days of first 
becoming aware of the event or 
as per local/regional regulations. 
• Reporting required through the 
end of the study 
If requested by Boston Scientific 
provide all relevant source 
documentation (unidentified) for the 
reported event 
• When documentation is 
available 
Adverse Events related to the 
study procedure for both 
surgical groups.  
Events assessed for reporting 
shall include but are not 
limited to: 
• 
Organ perforation 
• 
Bleeding (including 
hemorrhage and 
hematoma) 
• 
Pelvic pain 
• 
Infection 
• 
De novo dyspareunia 
• 
Urinary retention 
• 
Recurrent 
incontinence 
• 
Other urinary 
problems 
• 
Neuromuscular 
problems 
• 
Revision/re-surgery 
 
Complete the AE CRF page, which 
contains such information as onset date 
of the AE, treatment provided if any, 
resolution, assessment of seriousness, 
and relationship to study device. 
• Within 2 business days of first 
becoming aware of the event or 
as per local/regional regulations. 
•  
• Reporting required through end 
of subject participation 
Device Deficiencies (including 
but not limited to failures, 
malfunctions, and product 
nonconformities) 
Note:  Any Investigational 
Device Deficiency that might 
have led to a serious adverse 
event if a) suitable action had 
Complete CRF with all available new 
and updated information 
• Within 1 business day of first 
becoming aware of the event and 
as per local/regional regulations 
• Reporting required through the 
end of the study 
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