InterStim Basic Evaluation Lead Post Market Clinical Follow-Up Study
Phase: NA
Conditions: Overactive Bladder, Urinary Urge Incontinence, Urgency-frequency Syndrome
Sponsor: MedtronicNeuro

InterStim® BASIC Study 
Clinical Investigational Plan Version 1.0 
10-Jun-2019 
NCT04016324 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
© 2021 Medtronic. Medtronic and InterStim are trademarks of Medtronic. No use of any Medtronic 
trademark may be made except to identify the product or services of the company or as otherwise 
authorized in writing by Medtronic. All rights reserved. 

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Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  Basic Evaluation Lead Post-Market Clinical 
Follow-up (BASIC) Study 
Clinical Investigation Plan Identifier MDT19002 
EUDAMED unique identifier will be provided 
under a separate cover, once available. 
Study Product Name InterStim® Basic Evaluation lead with foramen 
needle and Basic Evaluation kit  
Sponsor/Local Sponsor United States (Sponsor): 
Medtronic Neuromodulation  
7000 Central Ave NE 
Minneapolis, MN 55432 USA 
 
Europe (Local Sponsor): 
Medtronic International Trading Sàrl 
Route du Molliau 31 
CH-1131 Tolochenaz, Switzerland 
 
Canada (Local Sponsor): 
Medtronic Canada ULC 
99 Hereford Street 
Brampton, ON, L6Y 0R3 Canada 
1-905-460-3800 
Document Version 1.0; 10-June-2019 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of 
Medtronic. Any distribution, copying, or disclosure without the prior written authorization of 
Medtronic is strictly prohibited. Persons to whom the information is disclosed must know that it is 
confidential and that it may not be further disclosed by them. 
 
 

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1. Investigator Statement 
Participating investigators will be provided with a separate investigator agreement to document their 
obligations and commitment with respect to study conduct. 
 
 

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Table of Contents  
 
1. 
Investigator Statement ...................................................................................................... 2 
Table of Contents ...................................................................................................................... 3 
2. 
Glossary .............................................................................................................................. 6 
3. 
Synopsis ............................................................................................................................. 7 
4. 
Introduction ..................................................................................................................... 11 
4.1. Background ........................................................................................................................ 11 
4.2. Purpose .............................................................................................................................. 11 
5. 
Objectives ........................................................................................................................ 12 
5.1. Objectives .......................................................................................................................... 12 
5.1.1. 
Primary Objective .................................................................................................................. 12 
 
 ............................................................................................................. 12 
5.1.3. 
Safety Assessment ................................................................................................................. 12 
6. 
Study Design .................................................................................................................... 12 
6.1. Duration ............................................................................................................................. 13 
6.2. Rationale ............................................................................................................................ 13 
7. 
Product Description.......................................................................................................... 13 
7.1. General .............................................................................................................................. 13 
7.2. Manufacturer ...................................................................................................................... 15 
7.3. Intended Study Population ................................................................................................... 15 
7.4. Product Return .................................................................................................................... 15 
7.5. Product Accountability ......................................................................................................... 15 
8. 
Selection of Subjects ........................................................................................................ 16 
8.1. Study Population ................................................................................................................. 16 
8.2. Subject Enrollment .............................................................................................................. 16 
8.3. Inclusion Criteria ................................................................................................................. 17 
8.4. Exclusion Criteria................................................................................................................. 17 
9. 
Study Procedures ............................................................................................................. 17 
9.1. Schedule of Events .............................................................................................................. 18 
9.2. Subject Screening ............................................................................................................... 20 

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9.3. Concomitant Medications ..................................................................................................... 21 
9.4. Subject Consent .................................................................................................................. 21 
9.5. Assessment of Efficacy ........................................................................................................ 21 
9.6. Assessment of Safety .......................................................................................................... 22 
9.7. Recording Data ................................................................................................................... 22 
9.8. Deviation Handling .............................................................................................................. 23 
9.9. Subject Withdrawal or Discontinuation .................................................................................. 23 
10. 
Risks and Benefits ......................................................................................................... 24 
10.1. 
Potential Risks ............................................................................................................... 24 
10.1.1. 
Risks Outlined in the Instructions for Prescribers (IFP) / Instructions for Use (IFU) .......... 24 
10.2. 
Potential Benefits ........................................................................................................... 25 
10.3. 
Risk-Benefit Rationale .................................................................................................... 25 
11. 
Adverse Events and Device Deficiencies ....................................................................... 26 
11.1. 
Definitions/Classifications ............................................................................................... 26 
11.2. 
Reporting of Adverse Events ........................................................................................... 30 
9.1.1. 
Device Deficiencies ........................................................................................................ 32 
9.1.2. 
Deaths .......................................................................................................................... 32 
12. 
Data Review Committees .............................................................................................. 33 
13. 
Statistical Design and Methods ..................................................................................... 33 
13.1. 
General Statistical Considerations .................................................................................... 33 
13.1.1. 
Sample Size Justification .................................................................................................... 33 
13.1.2. 
Investigation Site Pooling .................................................................................................. 33 
13.1.3. 
Other Specific Considerations ........................................................................................... 34 
13.1.4. 
Reports .............................................................................................................................. 34 
13.2. 
Demographics ............................................................................................................... 34 
13.3. 
Primary Objective – Motor or Sensory Response ............................................................... 35 
 
 ....................................................................................................... 35 
 
............................................................................................................ 35 
 
................... 36 
 
 .................................................. 36 
13.5. 
Safety Assessment ......................................................................................................... 36 

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14. 
Ethics ............................................................................................................................. 36 
14.1. 
Statement(s) of Compliance ........................................................................................... 36 
15. 
Study Administration ..................................................................................................... 37 
15.1. 
Principal Investigator Oversight....................................................................................... 37 
15.2. 
Sponsor ........................................................................................................................ 41 
15.3. 
Site Selection ................................................................................................................ 41 
15.4. 
Clinical Trial Agreement .................................................................................................. 41 
15.5. 
Curriculum Vitae ............................................................................................................ 41 
15.6. 
Monitoring .................................................................................................................... 41 
15.7. 
Source Documentation ................................................................................................... 42 
15.8. 
Medtronic Representative Role ........................................................................................ 42 
15.9. 
Direct Access to Source Data/Documents ......................................................................... 43 
15.10. 
Confidentiality ............................................................................................................... 43 
15.11. 
Liability ......................................................................................................................... 44 
15.11.1. 
Study Funding .................................................................................................................... 44 
15.11.2. 
Insurance ........................................................................................................................... 44 
15.11.3. 
Warranty ............................................................................................................................ 44 
15.11.4. 
Indemnification.................................................................................................................. 44 
15.12. 
CIP Amendments ........................................................................................................... 44 
15.13. 
Record Retention ........................................................................................................... 45 
15.14. 
Publication and Use of Information .................................................................................. 45 
15.15. 
Suspension or Early Termination ..................................................................................... 46 
16. 
References ..................................................................................................................... 47 
17. 
Appendices .................................................................................................................... 48 
17.1 Additional Information for Sites ............................................................................................ 48 
17.2 Institutional Review Boards/Ethics Committees ...................................................................... 48 
17.3 Participating Investigators and Institutions ............................................................................ 48 
17.4 Informed Consent Materials ................................................................................................. 48 
17.5 Labeling ............................................................................................................................. 49 
18. 
Version History .............................................................................................................. 49 
 

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2. Glossary 
Term 
Definition 
ADE 
Adverse Device Effect 
AE  
Adverse Event 
CFR 
Code of Federal Regulations 
CI 
Confidence Interval 
CIP 
Clinical Investigational Plan 
DD 
Device Deficiency  
eCRF 
Electronic Case Report Form 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability 
Act 
ICF 
Informed Consent Form 
IDE 
Investigational Device Exemption 
IRB 
Institutional Review Board 
OAB 
Overactive Bladder 
 
 
PNE 
Peripheral Nerve Evaluation 
  
 
Oracle RDC 
Oracle Remote Data Capture 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SNM 
Sacral Neuromodulation 
UF 
Urinary Frequency 
UI 
Urinary Incontinence 
UUI 
Urinary Urge Incontinence 
US 
United States 
 
 

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3. Synopsis 
Title 
InterStim Basic Evaluation Lead Post Market Clinical Follow-Up 
(BASIC) Study 
Clinical Study Type 
Prospective, Multicenter, Global, Post-Market 
Product Name 
InterStim Basic Evaluation Lead with foramen needle and Basic 
Evaluation kit. 
 
There are no investigational devices used in this study, all study 
products will be used in accordance with the product labeling.  
Sponsor  
Medtronic, Inc. 
Investigation Purpose 
Post-market clinical follow-up for continued assessment of safety and 
performance of the InterStim basic evaluation lead and foramen 
needle(s) used during a therapy evaluation. 
Intended Study Population 
The study will enroll patients with overactive bladder.  All subjects 
implanted must be candidates for sacral neuromodulation. 
Primary Objective 
To characterize proportion of subjects who demonstrate motor or 
sensory response(s) during lead placement using the InterStim Basic 
Evaluation Lead. 
 
 
  
 
   
 
 
Safety Assessment 
To characterize safety during the basic evaluation lead implant and 
therapy evaluation.  
 
Safety will be evaluated by the collection of reportable adverse 
events. Any adverse event meeting the definition of: serious, device 
related, therapy related and/or procedure related will be considered 
reportable for this study. 
 
Device deficiencies will be collected and reported. 
Study Design 
This is a prospective, multicenter, post market clinical follow-up study 
to characterize the clinical performance and safety of the InterStim 
basic evaluation lead with the commercially-approved foramen 
needle and basic evaluation kit. The study is intended to be 
conducted at approximately 30 centers in Europe, Canada, and the 
United States.   
 
Subjects will complete a baseline visit, basic evaluation lead 
placement visit, and 1-week follow-up visit.   Enrollment will be 

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defined as subjects who qualify for all eligibility requirements and 
undergo the basic evaluation lead implant procedure.  
 
The total study duration for a subject is approximately three weeks, 
depending on when the basic evaluation lead implant procedure is 
scheduled. 
Sample Size 
Subjects will be enrolled to obtain a sample size of approximately 100 
subjects who complete a basic evaluation with motor or sensory 
threshold testing to confirm clinical performance. The sample size of 
approximately 100 subjects is driven to obtain precision of the 
primary endpoint.  
 
Assuming that motor or sensory response is able to be obtained in 
95% of subjects during the basic evaluation lead placement, with 100 
subjects, this produces a two-sided 95% Confidence Interval (CI) of 
88.7-98.4% with a width equal to 9.6%. The confidence interval width 
will vary slightly depending on the actual proportion of subjects with 
motor or sensory responses.    
Inclusion/Exclusion Criteria 
Inclusion Criteria: 
1. Subjects 18 years of age or older 
2. Candidate for sacral neuromodulation in accordance with the 
InterStim System labeling 
3. Have a diagnosis of OAB as demonstrated by either urinary 
urge incontinence and/or urinary frequency on a 3-day 
voiding diary  
4. Willing and able to accurately complete study diaries, 
questionnaire, attend visits, and comply with the study 
protocol  
5. Willing and able to provide signed and dated informed 
consent  
 
Exclusion Criteria:    
1. Have neurological conditions such as multiple sclerosis, 
clinically significant peripheral neuropathy or spinal cord 
injury (e.g., paraplegia) 
2. Have implantable pacemakers, or defibrillators  
3. Have primary stress incontinence or mixed incontinence 
where the stress component overrides the urge component 
4. Have knowledge of planned MRIs, diathermy, microwave 
exposure, high output ultrasonic exposure, or RF energy 

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exposure not included within the scanning conditions 
provided with the InterStim System labeling 
5. Women who are pregnant or planning to become pregnant 
during participation in the study  
6.    Characteristics indicating a poor understanding of the study 
or characteristics that indicate the subject may have poor 
compliance with the study protocol requirements  
7.    Concurrent participation in another clinical study that may 
add additional safety risks and/or confound study results.* 
 
*Subjects in concurrent studies can only be enrolled with permission from 
Medtronic. Please contact Medtronic’s study manager to determine if the 
subject can be enrolled in both studies. 
Study Procedures and 
Assessments 
Study Visits:  
1. Baseline 
2. Enrollment / Basic Evaluation Lead Implant Procedure 
3. Therapy Evaluation 
4. One Week Follow-up Visit (Study Exit)  
 
Baseline 
Each subject must meet all of the inclusion and no exclusion criteria 
to be eligible to participate in the study.  At the baseline visit, data 
will be gathered from subjects including relevant medical history.  
 
The symptom diary will be explained and given to the subject to be 
completed for 3 consecutive days. The diary must be completed along 
with confirmation that the subject is not pregnant nor planning to 
become pregnant as part of the assessment for study eligibility.   
 
Collection of reportable adverse events and device deficiencies will 
begin after the informed consent form is signed.  
 
Enrollment/Basic Evaluation Lead Implant 
The basic evaluation lead(s) should be placed in accordance with the 
Basic Evaluation Lead Implant Manual. The therapy evaluation period 
using the basic evaluation lead(s) must not exceed seven days.   
Motor or sensory response must be tested intra-operatively during 
the foramen needle placement and when the basic evaluation lead(s) 
are placed.  Prior to discharge, the sensory threshold in a seated 
position will be collected for all subjects.  All reportable adverse 
events, device deficiencies and OAB medication changes will be 

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collected.  A daily symptom diary will be completed during the Basic 
Evaluation period (up to 7 days).   
 
1-Week Follow-up Visit (5-7 days post-implant) 
At the 1-week follow-up visit, any reportable adverse events, changes 
to OAB medications and/or device deficiencies will be collected.  
During the visit the subject’s sensory threshold amplitude will be 
tested.  Following confirmation of sensory threshold amplitude, 
programming data will be collected. 
 
 
 
 
 
  
 
The subject is exited from the study after the 1-week follow-up visit is 
complete.  
 
Unscheduled Visit   
If an unscheduled visit is needed for any device-related reason, any 
reportable adverse events and/or device deficiencies will be 
collected. Upon completion of any programming, programming data 
will be collected.   
 Statistics 
For the primary objective, the proportion of subjects who obtain 
motor or sensory response and its two-sided exact binomial 95% CI 
will be reported.    
 
    
 
Reportable adverse events and device deficiencies will be presented 
in summary tables. 
 
 

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4. Introduction  
4.1. Background  
Sacral Neuromodulation (SNM) delivered by the Medtronic InterStim System is a guideline 
recommended advanced therapy option for the treatment of overactive bladder.1,2 Prior to receiving an 
implanted system for chronic therapy, a patient can undergo a therapy evaluation in order to assess 
response to the therapy.  A therapy evaluation can be conducted with either a temporary trialing lead, 
connected to an external neurostimulator for a temporary trial (also known as the basic evaluation) or a 
chronic lead can be used with the same external neurostimulator for a longer duration trial, known as an 
advanced evaluation.  Both approaches are designed to deliver stimulation to the sacral nerves in order 
to assess whether the patient responds to therapy, thus allowing patients the ability to “test drive” SNM 
prior to committing to an implanted system.  This protocol uses the term basic evaluation to indicate the 
therapy evaluation period.   
The predicate temporary trialing lead obtained CE mark in 1998, was approved by FDA in 1998 and was 
licensed by Health Canada in 1999. Since that time, this lead has consistently been used for Medtronic’s 
basic evaluations as this is the only temporary trialing lead that is market released for the InterStim 
system.  Safety and performance have been reported in the literature for many years3-10, along with 
twenty years of clinical experience tracked in Medtronic’s post-market surveillance reporting system.   
Temporary trialing leads are intended to deliver temporary sacral neuromodulation for the duration of 
the therapy evaluation period.  Sacral nerves are mixed nerves containing both motor and sensory 
fibers. In order to ensure appropriate lead placement, motor and/or sensory responses such as bellows, 
movement of the perineum, plantar flexion of the great toe or sensation in the rectum, scrotum or 
vagina11 are assessed during the temporary trialing lead implant. The temporary trialing lead, now 
referred to as basic evaluation (BE) lead, foramen needles and procedure kit have been updated and the 
aim of this study is to evaluate the performance and safety of the recently market-released InterStim BE 
lead, foramen needles and BE kit (includes the updated lead and foramen needles). See Table 7-1 for 
product details.  This prospective clinical study will fulfill post-market clinical follow-up obligations for 
the updated BE products and is an active mechanism to assess performance and safety in patients 
undergoing a basic evaluation for sacral neuromodulation in an organized, systematic manner based on 
their intended use.   
  
4.2. Purpose 
The purpose of this post market investigation is for continued assessment of safety and performance of 
the InterStim basic evaluation lead and foramen needles used during a therapy evaluation. 
 

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5. Objectives  
5.1. Objectives 
5.1.1. 
Primary Objective 
To characterize the proportion of subjects who demonstrate motor or sensory response(s) during lead 
placement using the InterStim basic evaluation lead. 
 
  
 
 
  
 
 
   
 
 
5.1.3. 
Safety Assessment  
To characterize safety during the basic evaluation lead implant and therapy evaluation.  
Safety will be evaluated by the collection of reportable adverse events. Any adverse event meeting the 
definition of: serious, device related, therapy related and/or procedure related will be considered 
reportable for this study. 
Device deficiencies will be collected and reported. 
6. Study Design  
This is a prospective, multicenter, global, post market clinical follow-up study to characterize the clinical 
performance and safety of the InterStim basic evaluation lead with the commercially-approved foramen 
needle and basic evaluation kit.   Commercial devices will be used within their intended use as described 
in approved instructions for use for which approval has been obtained. 
Eligible subjects, who are already candidates for sacral neuromodulation, will sign a study-specific 
informed consent form (ICF).  All eligible subjects will complete baseline procedures, including a urinary 
voiding diary and assessment of medical history, prior to the BE lead implant procedure.   Subjects will 
be considered enrolled at the time of the BE lead procedure.  During the BE lead implant procedure, an 
assessment of motor or sensory response will be completed.  Subjects will be discharged for the therapy 
evaluation and instructed to start completing a daily urinary voiding diary. Subjects will return for a 1-

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week follow-up visit.  The urinary voiding diary will be collected.  Study requirements, including 
 
 sensory threshold testing and safety assessments will be completed as required in 
section 9.1.  Study follow-up is expected to last up to 7 days following the BE lead implant visit.  Subjects 
will be exited from the study after the 1-week follow-up visit is completed.  
A minimum of 100 subjects who complete the BE lead implant procedure with motor or sensory 
threshold testing is required to confirm clinical performance.  
The study is intended to be conducted at approximately 30 centers in Europe, Canada, and the United 
States.   
This is an on-label, post-market study of an approved system. All subjects implanted in the study will 
qualify under the approved indication for sacral neuromodulation. 
6.1. Duration 
Study subjects will be consented and will complete baseline assessment to determine eligibility for an 
InterStim therapy evaluation.  Subjects are considered enrolled at the time of the BE lead implant 
procedure.  Any subject not meeting eligibility criteria will be excluded from study participation. 
Following the BE lead implant, subjects will be required to return for the 1-week follow-up visit (no later 
than 7 days following the lead implant procedure).   
The estimated study duration, from first subject enrollment to last subject visit, is expected to last 
approximately 12 months. The completion of the study is defined as approval of the Final Study Report 
and closure of all sites.  
6.2. Rationale  
This post-approval study will collect data in an organized, systematic manner based on product use to 
fulfill post-market clinical follow-up obligations. Data related to the performance of the study device will 
be collected, and this may be used to support claims and intended performance of the study product.   
See Section 5.1 for study objectives.  
7. Product Description 
7.1. General 
There are no investigational devices used in this study.  
The designs of the BE lead, updated foramen needles and the BE kit reflect incremental changes and 
technological advancements from the market-released leads, needles and procedure kit.  A description 

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of the updated BE lead, foramen needles and BE kit are described below.  The estimated sample size for 
this study may yield approximately 100 BE kits (Model 309201); however, individual or multipack of 
leads (Model 306001, 306006) and foramen needles (Model 041838, 041839) may also be used in place 
of the kit.  Up to two leads may be placed during one implant procedure.  
Table 7-1 Study Product 
Model 
Description of the Device  
Intended Use  
306001 
A packaging configuration that includes 
one updated lead 
The lead consists of a coiled, insulated, 
multi-stranded wire with a stainless-
steel connector pin on the proximal 
end and a single electrode on the distal 
end. The lead is pre-loaded with a 
stylet that is removed after lead 
placement. 
 
The basic evaluation kit is a procedural 
kit intended for the basic evaluation of 
Sacral Neuromodulation Therapy 
(SNM), also referred to as "test 
stimulation" or "therapy evaluation". 
The kit contains the basic evaluation 
lead, also referred to as “test 
stimulation lead”, foramen needles and 
accessories for the lead implant 
procedure. 
 
 
306006 
A package of six updated leads   
041838 
Foramen needle package (six 8.8 cm 
needles)   
041839 
Foramen needle package (two 12.6 cm 
needles) 
309201 
Basic evaluation kit components:  
 
Sterile components in kit: 
• 
One basic evaluation lead  
• 
One test stimulation cable (also 
referred to as “test stimulation 
cable mini-hook”) 
• 
Two foramen needles (8.8 cm) 
• 
One foramen needle (12.6 cm) 
• 
Surgical drape 
• 
Applicator - sponge tip  
• 
Surgical marker 
• 
Ruler 
• 
Anesthetic needle 
• 
Syringe 
• 
Gauze pads 
• 
Transparent medical dressing 
 
Non-sterile components in kit: 
• 
One ground pad package 
(containing two ground pads) 
• 
One Model 3676 Patient cable 
(with ground pad connection) 
• 
One Model 3579 Patient cable 
(without ground pad connection) 
• 
Product literature 
 

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The BE lead and foramen needle will come into contact with the subject’s tissue during the therapy 
evaluation.  
 
 
 
 
 
Study devices will be connected to the approved Verify external neurostimulator and operated by each 
regions’ patient and/or clinician programmer.   
The study will be conducted in the United States, Canada and Europe, where the InterStim basic 
evaluation Lead, foramen needle and basic evaluation kit will be commercially available in the specific-
country prior to the start of study-specific activities.    
7.2. Manufacturer 
Medtronic, Inc. is the legal manufacturer of the products used in this study, identified in Section 7.1; the 
products will be approved for the indication in the study prior to the start of study-specific activities.  
Manufacturer 
Medtronic, Inc. 
710 Medtronic Parkway 
Minneapolis, MN 55432-5604 
USA 
7.3. Intended Study Population 
The study will enroll patients with overactive bladder.  All subjects implanted must be candidates for 
sacral neuromodulation.  
7.4. Product Return 
Since all products are commercially available, standard commercial processes should be used to return 
products (as applicable).  
7.5. Product Accountability  
All product used in the study are commercially available; therefore, no product accountability is 
required based on the applicable regulations.  

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8. Selection of Subjects 
8.1. Study Population 
This study has been designed to collect data in a setting that represents real world use, for the expected 
lifetime of these devices.  The BASIC study will enroll patients with symptoms of OAB at a broad set of 
enrolling centers in various geographies.  
 
  
 
 
 
 
 
 
   
In summary, the BASIC study will provide pertinent real-world evidence to the overall body of evidence 
of InterStim therapy. 
8.2. Subject Enrollment 
Each subject must meet all the inclusion criteria and no exclusion criteria to be eligible to participate in 
the study.  Subjects are considered enrolled at the time of the BE lead implant procedure.  Any subject 
not meeting eligibility criteria will be excluded from study participation.  Site personnel must complete 
logs related to recruitment and enrollment as required by the study.  
 
 

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8.3. Inclusion Criteria 
To be eligible to participate in the study, a subject must meet all the following inclusion criteria:  
1. Subjects 18 years of age or older 
2. Candidate for InterStim sacral neuromodulation in accordance with the InterStim System 
labeling 
3. Have a diagnosis of OAB as demonstrated by either urinary urge incontinence and/or urinary 
frequency (see Section 9.1 for definition) on a 3-day voiding diary  
4. Willing and able to accurately complete study diaries, questionnaire, attend visits, and comply 
with the study protocol  
5. Willing and able to provide signed and dated informed consent  
8.4. Exclusion Criteria 
A potential subject who meets any of the following criteria will be excluded from participating in the 
study:  
1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral 
neuropathy or spinal cord injury (e.g., paraplegia) 
2. Have implantable pacemakers, or defibrillators  
3.  Have primary stress incontinence or mixed incontinence where the stress component overrides 
the urge component 
4. Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic 
exposure, or RF energy exposure not included within the scanning conditions provided with the 
InterStim System labeling 
5. Women who are pregnant or planning to become pregnant during participation in the study  
6. Characteristics indicating a poor understanding of the study or characteristics that indicate the 
subject may have poor compliance with the study protocol requirements  
7. Concurrent participation in another clinical study that may add additional safety risks and/or 
confound study results.* 
 
*Subjects in concurrent studies can only be enrolled with permission from Medtronic.  Please contact 
Medtronic’s study manager to determine if the subject can be enrolled in both studies.  
9. Study Procedures  
The study schedule, procedures and methods of assessment are defined in detail to enable compliance 
with the required activities, and to ensure that the resulting data meets the criteria for evaluability.  See 
Section 9.1.  Electronic case report forms (eCRF) will be provided for use in collecting data for all 
subjects; the pertinent eCRFs along with the applicable source documentation will be completed for 
each subject.  

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The following will be conducted:  
1. Baseline 
2. Enrollment / Basic Evaluation Lead Implant Procedure 
3. Therapy Evaluation 
4. One Week Follow-up Visit (Study Exit)  
 
Baseline
Basic Evaluation
Lead Implant
1-Week Follow-up 
(Study Exit)
Therapy 
Evaluation
 
9.1. Schedule of Events 
Baseline 
The study-specific informed consent form must be signed prior to any study-specific procedures. Each 
subject must meet all inclusion and no exclusion criteria to be eligible to participate in the study.  At the 
baseline visit, data will be gathered from subjects including relevant medical history.  
The urinary voiding diary will be explained and given to the subject to be completed for a minimum of 3 
consecutive days for verification of OAB (either UUI or UF).  Urinary urge incontinence is defined 
involuntary loss of urine associated with urgency12 and urinary frequency is defined as > 8 voiding 
episodes per day.13  The diary must be completed along with confirmation that the subject is not 
pregnant or planning to become pregnant as part of the assessment for study eligibility. 
Collection of reportable adverse events and device deficiencies will begin after the informed consent 
form is signed.  
Basic Evaluation Lead Implant Procedure 
The BE lead(s) should be placed in accordance with the Basic Evaluation Lead Implant Manual. A subject 
is considered enrolled after all eligibility criteria is met but prior to the BE lead implant procedure.  
Motor or sensory response must be tested intra-operatively during foramen needle placement and 
confirmed when the BE lead(s) are placed.  The motor or sensory response will be confirmed for each 
lead placed.  Sensory threshold is defined as the lowest amplitude where the subject first perceives 
sensation of the stimulation.  Motor threshold is defined as the lowest amplitude of electrical 
stimulation where a motor response (e.g. bellows response, anal wink and/or plantar flexion of the big 
toe) is observed.
 
 

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.   Prior to discharge, the sensory threshold in a seated 
position will be collected for all subjects.  Programming parameters for the therapy evaluation will be at 
the institution’s discretion.  Programming data will be collected via a programming printout or 
Medtronic’s programming upload system.    
 
Therapy Evaluation 
The subject will then be discharged to start the therapy evaluation.  A daily urinary voiding diary will be 
completed for the entire therapy evaluation period (a minimum of 3 days). The therapy evaluation must 
not exceed seven days.   Any device-related visit that occurs prior to the one-week follow-up visit will be 
captured as an unscheduled visit.  
Surgical Modifications 
If a surgical modification (replacement) of the BE lead is required, each procedure will require the 
associated lead implant CRF and one-week follow-up CRF completed.  
1 Week Follow-up Visit (Study Exit)  
At the 1-week follow-up visit, any changes to OAB medications, reportable adverse events and/or device 
deficiencies will be collected.   During the visit the subject’s amplitude level for their sensory threshold 
will be re-assessed while in the seated position.  
 
 
. Programming data will be collected via a programming 
printout or Medtronic’s Programming Upload System.    
 
 
 
 
 
The subject is exited from the study after the 1-week follow-up visit is complete.  
Unscheduled Visit   
If an unscheduled visit is needed for any device-related reason, any reportable adverse events and/or 
device deficiencies will be collected. Upon completion of any programming, data will be collected via a 
programming printout or Medtronic’s programming upload system.   
 
 

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Table 9-1: Study Procedures 
 
Baseline 
BE Lead 
Implant 
(Visit #1) 
Therapy 
Evaluation*** 
 
One Week      
Follow-up Visit 
(5-7 days ) 
(Visit #2) 
Unscheduled 
Visit 
(Visit #3) 
Informed Consent 
  X* 
 
 
 
 
Relevant Medical History  
X 
 
 
 
 
Pregnancy Assessment 
X 
 
 
 
 
Assessment of Sensory Threshold 
 
X** 
 
X 
 
Assessment of Motor Threshold 
 
X** 
 
 
 
Urinary Voiding Diary 
X 
 
X 
 
 
Device Interrogation/ 
Programming Data 
 
X 
 
X 
X 
 
 
 
 
 
 
 
Concomitant OAB Medications 
X 
X 
X 
X 
X 
Assessment of Reportable 
Adverse Events and Device 
Deficiencies 
X 
X 
X 
X 
X 
*Must occur prior to any study-specific activities 
**Sensory response, motor response or both may be collected during the lead implant procedure 
*** Therapy evaluation must not exceed 7 days from the time of BE lead implant 
 
9.2. Subject Screening  
Subjects may be recruited through the investigator’s practice and referring physicians. Potential subjects 
may be identified through chart reviews or as new or existing patients attend clinic visits as appropriate. 
If subjects are recruited from outside the investigator’s practice, sites are to ensure that appropriate 
release for access to the subject’s records (paper and/or electronic) is obtained. Any subject recruitment 
materials disseminated to subjects (advertisements, handouts, posters, social media) must be approved 
by the IRB/EC prior to use. 
All subjects must be consented in accordance with the protocol prior to any study-specific procedures. 
Recruited subjects will be screened by the Principal Investigator or authorized site personnel by 
reviewing the study’s inclusion and exclusion criteria. 
A screening log should be completed by the site to maintain a cumulative log of all screened subjects 
with reason for any screening failures. 
The Investigator will maintain a listing of all subjects enrolled in the study. 

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9.3. Concomitant Medications 
OAB medication use will not be restricted during the trial; however, all OAB medication will be collected 
on a study-specific medication log.  
9.4. Subject Consent 
The informed consent process will be performed in accordance with the ethical principles that have 
their origin in the Declaration of Helsinki, 21CFR§50 Protection of Human Subjects (US only), SOR/98- 
282 (Canada only) and in accordance with local regulatory requirements. No vulnerable patients will be 
allowed to be consented to participate in the study. Data will be collected and treated in accordance 
with applicable Data Privacy Legislation. With regard to the EU this includes Directive 95/46/EC and 
subsequent legislation. 
Prior to entering the study, the Principal Investigator or qualified designee will explain to each subject 
the purpose and nature of the study, procedures, expected study duration, available alternative 
therapies, and the benefits and risks involved with study participation and the potential treatment. The 
person obtaining consent will avoid any coercion or undue improper influence on, or inducement of, the 
subject to participate and the ICF will not waive, or appear to waive, any legal rights. Subjects will be 
given a copy of the IRB/EC approved ICF and will have ample time to review the document and to ask 
questions and will be informed of their right to withdraw from the study at any time without prejudice; 
ICFs will be provided in a language understandable to the subject. After this explanation and before any 
study-specific procedures have been performed, the subject will voluntarily sign and personally date the 
ICF. Prior to participation in the study, the subject will receive a copy of the signed and dated written 
informed consent and any other written information provided to the subject. 
The Principal Investigator or qualified (delegated) designee will document the informed consent 
process, including the date of consent and name of the person conducting the consent process in the 
subject’s medical record. A copy of the signed ICF will also be placed in the subject’s medical record. 
Throughout study participation, any significant new information will be provided to the subject as 
outlined in the informed consent form. As appropriate, the ICF may be revised based on new 
information that becomes available. 
9.5. Assessment of Efficacy   
Motor and sensory response 
A motor or sensory response will be determined at the time of lead placement with the foramen needle 
and confirmed with the BE lead.   Amplitude will be titrated up from 0 until a response is reported 
and/or observed.  A sensory response is defined as the lowest amplitude where the subject first 
perceives sensation of the stimulation.  A motor response is defined as the lowest amplitude of 
electrical stimulation where a motor response (e.g. bellows response, anal wink and/or plantar flexion of 
the big toe) is observed.   
 
 

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Urinary Voiding Diary 
Symptoms related to OAB will be evaluated using paper voiding diaries. Subjects will be trained to 
complete the urinary voiding diaries for 3-days as part of the baseline procedures. The urinary voiding 
diaries will be completed daily following the BE lead implant until the 1-week follow-up visit.  Every 
effort should be made to remind subjects of the importance of real-time diary completion. 
 
Diaries will be used for comparison from the 1-week follow-up visit to baseline for the additional study 
measure of characterizing changes in bladder symptoms. 
 
 
 
  
 
 
 
  
 
 
 
 
   
 
 
 
 
  
  
 
  
9.6. Assessment of Safety 
All reportable adverse events (see Section 11.1) and device deficiencies will be collected throughout the 
study once the informed consent form is signed. 
9.7. Recording Data 
This study will be conducted using a remote data capture system. The Oracle Clinical Remote Data 
Capture (RDC) system which allows the study centers to enter study data into the sponsor’s database 
over a secure internet connection, will be used to capture study required Case Report Form (CRF) 
information. Data reported on urinary voiding diaries and subject questionnaire will be entered to the 
database by site personnel. Subjects will complete the study questionnaire confidentially on paper 
forms without site personnel consultation and these data will be entered to OC/RDC by site personnel. 

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Electronic CRFs (eCRFs) will be provided by the sponsor; required data will be taken from source 
documents and directly entered into the study database via the CRFs by the site personnel, in 
accordance with applicable regulations. 
 
Device interrogation (programming) data may be transmitted using either Medtronic’s programming 
upload system or by manual data entry on a programming CRF. 
 
Urinary voiding diaries 
 are to be completed only by the subject. Representatives 
from the research site may not make entries to the diaries 
 except for  
data fields confirmed by the subject on source documentation.  
 
The Principal Investigator, Sub-Investigator, or an individual delegated by the Principal Investigator on 
the Delegation of Authority and Signature Form, are responsible for documenting and entering data for 
the study on the eCRFs. The Principal Investigator or Sub-Investigator is required to approve all data on 
CRFs via electronic signature. 
9.8. Deviation Handling 
Protocol deviations are digressions from the written protocol defined as an event where the clinical 
investigator or site personnel did not conduct protocol-required procedures according to the study 
protocol. The investigator or delegated site personnel should contact the designated 
Medtronic study personnel to discuss the impact of the potential deviation. Site personnel should work 
with subjects to ensure subject follow-up visits are scheduled within the visit window; however, any 
visits completed outside of the visit window will require a protocol deviation to be reported. All protocol 
deviations must be reported on the Protocol Deviation eCRF promptly after the site’s awareness of the 
deviation and submitted to the IRB/EC (as required).  
 
Deviations will be reviewed by Medtronic on an ongoing basis. The sponsor may choose to terminate 
the study at a site for failure to follow the written protocol and investigator agreement. If this occurs, 
the Investigator, IRB/EC and governing regulatory authority (if applicable) will be notified in writing of 
the reasons for the termination. 
9.9. Subject Withdrawal or Discontinuation  
Subjects are free to voluntarily withdraw from the study at any time and for any reason. All implanted 
subjects will be followed until the 1-week follow-up visit, unless withdrawn from the study. Withdrawn 
or exited subjects will be followed under normal medical practice.   
 
 
 
 
 

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Examples of reasons for study discontinuation include, but are not limited to, those listed below: 
− 
Subject death 
− 
Subject lost to follow-up 
− 
Subject voluntarily withdraws from the study 
− 
Investigator terminates the subject’s participation in the study due to lack of 
compliance, violation of/change in eligibility criteria 
− 
Any clinical laboratory abnormality, current illness, or other medical condition or 
situation occurs such that continued study participation would not be in the best 
interest of the subject. 
− 
Normal study completion 
 
Prior to deeming a subject lost to follow-up, telephone calls must be documented in the subject’s 
medical record. If a minimum of three attempts to contact the subject have failed (e.g. phone and 
mailed letter), and no response is received, the site should exit the subject and complete the Study Exit 
eCRF. 
When a subject is withdrawn from the study, the Study Exit eCRF is to be completed and should include 
detailed notes as to why the subject was withdrawn from the study (e.g., discomfort, lack of efficacy, 
diary too burdensome). Withdrawn subjects will not be replaced. 
Once a subject completes participation in the study, follow-up will continue in accordance with the site’s 
standard of care. No study specific medical care will be provided for a subject after discontinuation 
from the study, unless outlined in the Clinical Trial Agreement and Informed Consent Form. 
10. Risks and Benefits 
10.1. Potential Risks 
The risks outlined below are the same risks found in commercial use of the BE lead and foramen needle. 
No study specific risks are present. 
 
The clinical investigation has been designed to involve as little pain, discomfort, fear and any other 
foreseeable risk as possible for the subjects, and both the risk threshold and the degree of distress are 
specifically defined in the clinical investigation plan and constantly monitored. 
10.1.1. 
Risks Outlined in the Instructions for Prescribers (IFP) / 
Instructions for Use (IFU) 
Refer to the appropriate Instructions for Prescribers (IFP) and Instructions for Use (IFU) for the InterStim 
System components for an updated list on contraindications, precautions, warnings, adverse events, 
directions for use and other product specific details on the InterStim System.   

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Patients should be appropriate candidates for therapy evaluation and for potential surgical 
implant of a SNM system. Patients are contraindicated for therapy evaluation if they are 
unable to properly operate the handset, external neurostimulator (ENS), and accessories. 
In addition to the risks normally associated with surgery, the following adverse events may 
occur with use of the BE lead and accessories.  
▪ Tissue damage 
▪ Infection 
▪ Technical device problems 
The following adverse events may occur with implantation or use of a neuromodulation system for 
sacral neuromodulation.  
• Adverse change in voiding function (bowel and/or bladder) 
• Allergic or immune system response to the implanted materials that could result in device rejections 
• Change in sensation of stimulation which has been described as uncomfortable (jolting or shocking) by 
some patients 
• Infection 
• New pain 
• Pain at neurostimulator and/or lead site 
• Seroma, hemorrhage, and/or hematoma 
• Suspected lead or neurostimulator migration or erosion 
• Suspected nerve injury 
• Suspected technical device problem 
• Transient electric shock 
The risk level for the devices and implant procedure is the same if the subject is in this clinical trial or 
not. Certain adverse events may necessitate surgical intervention. 
10.2. Potential Benefits 
Subjects will not receive any direct medical benefit from participation in this study. Participation in this 
study will not provide greater benefit than if the subject was receiving a therapy evaluation with the BE 
lead, foramen needles or procedure kit outside of the study. Information from this study might help 
researchers further understand the BE lead implant procedure and therapy evaluation. The benefit to 
subjects participating in this study, and to future patients, resides in the knowledge gained from this 
study. 
10.3. Risk-Benefit Rationale 
Participation in this study will not expose the subject to greater risks than if he/she were receiving a BE 
lead implant procedure and therapy evaluation outside of the study. There might be other discomforts 
and risks related to a BE lead implant and therapy evaluation and/or this study that are not foreseen at 
this time.  

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The risks associated with a BE lead implant and therapy evaluation are minimized in this study by 
selecting only qualified Investigators experienced in sacral neuromodulation, selecting an appropriate 
patient population via inclusion/exclusion screening, and monitoring subject progress and events 
reported for this study. The review and minimization of the potential risks to the patient and the 
potential benefits to the patient support the conduct of this study. 
11. Adverse Events and Device Deficiencies 
11.1. Definitions/Classifications 
Any adverse event meeting the definition of: serious, device related, therapy related and/or procedure 
related as well as all device deficiencies will be considered reportable for this study. The term 
“investigational device” is part of ISO 14155 definitions. The term “investigational device” refers to any 
device used in the study including market released devices. Adverse events and device deficiencies are 
defined as follows: 
− 
Device Related: An adverse event that results from the presence or performance 
(intended or otherwise) of the BE lead, foramen needle or BE kit 
− 
Procedure Related: An adverse event that occurs due to any procedure related to 
the implantation or surgical modification of the BE lead. The procedure is defined as 
the lead placement / implant procedure and surgical modification (explant 
procedure). 
− 
Therapy Related: An adverse event related to therapy delivery by device e.g. device 
stimulation issue (normally therapy-related events resolve when the device is 
turned off or reprogrammed). 
 
Adverse events that are classified as possible, probable or causal are considered to be related.  
 
Table 11-1: Adverse Event & Device Deficiency Definitions 
Term 
General  
Adverse Event 
(AE) 
(ISO 
14155:2011 3.2) 
Any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other 
persons, whether or not related to the investigational medical device.   
NOTE 1 This definition includes events related to the investigational medical device 
or the comparator. 
NOTE 2 This definition includes events related to the procedures involved. 

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NOTE 3 For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
Adverse Device 
Effect (ADE)* 
(ISO 
14155:2011 3.1) 
Adverse event related to the use of an investigational medical device. 
NOTE 1 This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or 
operation, or any malfunction of the investigational medical device. 
NOTE 2 This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device. 
Device Deficiency 
(DD)* 
(ISO 14155:2011 
3.15) 
(ISO 14155:2011 
3.27) 
(ISO 14155:2011 
3.43) 
Inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety or performance.  
NOTE Device deficiencies include malfunctions, use errors, and inadequate labeling. 
 
Malfunction: Failure of an investigational medical device to perform in 
accordance with its intended purpose when used in accordance with the 
instructions for use or CIP 
 
Use Error: Act or omission of an act that results in a different medical device 
response than intended by the manufacturer or expected by the user 
NOTE 1 Use error includes slips, lapses, mistakes. 
NOTE 2 An unexpected physiological response of the subject does not in 
itself constitute a use error. 
SERIOUSNESS  
Serious Adverse 
Event (SAE)*   
(ISO 
14155:2011 
3.37) 
Adverse event that 
a) led to a death, 
b) led to a serious deterioration in the health of the subject, that either resulted 
in: 
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function, or 
3. in-patient or prolonged hospitalization, or 
4. medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function. 
c) led to foetal distress, foetal death or a congenital abnormality or birth defect. 
 

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 NOTE Planned hospitalization for pre-existing condition, or a procedure required by 
the CIP, without serious deterioration in health, is not considered a serious adverse 
event.   
STUDY SPECIFIC NOTE  For this study, all adverse events will be collected however 
adverse events for system modifications (e.g. lead explants, revisions or 
replacements) will be considered non-serious unless the subject has clinical sequala 
which meets the seriousness definition outlined in the CIP.  
Serious Adverse 
Device Effect 
(SADE)*    
(ISO 
14155:2011 
3.36) 
Adverse device effect that resulted in any of the consequences characteristic of a 
serious adverse event 
RELATEDNESS 
Term 
Definition 
Not related 
Relationship to the device or procedures can be excluded when: 
- the event is not a known1 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 investigational 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 investigational device 
used for diagnosis2, 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. 
 

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1When the event is not a known side effect of the product category the device 
belongs to or of similar devices and procedures, generally is considered “not 
related”. Yet, the unexpected effect shall not be excluded from evaluation and 
reporting. 
2If an investigational device gives an incorrect diagnosis, the patient might, for 
example, receive an unnecessary treatment and incur all the risks that accompany 
that treatment, or might be incorrectly diagnosed with a serious disease. In other 
cases, the patient might not receive an effective treatment (thereby missing out on 
the benefits that treatment would confer) or might not be diagnosed with the 
correct disease or condition. 
Unlikely 
The relationship with the use of the device seems not relevant and/or the event can 
be reasonably explained by another cause, but additional information may be 
obtained. 
Possible 
The relationship with the use of the investigational device 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. 
Probable 
The relationship with the use of the investigational device seems relevant and/or 
the event cannot reasonably explained by another cause, but additional information 
may be obtained. 
Causal 
Relationship 
The serious event is associated with the investigational device or with procedures 
beyond reasonable doubt when: 
- the event is a known side effect of the product category the device belongs to or 
of similar devices and procedures; 
- the event has a temporal relationship with investigational device use/application 
or procedures; 
- the event involves a body-site or organ that 
o the investigational device or procedures are applied to; 
o the investigational 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 investigational device used for 
diagnosis1, when applicable; 

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- 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. 
 
1 If an investigational device gives an incorrect diagnosis, the patient might, for 
example, receive an unnecessary treatment and incur all the risks that accompany 
that treatment, or might be incorrectly diagnosed with a serious disease. In other 
cases, the patient might not receive an effective treatment (thereby missing out on 
the benefits that treatment would confer), or might not be diagnosed with the 
correct disease or condition. 
  *Reportable event categories that will be collected during this study 
11.2. Reporting of Adverse Events 
Any adverse event meeting the definition of serious, device-related, procedure-related and/or therapy-
related  as defined above will be considered reportable for this study.   
 
The following are not adverse events: 
• 
Any normal expected postoperative complaints or symptoms unless the event 
involves a clinically significant change in severity or duration of symptoms or requires 
clinical intervention that is different from ordinary postoperative care.  Expected 
postoperative outcomes include headache, incisional pain, nausea, vomiting, low 
grade fever, oozing at dressing, dizziness, irritability, sleepiness, nervousness, 
insomnia, constipation, urinary retention, confusion and similar events.       
• 
Any non-clinically significant, transient (lasting for only a short time) stimulation-
related effects that occur during the implant procedure, programming and follow-up 
period.   
• 
 
 
For reporting of all serious adverse events and/or serious adverse device effects, the following 
emergency Sponsor contact may be used:  
Phone: 1+763.514.4000 
Email: rs.pelvichealthresearchnetwork@medtronic.com 
Address: 7000 Central Avenue NE, RCE 375 | Minneapolis, MN, 55432 | USA 
All reportable adverse events will be classified using the following responsibility matrix:  
 
 
 

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Table 11-2 Event Classification Responsibilities 
What is Classified 
Who Classifies 
Classification Parameters 
Relatedness 
 Investigator, Medtronic 
Procedure related 
Device related 
Therapy related 
Seriousness 
Investigator 
SAE/SADE 
Diagnosis 
Investigator 
Based on presenting signs and symptoms and 
other supporting data 
Medtronic 
MedDRA term assigned based on the data 
provided by investigator 
 
All reportable adverse events must be recorded in the subject’s medical record and on an Adverse Event  
eCRF and promptly reported to Medtronic based on Table 11-2.  IRB/EC reporting must be completed in 
accordance with the policies of the governing IRB/EC.   Governing regulatory authority reporting along 
with safety and vigilance reporting will be completed in accordance with applicable local regulations.  
Reports of adverse events will include the following information, at a minimum: 
• 
Date of event 
• 
Diagnosis or description of the event 
• 
Assessment of the seriousness and relationship to the product(s) under study 
• 
Treatment 
• 
Outcome and date of resolution 
 
It is the responsibility of the Investigator to identify the occurrence of reportable adverse events and to 
ensure the required information is accurately documented on the eCRF.   
The clinical course of each adverse event must be followed until resolution or subject discontinuation 
from the study, whichever comes first.  “Ongoing” adverse events must be assessed at each protocol 
required visit, and new or updated information must be documented on the Adverse Event eCRF and 
promptly reported to Medtronic and if applicable to the IRB/EC.   Commercial medical device reporting 
processes will be followed for complaint handling.  
If necessary, the Investigator may report to the sponsor initially by telephone or email and follow-up 
with completed eCRFs and, if possible, copies of source documentation regarding the event (e.g., 
physician/nurse notes or summaries).    
Medtronic study personnel will promptly review all reported adverse events and if necessary request 
clarification and/or additional information from the Investigator.  If Medtronic disagrees with the 
Investigator’s assessment of the adverse event relationship to device, therapy and/or procedure, 

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Medtronic study personnel will document the disagreement and report or ensure reporting of both 
opinions to IRB/EC as necessary.  All reported adverse events will be reviewed by a Medtronic Medical 
Advisor to ensure consistent reporting. 
9.1.1. 
Device Deficiencies 
A device deficiency (DD) is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. Device deficiencies include malfunctions, misuse or use 
errors, and inadequate labeling. All device deficiencies must be documented and submitted to 
Medtronic on the Device Deficiency eCRF. In addition, the Investigator must also determine and 
document on the eCRF device deficiencies that did not lead to adverse event but could have led to a 
serious adverse device effect: 
• if either suitable action had not been taken, 
• if intervention had not been made, or 
• if circumstances had been less fortunate 
9.1.2. 
Deaths 
All subject deaths must be reported to Medtronic and the IRB/EC as soon as possible, but no more than 
5 working days after learning of a subject’s death, regardless of whether or not the death is related to 
the device system or therapy. If limited information is known, the Adverse Event eCRF must be 
completed with available information as soon as possible. As information becomes available, the eCRF 
will be updated. If the death occurs at a location remote from the study site, it is the study site’s 
responsibility to make every attempt to retrieve all pertinent information related to the subject’s death 
and submit the investigator’s death summary of the known events surrounding the death to Medtronic 
or its designee.  The Investigator should also attempt to determine, as conclusively as possible, whether 
such deaths are related to the device system, therapy, and/or procedure.   In addition, the principal 
investigator should follow commercial medical device reporting requirements. The principal investigator 
should provide as much of the following supporting documentation as possible for deaths: 
• 
Death certificate 
• 
Death summary/hospital records, if allowed by state/local law 
• 
Autopsy report, if allowed by state/local law 
All device system components that were being used at the time of the death should be returned to 
Medtronic for analysis, if applicable. Any subject death will be reported on the Adverse Event and Study 
Exit CRFs. 

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12. Data Review Committees  
This study will not use a Clinical Events Committee or Data Monitoring Committee. Instead, all reported 
adverse events and device deficiencies will be reviewed by a Medtronic Medical Advisor to ensure 
consistent reporting as defined in Section 11.2. 
13. Statistical Design and Methods 
13.1. General Statistical Considerations 
Data analysis will be performed by Medtronic-employed statisticians or designees. A validated statistical 
software package will be used for the analyses of the study results (e.g. SAS version 9.4 or higher). 
The Statistical Analysis Plan (SAP) will be developed prior to data analysis and will include a 
comprehensive description of the statistical methods to be included in the final study report. Any 
change to the data analysis methods described in the CIP will require an amendment only if it changes a 
principal feature of the CIP. Any other change to the data analysis methods described in the CIP, and the 
justification for making the change, will be described in the clinical study report.   
13.1.1. 
Sample Size Justification 
 
 
 
 
 
  
Using PASS 2011, assuming that motor or sensory response is able to be obtained in 95% of subjects 
who qualify for a BE lead placement, with 100 subjects, this produces a two-sided 95% CI of 88.7-98.4% 
with a width equal to 9.6%. The confidence interval width will vary slightly depending on the actual 
proportion of subjects with motor or sensory responses.  
13.1.2. 
Investigation Site Pooling 
The investigators of this study will conduct the study according to this protocol and use the same CRFs 
to collect study data. The site study personnel will be trained prior to the study initiation at each site. 
Periodic study monitoring by Medtronic will ensure compliance with protocol requirements.  

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There is no a priori provision to exclude any sites from the analysis. The data from all sites will be pooled 
for analysis. To reduce the possibility of atypical results from a site overly influencing the combined 
results, no more than 20 subjects will be implanted at each site unless the site gets pre-approval from 
the Medtronic for additional enrollments.  
13.1.3. 
Other Specific Considerations 
Adjustment for Baseline Covariates 
There is no plan to make adjustment of baseline covariates for the primary objective.  
Handling Missing Data 
Missing data are a potential source of bias when analyzing study data. A rigorous study design and 
execution will help prevent the incidence of missing data from occurring.  
For the primary objective of motor or sensory response, in case subject’s motor or sensory response is 
not tested or response data are lost during lead placement, a sensitivity analysis will be performed by 
displaying the full range of proportions on the potential impact of missing data by running an analysis 
assuming all missing values as not obtaining motor or sensory response to none of the missing values as 
not obtaining motor or sensory response.  
Adjustment for Multiple Endpoints 
As there is no hypothesis testing for the primary objective, adjustment for multiple endpoints is not 
required.  
Interim Analysis 
There is no planned interim analysis for the primary objective in this study.  
13.1.4. 
Reports 
A final clinical study report will be generated for this study. Periodic progress reports may also be 
generated for the study.  Reports may be submitted to the regulatory authorities, as required based on 
applicable local regulations.  
13.2. Demographics 
Demographics and baseline characteristics will be summarized in the report.  

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13.3. Primary Objective – Motor or Sensory Response 
To characterize proportion of subjects who demonstrate motor or sensory response(s) during lead 
placement using the InterStim BE Lead.  
Hypothesis 
There is no formal hypothesis. The objective is to estimate the proportion of subjects who demonstrate 
motor or sensory response(s) during lead placement using the InterStim BE Lead.  
Experimental Design 
During the lead placement procedure using the InterStim BE lead, subject’s motor and/or sensory 
response will be collected as specified in Section 9.5. Subjects may be implanted with more than one BE 
lead.  In this case subject’s motor and/or sensory response from all implanted BE leads will be recorded. 
In case more than one BE lead is implanted, the subject is considered as demonstrating a response if 
motor or sensory response is obtained from at least one BE lead.  
Analysis Methods 
Subjects who had the BE lead placement and provide data (completers) will be included in the primary 
analysis. The primary analysis will report the proportion of subjects who obtain motor or sensory 
response and its two-sided exact binomial 95% CI among those who had lead placement.  
In cases where surgical modifications for BE leads are needed, motor or sensory response from the 
initial lead placement will be used for the primary analysis 
In cases where subject’s motor or sensory response is not tested, or response data are lost during lead 
placement, or other reasons where missing data occur, a sensitivity analysis will be performed by 
displaying the full range of proportions on the potential impact of missing data by running an analysis 
assuming all missing values as not obtaining a response to none of the missing values as not obtaining a 
response.   
In addition to the subject level analysis described above, a lead level supporting analysis will be 
performed by estimating the proportion of BE Leads that have motor or sensory response(s) during 
initial lead placement. The leads that have motor or sensory responses during replacement BE lead 
implant will be summarized separately.  
 
 
 
 
 
 

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13.5. Safety Assessment 
To characterize safety during the Basic Evaluation lead implant and therapy evaluation.  
Safety will be evaluated by the collection of reportable adverse events. Reportable adverse events are 
defined as serious, device, procedure and/or therapy-related events.  
Device deficiencies will be collected and reported. 
14. Ethics 
14.1. Statement(s) of Compliance  
The study will be conducted in accordance with this protocol, the ethical principles that have their origin 
in the Declaration of Helsinki have been implemented in this clinical study by means of the informed 

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consent process, EC/IRB approval, competent authority approval (if applicable), study training, and risk 
benefit assessment. In addition, all applicable laws and regulatory requirements of the country/ies in 
which the study is conducted will be followed and in accordance with GCP. 
• 
In the US, the study will be conducted in accordance with 21 CFR§11 Electronic Records, 
Electronic Signatures, 21CFR§50 Protection of Human Subjects, 21CFR§56 IRB, 21 CFR§54 
Financial Disclosure by Clinical Investigators and 21CFR§803 Medical Device Reporting.  
• 
In Europe, the study will be conducted in accordance with European Union Medical Device 
Regulation in addition to regional or national regulations, as appropriate. 
• 
In Canada, the study will be conducted in accordance with Canada Medical Devices Regulations, 
1998 (SOR/98-282), and the Guidance document for Mandatory Problem Reporting. 
 
Any additional requirements imposed by the IRB/EC or governing regulatory authority shall be followed, 
if appropriate. 
 
Medtronic will report AEs and device deficiencies according to post-market vigilance reporting 
requirements,21 CFR 803 and to meet local, regional and geographical regulatory requirements. This 
study will be posted on ClinicalTrials.gov and EUDAMED once available, as part of Medtronic’s 
commitment to full disclosure for ongoing studies that meet the requirements for public posting. 
 
Medtronic will distribute the approved version of the CIP and all other materials required to conduct the 
study. Prior to site activation, Medtronic will provide study training relevant and pertinent to the 
involvement of personnel conducting study activities and investigator responsibilities.  All subject 
reimbursement (if provided) and insurance (if required) will be disclosed to the IRB/EC.  Medtronic will 
not activate any site until the required approval/favorable opinion from the Institutional Review Board 
(IRB)/Ethics Committee (EC) or notification/approval from a regulatory authority have been obtained, if 
appropriate. 
 
Site personnel must inform Medtronic of any change in status of the IRB/EC approval once the site has 
started enrollment. 
15. Study Administration 
15.1. Principal Investigator Oversight  
The Principal Investigator will provide adequate oversight to ensure the study is conducted in 
accordance with all protocol requirements, all applicable regulatory requirements and any applicable 
institutional requirements related to the conduct of clinical research. The Principal Investigator will 
ensure no study-related activities occur prior to regulatory and IRB/EC approval. Any actions taken by 
the IRB/EC with respect to the investigation will be forwarded to Medtronic as soon as possible. The 

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Principal Investigator is responsible for submitting all required reports to the sponsor and/or IRB/EC. 
Regulatory reporting of AEs/DDs will be completed according to local regulatory requirements. It is the 
responsibility of the Investigator to abide by any additional AE/DD reporting requirements stipulated by 
the IRB/EC responsible for oversight of the study. Investigators should report serious adverse events, 
device-, procedure- and therapy-related adverse events and device deficiencies to Medtronic after the 
Investigator learns of the event in accordance with Table 15-1.  
 
In addition, Principal Investigator, or designated personnel will provide Medtronic with the following 
minimum information related to serious adverse events, device-, procedure- and/or therapy-related 
adverse events: 
• Date of adverse event  
• Treatment provided 
• Resolution date 
• Assessment of seriousness 
• Relationship to the device, therapy and/or procedure 
 
Failure to perform the investigator obligations or to complete corrective and preventive actions 
identified during monitoring or auditing activities may result in Principal Investigator or site personnel 
disqualification, and/or lead to suspension or termination of the study at the site. 
 
Table 15-1 includes minimum reporting requirements for investigators participating in studies in Europe, 
the US and Canada. Medtronic study personnel will immediately report Adverse Events and Device 
Deficiencies, related to a CE marked, Canadian licensed or FDA approved device used during the study, 
to Medtronic’s Compliant Handling Unit who will ensure prompt review and appropriate reporting. The 
Therapeutic Products Directorate is a division of Heath Canada, and is responsible for regulating 
therapeutic products including Food, Drugs, Medical Devices, Natural Health Products, Cells, Tissues and 
Organs and Cosmetics. Table 15-1 includes minimum reporting requirements.  The Sponsor will 
complete reporting activities in accordance with timeframe as per local requirement.   
Table 15-1 Reporting Requirements 
Serious Adverse Events (SAEs) 
Investigator submit to:  
Medtronic Europe: Immediately after the investigator first learns of the event or of 
new information in relation with an already reported event 
 
All other geographies: Report to the sponsor, without unjustified delay, all 
serious adverse events 
 
 

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EC/IRB All other geographies: Reporting timeframe as per local EC/IRB per local 
requirement 
Serious Adverse Device Effects (SADEs)  
Investigator submit to: 
Medtronic US: As soon as possible to meet regulatory reporting requirements, but no 
later than 10 working days after the date you become aware 
 
Europe: Immediately after the investigator first learns of the event or of 
new information in relation with an already reported event 
 
All other geographies: Reporting timeframe as per local requirement 
EC/IRB Reporting timeframe as per local EC/IRB requirement 
All Other Adverse Events 
Investigator submit to: 
Medtronic All geographies: Submit in a timely manner after the Investigator first 
learns of the event 
EC/IRB All geographies: Reporting timeframe as per local EC/IRB requirement 
Deaths 
Investigator submit to: 
Medtronic All geographies: All subject deaths must be reported to Medtronic and the 
IRB/EC as soon as possible, but no more than 5 working days of learning of 
a subject’s death, regardless of whether or not the death is related to the 
device system or therapy 
EC/IRB All geographies: All subject deaths must be reported the 
IRB/EC as soon as possible, but no more than 5 working days of learning of 
a subject’s death, regardless of whether or not the death is related to the 
device system or therapy 
Device Deficiencies (DD) with SADE potentials 
Investigator submit to: 
Medtronic Europe: Immediately after the investigator first learns of the deficiency or 
of new information in relation with an already reported deficiency 
 
All other geographies: Reporting timeframe as per local requirement 
EC/IRB All other geographies: Reporting timeframe as per local EC requirement 
All other Device Deficiencies 
Investigator submit to: 
Medtronic All geographies: Submit in a timely manner after the investigator first 
learns of the deficiency 
EC/IRB All geographies: Reporting timeframe as per local EC requirement 
 
 

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Withdrawal of IRB Approval 
Investigator submit to: 
Medtronic All geographies: Report a withdrawal of the reviewing EC/IRB 
approval within 5 working days of investigator notification 
Protocol Deviations for Emergency Reasons 
Investigator submit to: 
Medtronic US: Submit to Medtronic and IRB within 5 working days of the occurrence 
of an emergency deviation (made to protect the life or physical well-being 
of a subject) 
 
Canada: Per institutional guidelines, report protocol deviations to 
Medtronic 
EC/IRB US: Submit to Medtronic and IRB within 5 working days of the occurrence 
of an emergency deviation (made to protect the life or physical well-being 
of a subject) 
 
Canada: Per institutional guidelines, report protocol deviations to the 
reviewing IRB 
Failure to Obtain Informed Consent 
Investigator submit to: 
Medtronic US and Europe: The Investigator must notify Medtronic within 5 working 
days upon awareness 
 
Canada: The Investigator must notify Medtronic within 5 working days after 
Procedure 
EC/IRB US and Europe: The Investigator must notify the EC/IRB within 5 working 
days after upon awareness 
 
Canada: The Investigator must notify the EC/IRB within 5 working 
days after procedure 
Final Report 
EC/IRB US and Europe: Study reports must be submitted within 6 months after 
termination or completion of the investigation or as required by applicable 
regulation 
 
Canada: Study reports must be submitted within 3 months after 
termination or completion of the investigation or as required by applicable 
regulation 
 
 

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15.2. Sponsor 
This study is sponsored by: 
Medtronic, Inc. 
7000 Central Avenue NE 
Minneapolis, MN 55432 
USA 
A list of sponsor’s study staff will be provided as a separate document to site personnel. Sponsor will 
maintain an updated list of contact information. 
15.3. Site Selection 
The role of the principal investigator is to implement and manage the day-to-day conduct of the study as 
well as ensure data integrity and the rights, safety and well-being of the patients involved in the study. 
Site selection criteria will be documented and utilized to ensure adequate site selection. 
15.4. Clinical Trial Agreement 
Medtronic contracts with participating institutions/investigators through a Clinical Trial Agreement that 
defines the scope and responsibilities and associated compensation related to carrying out the 
obligations under a clinical study sponsored by Medtronic. The investigator is indicating approval of the 
Clinical Investigation Plan and subsequent amendments, by a fully executed agreement.   
15.5. Curriculum Vitae 
A curriculum vitae from each Investigator participating in the study shall be obtained. 
15.6. Monitoring  
 Medtronic is responsible for ensuring the proper conduct of this study in terms of adherence to 
applicable regulations, protocol compliance, and the validity and accuracy of the study data entered on 
CRFs.  Monitoring and monitoring oversight will be provided by representatives of Medtronic who will 
support the investigation including center qualification, initiation, on-site monitoring, and study closure.  
Contact information for the study monitoring: 
Medtronic Core Clinical Solutions Monitor Group 
8200 Coral Sea Street, N.E., MVS33 
Mounds View, MN 55112 

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15.7. Source Documentation 
The Principal Investigator and center personnel will provide the Medtronic monitor(s) with complete 
access to primary source data (e.g., paper and electronic hospital/clinical charts, appointment books, 
laboratory records) that support the data on the CRFs as well as other documentation supporting the 
conduct of the study.  The monitor will perform source data verification and routine reviews of study-
related regulatory documents during scheduled monitoring visits and work to secure compliance should 
any deficiencies be observed. The monitoring plan contains the strategy for frequency of monitoring 
visits and source data verification to be performed for this study. Data Management 
Medtronic personnel will perform routine edit and consistency checks for items such as missing data or 
inconsistent data.  Identified data inconsistencies will be resolved by use of data discrepancies; 
investigators and site personnel will review data discrepancies and respond to the discrepancies in a 
timely manner.  The resolved discrepancy will become a part of the eCRF record for the subject. 
The Oracle Clinical Remote Data Capture (RDC) system which is 21CFR§11 Part E compliant controls user 
access, and ensures data integrity. This system is a fully validated system. The RDC system maintains an 
audit trail of entries, changes or corrections in eCRFs. User access will be granted to each individual 
based on his or her delegation of authority and completion of required training. If a person only 
authorized to complete eCRFs makes changes to an already signed eCRF, the system will require the 
Principal Investigator, or authorized delegate, to re-sign the eCRF. 
The Principal Investigator, or designated representative, is responsible for the data submitted and must 
review all data for accuracy and provide his/her approval of the eCRF and sign each form with an 
electronic signature.  
15.8. Medtronic Representative Role 
Medtronic representatives may participate in the conduct of the study to the extent listed below. 
Medtronic representatives can provide technical support to the investigator and other health care 
personnel as needed during study visits. This support may include the training of site personnel on use 
of the Medtronic equipment or the protocol-related procedures and forms. 
In addition, Medtronic personnel can perform certain activities to ensure study quality. These activities 
may include: 
• Observing testing or medical procedures to provide information relevant to protocol completion 
• Reviewing collected data and study documentation for completeness and accuracy 
• Perform device programming or device interrogation under the direction of the investigator(s) 
Medtronic personnel will not: 

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• Practice medicine 
• Provide medical diagnosis or treatment to subjects 
• Discuss a subject’s condition or treatment with a subject without the approval and presence of 
the health care provider. 
• Complete CRFs or make entries in the subject’s medical record 
15.9. Direct Access to Source Data/Documents  
Source data is all information, original records (or certified copies) of clinical findings, observations or 
other activities in a study necessary for the reconstruction and evaluation of the study. Examples of 
these original documents and records include, but are not limited to: hospital/clinic records, phone 
records, laboratory reports, etc.   Site personnel should clearly indicate the subjects’ participate in the 
study within the medical records.  
Principal Investigator and Institution must permit study-related monitoring, audits, IRB/EC review and 
regulatory inspections(s) by providing direct access to source data/documents.  Medtronic or third-party 
auditors representing Medtronic may perform clinical site audits to verify the performance of the 
monitoring process and study conduct, and to ensure compliance with applicable regulations.  
Representatives for regulatory bodies such as the FDA or Health Canada may also perform site 
inspections related to this clinical study.  The Principal Investigator, site personnel, and institution will 
provide auditors with direct access to primary source data and all study-related documentation.  
In accordance with GCP and regulatory requirements, Medtronic will investigate suspected cases of 
fraud. 
15.10. 
Confidentiality 
Subject confidentiality is assured through the use of subject identification numbers, and the de-
identifying of photocopied or records obtained by the Sponsor.  In addition to the review of records on 
site, release of de-identified records to Medtronic may be necessary, such as in the evaluation of 
adverse events.   
For purposes of monitoring this study, access to clinic and hospital records must be available to 
Medtronic, agents of Medtronic (e.g. CRO), the FDA, Health Canada and other regulatory agencies.   
Health Insurance Portability and Accountability Act (HIPAA) language will be required to be included at 
every site in the US.  HIPAA language may be included within the US ICF template.  

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15.11. 
Liability 
15.11.1. Study Funding 
The costs associated with study conduct will be documented in separate Clinical Trial Agreements that 
will be signed by Medtronic, the Principal Investigator, and/or the management of the institution. 
Subject compensation (if applicable) is detailed in the Patient Informed Consent Form. 
15.11.2. Insurance 
Medtronic of Canada, Ltd., Medtronic International Trading SARL, and Medtronic Logistics LLC are 
wholly owned subsidiaries of Medtronic, which as the parent company of such entities maintains 
appropriate clinical study liability insurance coverage as required under applicable laws and regulations 
and will comply with applicable law and custom concerning specific insurance coverage. If required, a 
Clinical Trial Insurance statement/certificate will be provided to the EC, governing regulatory authority 
(if applicable) and/or the IRB.  
15.11.3. Warranty 
Warranty information is provided in the product packaging for commercially available products. 
15.11.4. Indemnification 
Indemnification language will be contained in the Clinical Trial Agreements. 
15.12. 
CIP Amendments 
Protocol amendments may be initiated by Medtronic to address changes to the conduct of the study.  
Protocol amendments must be approved by Medtronic and submitted to the IRB/EC and governing 
regulatory authority (if applicable); protocol amendment approval and approval of any associated 
changes to the informed consent document must be obtained prior to implementation of the 
amendment except: 
• 
When necessary to eliminate an immediate/or apparent immediate hazard to participating 
subjects 
• 
When the change involves purely administrative or logistical aspects of the study  

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15.13. 
Record Retention 
At a minimum, the investigator is responsible for the preparation, review, and retention of the records 
listed below: 
• 
Essential correspondence that pertains to the investigation 
• 
Records of each subject’s case history and exposure to the device.  Case histories include the 
CRFs and supporting data (source documentation), such as: 
o 
Signed and dated ICFs 
o 
Medical records, including, for example, progress notes of the physicians, the 
subject’s hospital chart(s) and the nurses’ notes 
o 
All reportable adverse event information 
o 
Data related to the BE lead, foramen needle, BE kit and  therapy evaluation period.  
• 
Documentation of any deviation to the protocol, including the date and the rationale for such 
deviation 
• 
Signed Investigator Agreement and curriculum vitae for all Investigators 
• 
The protocol and any amendments 
The Principal Investigator is responsible for ensuring that all essential study documentation is retained 
and accessible for a minimum of 2 years following completion of the study.  The retention period may be 
longer If required by Medtronic or local or global regulatory requirements; Medtronic will be responsible 
for notifying sites of extensions to the 2-year minimum record retention requirements.  The Principal 
Investigator will ensure that essential study documents are not destroyed until written permission has 
been obtained from Medtronic. Medtronic will be notified in writing of any transfer of study 
documentation.  Medtronic will retain the study records according to Medtronic policy. 
15.14. 
Publication and Use of Information 
Medtronic intends to publish the results from the study in a timely manner upon study completion. 
These publication activities may include abstracts, presentations/posters to scientific meetings, and 
manuscripts. 
 
 
 
 
 
 

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15.15. 
Suspension or Early Termination 
Medtronic reserves the right to suspend or terminate the study at any time.  Reasons may include, but 
are not limited to, the following: 
• 
Insufficient enrollment to complete the study within the expected timeframe 
• 
Identification of unacceptable safety profile; suspicion of an unacceptable risk will result in a 
suspension, confirmation of an unacceptable risk will result in termination 
• 
Product performance/product supply issues  
Medtronic reserves the right to suspend or terminate the study at an individual site.  Reasons may 
include, but are not limited to, the following: 
• 
Noncompliance with the protocol  
• 
Serious or repeated deviations at the site 
• 
Failure to implement required corrective and preventive actions 
• 
Insufficient enrollment to complete the study within the expected timeframe 
• 
Loss of appropriately trained site personnel 
 
Investigators are required to notify the IRB/EC and governing regulatory authority (if applicable) of study 
suspension/termination.  Subjects will be notified by the investigator of suspension/termination due to 
unacceptable risk or of termination due to any other cause. 

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16. References 
1. Gormley EA, Lightner DL, Faraday M, Vasavada SP.  Diagnosis and Treatment of Overactive Bladder 
(Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment.  May 2015: 193, 1572-1580.  doi: 
10.1016/j.juro.2015.01.087. 
2. Lucas MG, Bosch R, Burkhard FC, et al. EAU Guidelines on Surgical Treatment of Urinary Incontinence. 
European Urology, 62 (6): 1118-1129. DOI: 10.1016/j.eururo.2017.03.048. 
3. Hilmy M, Tatarov O, McQueen L, Small D, Granitsiotis P, Conn IG. Sacral nerve stimulation for urinary 
dysfunction: the first year of the Scottish  national service. Scott Med J. 2012;57(4):200-203. 
doi:10.1258/smj.2012.012117. 
4. Leong RK, De Wachter SGG, Nieman FHM, de Bie RA, van Kerrebroeck PEV. PNE versus 1st stage tined 
lead procedure: A direct comparison to select the most sensitive test method to identify patients 
suitable for sacral neuromodulation therapy. Neurourol Urodyn. 2011;30(7):1249-1252. 
doi:10.1002/nau.20979. 
5. Marcelissen T, Leong R, Serroyen J, van Kerrebroeck P, de Wachter S. Is the screening method of 
sacral neuromodulation a prognostic factor for long-term success? J Urol. 2011;185(2):583-587. 
doi:10.1016/j.juro.2010.09.103.  
6. Bannowsky A, Wefer B, Braun PM, Junemann K-P. Urodynamic changes and response rates in patients 
treated with permanent electrodes compared to conventional wire electrodes in the peripheral nerve 
evaluation test. World J Urol. 2008;26(6):623-626. doi:10.1007/s00345-008-0307-7. 
7. Seif C, Eckermann J, Bross S, Portillo FJM, Junemann K-P, Braun P-M. Findings with Bilateral Sacral 
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