Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes - Post Market Clinical Follow-Up Study
Phase: NA
Conditions: Overactive Bladder, Fecal Incontinence, Non-obstructive Urinary Retention
Sponsor: MedtronicNeuro

InterStim Micro Post Market Clinical Follow-up Study (ELITE) 
Clinical Investigational Plan Version 2.0 
12-Dec-19 
NCT04506866 

ELITE Clinical Investigation Plan 
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Clinical Investigation Plan 
Clinical Investigation 
Plan/Study Title 
Evaluation of InterStim Micro System Performance and Safety (ELITE) to 
Confirm Long-Term Outcomes 
Clinical Investigation 
Plan Identifier 
MDT19006 
EUDAMED unique identifier will be provided under a separate cover, once 
available. 
Study Product Name This Post-Market Clinical Follow-Up (PMCF) will include the following 
commercially approved products: 

InterStim Micro implantable neurostimulator

InterStim SureScan MRI tined lead

Patient and clinician therapy application software

Wireless recharger

Recharger application software

Percutaneous extension (advanced therapy evaluation)

Temporary lead (basic therapy evaluation)

Verify external neurostimulator
Sponsor/Local Sponsor 
United States (Sponsor): 
Medtronic, Inc. 
7000 Central Ave NE 
Minneapolis, MN 55432 USA 
Europe (Local Sponsor): 
Medtronic International Trading Sàrl 
Route du Molliau 31 
CH-1131 Tolochenaz, Switzerland 
Europe (Legal Sponsor): 
Medtronic Bakken Research Center 
Endepolsdomein 5 
6229 GW Maastricht 
The Netherlands 
Canada (Local Sponsor): 
Medtronic Canada ULC 
99 Hereford Street 
Brampton, ON, L6Y 0R3 Canada 
1-905-460-3800 
Australia (Local Sponsor): 
Medtronic Australasia Pty Ltd 
2 Alma Road 
Macquarie Park, NSW 2113 Australia 
Document Version 2.0 
12-Dec-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 

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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 ...................................................................................................... 3 
Table of Contents ...................................................................................................................... 4 
2. 
Glossary .............................................................................................................................. 8 
3. 
Synopsis ........................................................................................................................... 10 
4. 
Introduction ..................................................................................................................... 21 
4.1. Background ........................................................................................................................ 21 
4.2. Purpose .............................................................................................................................. 21 
5. 
Objectives ........................................................................................................................ 21 
5.1. Overactive Bladder Cohort ................................................................................................... 21 
5.1.1. 
Primary Objective .................................................................................................................. 21 
5.1.2. 
Additional Measures ............................................................................................................. 21 
5.2. Fecal Incontinence Cohort .................................................................................................... 22 
5.2.1. 
Primary Objective .................................................................................................................. 22 
5.2.2. 
Additional Measures: ............................................................................................................ 22 
5.3. Non-Obstructive Urinary Retention Cohort ............................................................................. 22 
5.3.1. 
Primary Objective .................................................................................................................. 22 
5.3.2. 
Additional Measures: ............................................................................................................ 22 
6. 
Study Design .................................................................................................................... 23 
6.1. Duration ............................................................................................................................. 23 
6.2. Rationale ............................................................................................................................ 24 
7. 
Product Description.......................................................................................................... 24 
7.1. General .............................................................................................................................. 24 
7.2. Manufacturer ...................................................................................................................... 25 
7.3. Intended Population ............................................................................................................ 25 
7.4. Product Return .................................................................................................................... 25 
7.5. Product Storage & Accountability .......................................................................................... 25 
8. 
Selection of Subjects ........................................................................................................ 25 
8.1. Study Population ................................................................................................................. 25 

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8.2. Subject Enrollment .............................................................................................................. 26 
8.3. Eligibility Criteria ................................................................................................................. 26 
8.3.1. 
Overactive Bladder Eligibility Criteria ............................................................................... 26 
Overactive Bladder Inclusion Criteria ............................................................................................ 26 
Overactive Bladder Exclusion Criteria............................................................................................ 26 
8.3.2. 
Fecal Incontinence Eligibility Criteria ................................................................................ 27 
Fecal Incontinence Inclusion Criteria ............................................................................................ 27 
Fecal Incontinence Exclusion Criteria ............................................................................................ 27 
8.3.3. 
Non-Obstructive Urinary Retention Eligibility Criteria ......................................................... 28 
Non-Obstructive Urinary Retention Inclusion Criteria ..................................................................... 28 
Non-Obstructive Urinary Retention Exclusion Criteria ..................................................................... 28 
9. 
Study Procedures ............................................................................................................. 29 
9.1. Schedule of Events .............................................................................................................. 29 
9.2. Subject Screening ............................................................................................................... 36 
9.3. Subject Consent .................................................................................................................. 36 
9.4. Concomitant Medication ....................................................................................................... 37 
9.5. Assessment of Efficacy ........................................................................................................ 37 
9.6. Assessment of Safety .......................................................................................................... 39 
9.7. Recording Data ................................................................................................................... 39 
9.8. Deviation Handling .............................................................................................................. 40 
9.9. Subject Withdrawal or Discontinuation .................................................................................. 41 
10. 
Risks and Benefits ......................................................................................................... 41 
10.1. 
Potential Risks ............................................................................................................... 41 
10.1.1. 
Risks Outlined in the Instructions for Prescribers (IFP) ................................................... 42 
10.2. 
Potential Benefits ........................................................................................................... 42 
10.3. 
Risk-Benefit Rationale .................................................................................................... 42 
11. 
Adverse Events and Device Deficiencies ....................................................................... 43 
11.1. 
Definitions/Classifications ............................................................................................... 43 
11.2. 
Reporting of Adverse Events ........................................................................................... 49 
11.2.1. 
Device Deficiencies ..................................................................................................... 50 
11.2.2. 
Death ........................................................................................................................ 50 
12. 
Data Review Committees .............................................................................................. 51 

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13. 
Statistical Design and Methods ..................................................................................... 51 
13.1. 
General Statistical Considerations .................................................................................... 51 
13.1.1. 
Sample Size Justification ............................................................................................. 51 
13.1.2. 
Investigation Site Pooling ............................................................................................ 53 
13.1.3. 
Other Specific Considerations ...................................................................................... 54 
13.1.4. 
Reports ..................................................................................................................... 54 
13.2. 
Demographics ............................................................................................................... 55 
13.3. 
Treatment Characteristics ............................................................................................... 55 
13.4. 
Overactive Bladder Cohort .............................................................................................. 55 
13.4.1. 
Primary Objective ....................................................................................................... 55 
13.4.2. 
Additional Measures .................................................................................................... 55 
13.5. 
Fecal Incontinence Cohort .............................................................................................. 56 
13.5.1. 
Primary Objective ....................................................................................................... 56 
13.5.2. 
Additional Measures .................................................................................................... 56 
13.6. 
Non-Obstructive Urinary Retention Cohort ....................................................................... 57 
13.6.1. 
Primary Objective ....................................................................................................... 57 
13.6.2. 
Additional Measures .................................................................................................... 58 
13.7. 
Safety Assessment ......................................................................................................... 58 
14. 
Ethics ............................................................................................................................. 58 
14.1. 
Statement(s) of Compliance ........................................................................................... 58 
15. 
Study Administration ..................................................................................................... 59 
15.1. 
Principal Investigator Oversight....................................................................................... 59 
15.2. 
Sponsor ........................................................................................................................ 64 
15.3. 
Site Selection ................................................................................................................ 64 
15.4. 
Clinical Trial Agreement .................................................................................................. 64 
15.5. 
Curriculum Vitae ............................................................................................................ 64 
15.6. 
Monitoring .................................................................................................................... 65 
15.7. 
Medtronic Representative Role ........................................................................................ 65 
15.8. 
Data Management ......................................................................................................... 65 
15.9. 
Direct Access to Source Data/Documents ......................................................................... 66 
15.10. 
Confidentiality ............................................................................................................... 67 
15.11. 
Liability ......................................................................................................................... 67 

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15.11.1. 
Study Funding .................................................................................................................... 67 
15.11.2. 
Insurance ........................................................................................................................... 67 
15.11.3. 
Warranty ............................................................................................................................ 67 
15.11.4. 
Indemnification.................................................................................................................. 67 
15.12. 
CIP Amendments ........................................................................................................... 68 
15.13. 
Record Retention ........................................................................................................... 68 
15.14. 
Publication and Use of Information .................................................................................. 69 
15.15. 
Suspension or Early Termination ..................................................................................... 69 
16. 
References..................................................................................................................... 70 
17. 
Appendices .................................................................................................................... 71 
17.1 Additional Information for Sites ............................................................................................ 71 
17.2 Institutional Review Boards/Ethics Committees ...................................................................... 72 
17.3 Participating Investigators and Institutions ............................................................................ 72 
17.4 Informed Consent Materials ................................................................................................. 72 
17.5 Labeling ............................................................................................................................. 72 
18. 
Version History .............................................................................................................. 72 
 

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2.Glossary 
Term 
Definition 
ADE 
Adverse Device Effect 
Advanced Evaluation  
A tined lead is surgically implanted and 
externalized via a percutaneous extension for test 
stimulation. 
AE 
Adverse Event 
Basic Evaluation  
A temporary test stimulation lead is surgically 
implanted, externalized and connected to a patient 
cable for test stimulation. 
CCIS 
Cleveland Clinic Incontinence Score 
CFR 
Code of Federal Regulations 
CI 
Confidence Interval 
CIP 
Clinical Investigational Plan  
CISC 
Clean Intermittent Self-Catheterization  
eCRF 
Electronic Case Report Form  
EC 
Ethics Committee  
EU 
Europe 
FI 
Fecal Incontinence  
 
 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
HRQL 
Health Related Quality of Life  
ICF 
Informed Consent Form 
OAB-q 
Overactive Bladder Symptoms Quality of Life 
Questionnaire 
IDE 
Investigational Device Exemption 

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Term 
Definition 
IRB 
Institutional Review Board  
MedDRA 
Medical Dictionary for Regulatory Activities 
MI 
Multiple Imputation 
NOUR 
Non-Obstructive Urinary Retention  
OAB 
Overactive Bladder 
 
 
PMCF 
Post-Market Clinical Follow-up 
Oracle RDC 
Oracle Remote Data Capture 
QoL 
Quality of Life  
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event  
SAP 
Statistical Analysis Plan 
SNM 
Sacral Neuromodulation  
US 
United States  
UF 
Urgency Frequency 
UI
Urinary Incontinence
UUI 
Urinary Urge Incontinence 
 

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3.Synopsis
Title 
Evaluation of InterStim Micro System Performance and Safety (ELITE) 
Post Market Clinical Follow-Up Study to Confirm Long-Term Outcomes 
Clinical Study Type 
Prospective, Multicenter, Global, Single-arm, Open-label, Post-market 
Product Name 
This post-market clinical follow-up (PMCF) will include the following 
commercially approved products: 

InterStim Micro implantable neurostimulator  

InterStim SureScan MRI tined lead  

Patient and clinician therapy application software 

Wireless recharger  

Recharger application software 

Percutaneous extension (advanced therapy evaluation) 

Temporary lead (basic therapy evaluation) 

Verify external neurostimulator 
Sponsor  
Medtronic, Inc. 
Indication under 
investigation  
The indications under investigation are overactive bladder, fecal 
incontinence, and non-obstructive urinary retention.   Refer to 
geography-specific labeling for additional details on indications.  
 
There are no investigational devices used in this study, all study 
products will be used in accordance with the product labeling.
Investigation Purpose 
Post-market clinical follow-up to confirm long-term safety and 
performance of the InterStim Micro System for sacral 
neuromodulation.  
Overactive Bladder (OAB)    
Cohort Objectives 
Primary Objective:  
x
To demonstrate an improvement in Overactive Bladder 
Quality of Life (OAB-q) Questionnaire Health Related Quality 
of Life (HRQL) total score at 3 months post-implant compared 
to baseline 
 
Additional Measures: 
x
 
 

 
 
 
  

 
 

 
   
 

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Fecal Incontinence (FI)    
Cohort Objectives 
Primary Objective:  
x
To demonstrate an improvement in Cleveland Clinic 
Incontinence Score (CCIS) at 3 months post-implant compared 
to baseline  
 
Additional Measures: 
x
 
 

 
 

 
 
 

 
  
Non-Obstructive Urinary 
Retention (NOUR)    
Cohort Objectives 
Primary Objectives:  
x
To demonstrate an improvement in number of clean 
intermittent self-catheterizations (CISC) per day at 3 months 
post-implant compared to baseline 
 
Additional Measures: 
x
 
 
 

 
 
 

 
  
Safety Assessment 
To characterize safety of the InterStim Micro System by summarizing 
the adverse device effects and serious adverse device effects during 
the study. Safety measures will be summarized for each cohort as well 
as pooled for all patients regardless of indication. 
Device deficiencies will also be collected and reported. 
 

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Study Design 
This is a prospective, multicenter, global, single-arm, open-label, post 
market clinical follow-up study to characterize long-term clinical 
performance and safety of the InterStim Micro system. The study is 
intended to be conducted at approximately 40 centers in the United 
States (and United States Territories), Europe, Australia and Canada.   
 
Eligible subjects, who are already candidates for sacral 
neuromodulation, will sign a study-specific informed consent form 
(ICF).  Each subject will only be qualified for one of the study cohorts. 
Subjects will complete a Baseline Visit, a Lead Placement visit, 
Neurostimulator Device Implant visit and Three-month, Six-month, 
One-year, and Two-year Follow-up Visits.  All subjects who met all 
eligibility criteria and complete the neurostimulator implant 
procedure will be considered enrolled in the study.  
Sample Size
Approximately 160 subjects (60 for overactive bladder cohort, 60 for 
fecal incontinence cohort and 40 for non-obstructive urinary 
retention cohort), will be enrolled in the study to achieve a minimum 
of 50 evaluable implanted subjects each for overactive bladder and 
fecal incontinence cohorts and a minimum of 30 evaluable implanted 
subjects for non-obstructive urinary retention cohort at 3 months 
post implant.  
 

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Overactive Bladder (OAB) -   
Cohort Eligibility Criteria 
Inclusion Criteria:  
1. Have a diagnosis of OAB as demonstrated on a 3-day voiding diary with 
greater than or equal to 8 urgency frequency episodes per day and/or by 
having a minimum of 3 episodes of urinary urge incontinence in 72 hours 
2. Subjects 18 years of age or older 
3. Candidate for sacral neuromodulation therapy in accordance with the 
InterStim Micro System labeling 
4. Willing and able to accurately complete study diaries, questionnaires, 
attend visits, device recharging 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 primary stress incontinence or mixed incontinence where the stress 
component overrides the urge component 
3. Current urinary tract mechanical obstruction (e.g. benign prostatic 
enlargement or urethral stricture) 
4. Have had treatment of urinary symptoms with botulinum toxin therapy 
in the past 12 months 
5. Have knowledge of planned shortwave diathermy, microwave 
diathermy, or therapeutic diathermy  
6. Women who are pregnant or planning to become pregnant 
7. Characteristics indicating a poor understanding of the study or 
characteristics that indicate the subject may have poor compliance with 
the study protocol requirements. 
8. 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.                                   
Contact Medtronic’s study manager to determine if the subject can be enrolled in both studies. 
 

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Fecal Incontinence (FI) –
Cohort Eligibility Criteria 
Inclusion Criteria:  
1. Have a diagnosis of fecal incontinence as demonstrated by a 7-day 
bowel diary as greater than or equal to 2 incontinent episodes of 
more than staining (i.e., either slight, moderate or severe soiling)  
2. Subjects 18 years of age or older 
3. Candidate for sacral neuromodulation therapy in accordance with 
the InterStim Micro System labeling 
4. Willing and able to accurately complete study diaries, 
questionnaires, attend visits, device recharging 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. Uncorrected high grade internal rectal prolapse 
3. Have knowledge of planned shortwave diathermy, microwave 
diathermy, or therapeutic diathermy  
4. Women who are pregnant or planning to become pregnant 
5. Characteristics indicating a poor understanding of the study or 
characteristics that indicate the subject may have poor compliance 
with the study protocol requirements. 
6. 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.               
Contact Medtronic’s study manager to determine if the subject can be enrolled in both studies 
 
 

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Non-Obstructive Urinary 
Retention (NOUR) – Cohort 
Eligibility Criteria  
Inclusion Criteria:  
1. Have a diagnosis of non-obstructive urinary retention as 
demonstrated by a 7-day urinary voiding diary with a minimum of 
5 clean intermittent self-catheterizations 
2. Chronic non-obstructive urinary retention with an elevated post-
void residual (PVR) that has persisted for at least six months and is 
documented on two or more separate occasions. 
3. Subjects 18 years of age or older 
4. Candidate for sacral neuromodulation therapy in accordance with 
the InterStim Micro System labeling 
5. Willing and able to accurately complete study diaries, 
questionnaires, attend visits, device recharging and comply with 
the study protocol 
6. 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. Current urinary tract mechanical obstruction (e.g. benign 
prostatic enlargement or urethral stricture) 
3. Have knowledge of planned shortwave diathermy, microwave 
diathermy, or therapeutic diathermy . 
4.
Women who are pregnant or planning to become pregnant
5. Characteristics indicating a poor understanding of the study or 
characteristics that indicate the subject may have poor 
compliance with the study protocol requirements. 
6. 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.                
Contact Medtronic’s study manager to determine if the subject can be enrolled in both studies. 
 

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Study Procedures and 
Assessments 
Study Visits:  
1. Baseline Visit 
2. Evaluation Lead Implant Visit  
3. Tined lead (if applicable) /  Neurostimulator Device Implant 
4. Three-month Follow-up Visit 
5. Six-month Follow-up Visit  
6. One-year Follow-up Visit 
7. Two-year Follow-up Visit 
Baseline 
Each subject must meet all the inclusion and no exclusion criteria of 
one of the three study cohorts to be eligible to participate in the 
study.  At the baseline visit, data will be gathered from subjects 
 
  
 
For subjects who qualify with the overactive bladder indication:  
The urinary voiding 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 or planning to become pregnant as part of the 
assessment for study eligibility (female subjects of child bearing 
potential only).  The Overactive Bladder Quality of Life (OAB-q) 
questionnaire will be collected. 
 
For subjects who qualify with the fecal incontinence indication:  
The bowel diary will be explained and given to the subject to be 
completed for 7 consecutive days. 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 (female subjects of child bearing potential only).  The 
Cleveland Clinic Incontinence Score (CCIS) 
 
will be collected. 
 
For subjects who qualify with the non-obstructive urinary retention 
indication:   
The urinary voiding diary will be explained and given to the subject 
to be completed for 7 consecutive days. The diary must be 
completed, collection of baseline post-void residual volume and 
confirmation that the subject is not pregnant or planning to 
become pregnant as part of the assessment for study eligibility 
(female subjects of child bearing potential only).  
 
 
  

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Evaluation Lead Implant:  
If using basic evaluation, the basic evaluation lead should be placed in 
accordance with the device implant manual.  
 
  
If using advanced evaluation, the tined lead should be placed in 
accordance with the device implant manual.   
 
 
 
  
For both advanced and basic evaluation, throughout the study, 
unilateral stimulation is required.  Programming may be set per 
Investigator discretion for the duration of the study.   Any 
 
reportable adverse events/device deficiencies 
will be documented and reported. 
 
Therapy Evaluation 
The therapy evaluation period should be conducted in accordance 
with the labeling using the Verify® external neurostimulator and 
should not exceed the therapy evaluation duration for the specific 
geography.   
A study diary will be completed towards the end of the therapy 
evaluation period (completed for 3 consecutive days for overactive 
bladder, completed for 7 consecutive days for fecal incontinence and 
for non-obstructive urinary retention).   Therapeutic success must be 
achieved in order to qualify for a neurostimulator implant in the 
study. 
Any 
 reportable adverse events/device 
deficiencies will be documented and reported.  
 
 
   
 
Tined lead (if applicable) / Neurostimulator Device Implant 
Once the subject qualifies for the neurostimulator device implant, site 
personnel may proceed with the Neurostimulator Device Implant 
Visit. If a subject does not qualify for the neurostimulator device 
implant, they will be exited from the study 
For subjects who qualify for neurostimulator device implant following 
a successful basic evaluation, the tined lead should be placed in 
accordance with the device implant manual.  
 
 

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. The neurostimulator should be implanted in accordance 
with the device’s implant manual.  
For subjects who qualify for neurostimulator device implant following 
a successful advanced evaluation, the neurostimulator should be 
implanted in accordance with the device’s implant manual. 
 
 
   
Any 
 reportable adverse events/device 
deficiencies will be documented and reported. 
 
 
   
 
  
 
 
   
 
Three-month, Six-month, One-year, and Two-year Follow-up Visits   
 
For subjects within the overactive bladder cohort: 
 
 The Overactive Bladder 
Quality of Life (OAB-q), 
 
 
 will be collected. 
For subjects within the fecal incontinence cohort: 
 
  The Cleveland Clinic 
Incontinence Score (CCIS), 
 
 
 
will be collected. 
For subjects within the non-obstructive urinary retention cohort: 
The voiding diary will be given to the subject to be completed for 
7 days approximately 1 week prior to each follow-up visit. 
 
 
 
 

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For all subjects, 
 reportable 
adverse events/device deficiencies will be documented and reported. 
 
   
 
Unscheduled Visit   
An unscheduled visit may be needed for any device-related reason.  
During the visit, 
 reportable adverse 
events and/or device deficiencies will be collected. 
 
 
   
 
Surgical Revision 
A surgical revision may be needed for replacement, revision or 
explant of the tined lead, neurostimulator or both.   
During the visit, 
 
reportable adverse events and/or device deficiencies will be 
collected. 
 
 
     
 Statistics 
For the overactive bladder cohort, the primary objective is to 
demonstrate an improvement of Overactive Bladder Quality of Life 
(OAB-q) Questionnaire Health Related Quality of Life (HRQL) score at 
3 months post-implant compared to baseline. A sample size of 50 
achieves greater than 90% power to detect a difference from baseline 
of 30 points in Overactive Bladder Quality of Life (OAB-q) 
Questionnaire Health Related Quality of Life (HRQL) total score and a 
standard deviation of 27 with a significance level of 0.05 using a two-
sided one sample t-test.  
For the fecal incontinence cohort, the primary objective is to 
demonstrate an improvement in Cleveland Clinic Incontinence Score 
(CCIS) at 3 months post-implant compared to baseline. A sample size 
of 50 achieves greater than 90% power to detect a difference from 
baseline of 5 points in Cleveland Clinic Incontinence Score (CCIS) and a 
standard deviation of 6 with a significance level of 0.05 using a two-
sided one sample t-test.  
For the non-obstructive urinary retention cohort, the primary 
objective is to demonstrate an improvement in number of clean 
intermittent self-catheterizations (CISC) per day at 3 months post-

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implant compared to baseline. A sample size of 30 achieves greater 
than 90% power to detect a difference from baseline of 2 clean 
intermittent self-catheterizations (CISC)/day and a standard deviation 
of 3 with a significance level of 0.05 using a two-sided one sample t-
test.   
To accommodate attritions, approximately 160 subjects (60 for 
overactive bladder cohort, 60 for fecal incontinence cohort and 40 for 
non-obstructive urinary retention cohort), will be enrolled in the study 
to achieve a minimum of 50 evaluable subjects each for overactive 
bladder and fecal incontinence cohorts and a minimum of 30 evaluable 
implanted subjects for non-obstructive urinary retention cohort at 3 
months post implant. 
For the primary objective in each cohort, the analysis on the change 
of primary outcome parameter at 3 months from baseline will be 
performed on subjects who provide complete data at baseline and 3 
months.  A two-sided one sample t-test, or Wilcoxon Singed Rank test
will be performed to test the hypothesis depending on data 
normality. 
 
Adverse events and device deficiencies of all cohorts will be 
summarized using summary tables displaying the frequency and  
percentages. Adverse events will be summarized by seriousness as 
well. 
 

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4.Introduction  
4.1. Background  
Sacral Neuromodulation (SNM) is a treatment for bladder and bowel control symptoms through the 
modulation of sacral nerves.  SNM is delivered by sending electrical pulses to the sacral nerve to 
modulate the neural activity that influences the behavior of the pelvic floor, lower urinary tract, urinary 
and anal sphincters, and colon.  SNM delivered by the Medtronic InterStim System is an advanced 
therapy option for the treatment of the indications specified in the clinical investigational plan.1-4   
Safety and performance have been established with long-term follow-up reported in the literature.5-7   
This prospective clinical study will fulfill post-market clinical follow-up obligations for the InterStim 
Micro System and is an active mechanism to assess performance and safety in patients SNM therapy in 
an organized, systematic manner based on the intended use.  
4.2. Purpose 
The purpose of this investigation is to confirm long-term clinical performance and safety of the InterStim 
Micro System.  
The primary objectives of the study will evaluate data at 3 months post-implant; however, subjects will 
be followed for 2 years for the 
 safety assessments.  
5.Objectives  
5.1. Overactive Bladder Cohort 
5.1.1.
Primary Objective 
The primary objective for the overactive bladder cohort of the study is to demonstrate an improvement 
in Overactive Bladder Quality of Life (OAB-q) Questionnaire Health Related Quality of Life (HRQL) total 
score at 3 months post-implant compared to baseline. 
5.1.2.
 

 

 
 
 

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•
 
 

  
 
5.2. Fecal Incontinence Cohort 
5.2.1.
Primary Objective 
The primary objective for the fecal incontinence cohort of the study is to demonstrate an improvement 
in Cleveland Clinic Incontinence Score (CCIS) at 3 months post-implant compared to baseline.  
5.2.2.
  

 

 
 

 
 

 
 
5.3. Non-Obstructive Urinary Retention Cohort 
5.3.1.
Primary Objective 
The primary objective for the non-obstructive urinary retention cohort of the study is to demonstrate an 
improvement in number of clean intermittent self-catheterizations (CISC) per day at 3 months post-
implant compared to baseline. 
5.3.2.
  

 

 
 

 
 

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6.Study Design  
This is a prospective, multicenter, global, single arm, post market clinical follow-up study to confirm the 
clinical performance and safety of the InterStim Micro system. Commercial devices will be used within 
their intended use as described in each geography’s approved instructions for use. 
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 baseline 
diary 
 prior to the evaluation lead implant procedure.  Subjects must 
be screened and qualify to enroll in a single cohort of the study.   Following the therapy evaluation lead 
implant, subjects are expected to complete a study diary near the end of the therapy evaluation period.  
Upon completion of a successful therapy evaluation period, subjects will have a neurostimulator implant 
procedure. Subjects will be considered enrolled at the completion of the neurostimulator implant 
procedure.  Study requirements, including diaries, questionnaires and safety assessments will be 
completed as required in section 9.1.  Study follow-up is expected to last approximately 2 years 
following the neurostimulator implant visit.  Subjects will be exited from the study after the Two-Year 
Follow-up Visit is completed.  Any subjects that have the device permanently explanted during follow up 
will be exited from the study.  
A minimum of 50 subjects who complete the Three-month Follow-up Visit is required for the overactive 
bladder and fecal incontinence cohorts. A minimum of 30 subjects who complete the Three-month 
Follow-up Visit is required for the non-obstructive urinary retention cohort.  Each subject will only be 
qualified for one of the study cohorts. 
The study is intended to be conducted at approximately 40 centers in Europe, Canada, Australia and the 
United States (and United States Territories).   
This is an on-label, post-market study of an approved system. All subjects implanted in the study will 
qualify under the approved indications for sacral neuromodulation. 
6.1. Duration 
Study subjects will be consented and will complete a baseline assessment to determine eligibility for 
sacral neuromodulation.  Subjects are considered enrolled at the time of completion of the 
neurostimulator implant procedure.  Any subject not meeting eligibility criteria will be exited from study 
participation.  Subjects will be required to return for follow up visits at 3 months, 6 months, 1 year and 2 
years following the neurostimulator implant procedure.    
The estimated study duration, from first subject enrollment to last subject visit, is expected to last 
approximately 3.5 years.  The completion of the study is defined as approval of the Final Study Report 
and closure of all sites.  

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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 and will confirm long-term safety and performance of 
the InterStim Micro System.   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.   Evidence gathered from this study will be useful for clinicians and patients evaluating 
sacral neurostimulation as a potential treatment option. 
7.Product Description 
7.1. General 
There are no investigational devices used in this study and all product will be used in accordance with 
the product labeling. 
The Medtronic InterStim Micro System is designed to deliver therapeutic nerve stimulation through the 
following system components: a neurostimulator and lead with programmable electrodes. The system 
works by conducting electrical pulses, which are produced by the neurostimulator, through the lead 
system.  The implantable neurostimulator is a rechargeable device and is accompanied with a wireless 
recharger. The implantable neurostimulator is multi-programmable and is powered by a hermetically 
sealed battery. A clinician programmer and patient programmer control device are used to control the 
parameters of stimulation produced by the implantable neurostimulator.  
The estimated sample size for this study may yield approximately 160 implants with the InterStim Micro 
implantable neurostimulator (INS) and associated system accessory product (see table below).   
Model Number 
Device Description 
Intended Use 
97810 
InterStim Micro implantable neurostimulator (INS) 
The InterStim 
system is an 
implantable 
programmable 
neuromodulation 
system that 
delivers electrical 
stimulation to the 
sacral nerve.  
978A1*
InterStim SureScan MRI lead 
A52200 
Patient therapy application software (TAS) 
A51200 
Clinician therapy application software (TAS) 
WR9220** 
Wireless recharger (external ancillary device) 
A90300 
Recharger application software  
3560030* 
Percutaneous extension used for advanced therapy evaluation 
306001, 306006, 
305901, 305906  
Temporary lead for basic therapy evaluation 
3531 
Verify external neurostimulator 
*Model 978B1 (lead) and model 3560022 (percutaneous extension) for InterStim II will not be used as the devices are 
equivalent to 978A1 (lead) and 3560030 (percutaneous extension) except for the contact spacing at the proximal end due to 
differences in header size between InterStim II and InterStim Micro. 
**Provided in the Model RS5200 kit. 

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All materials and substances that may come in contact with human tissue or bodily fluids is defined in 
the product labeling. 
The study will be conducted in the United States (and United States Territories), Canada, Australia and 
Europe, where the InterStim Micro System 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 Population 
The study will enroll patients with overactive bladder, fecal incontinence and non-obstructive urinary 
retention.  All subjects implanted must be candidates for sacral neuromodulation based on the 
geography-specific labeling.  
7.4. Product Return 
Since all products are commercially available, standard commercial processes should be used to return 
products (as applicable).  
7.5. Product Storage & Accountability  
No investigational product will be used in the study.  Any requirements for commercial product storage 
and accountability will be outlined in the Product Accountability section of the Regulatory Binder.  
8.Selection of Subjects 
8.1. Study Population 
The intended study population is subjects diagnosed with overactive bladder, fecal incontinence and 
non-obstructive urinary retention.  Eligibility criteria provides use of the study device based on 

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adherence to the product labeling in a post-market study for subjects with the approved indications.  
Refer to geography-specific labeling for additional details on indications.  
8.2. Subject Enrollment 
Each subject must meet all the inclusion criteria and no exclusion criteria for one of the three study 
cohorts to be eligible to participate in the study.    Each subject will only be enrolled in one study cohort. 
Subjects are considered enrolled at completion of the neurostimulator 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.  
8.3. Eligibility Criteria  
8.3.1.
Overactive Bladder Eligibility Criteria 
Overactive Bladder Inclusion Criteria 
To be eligible to participate in the overactive bladder cohort of the study, a subject must meet all the 
following inclusion criteria:  
1. Have a diagnosis of OAB as demonstrated on a 3-day voiding diary with greater than or equal to 
8 urgency frequency episodes per day and/or by having a minimum of 3 episodes of urinary urge 
incontinence in 72 hours 
2. Subjects 18 years of age or older 
3. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System 
labeling 
4. Willing and able to accurately complete study diaries, questionnaires, attend visits, device 
recharging and comply with the study protocol
5. Willing and able to provide signed and dated informed consent 
Overactive Bladder Exclusion Criteria 
A potential subject who meets any of the following criteria will be excluded from participating in the 
overactive bladder cohort of the study:  
1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral 
neuropathy or spinal cord injury (e.g., paraplegia) 
2. Have primary stress incontinence or mixed incontinence where the stress component overrides 
the urge component 
3. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral 
stricture) 

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4. Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12 months 
5. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic 
diathermy  
6. Women who are pregnant or planning to become pregnant 
7. Characteristics indicating a poor understanding of the study or characteristics that indicate the 
subject may have poor compliance with the study protocol requirements. 
8. 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.                                                                                            
Contact Medtronic’s study manager to determine if the subject can be enrolled in both studies. 
8.3.2.
Fecal Incontinence Eligibility Criteria 
Fecal Incontinence Inclusion Criteria 
To be eligible to participate in the fecal incontinence cohort of the study, a subject must meet all the 
following inclusion criteria:  
1. Have a diagnosis of fecal incontinence as demonstrated by a 7-day bowel diary as greater than 
or equal to 2 incontinent episodes of more than staining (i.e., either slight, moderate or severe 
soiling)  
2. Subjects 18 years of age or older 
3. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System 
labeling 
4. Willing and able to accurately complete study diaries, questionnaires, attend visits, device 
recharging and comply with the study protocol
5. Willing and able to provide signed and dated informed consent 
Fecal Incontinence Exclusion Criteria 
A potential subject who meets any of the following criteria will be excluded from participating in the 
fecal incontinence cohort of the study:  
1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral 
neuropathy or spinal cord injury (e.g., paraplegia) 
2. Uncorrected high grade internal rectal prolapse 
3. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic 
diathermy  
4. Women who are pregnant or planning to become pregnant 
5. Characteristics indicating a poor understanding of the study or characteristics that indicate the 
subject may have poor compliance with the study protocol requirements. 
6. Concurrent participation in another clinical study that may add additional safety risks and/or 
confound study results.* 

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*Subjects in concurrent studies can only be enrolled with permission from Medtronic.                                                                                                       
Contact Medtronic’s study manager to determine if the subject can be enrolled in both studies 
8.3.3.
Non-Obstructive Urinary Retention Eligibility Criteria 
Non-Obstructive Urinary Retention Inclusion Criteria 
To be eligible to participate in the non-obstructive urinary retention cohort of the study, a subject must 
meet all the following inclusion criteria:  
1. Have a diagnosis of non-obstructive urinary retention as demonstrated by a 7-day urinary 
voiding diary with a minimum of 5 clean intermittent self-catheterizations 
2. Chronic non-obstructive urinary retention with an elevated post-void residual (PVR) that has 
persisted for at least six months and is documented on two or more separate occasions.
3. Subjects 18 years of age or older 
4. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System 
labeling 
5. Willing and able to accurately complete study diaries, questionnaires, attend visits, device 
recharging and comply with the study protocol
6. Willing and able to provide signed and dated informed consent 
Non-Obstructive Urinary Retention Exclusion Criteria 
A potential subject who meets any of the following criteria will be excluded from participating in the 
non-obstructive urinary retention cohort of the study:  
1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral 
neuropathy or spinal cord injury (e.g., paraplegia) 
2. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral 
stricture) 
3. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic 
diathermy . 
4. Women who are pregnant or planning to become pregnant 
5. Characteristics indicating a poor understanding of the study or characteristics that indicate the 
subject may have poor compliance with the study protocol requirements. 
6.
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.                                                                                                       
Contact Medtronic’s study manager to determine if the subject can be enrolled in both studies. 

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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. 
Figure 9-1: Study Procedures 
Baseline
Study 
Eligibility
Lead Implant
Therapy Evaluation
Device 
Implant
3 Month 
Follow-up
6 Month 
Follow-up
1 Year 
Follow-up
2 Year 
Follow-up
Study 
Exit
The following will be conducted:
1. Baseline Visit
2. Evaluation Lead Implant Visit 
3. Tined lead (if applicable) / Neurostimulator Device Implant
4. Three-month Follow-up Visit
5. Six-month Follow-up Visit 
6. One-year Follow-up Visit
7. Two-year Follow-up Visit (Study Exit)
 
9.1. Schedule of Events 
Baseline 
Each subject must meet all the inclusion and no exclusion criteria to be eligible to participate in the 
study.  At the baseline visit, data will be gathered from subjects 
 
  

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For subjects who qualify with the overactive bladder indication:  
The urinary voiding 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 or planning to become pregnant as part of the assessment for study eligibility (female 
subjects of child bearing potential only).  The OAB-q questionnaire will be collected. 
For subjects who qualify with the fecal incontinence indication:  
The bowel diary will be explained and given to the subject to be completed for 7 consecutive 
days. 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 (female subjects of 
child bearing potential only).  The CCIS 
 Questionnaire will be collected. 
For subjects who qualify with the non-obstructive urinary retention indication:   
The urinary voiding diary will be explained and given to the subject to be completed for 7 
consecutive days. 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 (female 
subjects of child bearing potential only).  
 
 
Evaluation Lead Implant: 
If using basic evaluation, the basic evaluation lead should be used in accordance with the device implant 
manual.  If using advanced evaluation, the tined lead should be placed in accordance with the device 
implant manual with a motor response confirmed based on the recommendations below.   
Amplitude 
Lead placement recommendation 
Less than 1 milliamp 
If strong motor responses are observed, the proximity of the 
lead to the intended sacral nerve may require programming 
adjustments to allow for patient comfort. 
1 to 2 milliamps 
Desired range 
2 to 3 milliamps 
Consider repositioning the lead to achieve the desired range of 
1 to 2 milliamps. 
Greater than 3 
milliamps 
Consider repositioning the lead to achieve the desired range of 
1 to 2 milliamps. 
 
For both advanced and basic evaluation, throughout the study, unilateral stimulation is required. 
Programming may be set per Investigator discretion for the duration of the therapy evaluation.   Any 

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 reportable adverse events/device deficiencies will be documented and 
reported. 
Therapy Evaluation  
The therapy evaluation period should be conducted in accordance with the labeling using the Verify 
external neurostimulator and should not exceed the therapy evaluation duration for the specific 
geography.   
The applicable diary for the study cohort diary will be completed towards the end of the therapy 
evaluation period (completed for 3 consecutive days for OAB, completed for 7 consecutive days for FI 
and completed for 7 consecutive days for NOUR).   Therapeutic success must be achieved in order to 
qualify for a neurostimulator implant in the study.  A successful therapy evaluation is recommended as: 
• 50% or greater improvement from baseline in average voids/day or a return to normal voiding 
(less than 8 voids/day) for subjects with urgency frequency at baseline* 
• 50% improvement from baseline in average leaks/day for subjects with urinary incontinence at 
baseline* 
•  50% improvement from baseline in average fecal incontinence episodes/week for subjects with 
fecal incontinence at baseline 
• 50% reduction from baseline in average number of CISC/day for subjects with non-obstructive 
urinary retention at baseline 
*Subjects with both urgency frequency and urinary urge incontinence at baseline must meet at least one of the above 
criteria to be considered a success. 
Any 
 reportable adverse events/device deficiencies will be documented 
and reported.  
 
   
Tined lead (if applicable) / Neurostimulator Device Implant 
Once the subject qualifies for the neurostimulator device implant, site personnel may proceed with the 
Neurostimulator Device Implant Visit. If a subject does not qualify for the neurostimulator device 
implant, they will be exited from the study.
 

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For subjects who qualify for neurostimulator device implant following a successful basic 
evaluation, the tined lead should be placed in accordance with the device implant manual.  
Motor response(s) must be confirmed 
 during the lead 
implant procedure based on the recommendations below.   
Amplitude 
Lead placement recommendation 
Less than 1 
milliamp 
If strong motor responses are observed, the proximity of the lead 
to the intended sacral nerve may require programming 
adjustments to allow for patient comfort. 
1 to 2 milliamps 
Desired range 
2 to 3 milliamps 
Consider repositioning the lead to achieve the desired range of 1 to 
2 milliamps. 
Greater than 3 
milliamps 
Consider repositioning the lead to achieve the desired range of 1 to 
2 milliamps. 
Following placement of the lead, the neurostimulator should be implanted in accordance with the 
device’s implant manual.  
 
  
For subjects who qualify for neurostimulator device implant following a successful advanced evaluation, 
the neurostimulator should be implanted in accordance with the device’s implant manual. 
Any 
 reportable adverse events/device deficiencies will be documented 
and reported. 
   
  
 
   
Three-month, Six-month, One-year, and Two-year Follow-up Visits   
Follow-up visits should be scheduled within the following targeted visit windows, when possible:  
(Target Visit Windows are Calculated from the Date of Neurostimulator Implant) 
Three-month visit 
13 weeks ± 7 days 
Six-month visit  
26 weeks ± 14 days 
One-year visit 
52 weeks ± 28 days 
Two-year visit 
104 weeks ± 28 days 

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For subjects within the OAB cohort: 
 
 The OAB-q, 
 will 
be collected. 
For subjects within the FI cohort: 
 
  The CCIS, 
 
 will be collected. 
For subjects within the NOUR cohort: 
The voiding diary will be given to the subject to be completed for 7 days approximately 1 week 
prior to each follow-up visit.  
 
 
   
For all subjects, any 
 reportable adverse events/device deficiencies will 
be documented and reported. 
 
   
Unscheduled Visit   
An unscheduled visit may be needed for any device-related reason.  During the visit, any 
 
 reportable adverse events and/or device 
deficiencies will be collected. 
 
   
 

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Surgical Revision 
A surgical revision may be needed for replacement or explant of the tined lead or neurostimulator. 
 
Intra-
procedural motor response will be collected in procedures with a new tined lead implant, based on the 
recommendations below.   
Amplitude 
Lead placement recommendation 
Less than 1 
milliamp 
If strong motor responses are observed, the proximity of 
the lead to the intended sacral nerve may require 
programming adjustments to allow for patient comfort. 
1 to 2 milliamps 
Desired range 
2 to 3 milliamps 
Consider repositioning the lead to achieve the desired 
range of 1 to 2 milliamps. 
Greater than 3 
milliamps 
Consider repositioning the lead to achieve the desired 
range of 1 to 2 milliamps. 
 
     
Any 
 reportable adverse events/device deficiencies will be documented 
and reported.  
 

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Table 9-1: Study Procedures  
 
Baseline
Evaluation Lead 
Implant
Tined Lead Implant** /  
Neurostimulator 
Implant 
Follow-
up Visits
Unscheduled 
Visit 
Surgical 
Revision 
All Cohorts 
 
 
 
 
 
 
Informed Consent* 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy Assessment 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Assessment of Reportable Adverse Events and Device 
Deficiencies 
X 
X 
X 
X 
X 
X 
Overactive Bladder 
 
 
 
 
 
 
OAB-q Questionnaire  
X 
 
 
X 
 
 
Completed 3-day Urinary Voiding Diary  
X 
 
 
 
 
 
Fecal Incontinence 
 
 
 
 
 
 
CCIS Questionnaire 
X 
 
 
X 
 
 
Completed 7-day Bowel Diary 
X 
 
 
 
 
 
  
 
 
 
 
 
 
Non-Obstructive Urinary Retention 
 
 
 
 
 
 
Completed 7-day Urinary Voiding Diary 
X 
 
X 
X 
X*** 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
*Must be completed prior to any study-specific procedures 
  
***If applicable 

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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 referred 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 pre-screen (recruitment) log will be completed for all subjects screened but not consented for the 
study.  No subject-specific information will be collected on this log, only the date of review and the 
reason for the screen failure.  
A screening log will 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. 
9.3. Subject Consent 
Informed consent should be obtained in written format and using a form approved by the local IRB/EC, if 
applicable. The form should contain standard language consistent with local policies for ensuring privacy 
of confidential information.  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 

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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 
Subject assessments will be administered by appropriately trained, qualified and delegated site 
personnel according to the usual practices of the site.  Subjects will complete the study questionnaires 
confidentially on paper forms without site personnel consultation during the visit and these data will be 
entered to OC/RDC by site personnel.   Bowel and Voiding Diaries should be completed prior to or 
directly after the follow-up visit when data are collected. Site personnel should review forms for 
completeness. 
Overactive Bladder Quality of Life Questionnaire (OAB-q) 
The Overactive Bladder Quality of Life Questionnaire (OAB-q) is a 33-item validated questionnaire that 
was developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related 
quality of life (HRQL).9  The questionnaire used in the current study includes a 4-week recall for 
symptom assessment.  The questionnaire may also be used to drive health state utilities.    
This questionnaire will be completed by the subject at Baseline, Three-month, Six-month, One-year, and 
Two-year Follow-up Visits.  
Cleveland Clinic Incontinence Score  
The Cleveland Clinic Incontinence Score (Wexner Score) is an established 5-item questionnaire that was 
developed to assess the frequency and severity of fecal incontinence.10   
This questionnaire will be completed by the subject at Baseline, Three-month, Six-month, One-year, and 
Two-year Follow-up Visits.  

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Urinary Voiding Diary 
Symptoms related to OAB and NOUR will be evaluated using either paper or electronic voiding diaries. 
Subjects will be trained to complete the urinary voiding diaries for 3-days for OAB with diary details 
collected (such as time, type of episode, urgency, sleep/awake status, etc.) and for 7-days for NOUR 
with diary details collected (such as time, type of episode, volume, etc.) as part of the baseline 
procedures.  The urinary voiding diaries will be completed for 3-days for OAB and 7-days for NOUR 
towards the end of the therapy evaluation and prior to each subsequent follow-up visit.  Every effort 
should be made to remind subjects of the importance of real-time diary completion.  
Bowel Diary  
Symptoms related to FI will be evaluated using either paper or electronic voiding diaries. Subjects will be 
trained to complete the bowel voiding diary for 7-days as part of the baseline procedures with diary 
details collected (such as time, type of episode, urgency, sleep/awake status, etc.).  The bowel diaries 
will be completed for 7-days towards the end of the therapy evaluation 
 
Every effort should be made to remind subjects of the importance of real-time diary 
completion. 
  
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 

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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 until the subject is exited from the study. 
9.7. Recording Data 
Oracle Clinical Remote Data Capture (RDC) 
This study will be conducted using a remote data capture system. The Oracle Clinical (OC) 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 questionnaires will be entered into the 
database by site personnel. Subjects will complete the study questionnaires confidentially on paper 
forms without site personnel consultation and these data will be entered to OC/RDC by site personnel. 
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 eCRFs by the site personnel, in 
accordance with applicable regulations. 
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 
eCRFs via electronic signature. 
 
 
 

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Urinary Voiding Diaries & Bowel Diaries 
Symptom data for this study will be collected using either electronic or paper diaries.  
Electronic Diary
Electronic diaries may be provided by the sponsor for US study centers; the electronic diary 
collects details associated with symptoms for each episode. The system contains reminders and 
allows subjects to collect real-time voiding behavior onto a secure server. The system controls 
user access and maintains an audit trail. The information in the diary is de-identified and the 
data transmission contains two points of encryption. The de-identified data export files will be 
filed in the subject’s medical record. 
Paper Diary 
A paper diary is also available for use in the study. If a paper diary is used, the data will be 
entered to the RDC database by center personnel. Center personnel may not complete the diary 
for subjects except for data fields confirmed by the subject as documented within source 
documentation.  
Diaries are to be completed only by the subject. Representatives from the research site may not 
make entries to the diaries or questionnaires except for data fields confirmed by the subject as 
documented within source documentation.
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 is not allowed to deviate from the CIP, except under emergency 
circumstances to protect the rights, safety and well-being of human subjects. 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. 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 and 
CA(as required).  Any deviations resulting in signification updates to the clinical investigational plan will 
require CA notification and/or approval, where 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 competent authority (if applicable) will be notified in writing of 
the reasons for the termination. 

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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 Two-year Follow-up Visit, unless withdrawn from the study. 
Withdrawn or exited subjects will be followed under normal medical practice. 
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 InterStim Micro System. 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.  

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10.1.1.
Risks Outlined in the Instructions for Prescribers (IFP) 
Refer to the appropriate Information for Prescribers (IFP) manual for the InterStim Micro System 
components for an updated list on contraindications, precautions, warnings, adverse events, directions 
for use and other product specific details on the InterStim Micro System.   
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.  For a comprehensive summary of 
adverse events, refer to the Information for Prescribers manual. 
There might be other discomforts and risks related to an InterStim Micro System implant, sacral 
neuromodulation therapy with the InterStim Micro System and/or this study that are not foreseen at 
this time. 
The following inconveniences may occur due to participation in the study:
x
The time needed to complete your study diary may be an inconvenience 
x
You may find some of the questions or completing the study diary embarrassing 
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 an InterStim Micro System 
implant and sacral neuromodulation therapy with the InterStim Micro System outside of the study. 
Information from this study might help researchers further understand the InterStim Micro System. 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 an 
InterStim Micro System implant and sacral neuromodulation therapy with the InterStim Micro System  
outside of the study.  
The risks associated with an InterStim Micro System implant and sacral neuromodulation therapy with 
the InterStim Micro System 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. 

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11. Adverse Events and Device Deficiencies 
11.1. Definitions/Classifications 
Any adverse event meeting the definition of: serious adverse events and/or adverse device effects  
as well as all device deficiencies will be considered reportable for this study and will be collected after 
the subject is consented to participate in the study through study exit. The term “investigational device” 
is part of ISO 14155:2011 definitions. The term “investigational device” refers to any device used in the 
study including market released devices.  
Reportable adverse event terms are defined as follows: 
−
Device Related: An adverse event that results from the presence or performance 
(intended or otherwise) of any component of the InterStim Micro System 
−
Procedure Related: An adverse event that occurs due to any procedure related to 
the implantation or surgical revision of the InterStim Micro System. The procedure is 
defined as the lead placement, neurostimulator implant procedure and surgical 
revision (including 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 for 
analysis purposes.  
The following are not adverse events: 
x
Any normal expected postoperative (implant or revision) 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.       
x
Any non-clinically significant, transient (lasting for only a short time) stimulation-
related effects that occur during the implant/revision procedure, programming and 
follow-up period.   
x
Worsening of OAB, FI and/or NOUR symptoms will be collected as part of the study 
objectives and/or additional measures and are not considered a reportable adverse 
event.  

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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. 
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. 
STUDY SPECIFIC NOTE: These are considered the device related, therapy related 
and/or procedure related.   
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 1 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 2 Use error includes slips, lapses, mistakes. 

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NOTE 3 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. 
 
 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.   
Serious Adverse 
Event (SAE)*   
(MPSV § 2 
Definitions Abs 5) 
A serious adverse event is an event that occurs in a clinical investigation subject 
to approval or occurring in a performance evaluation which led, might have led or 
could lead directly or indirectly to death or serious deterioration of health of the 
subject, the user or a third party, without consideration if the event has been 
caused by the medical device itself; this applies accordingly to serious adverse 
events occurring in a clinical investigation or performance evaluation for which an 
exemption of the approval authorization as per MPG § 20 paragraph 1 sentence 2 
has been granted. 
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 
STUDY SPECIFIC NOTE: For this study, all reportable adverse events will be 
collected however adverse events for system revisions (e.g. explants, revisions or 
replacements) will be considered non-serious unless the subject has clinical 
sequela which meets the seriousness definition outlined in the CIP.  

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 Any extended hospitalizations for implants and surgical revisions due to non-
medical reasons will not be considered a reportable 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. 
 
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. 

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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; 
- 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. 

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*Reportable event categories that will be collected during this study 
11.2. Reporting of Adverse Events 
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:  
Table 11-2 Event Classification Responsibilities 
What is Classified 
Who Classifies 
Classification Parameters 
Relatedness 
 Investigator, Medtronic 
Procedure related 
Device related 
Therapy related 
Seriousness 
Investigator, Medtronic 
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 15-1.  IRB/EC reporting must be completed in 
accordance with the policies of the governing IRB/EC.   Governing competent 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: 
x
Model and identifier (serial, lot number) for the involved device (if applicable) 
x
Date of event 
x
Diagnosis or description of the event 
x
Assessment of the seriousness and relationship to the product(s) under study 
x
Treatment 
x
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 

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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 CA or IRB/EC (by the institution or by 
Medtronic, as necessary). 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, 
Medtronic study personnel will document the disagreement and report or ensure reporting of both 
opinions to CA, IRB/EC as necessary.  All reported adverse events will be reviewed by a Medtronic 
Medical Advisor to ensure consistent reporting. 
11.2.1.
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 
11.2.2.
Death 
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 

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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: 
x
Death certificate
x
Death summary/hospital records, if allowed by state/local law 
x
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. 
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 
OAB Cohort 
For OAB cohort to demonstrate a statistically significant improvement of OAB-q HRQL score at 3 months 
post-implant from baseline, a two-sided one sample t-test, assuming normal distribution, was built as 
follows: 
H0: μ = 0 

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Ha: μ ≠ 0 
Where μ indicates the mean change in OAB-q HRQL total score from baseline to 3 months post-implant. 
The power calculations were performed using PASS 11 statistical software. Based on the results of HRQL 
in OAB-q at 3 months post-implant reported in the InSite study, a mean score change of 30 at 3 months 
from baseline with the standard deviation of 27 are the assumptions used for the power calculation for 
this study. At an alpha level of 0.05, a sample size of 50 evaluable subjects results a power greater than 
90% for this cohort. 
The HRQL module and its subscales for International Consultation on Incontinence Questionnaire (ICIQ)-
OABqol and OAB-q questionnaires are the same measures.9,19   
The attrition between implant and the primary endpoint at the 3-month Follow-up Visit is expected to 
be less than 10%. To accommodate attritions between implant and 3-month Follow-up Visit as well as 
during long-term follow-up, approximately 60 subjects will be implanted for this cohort. Based on 
historical Medtronic sponsored SNM studies (InSite study and SNS bowel), attrition at 2 year long-term 
follow-up visits is typically around 20%.  Therefore, we expect attrition in this post-market study to be 
similar. In all cases of missing data, the reason will be collected and sensitivity analyses will be 
performed to evaluate the impact of missing data on primary objective. 
FI Cohort 
For FI cohort, to demonstrate a statistically significant improvement in Cleveland Clinic Incontinence 
Score (CCIS) at 3 months post-implant from baseline, a two-sided one sample t-test, assuming normal 
distribution, was built as follows: 
H0: μ = 0 
Ha: μ ≠ 0 
Where μ indicates the mean change in CCIS total score from baseline to 3 months post implant. 
The power calculations were performed using PASS 11 statistical software.  Based on the result of meta-
analysis conducted by Thin et al (2013), a mean CCIS score (μ) change of 5 at 3 months from baseline with 
the standard deviation of 6.2 are the assumptions used for the power calculation for this study. At an 
alpha level of 0.05, a sample size of 50 evaluable subjects results in a power greater than 90% for this 
cohort. 
The attrition between implant and the primary endpoint at the 3-month Follow-up Visit is expected to 
be less than 10%. To accommodate attritions between implant and 3-month Follow-up Visit as well as 
during long-term follow-up, approximately 60 subjects will be implanted for this cohort. Based on 

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historical Medtronic sponsored SNM studies (InSite study and SNS bowel), attrition at 2 year long-term 
follow-up visits is typically around 20%.  Therefore, we expect attrition in this post-market study to be 
similar. In all cases of missing data, the reason will be collected and sensitivity analyses will be 
performed to evaluate the impact of missing data on primary objective. 
NOUR Cohort 
For NOUR cohort, to demonstrate a statistically significant improvement in the number of CISC at 3 
months post-implant from baseline, a two-sided one sample t-test, assuming normal distribution, was 
built as follows: 
H0: μ = 0 
Ha: μ ≠ 0 
Where μ indicates the mean change in the number of CISC/day from baseline to 3 months post implant. 
The power calculations were performed using PASS 11 statistical software.  
Based on the literature results published in Van Kerrebroeck et al (2007), Sutherland et al (2007), 
Cardarelli et al (2012) and MDT-103 and SOUNDS interim reports, a mean change of 2 in the number of 
CISC/day (μ)  between baseline and 3 months post-implant (μ) with a standard deviation of 3 are the 
assumptions used for the power calculation for this study. 
At an alpha level of 0.05, a sample size of 30 evaluable subjects results in a greater than 90% for this 
cohort. 
The attrition between implant and the primary endpoint at the 3-month Follow-up Visit is expected to 
be less than 10%. To accommodate the attritions between implant and 3-month Follow-up Visit as well 
as during long-term follow-up, approximately 40 subjects will be implanted for this cohort.  Based on 
historical Medtronic sponsored SNM studies (InSite study and SNS bowel), attrition at 2 year long-term 
follow-up visits is typically around 20%.  Therefore, we expect attrition in this post-market study to be 
similar. In all cases of missing data, the reason will be collected and sensitivity analyses will be 
performed to evaluate the impact of missing data on primary objective. 
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. 
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 

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results, no more than 20% subjects, i.e., 12 subjects for OAB cohort, 12 subjects for FI cohort, and 8 
subjects for NOUR cohort, will be enrolled 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. All efforts will be made to 
ensure patient follow-ups are completed with limited attrition to ensure interpretability of study results. 
For the primary objectives, in case subject’s Baseline Visit and/or Three-month Follow-up Visit data are 
missing, a sensitivity analysis will be performed by imputing missing data using multiple imputation 
method. 
Adjustment for Multiple Endpoints 
Adjustment for multiple endpoints is not required as the study focuses on three independent and 
different cohorts with independent endpoints and cutoff times.  There is only one primary objective 
within each cohort.  
Interim Analysis 
There is no planned interim analysis for the primary objective in this study. 
Analysis Population 
The analysis on the primary outcome parameter and for the additional measures will be performed on 
subjects who provide complete data at baseline and 3 months (complete cases). For all primary 
objectives, a sensitivity analysis will be performed on imputed data using Multiple Imputation (MI) 
techniques. The details of MI will be described in the study SAP. 
13.1.4.
Reports 
A final clinical study report will be generated for this study. Annual progress reports will also be 
generated for the study. A Cohort specific report may be generated if subjects from one cohort 
complete study follow-up. Reports may be submitted to the regulatory authorities, as required based on 
applicable local regulations. 

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13.2. Demographics 
Demographics and baseline characteristics will be described and summarized in the report either by 
means and standard deviations  for continuous data, or by number and percentages for categorical data. 
13.3. Treatment Characteristics 
Treatment characteristics using InterStim Micro System will be described and summarized in the report 
either by means and standard deviations as appropriate for continuous data, or by number and 
percentages for categorical data. 
13.4. Overactive Bladder Cohort 
13.4.1.
Primary Objective 
The primary objective for overactive bladder cohort of the study is to demonstrate there is an 
improvement in Overactive Bladder Quality of Life (OAB-q) Questionnaire Health Related Quality of Life 
(HRQL) total score at 3 months post-implant compared to baseline. 
Hypothesis 
The null (H0) and alternative (H1) hypotheses are: 
H0: μ = 0 
Ha: μ ≠ 0 
Where μ indicates the mean change in OAB-q HRQL total score from baseline to 3 months post-implant. 
Analysis Methods
A two-sided one sample t-test or Wilcoxon Singed Rank test will be performed to test the hypothesis 
depending on data normality. In addition to the hypothesis testing, the two-sided 95% confidence 
interval for the mean change in HRQL total score will be calculated and reported. 
In cases where subject’s OAB-q HRQL total score is missing at baseline and/or at 3 months post-implant 
for any reasons, a sensitivity analysis using multiple imputation will be performed.  
In addition, the OAB-q HRQL total score at baseline and 3 months post-implant will be summarized.  
13.4.2.
 

 

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x
 
 
 

 
 

 
  
 
 
 
 
13.5. Fecal Incontinence Cohort 
13.5.1.
Primary Objective 
The primary objective for fecal incontinence cohort of the study is to demonstrate there is an 
improvement in Cleveland Clinic Incontinence Score (CCIS) at 3 months post-implant compared to 
baseline. 
Hypothesis 
The null (H0) and alternative (H1) hypotheses are: 
H0: μ = 0 
Ha: μ ≠ 0 
Where μ indicates the mean change in CCIS from baseline to 3 months post-implant. 
Analysis Methods 
A two-sided one sample t-test or Wilcoxon Singed Rank test will be performed to test the hypothesis 
depending on data normality. In addition to the hypothesis testing, the two-sided 95% confidence 
interval for the mean change in CCIS total score will be calculated and reported. 
In cases where subject’s CCIS is missing at baseline and/or at 3 months post-implant for any reasons, a 
sensitivity analysis using multiple imputation will be performed.  
In addition, the CCIS at baseline and 3 months post-implant will be summarized.  
13.5.2.
 

 

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
 

 
 
 
 
 
 
13.6. Non-Obstructive Urinary Retention Cohort 
13.6.1.
Primary Objective 
The primary objective for non-obstructive urinary retention cohort of the study is to demonstrate there 
is an improvement in number of clean intermittent self-catheterizations (CISC) per day at 3 months post-
implant compared to baseline. 
Hypothesis 
The null (H0) and alternative (H1) hypotheses are: 
H0: μ = 0 
Ha: μ ≠ 0 
Where μ indicates the mean change in number of CISC per day from baseline to 3 months post-implant. 
Analysis Methods 
A two-sided one sample t-test or Wilcoxon Singed Rank test will be performed to test the hypothesis 
depending on data normality. In addition to the hypothesis testing, the two-sided 95% confidence 
interval for the mean change in number of CISC/day will be calculated and reported. In cases where 
subject’s number of CISC per day is missing at baseline and/or at 3 months post implant for any reasons 
where missing data occur, a sensitivity analysis using multiple imputation will be performed.  
In addition, the number of CISC/day at baseline and 3 months post-implant will be summarized.  

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13.6.2.
 
x
 

 
 

 
 
 
 
 
13.7. Safety Assessment 
To characterize safety during the study duration. 
To characterize safety of the InterStim Micro System by summarizing the adverse device effects and 
serious adverse device effects during the study.  Safety measures will be summarized for each cohort as 
well as pooled for all patients regardless of indication. Device deficiencies will also be collected and 
reported. 
Summaries will be presented as number of serious events, number of events, number of subjects who 
experienced the event, and percent of subjects who experienced the event. All adverse events and 
device deficiencies will be reported for each cohort as well as pooled for the three cohorts together. 
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 
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/(s) in 
which the study is conducted will be followed and in accordance with GCP. 
x
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.  

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x
In Europe, the study will be conducted in accordance with European Union Medical Device 
Regulation in addition to regional or national regulations, as appropriate. 
x
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 (H164-
145/2011E). 
x
In Australia, all applicable local laws and regulations will be followed.  
Any additional requirements imposed by the IRB/EC or governing competent authority shall be followed, 
if appropriate. 
Medtronic will report all reportable AEs and device deficiencies according to post-market vigilance and 
safety 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 governing competent 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 shall not 
begin at any site until the required approval/favorable opinion from the Ethics Committee 
(EC)/Institutional Review Board (IRB) or notification/approval from a regulatory authority have been 
obtained, if appropriate. Any actions taken by the IRB/EC with respect to the investigation will be 

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forwarded to Medtronic as soon as possible. The Principal Investigator is responsible for submitting all 
required reports to the sponsor and/or IRB/EC/Regulatory Authorities (if applicable). 
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.  It is the responsibility of the investigator 
and Medtronic personnel to report all product complaint(s) associated with a medical device related to 
intended use, misuse or abuse.  All regional reporting requirements shall be followed.   
In addition, Principal Investigator, or designated personnel will provide Medtronic with requested 
information related to serious adverse events, device-, procedure- and/or therapy-related adverse 
events. 
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 (including US territories), Australia 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 Complaint 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 
EC/IRB All other geographies: Reporting timeframe as per local EC/IRB per local 
Requirement.  For institutions in Europe, reporting will be completed by 
Medtronic directly to EC and competent authorities, based on local 
regulations.  
Serious Adverse Device Effects (SADEs)  

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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.  For institutions in 
Europe, reporting will be completed by Medtronic directly to EC and 
competent authorities, based on local regulations. 
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. For 
institutions in Europe, reporting will be completed by Medtronic directly to 
EC and competent authorities, based on local regulations. 
 

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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 10 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 Canada: All subject deaths must be reported the EC as soon as possible, but 
no more than 72 hours of learning of a subject’s death, regardless of 
whether or not the death is related to the device system or therapy.   
 
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.  For institutions in Europe, reporting will be 
completed by Medtronic directly to EC and competent authorities, based on 
local regulations. 
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. 
For institutions in Europe, reporting will be completed by Medtronic directly 
to EC and competent authorities, based on local regulations. 
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. For 
institutions in Europe, reporting will be completed by Medtronic directly to 
EC and competent authorities, based on local regulations. 
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 
 

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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 
All other geographies: Reporting timeframe as per local EC/institutional 
requirements 
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 
 
All other geographies: Reporting timeframe as per local EC/institutional 
requirements 
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 
 
All other geographies: Promptly notify Medtronic upon awareness 
EC/IRB US and Europe: The Investigator must notify the EC/IRB within 5 working 
days after upon awareness. For institutions in Europe, reporting will be 
completed by Medtronic directly to EC and competent authorities, based on 
local regulations. 
 
Canada: The Investigator must notify the EC/IRB within 5 working 
days after SURFHGXUH

All other geographies: Reporting timeframe as per local EC/institutional 
requirements 
 

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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.  For institutions in Europe, reporting will be completed by 
Medtronic directly to EC and competent authorities, based on local 
regulations. 
 
Canada: Study reports must be submitted within 3 months after 
termination or completion of the investigation or as required by applicable 
regulation 
 
All other geographies: Study reports must be submitted per EC 
requirements 
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. 

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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.  
 
 
 
 
15.7. 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: 
• 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 
15.8. 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 

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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. 
15.9. Direct Access to Source Data/Documents  
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.  
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.  Principal Investigator 
should be available to support study activities, such as study-related monitoring, audits, IRB/EC review 
and regulatory inspection(s).  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. 

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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. 
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 Canada ULC., Medtronic International Trading SARL, Medtronic Australasia Pty Ltd and 
Medtronic Logistics LLC are  indirectly owned subsidiaries of Medtronic, Inc. which  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 competent 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. 

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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 
competent 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: 
x
When necessary to eliminate an immediate/or apparent immediate hazard to participating 
subjects 
x
When the change involves purely administrative or logistical aspects of the study  
15.13.
Record Retention 
At a minimum, the investigator is responsible for the preparation, review, and retention of the records 
listed below: 
x
Essential correspondence that pertains to the investigation 
x
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 InterStim Micro System and InterStim Therapy.  
x
Documentation of any deviation to the protocol, including the date and the rationale for such 
deviation 
x
Signed Investigator Agreement and curriculum vitae for all Investigators 
x
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 or according to local regulatory 
requirements, whichever is greater.  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. 

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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. 
Investigators who gathered data for this study (i.e., enrolled subjects, contributed quality data and 
complied with the protocol) and are interested in publishing may have the opportunity to write or 
contribute to the writing of abstracts and manuscripts based on the results of this study. Principal 
investigators who meet the study-specific criteria above will be considered for abstract/manuscript 
authorship if they meet the International Committee of Medical Journal Editors, Ethical Considerations 
in the Conduct and Reporting of Research criteria available via the following link: 
http://www.icmje.org. Specifically, authorship credit should be based on the following and should meet 
all criteria listed below: 
x
Substantial contributions to conception or design; or the acquisition, analysis and interpretation 
of data for the work; 
x
Drafting the article or revising it critically for important intellectual content; and 
x
Final approval of the version to be published; and. 
x
Agreement to be accountable for all aspects of the work in ensuring that questions related to 
the accuracy or integrity of any part of the work are appropriately investigated and resolved. 
Medtronic employees who meet the International Committee of Medical Journal Editors criteria for 
authorship will have the right to authorship. 
All contributors who do not meet the criteria for authorship are to be listed in an acknowledgment 
section according to the guidelines of the applicable scientific journal. Examples of those who might be 
acknowledged include a person who provided purely technical help, writing assistance, or a department 
chair who provided only general support. 
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: 
x
Insufficient enrollment to complete the study within the expected timeframe 
x
Identification of unacceptable safety profile; suspicion of an unacceptable risk will result in a 
suspension, confirmation of an unacceptable risk will result in termination 
x
Inadequate subject adherence to follow-up requirements 
x
Product performance/product supply issues  

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Medtronic reserves the right to suspend or terminate the study at an individual site.  Reasons may 
include, but are not limited to, the following: 
x
Noncompliance with the protocol, including Inadequate subject adherence to follow-up 
requirements 
x
Serious or repeated deviations at the site 
x
Failure to implement required corrective and preventive actions 
x
Insufficient enrollment to complete the study within the expected timeframe 
x
Loss of appropriately trained site personnel 
Investigators are required to notify the IRB/EC and governing competent authority (if applicable) of 
study suspension/termination.  In addition, Investigators should assess whether or not to continue the 
study based on reasons above. Subjects will be notified by the investigator of suspension/termination 
due to unacceptable risk or of termination due to any other cause. 
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. Paquette IM, Varma MG, Kaiser AM, et al.  The American Society of Colon and Rectal Surgeons’ 
Clinical Practice Guideline for the Treatment of Fecal Incontinence. Dis Colon Rectum 2015; 58: 623–
636. 
4. Stoffel J, Lightner D, Peterson A, et al. Non-Neurogenic Chronic Urinary Retention: Consensus 
Definition, Management Strategies, and Future Opportunities. 
https://www.auanet.org/guidelines/chronic-urinary-retention. Published 2016. 
5. Hull T, Giese C, Wexner SD, et al. Long term durability of sacral nerve stimulation therapy for chronic 
fecal incontinence. Dis Colon Rectum. 2013;56(2):234-245. doi: 10.1097/DCR.0b013e318276b24c 
6. Siegel S, Noblett K, Mangel J, et al. Five Year Follow-up Results of a Prospective, Multicenter Study in 
Overactive Bladder Subjects Treated with Sacral Neuromodulation. J Urol. 2018; 199(1), 229 – 236. 
doi: 10.1016/j.juro.2017.07.010 
7. Jonas U, Fowler CJ, Chancellor MB, et al.  Efficacy of Sacral Nerve Stimulation for Urinary Retention: 
Results 18 Months after Implantation. J Urol. 2001 Vol. 165, 15–19. 
8. Van Kerrebroeck (van Kerrebroeck PE, van Voskuilen AC, Heesakkers J, et al. Results of Sacral 
Neuromodulation Therapy for Urinary Voiding Dysfunction: Outcomes of a Prospective, Worldwide 
Clinical Study. J Urol. 2007. Vol. 178, 2029-2034. 

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9. Coyne KS, Gelhorn H, Thompson C, Kopp ZS, & Guan Z. The psychometric validation of a 1-week 
recall period for the OAB-q. Int Urogynecol J. 2011; 22(12):1555-63.                                                                 
doi: 10.1007/s00192-011-1486-0 
10.Jorge JMN, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum 
1993;36:77-97. doi: 10.1007/BF02050307 
11.Rockwood TH, Church JM, Fleshman JW, et al. Fecal Incontinence Quality of Life Scale: quality of life   
instrument for patients with fecal incontinence. Dis Colon Rectum. 2000;43:9–16.                                     
doi: 10.1007/BF02237236 
12.Brookes, S., Donovan, J., Wright, M., Jackson, S., Abrams, P. A scored form of the Bristol Lower 
Urinary Tract Symptoms questionnaire: data from a randomized controlled trial of surgery for 
women with stress incontinence. Am.J.Obstet.Gynecol. 2004; 191(1): 73-82. 
doi:10.1016/j.ajog.2003.12.027 
13.Donovan J, Peters T, Abrams P, Brooks S, de la Rosette J, Schafer W. Scoring the short form ICSmale 
SF questionnaire. J Urol. 2000; 164(6):1948-1955. doi: 10.1016/S0022-5347(05)66926-1 
14.Yalcin I, Bump R. Validation of two global impression questionnaires for incontinence. Am J  Obstet 
Gynecol. 2003;189(1):98-101.  doi: 10.1002/nau.23447. 
15.Tincello D, Owen R, Slack M, Abrams K. Validation of the Patient Global Impression scales for use    in 
detrusor overactivity: secondary analysis of the RELAX study. BJOG 2013; 120: 212–216.                      
doi: 10.1111/1471-0528.12069.  
16.Thin NN, Horrocks EJ, Hotouras A, Palit S, Thaha MA, Chan CL, Matzel KE, Knowles CH. Systematic 
review of the clinical effectiveness of neuromodulation in the treatment of faecal incontinence. Br J 
Surg. 2013 Oct;100(11):1430-47. doi: 10.1002/bjs.9226. 
17.Sutherland SE, Lavers A, Carlson A, Holtz C, Kesha J, Siegel SW. Sacral nerve stimulation for voiding 
dysfunction: One institution's 11-year experience. Neurourol Urodyn. 2007;26(1):19-28.                             
doi: 10.1002/nau.20345 
18.Cardarelli S, D'Elia C, Cerruto MA, Curti P, Ostardo E, Signorello D, Pastorello M, Caleffi G, Molon A, 
Artibani W. Efficacy of sacral neuromodulation on urological diseases: a multicentric research 
Project. Urologia. 2012 Apr-Jun;79(2):90-6. doi: 10.5301/RU.2012.9278. 
19.ICIQ Development Group.  The International Consultation on Incontinence Questionnaires. 
https://iciq.net.  Accessed 01 October 2019. 
17. Appendices  
17.1Additional Information for Sites  
Detailed sponsor contact information, including the contact information for the local sponsor/legal 
representative in Europe, Medical Advisor, not outlined in the Clinical Investigational Plan will be 
provided under a separate cover. 

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17.2 Institutional Review Boards/Ethics Committees  
At the time of the completion of the Clinical Investigation Plan, site selection is not yet complete. 
Therefore, a complete list of participating IRB/EC names, locations, and the Chairperson(s) will be 
distributed under a separate cover when available. 
17.3Participating Investigators and Institutions 
At the time of completion of the Clinical Investigation Plan, site selection is not yet complete. Therefore, 
a complete list of names, addresses, contact details and professional positions of the clinical  
investigators and institutions will be distributed under a separate cover when available.  No coordinating 
principal investigator will be assigned for the global portion of the study.  
17.4 Informed Consent Materials 
Copies of all informed consent materials will be provided to the site under a separate cover, based on 
regional requirements.  
17.5Labeling  
Copies of the InterStim System Information for Prescribers will be provided to the site under a separate 
cover, based on regional and local language requirements.  All other labeling for commercial products 
used in the study will be provided through commercial channels.  
18. Version History 
Version 
Summary of Changes 
Author(s)/Title 
1.0 
x
 ‘Not Applicable, New Document’ 
 
 
 
 
2.0 
x
European Legal Sponsor was added to title page
x
Study title and purpose was updated to include 
confirmation of long-term outcomes. Updates 
based on this change were made throughout the 
document where applicable. 
x
Table 11-1: added MPSV (German Safety Plan for 
Medical Devices) SAE definition 
x
Section 13.1.1: sample size justification was 
elaborated to include expected attrition rates and 
to provide historical rationale for the estimate. 
x
Section 13.1.3: "All efforts will be made to ensure 
patient follow-ups are completed with limited 
 
 

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attrition to ensure interpretability of study results" 
was added to the Handling Missing Data 
paragraph. 
x
Minor grammatical updates throughout