InterStim® Amplitude Study
Phase: NA
Conditions: Urinary Urge Incontinence
Sponsor: MedtronicNeuro

InterStim® Amplitude Study 
Clinical Investigational Plan Version 2.0 
23-Aug-2018 
NCT03335761 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ
MDT17030 
Version 2.0 
Page 1 of 61 
0HGWURQLF&RQILGHQWLDO
)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH
Clinical Investigation Plan 
Clinical Investigation Plan/Study Title InterStim® Amplitude Study 
Study Product Name InterStim II System 
Sponsor/Local Sponsor United States (Sponsor):
Medtronic, Inc.  
7000 Central Avenue NE 
Minneapolis, MN 55432 USA 
Europe (Local Sponsor): 
Medtronic International Trading Sàrl 
Route du Molliau 31 
CH-1131 Tolochenaz, Switzerland 
Canada (Local Sponsor): 
Medtronic of Canada 
99 Hereford Street 
Brampton, ON, L6Y 0R3 Canada 
1-905-460-3800 
Document Version 2.0 / 23 Aug 2018 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of 
Medtronic. Any distribution, copying, or disclosure without the prior written authorization of 
Medtronic is strictly prohibited. Persons to whom the information is disclosed must know that it is 
confidential and that it may not be further disclosed by them. 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 2 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


 
  
 
 
 
 
 
 
  
 
  
 
 
  
 
 
  
 
 
 
 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 3 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


,QYHVWLJDWRU6WDWHPHQW
Participating investigators will be provided with a separate investigator agreement to document their 
obligations and commitment with respect to study conduct. 
 
 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 4 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


7DEOHRI&RQWHQWV
 
,QYHVWLJDWRU6WDWHPHQW 
7DEOHRI&RQWHQWV 
 
*ORVVDU\ 
 
6\QRSVLV 
 
,QWURGXFWLRQ 
 %DFNJURXQG 
 3XUSRVH 
 
2EMHFWLYHVDQG(QGSRLQWV 
 2EMHFWLYHV 
5.1.1. 
Primary Objective .................................................................................................................. 18 
5.1.2. 
Secondary Objective.............................................................................................................. 18 
5.1.3. 
Additional Measures ............................................................................................................. 18 
 
6WXG\'HVLJQ 
 'XUDWLRQ 
 5DWLRQDOH 
 
3URGXFW'HVFULSWLRQ 
 *HQHUDO 
 0DQXIDFWXUHU 
 ,QWHQGHG3RSXODWLRQ 
 3URGXFW5HWXUQ 
 3URGXFW$FFRXQWDELOLW\ 
 
6HOHFWLRQRI6XEMHFWV 
 6WXG\3RSXODWLRQ 
 6XEMHFW(QUROOPHQW 
 ,QFOXVLRQ&ULWHULD 
 ([FOXVLRQ&ULWHULD 
 
6WXG\3URFHGXUHV 
 6FKHGXOHRI(YHQWV 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 5 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


 6XEMHFW6FUHHQLQJ 
 3ULRUDQG&RQFRPLWDQW2$%0HGLFDWLRQV 
 6XEMHFW&RQVHQW 
 5DQGRPL]DWLRQDQG7UHDWPHQW$VVLJQPHQW 
 2$%0HGLFDWLRQ&RPSOLDQFH 
 $VVHVVPHQWRI(IILFDF\  
 $VVHVVPHQWRI6DIHW\ 
 5HFRUGLQJ'DWD 
 
'HYLDWLRQ+DQGOLQJ 
 
6XEMHFW:LWKGUDZDORU'LVFRQWLQXDWLRQ 
 5LVNVDQG%HQHILWV 
 
3RWHQWLDO5LVNV 
 
5LVNV2XWOLQHGLQWKH,QVWUXFWLRQVIRU8VH,)8 
 
3RWHQWLDO%HQHILWV 
 
5LVN%HQHILW5DWLRQDOH 
 $GYHUVH(YHQWVDQG'HYLFH'HILFLHQFLHV 
 
'HILQLWLRQV&ODVVLILFDWLRQV 
 
5HSRUWRI$GYHUVH(YHQWV 
 
'HYLFH'HILFLHQFLHV 
 
'HDWKV 
 'DWD5HYLHZ&RPPLWWHHV 
 6WDWLVWLFDO'HVLJQDQG0HWKRGV 
 *HQHUDO6WDWLVWLFDO&RQVLGHUDWLRQV  
13.1.1 
Study Sample Size Justification .......................................................................................... 43 
13.1.2 
Description of demographic and baseline variables ......................................................... 44 
13.1.3 
Center Pooling ................................................................................................................... 44 
13.1.4 
Missing Data ...................................................................................................................... 44 
13.1.5 
Interim Analysis ................................................................................................................. 44 
13.1.6 
Reports .............................................................................................................................. 44 
13.1.7 
Study Success ..................................................................................................................... 44 
13.1.8 
Subgroup Analyses ............................................................................................................ 44 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 6 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


13.1.9 
Patient Populations ........................................................................................................... 44 
 3ULPDU\2EMHFWLYH 
6HFRQGDU\2EMHFWLYH 
 $GGLWLRQDO0HDVXUHV 
 (WKLFV 
 
6WDWHPHQWVRI&RPSOLDQFH 
 
3ULQFLSDO,QYHVWLJDWRU2YHUVLJKW 
 6WXG\$GPLQLVWUDWLRQ 
 
6SRQVRU 
 
6LWH6HOHFWLRQ 

&OLQLFDO7ULDO$JUHHPHQW 
 
&XUULFXOXP9LWDH 
 
0RQLWRULQJ 
 
0HGWURQLF5HSUHVHQWDWLYH5ROH 
 
'DWD0DQDJHPHQW 
 
'LUHFW$FFHVVWR6RXUFH'DWD'RFXPHQWV 
 
&RQILGHQWLDOLW\ 
 
/LDELOLW\ 
 
&,3$PHQGPHQWV 
 
5HFRUG5HWHQWLRQ 
 
3XEOLFDWLRQDQG8VHRI,QIRUPDWLRQ 
 
6XVSHQVLRQRU(DUO\7HUPLQDWLRQ 
 5HIHUHQFHV 
 $SSHQGLFHV 
 
$SSHQGL[$$GGLWLRQDO,QIRUPDWLRQIRU6LWHV 
 
$SSHQGL[%,QVWLWXWLRQDO5HYLHZ%RDUGV(WKLFV&RPPLWWHHV 
 
$SSHQGL[&3DUWLFLSDWLQJ,QYHVWLJDWRUVDQG,QVWLWXWLRQV 
 
$SSHQGL[',QIRUPHG&RQVHQW0DWHULDOV 
 9HUVLRQ+LVWRU\ 
 
 
 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 7 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


*ORVVDU\
TERM 
DEFINITION 
ADE 
Adverse Device Effect 
ADVANCED EVALUATION 
Therapy evaluation using InterStim Tined Lead  
AE 
Adverse Event 
AT 
As Treated 
AWC 
Adjusted Worst Case 
BASIC EVALUATION 
Therapy evaluation using temporary Test Stimulation Lead  
CC 
Complete Case 
CFR 
Code of Federal Regulations 
CIP 
Clinical Investigational Plan  
eCRF 
Electronic Case Report Form 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
IDE 
Investigational Device Exemption 
IRB 
Institutional Review Board 
LOCF 
Last Observation Carried Forward 
NPU 
Neuro Programmer Upload 
OAB 
Overactive Bladder 
ICIQ-OABqol
International Consultation on Incontinence Modular 
Questionnaire - Overactive Bladder Symptoms Quality of Life 
Questionnaire 
 
 
PNE 
Peripheral Nerve Evaluation 
QoL 
Quality of Life 
ORACLE RDC 
Oracle Remote Data Capture 
REPORTABLE ADVERSE EVENTS AND 
DEVICE DEFICIENCIES 
Serious, device-related, procedure-related, therapy-related 
adverse events and all device deficiencies will be considered 
reportable for this study 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Events 
SAP 
Statistical Analysis Plan 
SENSORY THRESHOLD 
Sensory threshold is defined as the lowest amplitude where 
the subject first perceives sensation of the stimulation in the 
perineum, perianal, vaginal, or any location deemed 
appropriate by the investigator while in a seated position.     
SNM 
Sacral Neuromodulation  

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 8 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


TERM 
DEFINITION 
USADE 
Unanticipated Serious Adverse Device Effect 
UF 
Urgency Frequency 
UI 
Urinary Incontinence 
UUI 
Urinary Urge Incontinence 
US
United States 
UTI 
Urinary Tract Infection 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 9 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


6\QRSVLV
Title
InterStim Amplitude Study
Clinical Study Type 
Post-Market, On-Label  
Product Name 
InterStim II (Model 3058) and InterStim Quadripolar Lead Model 
3889-XX (hereinafter referred to only as the tined lead or Model 
3889) with commercially-approved accessories. Either the InterStim 
Tined Lead Model 3889  or the temporary Test Stimulation Lead (the 
lead is sold via Models 305901, 305906 or 309101, hereinafter 
referred to only as the Test Stimulation Lead) may be used for the 
therapy evaluation. 
In the rest of this document, “advanced evaluation” will refer to 
therapy evaluation using InterStim Tined Lead and “basic evaluation” 
will refer to therapy evaluation using temporary Test Stimulation 
Lead. 
Sponsor  
Medtronic, Inc. 
Indication under 
investigation  
The indication under investigation is overactive bladder (OAB).   
 
There are no investigational devices used in this study, all study 
products will be used in accordance with the product labeling. 
Investigation Purpose
To assess the effect of three different amplitude settings (50% of 
sensory threshold, 80% of sensory threshold and sensory threshold) 
on urinary urge incontinence (UUI).   
 
Sensory threshold is defined as the amplitude where the subject first 
perceives the sensation of the stimulation in the perineum, perianal, 
vaginal, or any location deemed appropriate by the investigator while 
in a seated position.    
Product Status 
The InterStim II system is commercially approved for the treatment of 
patients with OAB. 
Primary Objective 
To explore the effect of three different amplitude settings on urinary 
urge incontinence (UUI). 
Secondary Objective 
To characterize results from the ICIQ-OABqol questionnaire for the 
three different amplitude settings.  
Additional Measures 
 to summarize safety 
for the three different amplitude settings.   
Study Design 
This is a prospective, randomized, multicenter, single-blinded study to 
explore the efficacy and quality of life (QoL) of 3 different amplitude 
settings.  The study will be conducted at approximately 20 centers in 
the United States, Canada and Europe.   
 
Enrolled subjects who meet all eligibility criteria, have successful 
therapy evaluation (50% improvement in UUI or UF voiding 
symptoms, or return to normal voiding of < 8 voids per day for UF 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 10 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


subjects) and qualify for a neurostimulator device implant in the study 
will be randomized to one of the 3 amplitude settings.  Subjects will 
complete enrollment/baseline visits, lead implant, therapy evaluation, 
neurostimulator device implant, randomization, 1-week follow-up 
visit, 6-week follow-up visit and 12-week follow-up visit.  
 
The total study duration for a subject is approximately 16 weeks. 
Randomization 
Subjects must meet all eligibility criteria and demonstrate a successful 
therapy evaluation prior to being randomized to one of three therapy 
amplitudes: sensory threshold, 50% of sensory threshold or 80% of 
sensory threshold.   
Sample Size 
This study requires approximately 42 implanted and randomized 
subjects with 12-week follow-up to be analyzed for the primary 
objective.  Approximately 60 subjects are estimated to be enrolled in 
the study with approximately 48 randomized; however, these 
numbers may vary to ensure that a minimum of 42 implanted 
subjects complete the study.  
Inclusion/Exclusion Criteria 
Inclusion Criteria: 
1. Primary diagnosis of urinary urge incontinence (UUI) as 
demonstrated on a 3-day baseline voiding diary 
demonstrating at least 3 UUI episodes 
2. Female subjects 18 years of age or older 
3. Candidate for InterStim Lead Placement 
4. Willing and able to accurately complete voiding diaries, 
questionnaires, attend visits, and comply with the study 
protocol (which includes maintenance of InterStim II 
programming settings over the course of the study) 
5. Willing and able to provide signed and dated informed 
consent  
6. Willing to maintain current regimen (dosage and frequency) 
of any overactive bladder (OAB) medication  
 
Exclusion Criteria:    
1. Have neurological conditions such as multiple sclerosis, 
clinically significant peripheral neuropathy or spinal cord 
injury  
2. History of diabetes unless the diabetes is well-controlled 
through diet and/or medications 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 11 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


3. Symptomatic urinary tract infection (UTI)  
4. Have primary stress incontinence or mixed incontinence 
where the stress component overrides the urge component 
5. Treatment of urinary symptoms with botulinum toxin in the 
past 9 months or any plan to have botulinum toxin treatment 
during the study  
6. Implanted with a neurostimulator, pacemaker, or defibrillator 
7. Have knowledge of planned MRIs, diathermy, microwave 
exposure, high output ultrasonic exposure, or RF energy 
exposure not included within the scanning conditions 
provided with the MRI Guidelines for InterStim Therapy 
8. Women who are pregnant or planning to become pregnant  
9. Characteristics indicating a poor understanding of the study 
or characteristics that indicate the subject may have poor 
compliance with the study protocol requirements  
 Currently enrolled or planning to enroll in a potentially 
confounding clinical study during the course of the study (co-
enrollment in concurrent studies is only allowed when 
documented pre-approval is obtained from the Medtronic 
study manager (or designee)
Study Procedures and 
Assessments 
Study Visits:  
1.Enrollment / Baseline  
2.Tined Lead or temporary Test Stimulation Lead Implant  
3.Therapy Evaluation 
4.Tined Lead (if applicable) / Neurostimulator Device Implant 
(randomization procedures) 
5.One Week Follow-up Visit 
6.Six Week Follow-up Visit 
7.Twelve Week Follow-up Visit 
 
Enrollment/Baseline 
Subjects are considered enrolled at the time the study-specific 
informed consent is signed.  Each subject must meet all the inclusion 
and no exclusion criteria to be eligible to participate in the study.  At 
the enrollment/baseline visit, data will be gathered from subjects 
including relevant medical history and concomitant OAB medication.  
 
Subjects will complete the following questionnaire: 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 12 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


x
Overactive Bladder Symptoms Quality of Life 
Questionnaire    (ICIQ-OABqol)  
The voiding diary will be explained and given to the subject to be 
completed for 3 consecutive days. The 3-day voiding diary must be 
completed along with confirmation that the subject is not pregnant or 
planning to become pregnant during participation in the trial, as part 
of the assessment for study eligibility.   
 
Tined Lead or temporary Test Stimulation Lead Implant  
If using basic evaluation, the temporary Test Stimulation Lead should 
be placed in accordance with the InterStim system Test Stimulation 
Lead Kit and Test Stimulation Lead Technical Manual. 
 
If using advanced evaluation, the InterStim tined lead  should be 
placed in accordance with the InterStim Therapy Model 3889 Lead 
Implant Manual.   
 
For both advanced and basic evaluation, throughout the study, 
unilateral stimulation is required. 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
Settings may be set per Investigator discretion during the therapy 
evaluation period.   Any 
 reportable 
adverse events/device deficiencies will be documented and reported.  
 
Therapy Evaluation  
The therapy evaluation period should be conducted in accordance 
with the InterStim II System Labeling using the Verify® External 
Neurostimulator.  The therapy evaluation period must not exceed 
either 14 days if using InterStim tined lead, or 7 days if using the 
temporary Test Stimulation Lead or the approved duration in the 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 13 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


commercially available labeling in the respective country. A 3-day 
voiding diary will be completed towards the end of the therapy 
evaluation period.   A minimum of a 50% improvement in voiding 
symptoms (either UUI or UF), or return to normal voiding of < 8 voids 
per day for UF subjects, is required 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 
(randomization procedures) 
Once the subject qualifies for the neurostimulator device implant, site 
personnel may proceed with the Neurostimulator Device Implant Visit 
and randomization procedures.  If a subject does not qualify for the 
neurostimulator device implant, they will be exited from the study.  
For subjects who qualify for device implant following a successful 
basic evaluation, the InterStim tined lead should be placed in 
accordance with the InterStim Therapy Model 3889 Lead Implant 
Manual. 
 
 
 
At the time of the neurostimulator device implant, site personnel will 
obtain a randomization assignment to randomize each subject to one 
of the following therapy amplitudes: sensory threshold, 50% of 
sensory threshold or 80% of sensory threshold.  Subjects are blinded 
to their randomized setting.   All measures should be taken to ensure 
that the subject does not become unblinded to their randomization 
throughout the study.  
 
Subjects will be implanted with the Neurostimulator in accordance 
with the InterStim Therapy InterStim II Model 3058 Neurostimulator 
Implant Manual.   
After the device implant is complete, it is required that subjects be 
programmed to 14 hertz (Hz), 210 μs pulse width (pw) and continuous 
stimulation for the duration of the study. During programming 
throughout the study, the subject’s sensory threshold amplitude will 
be determined by following this protocol:  start at 0.05 volts (V) and 
increase voltage in 0.05 V increments until the subject reports 
sensation.  Prior to discharge, the amplitude at each electrode 
configuration that elicits a sensory response must be determined in 
 seated 
 positions.  As part of the programming, 
impedance checks should be completed during each study visit.  

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 14 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


Following determination of sensory threshold (seated position), 
amplitude will be programmed based on the assigned randomization 
of sensory threshold, 80% of sensory threshold, or 50% of sensory 
threshold. Subjects will be allowed to adjust amplitude +/- 0.05 V 
during the study.  Therapy amplitude will remain at this level (± 0.05 
V) until the next follow-up visit or programming session.     Any 
 reportable adverse events will be 
documented and reported.  
  
1-Week Follow-up Visit   
At the 1-week follow-up visit, any reportable adverse events, device 
deficiencies and 
 will be collected.    
 
Prior to the completion of the visit, the amplitude at each electrode 
configuration that elicits a sensory response must be determined in 
 seated 
 positions.  Following determination of 
sensory threshold, amplitude will be programmed based on the 
assigned randomization.   
 
Over the course of the study any changes to programmed parameters 
(amplitude, PW, rate or cycling) outside of the allowable settings in 
the study will be considered a protocol deviation; however, subjects 
will be encouraged to continue in the study.    
 
The voiding diary will be explained and given to the subject to be 
completed approximately 3 days prior to the 6-week follow-up visit.  
 
6-Week Follow-up Visit  
At the 6-week follow-up visit, the subject’s voiding diary completed 
during the previous period will be collected.  
 
reportable adverse events, device deficiencies and other 
information will be collected from the subject.    
 
 

 
Prior to the completion of the visit, the amplitude at each electrode 
configuration that elicits a sensory response must be determined in 
 seated 
 positions. Following determination of 
sensory threshold, amplitude will be programmed based on the 
assigned randomization using the sensory threshold in the seated 
position.   
 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 15 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


The voiding diary will be explained and given to the subject to be 
completed approximately 3 days prior to the 12-week visit.  
 
12-Week Follow-up Visit 
At the 12-week follow-up visit, the subject’s voiding diary completed 
during the previous period will be collected.  
 
 reportable adverse events, device deficiencies and other 
information will be collected from the subject.  Prior to the 
completion of the visit, the amplitude at each electrode configuration 
that elicits a sensory response must be determined in 
 seated 
 positions.  
 
Subjects will complete the following questionnaires: 
x
ICIQ-OABqol 

 
 
The subject is exited from the study after the 12-week follow-up visit 
is complete.  Programming parameters after the subject has 
completed the study are at the Investigator’s discretion. 
 
Unscheduled Visit   
If an unscheduled visit is needed for any device-related reason, the 
amplitude at each electrode configuration that elicits a sensory 
response must be determined in 
 seated 
 positions. 
Following determination of sensory threshold, amplitude will be 
programmed based on the assigned randomization using the sensory 
threshold in the seated position.   
 
In addition to programming activities, 
, 
reportable adverse events and device deficiencies will be collected.  
 
Surgical Revision  
If a surgical revision is required after the full system implant, the 
subject will be exited from the study.  
Safety Assessments 
Safety will be evaluated by the collection of reportable adverse events 
and device deficiencies.  
 Statistics 
This study will explore the effect of three different amplitude settings 
(50% of sensory threshold, 80% of sensory threshold and sensory 
threshold) on UUI episodes per day.   Change of average UUI episodes 
per day at 12-week follow-up from baseline will be assessed under 
each amplitude setting.  

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 16 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


This study requires approximately 42 implanted and randomized 
subjects with 12-week follow-up to be analyzed for the primary 
objective. Approximately 60 subjects are estimated to be enrolled in 
the study with approximately 48 randomized; however, these 
numbers may vary to ensure that a minimum of 42 implanted 
subjects complete the study.  
Assuming a mean reduction between 1.8 to 2.3 UUI episodes per day 
with a standard deviation of 2.2 to 2.7 UUI episodes per day is 
observed, with ɲсϬ͘ϬϱƚǁŽ-sided and using a t-statistic to construct 
the confidence interval, a sample size of 14 subjects would have a 
precision of 1.56 UUI episodes per day for the assumption with a 
standard deviation of 2.7. Precision is defined as one-half of the 
confidence interval (also known as the distance from the confidence 
limits to the mean). This precision is less than our lowest assumed 
treatment effect (1.8 UUI), so it is expected that the lower 95% CI will 
be greater than 0 for all treatment arms, even in the scenario when 
the largest standard deviation was applied. 
 
This sample size calculation intends to be sufficient to explore the 
effect of each of three amplitude settings on UUI; however, the 
sample size is not sufficient for between group comparisons. 
 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 17 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


,QWURGXFWLRQ
 %DFNJURXQG
One of the most common patient complaints about sacral neuromodulation (SNM) for overactive 
bladder (OAB) is unwanted or uncomfortable stimulation.1,2   It is often assumed that higher amplitude 
stimulation will provide better efficacy, but there is a lack of clinical evidence regarding amplitude 
effects of SNM for OAB. However, there is some evidence that SNM for fecal incontinence is effective at 
sub-sensory threshold/amplitude.3 This study will explore whether lower amplitude stimulation can 
provide improved symptom control when compared to baseline.   Potential effects of lower amplitude 
may include changes in or sustained efficacy, or reduced patient complaints due to uncomfortable 
stimulation. This feasibility study will provide an initial understanding of various amplitude stimulation 
settings and the impact on symptoms.  
The effect of amplitude on SNM therapy efficacy is not well characterized clinically for either OAB4 or 
fecal incontinence5. However, preclinical data suggest the effect of SNM is amplitude-dependent. Using 
the rodent model of rhythmic bladder contractions (RBC), Su et al (2012) showed that increasing 
amplitude of spinal nerve stimulation from motor threshold amplitude to 3x motor threshold resulted in 
inhibition of bladder contractions by 20 to 90%, respectively.6  Similarly, using the RBC model in cats, 
Snellings and Grill (2012) showed that stimulation of the of the pudendal nerves inhibited the frequency 
of contractions and increased bladder capacity at 0.8, 1, and 2 times motor threshold in an intensity-
dependent manner.7  Finally, stimulation of tibial nerve and dorsal nerve of the penis produced an 
amplitude-dependent inhibition of bladder contractions in the rodent.8  The sum of these studies 
suggest that the effect of neuromodulation on bladder function is amplitude-dependent. 
Duelund-Jakobsen et al (2013) demonstrated that there was no significant difference in reduction of 
fecal incontinent episodes when subjects were programmed to 50%, 75%, and 100% of sensory 
ƚŚƌĞƐŚŽůĚ;ŶсϭϵͿ͘3   In a recent clinical study using fMRI, Gill et al demonstrated a stimulation amplitude-
dependent response in brain activity in 6 patients receiving sub-sensory, sensory, and supra-sensory 
SNM.6 These studies suggest SNM efficacy at sub-sensory amplitudes.  
Given the preclinical data showing an amplitude-dependent effect of neuromodulation on bladder 
function and the clinical data demonstrating a therapeutic effect of sub-sensory amplitude, it is 
important to understand the efficacy of SNM at different subsensory and sensory threshold amplitudes. 
 3XUSRVH
The purpose of this prospective, multicenter, randomized, single-blind feasibility study is to explore the 
efficacy and quality of life under 3 different amplitude settings (sub-sensory amplitudes of 50% and 80% 
of sensory threshold and sensory threshold).  Efficacy will be characterized with change from baseline 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 18 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


through 12 weeks in UUI episodes and patient reported outcomes.    Quality of life will be characterized 
with the ICIQ-OABqol Questionnaire at baseline and 12 weeks. Subject participation will last 
approximately 16 weeks following the enrollment visit.  Subjects are exited from the study after the 12-
week follow-up visit is completed.    
2EMHFWLYHVDQG(QGSRLQWV
 2EMHFWLYHV

3ULPDU\2EMHFWLYH
The primary objective in the study is to explore the effect of three different amplitude settings (50% of 
sensory threshold, 80% of sensory threshold and sensory threshold) on number of UUI episodes per day  

6HFRQGDU\2EMHFWLYH
Secondary objective of this study is quality of life (ICIQ-OABqol) for the three different amplitude 
settings.  

$GGLWLRQDO0HDVXUHV
Additional measures include: 
x
Safety 

 

 
6WXG\'HVLJQ
This is a prospective, multicenter, randomized, single-blind, feasibility study to explore the efficacy and 
quality of life of 3 different amplitude settings in patients with UUI.  Subjects will remain blinded to their 
assigned randomization for the duration of the study.  
Eligible subjects will sign a study-specific informed consent form (ICF).  Following verification of eligibility 
criteria, subjects will go through therapy evaluation with the InterStim II System.  After qualifying for the 
device implant, the subject will proceed with a neurostimulator device implant and randomization 
procedures.   Subjects will be randomized to one of the three amplitude settings:  50% of sensory 
threshold, 80% of sensory threshold and sensory threshold.   

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 19 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


Study requirements, including voiding diaries, quality of life questionnaires 
, and safety 
assessments will be completed as required in Figure 9-1: Study Visits.  The study is expected to last 
approximately 16 weeks per subject following the enrollment visit.  Subjects will be exited from the 
study after the 12-week follow-up visit is complete.  
A minimum of forty-two implanted subjects (at least 14 subjects per arm) who have completed the 12-
week follow-up visit are needed to assess the study primary objective.  To account for screen failures, 
therapy evaluation conversion rate and loss to follow-up or missing data, it is anticipated that 
approximately 60 subjects will be consented and approximately 48 subjects will be 
implanted/randomized.  
The study will be conducted at approximately 20 sites in the United States, Canada, and Europe.   
This is an on-label, post-market study of an approved system.  All subjects enrolled in the study will 
qualify under the approved indication for the InterStim II System.  
 'XUDWLRQ
Study subjects will be enrolled and will complete enrollment and baseline assessments to determine 
eligibility for an InterStim lead implant procedure.  Subjects that do not meet eligibility criteria and/or 
qualify for a neurostimulator device implant will be exited from the study.  All enrolled subjects that 
qualify for the study (meet all inclusion and no exclusion criteria) will be randomized and undergo an 
InterStim II device implant procedure.  Post implant, subjects will be required to attend the 1-week 
follow-up visit (window +/- 3 days), 6-week follow-up visit (window +/- 7 days), and 12-week follow-up 
visit (window +/- 7 days).  The visits are expected to occur over approximately 16 weeks starting at the 
enrollment visit. 
The estimated study duration, from first subject enrollment to last subject visit, is expected to last 
approximately 18 months.  The completion of the study is defined as the approval of the Final Study 
Report and closure of all sites. 
 5DWLRQDOH
While there is extensive literature on the safety and efficacy of SNM in patients with OAB, there is a 
paucity of published literature regarding amplitude programming, specifically programming to levels 
below sensory threshold.   The purpose of this study is to explore the effect of sensory and sub-sensory 
stimulation using the InterStim II System.  The InterStim II System is approved and will be used in 
accordance with commercially available product labeling for the specific geography.  

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 20 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


3URGXFW'HVFULSWLRQ
 *HQHUDO
There are no investigational devices used in this study.   
The study will be conducted in the US, Canada, and Europe, countries where the Neurostimulator Model 
3058 (InterStim II), tined lead model 3889 and the temporary Test Stimulation Lead (sold via Models 
305901, 305906 or 309101, hereinafter referred to only as the temporary Test Stimulation Lead)are 
commercially available as part of the InterStim system  (for the treatment of OAB).  The 3 amplitude 
settings under investigation are within the commercially-approved programming parameters.  For the 
present study, the subject will be able to turn off the stimulator or decrease amplitude if needed for 
safety reasons, and to make minor increases to amplitude (if desired).  
Labeling will be provided in accordance with local language and regulatory requirements. 
 0DQXIDFWXUHU
The products used in this study, identified in Section 7.1, are manufactured by Medtronic, Inc. and are 
approved for use in treating patients with OAB.  
Manufacturer 
Medtronic, Inc. 
710 Medtronic Parkway 
Minneapolis, MN 55432-5604 
USA 
 ,QWHQGHG3RSXODWLRQ
The study will enroll patients with a diagnosis of OAB and associated symptoms of UUI.   All subjects 
implanted must be candidates for InterStim Therapy.  
 3URGXFW5HWXUQ
Since all products are commercially available, standard commercial processes should be used to return 
product (as applicable).   
 3URGXFW$FFRXQWDELOLW\
All product used in the study are commercially available; therefore, no product accountability will be 
required for the study.  

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 21 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


6HOHFWLRQRI6XEMHFWV
 6WXG\3RSXODWLRQ
The intended study population is subjects diagnosed with OAB and associated signs and symptoms of 
UUI.  
 6XEMHFW(QUROOPHQW
Subjects are considered enrolled at the time the study-specific ICF is signed.  Each subject must meet all 
the inclusion criteria and no exclusion criteria to be eligible to participate in this study.  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.  
 ,QFOXVLRQ&ULWHULD
To be eligible to participate in the study, a subject must meet all the following inclusion criteria:  
1. Primary diagnosis of urinary urge incontinence (UUI) as demonstrated on a 3-day baseline 
voiding diary demonstrating at least 3 UUI episodes 
2. Female subjects 18 years of age or older 
3. Candidate for InterStim Lead Placement  
4. Willing and able to accurately complete voiding diaries, questionnaires, attend visits, and 
comply with the study protocol (which includes maintenance of InterStim II programming 
settings over the course of the study) 
5. Willing and able to provide signed and dated informed consent  
6. Willing to maintain current regimen (dosage and frequency) of any overactive bladder (OAB) 
medication  
 ([FOXVLRQ&ULWHULD
A potential subject who meets any of the following criteria will be excluded from participating in the 
study: 
1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral 
neuropathy or spinal cord injury  
2. History of diabetes unless the diabetes is well-controlled through diet and/or medications 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 22 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


3. Symptomatic urinary tract infection (UTI)  
4. Have primary stress incontinence or mixed incontinence where the stress component overrides 
the urge component 
5. Treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have 
botulinum toxin treatment during the study  
6. Implanted with a neurostimulator, pacemaker, or defibrillator 
7. Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic 
exposure, or RF energy exposure not included within the scanning conditions provided with the 
MRI Guidelines for InterStim Therapy 
8. Women who are pregnant or planning to become pregnant  
9. Characteristics indicating a poor understanding of the study or characteristics that indicate the 
subject may have poor compliance with the study protocol requirements  
10.Currently enrolled or planning to enroll in a potentially confounding clinical study during the 
course of the study (co-enrollment in concurrent studies is only allowed when documented pre-
approval is obtained from the Medtronic Study Manager (or designee)  
6WXG\3URFHGXUHV
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 meet the criteria for evaluability.  See 
Figure 9-1 for Study Visit.  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.  
The following study visits will be conducted: 
1.Enrollment / Baseline  
2.Tined Lead or temporary Test Stimulation Lead Implant  
3.Therapy Evaluation 
4.Tined Lead (if applicable) / Neurostimulator Device Implant (randomization procedures) 
5.One Week Follow-up Visit 
6.Six Week Follow-up Visit 
7.Twelve Week Follow-up Visit 
 
 
 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 23 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


 6FKHGXOHRI(YHQWV
Enrollment/Baseline 
Subjects are considered enrolled at the time the study-specific informed consent is signed.  Each subject 
must meet all the inclusion and no exclusion criteria to be eligible to participate in the study.  At the 
enrollment/baseline visits, data will be gathered from subjects including relevant medical and 
concomitant OAB medication history.  Enrollment and Baseline Visit requirements will occur at separate 
visits.  
Subjects will complete the following questionnaire: 
x
Overactive Bladder Symptoms Quality of Life Questionnaire (ICIQ-OABqol)  
The voiding diary will be explained and given to the subject to be completed for 3 consecutive days. The 
3-day voiding diary must be completed along with confirmation that the subject is not pregnant or 
planning to become pregnant during participation in the trial, as part of the assessment for study 
eligibility.   
 Any reportable adverse events following informed consent will be documented and reported.  Device 
deficiencies will be collected beginning at the time of the first exposure to the InterStim II System. 
Tined Lead or temporary Test Stimulation Lead Implant  
If using basic evaluation, the temporary Test Stimulation Lead should be placed in accordance with the 
InterStim System Test Stimulation Lead Kit and Test Stimulation Lead Technical manual.     
If using advanced evaluation, the InterStim tined lead (model 3889) should be placed in accordance with 
the InterStim Therapy Model 3889 Lead Implant Manual. 
 
 
 
 
 
   
 
 
 
 
 
 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 24 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


 
  
Settings may be set per Investigator discretion during the therapy evaluation period and will be 
documented.   Any 
 reportable adverse events/device deficiencies will be 
documented and reported.  
Therapy Evaluation  
The therapy evaluation period should be conducted in accordance with the InterStim II System Labeling.  
The therapy evaluation period must not exceed either 14 days if using InterStim tined lead or 7 days if 
using the temporary Test Stimulation Lead as defined by current labeling, or a new approved duration in 
an updated commercially available labeling in the respective country. A 3-day voiding diary will be 
completed towards the end of the therapy evaluation period.   A minimum of a 50% improvement in 
UUI or UF voiding symptoms, or return to normal voiding of < 8 voids per day for UF subjects, is required 
in order to qualify for a neurostimulator implant in the study.  Settings used during therapy evaluation 
will be documented during this visit.  Any 
 reportable adverse 
events/device deficiencies will be documented and reported.  
Tined Lead (if applicable) / Neurostimulator Device Implant (randomization procedures) 
Once the subject qualifies for the neurostimulator device implant, site personnel may proceed with the 
neurostimulator device implant and randomization procedures.  If a subject does not qualify for the 
neurostimulator device implant, they will be exited from the study.  
For subjects who qualify for device implant following a successful basic evaluation, the InterStim tined 
lead should be placed in accordance with the InterStim Therapy Model 3889 Lead Implant Manual.  
 
 
At the time of the neurostimulator device implant, site personnel will obtain a randomization 
assignment to randomize each subject to one of the following therapy amplitudes: sensory threshold, 
50% of sensory threshold or 80% of sensory threshold.  Subjects are blinded to their randomization.   All 
measures should be taken to ensure that the subject does not become unblinded to their randomization 
throughout the study.  
 
Subjects will be implanted with the Neurostimulator in accordance with the InterStim Therapy InterStim 
II Model 3058 Neurostimulator Implant Manual.   
After the device implant is complete, it is required that subjects be programmed to 14 hertz (Hz), 210 μs 
pulse width (pw) and continuous stimulation for the duration of the study.  During programming, the 
subject’s sensory threshold amplitude will be determined by following this protocol:  start at 0.05 volts 
(V) and increase voltage using fine resolution in 0.05 V increments until the subject reports sensation.  

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 25 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


Prior to discharge, the amplitude at each electrode configuration that elicits a sensory response must be 
determined in 
 seated 
 positions. To determine sensory threshold, each electrode 
(0,1,2,3) will be programmed as the cathode (negative) in a bipolar configuration in a systematic fashion.    
 
Following determination of sensory threshold, amplitude will be programmed based on the assigned 
randomization of sensory threshold, 80% of sensory threshold, or 50% of sensory threshold using the 
sensory threshold in a seated position.  As part of the programming, impedance checks should be 
completed. Upon completion of programming, data will be collected via a programming printout or 
Neuro Programmer Upload (NPU).    
 
Subjects will be allowed to adjust amplitude +/- 0.05 V during the study.  Therapy amplitude will remain 
at this level (± 0.05 V) until the next follow-up visit or programming session.   Any 
 
 reportable adverse events/device deficiencies will be documented and reported.  
1-Week Follow-up Visit   
At the 1-week follow-up visit, any reportable adverse events, device deficiencies 
 
 will be collected.    
During the visit, the subject’s sensory threshold amplitude will be captured by following this protocol: 
start at 0.05 V and increase voltage using fine resolution in 0.05 V increments until the subject reports 
sensation.    Prior to the completion of the visit, the amplitude at each electrode configuration that 
elicits a sensory response must be determined in 
 seated 
 positions. To determine 
sensory threshold, each electrode (0,1,2,3) will be programmed as the cathode (negative) in a bipolar 
configuration in a systematic fashion.    
Following determination of sensory threshold amplitude, amplitude will be programmed based on the 
assigned randomization using sensory threshold in a seated position.  Subjects will be allowed to adjust 
amplitude +/- 0.05 V during the study.  As part of the programming, impedance checks should be 
completed. Upon completion of programming, data will be collected via a programming printout or 
NPU.    
Over the course of the study any changes to programmed parameters (amplitude, PW, rate or cycling) 
outside of the allowable settings in the study will be considered a protocol deviation; however, subjects 
will be encouraged to continue in the study.    
The voiding diary will be explained and given to the subject to be completed approximately 3 days prior 
to the 6-week follow-up visit.   
 
 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 26 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


6-Week Follow-up Visit  
At the 6-week follow-up visit, the subject’s voiding diary completed during the previous period will be 
collected.  
 reportable adverse events, device deficiencies and other 
information will be collected from the subject.    
 
 

 
During the visit, the subject’s sensory threshold amplitude will be captured by following this protocol: 
start at 0.05 V and increase voltage using fine resolution in 0.05 V increments until the subject reports 
sensation.  Prior to the completion of the visit, the amplitude at each electrode configuration that elicits 
a sensory response must be determined in 
 seated 
 positions. To determine sensory 
threshold, each electrode (0,1,2,3) will be programmed as the cathode (negative) in a bipolar 
configuration in a systematic fashion.    
 
Following determination of sensory threshold, amplitude will be programmed based on the assigned 
randomization using the sensory threshold in the seated position.  Subjects will be allowed to adjust 
amplitude +/- 0.05 V during the study.   As part of the programming, impedance checks should be 
completed.  Upon completion of programming, data will be collected via a programming printout or 
NPU.    
The voiding diary will be explained and given to the subject to be completed approximately 3 days prior 
to the 12-week visit.  
12-Week Follow-up Visit 
At the 12-week follow-up visit, the subject’s voiding diary completed during the previous period will be 
collected.  
 reportable adverse events, device deficiencies and other 
information will be collected from the subject.  During the visit, the subject’s sensory threshold will be 
captured by following this protocol: start at 0.05 V and increase voltage in 0.05 V increments until the 
subject reports sensation.  Prior to the completion of the visit, the amplitude at each electrode 
configuration that elicits a sensory response must be determined in 
 seated 
 positions. 
To determine sensory threshold, each electrode (0,1,2,3) will be programmed as the cathode (negative) 
in a bipolar configuration in a systematic fashion.     As part of the programming, impedance checks 
should be completed. Upon completion of programming, data will be collected via a printout or NPU.   

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 27 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


Subjects will complete the following questionnaires: 
x
ICIQ-OABqol 

 
The subject is exited from the study after the 12-week follow-up visit is complete.  Programming 
parameters after the subject has completed the study are at the Investigator’s discretion. 
Unscheduled Visit   
If an unscheduled visit is needed for any device-related reason, the subject’s sensory threshold 
amplitude will be confirmed by following this protocol: start at 0.05 V and increase voltage in 0.05V 
increments until the subject reports sensation.  Prior to the completion of the study, the amplitude at 
each electrode configuration that elicits a sensory response must be determined in 
 seated 
 
 positions. To determine sensory threshold, each electrode (0,1,2,3) will be programmed as the 
cathode (negative) in a bipolar configuration in a systematic fashion.     
Following determination of sensory threshold amplitude, amplitude will be programmed based on the 
assigned randomization using the sensory threshold in a seated position.  Subjects will be allowed to 
adjust amplitude +/- 0.05 V during the trial.  As part of the programming, impedance checks should be 
completed.  Upon completion of programming, data will be collected via a programming printout or 
NPU.   
All efforts should be made to maintain subject in the randomized arm.  If the subject must be changed 
from their randomized arm, subjects should be encouraged to complete a 3-day voiding diary prior to 
the unscheduled visit.   
In addition to programming activities, any 
reportable adverse events and 
device deficiencies will be collected.  
Surgical Revision  
If a surgical revision is required after the full system implant, the subject will be exited from the study.   
 
 
 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 29 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


Table 9-1: Study Procedures 
Enrollment
/  Baseline 
Tined Lead 
or Test 
Stimulation 
Lead Implant 
Therapy 
Evaluation 
Tined Lead (if 
applicable)/ 
Neurostimulato
r Device Implant 
1-Week
Follow-Up Visit 
(+/- 3 days) 
6-Week
Follow-Up Visit 
(+/- 7 days) 
12-Week
Follow-Up Visit 
(+/- 7 days) 
Unscheduled 
Visit  
Informed Consent 
 X* 
 
 
 
 
 
 
 
Randomization Procedures 
 
 
 
X*** 
 
 
 
 
Relevant Medical History 
X 
 
ICIQ-OABqol Questionnaire  
X 
 
 
 
 
 
X 
 
Pregnancy Assessment 
X 
 
 
 
 
 
 
 
 
 
 
 
Assessment of Sensory Threshold 
 
X 
 
X 
X 
X 
X 
X 
PGI-I Questionnaire  
 
 
 
 
 
X 
X 
 
3-Day Voiding Diary 
X** 
 
X** 
 
 
X 
X 
X**** 
Device Interrogation/        
Programming Data  
 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
Assessment of Reportable Adverse 
Events and Device Deficiencies 
X 
X 
X 
X 
X 
X 
X 
X 
* Must occur prior to any study specific activities   
**50% improvement in UUI or UF voiding symptoms, or return to normal voiding of < 8 voids per day for UF subjects, required for neurostimulator implant 
***Randomization must occur after study qualification; however, may be prior to or after neurostimulator device implant  
****If the subject must be changed from their randomized arm, subjects should be encouraged to complete a 3-day voiding diary prior to the unscheduled visit.   
 
 
Note: Programming settings of 14 hz, 210 pw and continuous stimulation are required following the neurostimulator device implant for the duration of the study 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 30 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


 6XEMHFW6FUHHQLQJ
Subjects may be recruited through the investigator’s practice and referring physicians.
Potential subjects may be identified through chart reviews or as new or existing patients attend clinic 
visits as appropriate.  If subjects are recruited from outside the investigator’s practice, sites are to 
ensure that appropriate release for access to the subject’s records (paper and/or electronic) is obtained. 
Any subject recruitment materials disseminated to subjects (advertisements, handouts, posters, social 
media) must be approved by the IRB/EC prior to use.  
 
All subjects must be consented in accordance with the protocol prior to any study-specific procedures. 
Recruited subjects will be screened by the Principal Investigator or authorized site personnel by 
reviewing the study’s inclusion and exclusion criteria.   
A screening log should be completed by the site to maintain a cumulative log of all screened subjects 
with reason for screening failure. 
 
The Investigator will maintain a listing of all subjects enrolled in the study. 

  
 6XEMHFW&RQVHQW
The informed consent process will be performed in accordance with the ethical principles that have 
their origin in the Declaration of Helsinki, 21CFR§50 Protection of Human Subjects (US only), SOR/98-
282 (Canada only) and in accordance with local regulatory requirements.  No vulnerable patients will be 
allowed to be consented to participate in the study. Data will be collected and treated in accordance 
with applicable Data Privacy Legislation. With regard to the EU this includes Directive 95/46/EC and 
subsequent legislation. 
Prior to entering the study, the Principal Investigator or qualified designee will explain to each subject 
the purpose and nature of the study, procedures, expected study duration, available alternative 
therapies, and the benefits and risks involved with study participation and the potential treatment.   The 
person obtaining consent will avoid any coercion or undue improper influence on, or inducement of, the 
subject to participate and the ICF will not waive, or appear to waive, any legal rights.  Subjects will be 
given a copy of the IRB/EC approved ICF and will have ample time to review the document and to ask 
questions and will be informed of their right to withdraw from the study at any time without prejudice; 
ICFs will be provided in a language understandable to the subject.  After this explanation and before any 
study-specific procedures have been performed, the subject will voluntarily sign and personally date the 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 31 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


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.  
 5DQGRPL]DWLRQDQG7UHDWPHQW$VVLJQPHQW
Once the subject meets all eligibility criteria for the study, and has a successful therapy evaluation, site 
personnel may proceed with the neurostimulator device implant and randomization procedures.  If a 
subject does not meet all eligibility criteria, subjects should be exited and not proceed to the 
neurostimulator device implant and randomization procedures.  
At the time of the device implant, site personnel will obtain randomization for one of the following 
therapy amplitudes: sensory threshold, 50% of sensory threshold or 80% of sensory threshold.  
Randomization will be assigned in a 1:1:1 ratio, and stratified by site. Site personnel will obtain the 
subject’s randomization sequence on the Randomization eCRF which will be generated from the 
database.  
The investigator and research staff at the study site will be instructed to keep the subject blinded to 
their randomization; however, subjects may or may not feel stimulation. The outcome measures in this 
study are based on the subject’s own assessment. Therefore, keeping the subject blinded to their 
randomization reduces bias in the outcome measurement reporting. 
 
 
During the study, subjects will be encouraged to remain in the randomized treatment arm; however, a 
subject may request to be re-programmed with a different amplitude setting.  If this occurs, a protocol 
deviation will be required and subjects should continue in the study and complete the remaining follow-
up visits.  

 
 
 
 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 32 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


 
  
 $VVHVVPHQWRI(IILFDF\
Subject assessments will be performed by appropriately trained, qualified and delegated site personnel 
according to the usual practices of the site. 
Urinary Voiding Diary 
Symptoms related to OAB will be evaluated using paper voiding diaries.  Subjects will be trained to 
complete the urinary voiding diaries for 3-days as part of the baseline and therapy evaluation 
procedures.  The voiding diaries will be completed at baseline, therapy evaluation and prior to the 6 and 
12-week follow-up visits. Every effort should be made to remind subjects of the importance of real-time 
diary completion. 
Voiding diary data will be used to verify study inclusion criteria for UUI episodes at baseline.  Diaries will 
also be used for comparison of efficacy from 12-week follow-up visit to baseline for the primary study 
endpoint of UUI 
  
Assessments for Quality of Life Measures 
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.   Questionnaires should be 
completed prior to the follow-up visit when data is collected. Site personnel are encouraged to review 
forms for completeness. 
ICIQ-OABqol Questionnaire  
The ICIQ-OABqol is a robust, patient-completed questionnaire for evaluating quality of life (QoL) in 
patients with overactive bladder, for use in research and clinical practice.9  The questionnaire used in the 
current study includes 26 questions which are 4-week recall for symptom assessment.  
 
 
 
 
 
 
 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 33 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


 $VVHVVPHQWRI6DIHW\
9.8.1 
Reportable Adverse Events and Device Deficiencies 
All reportable adverse events and device deficiencies will be collected throughout the study once the 
informed consent form is signed.  
 5HFRUGLQJ'DWD
This study will be conducted using a remote data capture system.  The Oracle Clinical Remote Data 
Capture (RDC) system which allows the study centers to enter study data into the sponsor’s database 
over a secure internet connection, will be used to capture study required Case Report Form (CRF) 
information.  Data reported on voiding diaries and subject questionnaires will be entered to 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 CRFs by the site personnel, in 
accordance with applicable regulations.   
Device interrogation (programming) data may be transmitted using either NPU or by manual data entry 
on a programming CRF.   
Subject voiding diaries and questionnaires are to be completed only by the subject.  Representatives 
from the research site may not make entries to the diaries or questionnaires except for administrative 
clarification on source documentation.  
The Principal Investigator, Sub-Investigator, or an individual delegated by the Principal Investigator on 
the Delegation of Authority and Signature Form, are responsible for documenting and entering data for 
the study on the eCRFs.  The Principal Investigator or Sub-Investigator is required to approve all data on 
CRFs via electronic signature. 
'HYLDWLRQ+DQGOLQJ
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.  Protocol deviations are to be preapproved by Medtronic study personnel and the IRB/EC (as 
required) unless the deviation is necessary to protect the health, safety, or welfare of a subject in an 
emergency situation.  The investigator or delegated site personnel should contact the designated 
Medtronic study personnel to discuss the impact of the potential deviation; prior approval of deviations 
should be documented.  Prior approval is generally not required if the deviation is due to an emergency 
circumstance or an unforeseen circumstance that is beyond the investigator’s control; however, these 
deviations should be reported to Medtronic and the IRB/EC (as required) after site personnel become 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 34 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


aware of the deviation.  Site personnel should work with subjects to ensure subject follow-up visits are 
scheduled within the visit window; however, any visits completed outside of the visit window will 
require a protocol deviation to be reported.  All protocol deviations must be reported on the Protocol 
Deviation eCRF after the site’s awareness of the deviation.    
The sponsor may choose to terminate the study at a site for failure to follow the written protocol and 
investigator agreement.  If this occurs, the Investigator, IRB/EC and governing regulatory authority (if 
applicable) will be notified in writing of the reasons for the termination. 
6XEMHFW:LWKGUDZDORU'LVFRQWLQXDWLRQ
Subjects are free to voluntarily withdraw from the study at any time and for any reason.   All implanted 
subjects will be followed until the 12-week 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: 
x
If the subject does not meet eligibility criteria of at least 3 UUI episodes demonstrated on a 3-
day baseline urinary voiding diary  
x
Subject death 
x
Subject lost to follow-up 
x
Subject voluntarily withdraws from the study 
x
Subject becomes pregnant 
x
Investigator terminates the subject’s participation in the study due to lack of compliance, 
violation of/change in eligibility criteria 
x
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. 
x
Subject is not a candidate for InterStim Therapy  
x
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.  

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 35 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


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.  
 5LVNVDQG%HQHILWV
3RWHQWLDO5LVNV
The risks outlined below are the same risks found in commercial InterStim II System use; however, 
based on the amplitude settings, subjects may experience less than desired improvements in OAB 
symptoms.  No additional study specific risks are present. 

5LVNV2XWOLQHGLQWKH,QVWUXFWLRQVIRU8VH,)8
Refer to the appropriate Instructions for Use (IFU) for the InterStim System components for updated list 
on contraindications, precautions, warnings, adverse events, directions for use and other product 
specific details. 
In addition to the risks normally associated with surgery, implantation, or use of a neurostimulation 
system includes, but is not limited to, the following risks. Certain adverse events may necessitate 
surgical intervention. 
ͻĚǀĞƌƐĞĐŚĂŶŐĞŝŶǀŽŝĚŝŶŐĨƵŶĐƚŝŽŶ;ďŽǁĞůĂŶĚͬŽƌ bladder) 
ͻůůĞƌŐŝĐŽƌŝŵŵƵŶĞƐǇƐƚĞŵƌĞƐƉŽŶƐĞƚŽƚŚĞŝŵƉůĂŶƚĞĚŵĂƚĞƌŝĂůƐƚŚĂƚĐŽƵůĚƌĞƐƵůƚŝŶ 
device rejections 
ͻŚĂŶŐĞŝŶƐĞŶƐĂƚŝŽŶŽĨƐƚŝŵƵůĂƚŝŽŶǁŚŝĐŚŚĂƐďĞĞŶĚĞƐĐƌŝďĞĚĂƐƵŶĐŽŵĨŽƌƚĂďůĞ;ũŽůƚŝŶŐ 
or shocking) by some patients 
ͻ/ŶĨĞĐƚŝŽŶ 
ͻEĞǁƉĂŝŶ 
ͻPain at neurostimulator and or lead site 
ͻ^ĞƌŽŵĂ͕ŚĞŵŽƌƌŚĂŐĞ͕ŚĞŵĂƚŽŵĂ 
ͻ^ƵƐƉĞĐƚĞĚůĞĂĚŽƌŶĞƵƌŽƐƚŝŵƵůĂƚŽƌŵŝŐƌĂƚŝŽŶŽƌĞƌŽƐŝŽŶ 
ͻ^ƵƐƉĞĐƚĞĚŶĞƌǀĞŝŶũƵƌǇ 
ͻ^ƵƐƉĞĐƚĞĚƚĞĐŚŶŝĐĂůĚĞǀŝĐĞƉƌŽďůĞŵ 
ͻdƌĂŶƐŝĞŶƚĞůĞĐƚƌŝĐƐŚŽĐŬ 
 
The safety of SNM has not been established for pregnant women, for an unborn fetus, or during 
childbirth. This precaution is provided in the InterStim Therapy commercial labeling and should be 
adopted in this study; thus, no one who is pregnant or planning to become pregnant will be enrolled. 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 36 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


If a subject learns or suspects that she is pregnant, the investigator will instruct her to turn her 
neurostimulator OFF and to visit the study site as soon as possible; however, this will not be considered 
a reportable AE.  
3RWHQWLDO%HQHILWV
Subjects may not receive any direct medical benefit from participation in this study but subjects will 
receive additional medical oversight of treatment.  Participation in this study may not provide greater 
benefit than if the subject was receiving InterStim Therapy outside of the study, as required study 
programming is within approved programming specifications.  Information from this study might help 
researchers further understand InterStim Therapy related to uncomfortable stimulation.  The benefit to 
subjects participating in this study, and to future patients, resides in the knowledge gained from this 
study. 
5LVN%HQHILW5DWLRQDOH
Participation in this study will not expose the subject to greater risks than if he/she were receiving 
InterStim Therapy outside of the study. There might be other discomforts and risks related to InterStim 
Therapy and/or this study that are not foreseen at this time.  In addition, based on the amplitude 
settings, subjects may experience less than desired improvements in OAB symptoms. 
The risks associated with InterStim II System are minimized in this study by selecting only qualified 
Investigators experienced in InterStim Therapy, 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. 
 $GYHUVH(YHQWVDQG'HYLFH'HILFLHQFLHV
'HILQLWLRQV&ODVVLILFDWLRQV
Any adverse event meeting the definition of: serious, device related, therapy related and/or procedure 
related as well as all device deficiencies will be considered reportable for this study.   The term 
“investigational device” is part of ISO14155 definitions.  The term “investigational device” refers to any 
device used in the study including market released devices.  Adverse events and device deficiencies are 
defined as follows: 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 41 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


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 IRB/EC as necessary.  All reported adverse events and device deficiencies will be 
reviewed by a Medtronic Medical Advisor to ensure consistent reporting 

'HYLFH'HILFLHQFLHV
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: 
Ь if either suitable action had not been taken, 
Ь if intervention had not been made, or 
Ь if circumstances had been less fortunate 

'HDWKV
All subject deaths must be reported to Medtronic and the IRB/EC as soon as possible, but no more than 
5 working days after learning of a subject’s death, regardless of whether or not the death is related to 
the device system or therapy. If limited information is known, the Adverse Event eCRF must be 
completed with available information as soon as possible. As information becomes available, the eCRF 
will be updated. If the death occurs at a location remote from the study site, it is the study site’s 
responsibility to make every attempt to retrieve all pertinent information related to the subject’s death 
and submit the investigator’s death summary of the known events surrounding the death to Medtronic 
or its designee.  The Investigator should also attempt to determine, as conclusively as possible, whether 
such deaths are related to the device system, therapy, and/or procedure. If the death is evaluated as 
device, therapy and/or procedure related and unanticipated, the event will be reported as a USADE by 
Medtronic or its designee to the appropriate regulatory agencies.  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: 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 42 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


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. 
 'DWD5HYLHZ&RPPLWWHHV
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. 
 6WDWLVWLFDO'HVLJQDQG0HWKRGV
*HQHUDO6WDWLVWLFDO&RQVLGHUDWLRQV
This study is a three-arm parallel design to explore effectiveness, and quality of life under three 
amplitude settings. For the primary objective, the primary analysis will be performed in the complete 
case (CC) population, or the population of subjects who have data available at baseline and follow-up 
based on their randomization. 
 
Details of the primary and supporting analyses are outlined in the 
sections below.  
Continuous measures will be reported as N, means, medians, standard deviations, minimums and 
maximums. All summaries will be provided by group.  Categorical measures will be reported in 
frequency distributions.  
Data analysis will be performed by Medtronic-employed statisticians or designees. A validated statistical 
software package (e.g., SAS version 9.2 or higher) will be used to analyze the study results.  
The Statistical Analysis Plan (SAP) will be developed prior to data analysis and will include a 
comprehensive description of the statistical methods and reports 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.    

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 43 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH



6WXG\6DPSOH6L]H-XVWLILFDWLRQ
This study will explore the effect of three different amplitude settings (50% of sensory threshold, 80% of 
sensory threshold, and sensory threshold) on UUI episodes per day. Change of average UUI per day at 
12-week follow-up will be assessed under each amplitude setting. This study requires approximately 42 
implanted and randomized subjects with 12-week follow-up data to be analyzed for the primary 
objective. Assuming 10% attrition after full system implant and 80% therapy evaluation success rate, 
approximately 48 subjects will be implanted and randomized in 3 arms.  However, these numbers may 
be exceeded to ensure that a minimum of 42 subjects complete the study. 
The objectives are descriptive in nature.   Confidence intervals will be calculated to describe the 
precision of the treatment effect in each arm. Precision is defined as one-half of the confidence interval 
(also known as the distance from the confidence limits to the mean). Sample size calculations were 
completed using the PASS 11 Confidence Intervals for One Mean module.  
From the randomized portion of the InSite study13, a mean reduction of 2.1±1.8 UUI episodes per day 
was observed at 3 months in SNM subjects; and from the all implanted cohort of InSite, a mean 
reduction of 2.3±2.7 UUI episodes per day was observed at 3 months in SNM subjects.  Based on this, we 
are assuming mean reductions between 1.8 and 2.3 will be observed in the study, along with standard 
deviations ranging from 2.2 to 2.7. 
Based on a confidence interval constructed with a t-statistic, a two-sided type-I error rate of 0.05, and 
using the largest standard deviation assumed (2.7), a sample size of 14 subjects per arm will have a 
precision of 1.56 (Table 13-1). This precision is less than our lowest assumed treatment effect (1.8 UUI), 
so that it is expected that the lower 95% CI will be greater than 0 for all treatment arms, even in the 
scenario when the largest assumed standard deviation is applied. 
Table 13-1. Standard deviations and precision 
Standard 
deviation 
Precision 
2.2 
1.27 
2.3 
1.33 
2.4 
1.39 
2.5 
1.44 
2.6 
1.5 
2.7 
1.56 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 44 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH



'HVFULSWLRQRIGHPRJUDSKLFDQGEDVHOLQHYDULDEOHV
Summary statistics will be provided, by group, for baseline and demographic variables for subjects who 
are enrolled and randomized.  

&HQWHU3RROLQJ
Data from all study centers will be pooled for the analysis. There are no planned statistical methods to 
test for treatment differences among centers. The study will be conducted at approximately 20 centers 
in the United States, Canada and Europe.   

0LVVLQJ'DWD
Missing data imputations will not be performed.  

,QWHULP$QDO\VLV
No formal interim analysis is planned for this study.  Interim descriptive summaries may be performed; 
however, if provided, the study team, investigators and site personnel will be blinded to this 
information. No study decisions will be made from descriptive summaries; therefore, no sample size 
adjustment is needed. 

5HSRUWV
A final report will be generated for this study.  Periodic progress reports may also be generated for the 
study.  

6WXG\6XFFHVV
As the study objective is to characterize the efficacy and QoL of 3 different amplitude settings, there is 
no pass/fail criteria proposed to define study success.  

6XEJURXS$QDO\VHV
Subgroup analyses will be detailed in the SAP, if any will be conducted. 

3DWLHQW3RSXODWLRQV
The full analysis patient set (FAS) includes all subjects who signed the study-specific ICF and enrolled in 
the study.  
The complete case (CC) patient set will consist of the subject set who have data available at baseline and 
follow-up.  

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 45 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


 3ULPDU\2EMHFWLYH

3ULPDU\REMHFWLYH
To explore the effect of three different amplitude settings (50% of sensory threshold, 80% of sensory 
threshold, and sensory threshold) on urinary urge incontinence (UUI) episodes per day.  
Descriptive statistics for change in UUI from baseline to 12 weeks will be provided in each randomized 
group.  
Negative values for a change from baseline represent an improvement in UUI episodes and positive 
values represent an increase in UUI episodes.  

([SHULPHQWDOGHVLJQ
Subjects’ number of UUI episodes will be reported in the voiding diary. Data will be collected daily in the 
3 days prior to each visit for all subjects and the value reported at each visit will be calculated as the 
daily average of the available diary days at that visit. All available data will be used for analysis, 
regardless of whether 1 day is available or 3 days are available.  The change in scores from Baseline to 
12 weeks will be calculated for each subject and the average change across all subjects in each group 
will be reported.  
(QGSRLQWVXFFHVVGHILQLWLRQ
This objective is to explore and characterize the reduction in number of UUI episodes under each 
amplitude setting from baseline.  There are no pass/fail criteria proposed to define this endpoint 
success. 
$QDO\VLVPHWKRGV
Descriptive statistics including mean, standard deviation, 95% confidence intervals, median, minimum 
and maximum will be provided.  
$QDO\VLVSRSXODWLRQVDQGVHQVLWLYLW\DQDO\VHV
The analysis population for this objective will be on the CC population, as described in Section 13.1.9.   
In addition to the primary analysis, an as-treated (AT) sensitivity analysis will be completed to assess the 
robustness of results. The AT analysis will include the population of subjects who have data available at 
baseline and 12 weeks, but will analyze subjects according to the treatment they receive.  
In addition to the summaries described above, responder rate analyses will be conducted to further 
describe the treatment effect of each randomization group. Responder rates will be described as the 
percent of patients who achieve therapeutic success, defined as ı 50% reduction in average UUI 
episodes/day from baseline to 12 weeks, divided by the number of subjects included in the analysis. 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 46 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


Responder rate analyses will be completed based on the CC and AT analyses described above.  
6HFRQGDU\2EMHFWLYH
6HFRQGDU\REMHFWLYH
To explore the effect of three different amplitude settings (50% of sensory threshold, 80% of sensory 
threshold, and sensory threshold) on quality of life with the ICIQ-OABqol Questionnaire.  
Descriptive statistics for the change in all domains of this questionnaire from baseline to 12 weeks will 
be provided in each randomized group. 
([SHULPHQWDOGHVLJQ
The change in each subscale score from Baseline to 12 weeks will be calculated for each subject and the 
average change across all subjects in each group will be reported.  
(QGSRLQWVXFFHVVGHILQLWLRQ
This objective is to explore and characterize the QoL under each amplitude setting from baseline to 12 
weeks. There are no pass/fail criteria proposed to define this endpoint success. 
$QDO\VLVPHWKRGV
Descriptive statistics including mean, standard deviation, 95% confidence intervals, median, minimum 
and maximum will be provided.  
$QDO\VLVSRSXODWLRQVDQGVHQVLWLYLW\DQDO\VHV
The analysis population for this objective will be on the CC population, as described in Section 13.1.9.   
In addition to the primary analysis of the secondary objective, an as-treated (AT) sensitivity analysis will 
be completed to assess the robustness of results. The AT analysis will include the population of subjects 
who have data available at baseline and 12 weeks, but will analyze subjects according to the treatment 
they receive. 
 $GGLWLRQDO 0HDVXUHV
Additional measures have been added to provide relevant information on parameters of interest in SNM 
therapy under different amplitude settings and to provide additional information.  
 
 
 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 47 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


Additional measures to summarize are:  
x Incidence of device-related, procedure-related and/or therapy-related adverse events 

 

 
Reportable device-related, procedure-related and/or therapy-related adverse events will be 
summarized for subjects who are implanted and randomized under each amplitude setting. Device-
deficiencies will be summarized in the similar fashion. In addition, serious adverse events will be 
summarized. 
 
  
 
 
 
  
 
 (WKLFV
6WDWHPHQWVRI&RPSOLDQFH
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, study training, and risk benefit assessment.  In addition, all applicable 
laws and regulatory requirements of the country/ies in which the study is conducted will be followed 
and in accordance with GCP.    

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 48 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


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, and 
21CFR§803 Medical Device Reporting.   Financial disclosures will be collected; however, this 
study is not considered a “covered study” under 21 CFR§54 Financial Disclosure by Clinical 
Investigators. 
x In Europe, the study will be conducted in accordance with 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.  
Any additional requirements imposed by the IRB/EC or governing regulatory authority shall be followed, 
if appropriate. 
 
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.  Medtronic will 
not activate any site until the required approval/favorable opinion from the Institutional Review Board 
(IRB)/Ethics Committee (EC) or notification/approval from a regulatory authority have been obtained, if 
appropriate. 
 
Site personnel must inform Medtronic of any change in status of the IRB/EC approval once the site has 
started enrollment. 
3ULQFLSDO,QYHVWLJDWRU2YHUVLJKW
The Principal Investigator will provide adequate oversight to ensure the study is conducted in 
accordance with all protocol requirements, all applicable regulatory requirements and any applicable 
institutional requirements related to the conduct of clinical research. The Principal Investigator will 
ensure no study-related activities occur prior to regulatory and IRB/EC approval.  Any actions taken by 
the IRB/EC with respect to the investigation will be forwarded to Medtronic as soon as possible.  The 
Principal Investigator is responsible for submitting all required reports to the sponsor and/or IRB/EC.  
Regulatory reporting of AEs/DDs will be completed according to local regulatory requirements. It is the 
responsibility of the Investigator to abide by any additional AE/DD reporting requirements stipulated by 
the IRB/EC responsible for oversight of the study. Investigators should report serious adverse events, 
device-, procedure- and therapy-related adverse events and device deficiencies to Medtronic after the 
Investigator learns of the event in accordance with Table 14-1.  

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 49 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


In addition, Principal Investigator, or designated personnel will provide Medtronic with the following 
minimum information related to serious adverse events, device-, procedure- and/or therapy-related 
adverse events and device deficiencies: 
x Date of adverse event or device deficiency 
x Treatment provided 
x Resolution date 
x Assessment of seriousness 
x Relationship to the device, therapy and/or procedure 
Failure to perform the investigator obligations or to complete corrective and preventive actions 
identified during monitoring or auditing activities may result in Principal Investigator or site personnel 
disqualification, and/or lead to suspension or termination of the study at the site. 
Table 14-1 includes minimum reporting requirements for investigators participating in studies in Europe, 
the US and Canada.  Medtronic study personnel will immediately report Adverse Events and Device 
Deficiencies, related to a CE marked or FDA approved device used during the study, to Medtronic’s 
Compliant Handling Unit who will ensure prompt review and appropriate reporting.   The Therapeutic 
Products Directorate is a division of Heath Canada, and is responsible for regulating therapeutic 
products including Food, Drugs, Medical Devices, Natural Health Products, Cells, Tissues and Organs and 
Cosmetics.  Table 14-1 includes minimum reporting requirements in Canada.  
  
Table 14-1 5HSRUWLQJ5HTXLUHPHQWV 
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 
IRB/EC 
All geographies: Reporting timeframe as per local EC/IRB per local 
requirement 
Sponsor submit to:  
EC/IRB 
All geographies: Reporting timeframe as per local EC/IRB per local 
requirement 
Regulatory Authorities 
All geographies: Reporting timeframe as per local requirement 
Serious Adverse Device Effects (SADEs), Unanticipated Serious Device Effects (USADEs) and 
Unanticipated Adverse Device Effects (UADEs) 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 50 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


Investigator submit to: 
Medtronic 
US: As soon as possible to meet regulatory reporting requirements, but no 
later than 10 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: Submit as soon as possible after the Investigator first 
learns of the event, and per local requirements 
IRB/EC 
Reporting timeframe as per local EC/IRB requirement 
Sponsor submit to:  
EC/IRB 
All geographies: Reporting timeframe as per local EC/IRB per local 
requirement 
Regulatory Authorities
Canada (Medtronic of Canada Regulatory Compliance) to submit to Health
Canada: As soon as possible to meet regulatory reporting requirements 
within 10 days after the date Medtronic becomes aware 
 
All other geographies: Reporting timeframe as per local requirement 
All Other Adverse Events 
Investigator submit to: 
Medtronic 
All geographies: Submit in a timely manner after the Investigator first 
learns of the event 
IRB/EC 
All geographies: Reporting timeframe as per local EC/IRB requirement 
Deaths 
Investigator submit to: 
Medtronic 
All geographies: All subject deaths must be reported to Medtronic and the 
IRB/EC as soon as possible, but no more than 5 working days of learning of 
a subject’s death, regardless of whether or not the death is related to the 
device system or therapy 
IRB/EC 
All geographies: All subject deaths must be reported to Medtronic and the 
IRB/EC as soon as possible, but no more than 5 working days of learning of 
a subject’s death, regardless of whether or not the death is related to the 
device system or therapy 
USADE, SADE, DD (Canada only) 
(referred to here as “incidents”) occurring outside Canada requiring corrective action or imposed by 
local regulatory authorities 
Sponsor submit to: 
Regulatory Authorities 
Canada (Medtronic of Canada Regulatory Compliance) to submit report to 
Health Canada: 
 
When Medtronic has indicated to a regulatory authority of the country in 
which the incident occurred, intention to take corrective action, or if the 
regulatory authority has required Medtronic to take corrective action. In 
this case, the incident must be reported to the Health Canada as soon as 
possible after either Medtronic has reported to the local regulatory 
authority or a corrective action has been imposed by the local regulatory

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 51 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


authority. 
Device Deficiencies that has resulted in an SAE (Canada only) 
Sponsor submit to: 
Regulatory Authorities 
Canada (Medtronic of Canada Regulatory Compliance) to submit report to 
Health Canada: As soon as possible to meet regulatory reporting 
requirements within 10 days after the date Medtronic becomes aware 
Device Deficiencies (DD) with SADE potentials 
Investigator submit to: 
Medtronic 
US & Europe: Immediately after the investigator first learns of the 
deficiency or of new information in relation with an already reported 
deficiency 
 
All geographies: Report to the sponsor, without unjustified delay, all device 
deficiencies that could have led to a serious adverse device effect 
IRB/EC 
All geographies: Reporting timeframe as per local EC requirement 
Sponsor submit to:  
EC/IRB 
All geographies: Reporting timeframe as per local EC/IRB requirement 
Regulatory Authorities 
Canada (Medtronic of Canada Regulatory Compliance) submits to Health
Canada: As soon as possible to meet regulatory reporting requirements 
within 30 days after the date Medtronic becomes aware 
 
All other geographies: Reporting timeframe as per local requirement 
All other Device Deficiencies 
Investigator submit to: 
Medtronic 
All geographies: Submit in a timely manner after the investigator first 
learns of the deficiency 
IRB/EC 
All geographies: Reporting timeframe as per local EC requirement 
Withdrawal of IRB Approval 
Investigator submit to: 
 
Medtronic 
All geographies: Report a withdrawal of the reviewing EC/IRB approval 
within 
5 days of investigator notification 
Protocol Deviations for Emergency Reasons 
Investigator submit to: 
 
Medtronic 
US: Submit to Medtronic and IRB within 5 working days of the occurrence 
of an emergency deviation (made to protect the life or physical well-being 
of a subject) 
 
Canada: Per institutional guidelines, report protocol deviations to 
Medtronic 
EC/IRB 
US: Submit to Medtronic and IRB within 5 working days of the occurrence 
of an emergency deviation (made to protect the life or physical well-being 
of a subject) 
 
Canada: Per institutional guidelines, report protocol deviations to the 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 52 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


reviewing IRB 
Prior Notification of Protocol Deviations 
Medtronic 
All geographies:
Except in the occurrence of an emergency deviation, the Investigator must 
obtain prior approval from Medtronic of protocol deviations. Prior approval 
from the IRB may also be required according to local requirements. 
EC/IRB 
All geographies:
Except in the occurrence of an emergency deviation, the Investigator must 
obtain prior approval from Medtronic of protocol deviations. Prior approval 
from the IRB may also be required according to local 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 
EC/IRB 
US and Europe: The Investigator must notify the EC/IRB within 5 working 
days after upon awareness 
 
Canada: The Investigator must notify the EC/IRB within 5 working 
days after SURFHGXUH 
Final Report 
Medtronic 
US and Europe: Study reports must be submitted within 6 months after 
termination or completion of the investigation or as required by applicable 
regulation 
 
Canada: Study reports must be submitted within 3 months after 
termination or completion of the investigation or as required by applicable 
regulation  
EC/IRB 
US and Europe: Study reports must be submitted within 6 months after 
termination or completion of the investigation or as required by applicable 
regulation 
 
Canada: Study reports must be submitted within 3 months after 
termination or completion of the investigation or as required by applicable 
regulation 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 53 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


 6WXG\$GPLQLVWUDWLRQ
 6SRQVRU
This study is sponsored by: 
Medtronic, Inc.  
7000 Central Avenue NE 
Minneapolis, MN 55432  
USA 
A list of sponsor’s study staff will be provided as a separate document to site personnel.  Sponsor will 
maintain an updated list of contact information.  
6LWH6HOHFWLRQ
The role of the principal investigator is to implement and manage the day-to-day conduct of the study as 
well as ensure data integrity and the rights, safety and well-being of the patients involved in the study.  
Site selection criteria will be documented and utilized to ensure adequate site selection.   
&OLQLFDO7ULDO$JUHHPHQW
A Clinical Trial Agreement shall be in place, signed by the participating investigation site and/or principal 
investigator of each investigation site, as per the local legal requirements, and returned to Medtronic 
prior to the commencement of any study activities. The investigator is indicating approval of the Clinical 
Investigation Plan and subsequent amendments, by a fully executed agreement.  
&XUULFXOXP9LWDH
A curriculum vitae from each Investigator participating in the study shall be obtained.  
0RQLWRULQJ
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.  The Principal Investigator, his/her delegate(s) and the study coordinator(s) shall be accessible to 
Medtronic field personnel and the Clinical Study Manager. The Principal Investigator and site personnel 
will provide the Medtronic monitor(s) with complete access to primary source data or certified copies 
(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 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 54 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


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. 
0HGWURQLF5HSUHVHQWDWLYH5ROH
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: 
x
Observing testing or medical procedures to provide information relevant to protocol completion 
x
Reviewing collected data and study documentation for completeness and accuracy 
x
Perform device programming or device interrogation under the direction of the investigator(s) 
Medtronic personnel will not: 
x
Practice medicine 
x
Provide medical diagnosis or treatment to subjects 
x
Discuss a subject’s condition or treatment with a subject without the approval and presence of 
the health care provider. 
x
Complete CRFs or make entries in the subject’s medical record 
'DWD0DQDJHPHQW
Medtronic personnel will perform routine edit and consistency checks for items such as missing data or 
inconsistent data.  Identified data inconsistencies will be resolved by use of data discrepancies; 
investigators and site personnel will review data discrepancies and respond to the discrepancies in a 
timely manner.  The resolved discrepancy will become a part of the eCRF record for the subject. 
The Oracle Clinical Remote Data Capture (RDC) system which is 21CFR§11 Part E compliant controls user 
access, and ensures data integrity. This system is a fully validated system. The RDC system maintains an 
audit trail of entries, changes or corrections in eCRFs. User access will be granted to each individual 
based on his or her delegation of authority and completion of required training. If a person only 
authorized to complete eCRFs makes changes to an already signed eCRF, the system will require the 
Principal Investigator, or authorized delegate, to re-sign the eCRF. 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 55 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


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.  
'LUHFW$FFHVVWR6RXUFH'DWD'RFXPHQWV
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 originaldocuments and records include, but are not limited to: hospital/clinic records, phone 
records, laboratory reports, etc.   Site personnel should clearly indicate the subjects’ participate in the 
study within the medical records.  
Principal Investigator and Institution must permit study-related monitoring, audits, IRB/EC review and 
regulatory inspections(s) by providing direct access to source data/documents.  Medtronic or third-party 
auditors representing Medtronic may perform clinical site audits to verify the performance of the 
monitoring process and study conduct, and to ensure compliance with applicable regulations.  
Representatives for regulatory bodies such as the FDA 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. 
&RQILGHQWLDOLW\
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, 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.  

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 56 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


 /LDELOLW\
 6WXG\)XQGLQJ
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. 
 ,QVXUDQFH
Medtronic of Canada, Ltd., Medtronic International Trading SARL, and Medtronic Logistics LLC are 
wholly owned subsidiaries of Medtronic, which as the parent company of such entities maintains 
appropriate clinical study liability insurance coverage as required under applicable laws and regulations 
and will comply with applicable law and custom concerning specific insurance coverage. If required, a 
Clinical Trial Insurance statement/certificate will be provided to the EC, governing regulatory authority 
(if applicable) and/or the IRB.  
 :DUUDQW\
Warranty information is provided in the product packaging for commercially available products. 
 ,QGHPQLILFDWLRQ
Indemnification language will be contained in the Clinical Trial Agreements. 
 &,3$PHQGPHQWV
Protocol amendments may be initiated by Medtronic to address changes to the conduct of the study.  
Protocol amendments must be approved by Medtronic and submitted to the IRB/EC and governing 
regulatory authority (if applicable); protocol amendment approval and approval of any associated 
changes to the informed consent document must be obtained prior to implementation of the 
amendment except: 
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 
 5HFRUG5HWHQWLRQ
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 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 57 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


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: 
R
Signed and dated ICFs 
R
Medical records, including, for example, progress notes of the physicians, the 
subject’s hospital chart(s) and the nurses notes 
R
All reportable adverse event information 
R
Data related to the SNM therapy session  
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 longer if required per local 
regulations.  Medtronic will be notified in writing of any transfer of study documentation.   
 3XEOLFDWLRQDQG8VHRI,QIRUPDWLRQ
This feasibility study will provide an initial understanding of various amplitude stimulation settings and 
impact on symptoms.  The study will be registered on clinicaltrials.gov and the results of the study may 
be published.  
 6XVSHQVLRQRU(DUO\7HUPLQDWLRQ
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
Product performance/product supply issues  
Medtronic reserves the right to suspend or terminate the study at an individual site.  Reasons may 
include, but are not limited to, the following: 
x
Noncompliance with the protocol  
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 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 58 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


Investigators are required to notify the IRB/EC and governing regulatory authority (if applicable) of study 
suspension/termination.  Subjects will be notified by the investigator of suspension/termination due to 
unacceptable risk or of termination due to any other cause. 

,QWHU6WLP$PSOLWXGH&OLQLFDO,QYHVWLJDWLRQ3ODQ

 
MDT17030 
Version 2.0 
Page 59 of 61 
0HGWURQLF&RQILGHQWLDO

)Y&OLQLFDO,QYHVWLJDWLRQ3ODQ7HPSODWH


 5HIHUHQFHV
1.   Siegel SW, Catanzaro F, Dijkema HE, Elhilali MM, Fowler CJ, Gajewski JB, Hassouna MM, Jonas U, 
van Kerrebroeck PE, Lycklama a Nijeholt AA, Oleson KA, Schmidt RA. Long-term results of a 
multicenter study on sacral nerve stimulation for treatment of urinary urge incontinence, 
urgency-frequency, and retention. Urology 56: 87-91. 2000.  
2.   Noblett K, Benson K, and Kreder K. Detailed analysis of adverse events and surgical Interventions 
in a large prospective trial of sacral neuromodulation therapy for Overactive bladder patients. 
Neurourology Urodynamics 36:1136-1139. 2017. 
3.   Duelund-Jakobsen J, Buntzen S, Lundby, Laurberg S. Sacral nerve stimulation at subsensory 
threshold does not compromise treatment efficacy: results from a randomized, blinded 
crossover study. Ann Surg 257: 219-223. 2013. 
4.   Gleason JL, Kenton K, Greer WJ, Ramm O, Szychowski JM, Wilson T, Richter HE.  Sacral 
neuromodulation effects on periurethral sensation and urethral sphincter activity. Neurourology 
Urodynamics. 32(5):476-9. 2013. 
5.   hůƵĚĂŒK͕<ŽĐŚ^D͕sůŝĞŐĞŶZ&͕ĞũŽŶŐ,͕ǀĂŶ'ĞŵĞƌƚt'͕ĂĞƚĞŶ'͘Sacral 
neuromodulation: does it affect the rectoanal angle in patients with fecal incontinence? World J 
Surg. 34(5):1109-14. 2010. 
6.   Su X, Nickles A, Nelson DE. Optimization of Neuromodulation for Bladder Control in a Rat Cystitis 
Model. Am J Physiol Renal Physiol 302: F477-486. 2012a. 
7.   Snellings AE and Grill WM. Effects of stimulation site and stimulation parameters on bladder 
inhibition by electrical nerve stimulation. BJU Int 110: 136-143. 2012. 
8.   Gill B, Pizarro-Berdichevsky J, Bhattacharyya P, Brink TS, Marks B, Quirouet A, Vasavada, S, Jones 
SE and Goldman HB.  Real-time changes in brain activity during sacral neuromodulation for 
overactive bladder.  J Urol, In Review. 2017. 
9.   Coyne, K., Revicki, D., Hunt, T., Corey, R., Stewart, W., Bentkover, J., Kurth, H., Abrams, P. 
Psychometric validation of an overactive bladder symptom and health-related quality of life 
questionnaire: the OAB-q. Qual.Life.Res. 2002; 11(6); 563-574. 
10.Vecchioli-Scaldazza C, Morosetti C, Berouz A, Giannubilo W, Ferrara V. Solifenacin succinate 
versus percutaneous tibial nerve stimulation in women with overactive bladder syndrome: 
Results of a randomized controlled crossover study. Gynecologic and Obstetric Investigation 
2013; 75(4):230-234.