PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation (PTNM) System in Patients With OAB
Phase: NA
Conditions: Overactive Bladder
Sponsor: MedtronicNeuro

RESET Study 
PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial 
Neuromodulation System in Patients With OAB  
Clinical Investigational Plan Version 1.0 
03-Jun-2016 
NCT02857816 

Confidential 
Version 1.0 
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June 2, 2016 
 
 
 
Clinical Investigation Plan 
Clinical Investigation Plan/Study Title  PRospective Study to Evaluate EffectivenesS with 
the NURO™ PErcutaneous Tibial Neuromodulation 
System in Patients with OAB (RESET) 
Clinical Investigation Plan Identifier 1679 
Study Product Name NURO System 
Sponsor Medtronic, Inc.  
7000 Central Avenue NE 
Minneapolis, MN 55432 USA 
Document Version Version 1.0 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of Medtronic. Any 
distribution, copying, or disclosure without the prior written authorization of Medtronic is strictly 
prohibited. Persons to whom the information is disclosed must know that it is confidential and that it may 
not be further disclosed by them. 
 
 

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1. Version History 
Version 
Summary of Changes 
Author(s)/Title 
1.0 
• 
Not Applicable, New Document 
Elizabeth Michaud, Sr. Principal 
Clinical Research Specialist  
2. Investigator Statement 
Participating investigators will be provided with a separate investigator agreement to document their 
obligations and commitment with respect to study conduct. 
 
 

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Table of Contents  
 
1. 
Version History ................................................................................................................ 2 
2. 
Investigator Statement ................................................................................................... 2 
Table of Contents ...................................................................................................................... 3 
3. 
Glossary ........................................................................................................................... 5 
4. 
Synopsis ........................................................................................................................... 6 
5. 
Introduction .................................................................................................................. 10 
5.1. 
Background ............................................................................................................. 10 
5.2. 
Purpose ................................................................................................................... 11 
6. 
Objectives and Endpoints .............................................................................................. 11 
6.1. 
Objectives ............................................................................................................... 11 
6.1.1. 
Primary Objective(s)...................................................................................................... 11 
6.1.2. 
Secondary Objective ..................................................................................................... 11 
6.2. 
Endpoints ................................................................................................................ 12 
6.2.1. 
Primary Endpoint .......................................................................................................... 12 
6.2.2. 
Secondary Endpoints ..................................................................................................... 12 
6.2.3. 
Additional Measures ...................................................................................................... 12 
7. 
Study Design .................................................................................................................. 12 
7.1. 
Duration .................................................................................................................. 13 
7.2. 
Rationale ................................................................................................................. 13 
8. 
Product Description ....................................................................................................... 13 
8.1. 
General .................................................................................................................... 13 
8.2. 
Manufacturer ........................................................................................................... 13 
8.3. 
Intended Population ............................................................................................... 13 
8.4. 
Product Return ........................................................................................................ 13 
8.5. 
Product Accountability ............................................................................................ 14 
9. 
Selection of Subjects ..................................................................................................... 14 
9.1. 
Study Population ..................................................................................................... 14 
9.2. 
Subject Enrollment .................................................................................................. 14 
9.3. 
Inclusion Criteria .................................................................................................... 14 
9.4. 
Exclusion Criteria .................................................................................................... 14 
10. 
Study Procedures........................................................................................................... 15 
10.1. 
Schedule of Events .................................................................................................. 16 
10.2. 
Subject Screening ................................................................................................... 19 
10.3. 
Prior and Concomitant Medications ........................................................................ 19 
10.4. 
Subject Consent ...................................................................................................... 19 
10.5. 
Medication Compliance ........................................................................................... 19 
10.6. 
Assessment of Efficacy ............................................................................................ 20 
10.7. 
Assessment of Safety .............................................................................................. 21 
10.8. 
Recording Data........................................................................................................ 21 
10.9. 
Deviation Handling .................................................................................................. 22 
10.10. 
Subject Withdrawal or Discontinuation ............................................................... 22 

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11. 
Risks and Benefits ......................................................................................................... 23 
11.1. 
Potential Risks ........................................................................................................ 23 
11.1.1. 
Health Risks .............................................................................................................. 23 
11.1.2. 
NURO System Warnings ............................................................................................. 23 
11.1.3. 
NURO System Contraindications ................................................................................. 25 
11.1.4. 
NURO System Precautions .......................................................................................... 25 
11.2. 
Potential Benefits .................................................................................................... 26 
11.3. 
Risk-Benefit Rationale ............................................................................................ 26 
12. 
Adverse Event Assessments .......................................................................................... 26 
12.1. 
Definitions/Classifications ...................................................................................... 26 
12.2. 
Reporting of Adverse Events ................................................................................... 28 
13. 
Data Review Committees .............................................................................................. 29 
14. 
Statistical Design and Methods ..................................................................................... 29 
14.1. 
General Statistical Considerations .......................................................................... 29 
14.1.1. 
Study Sample Size Justification ................................................................................... 29 
14.1.2. 
Description of Baseline variables ................................................................................. 30 
14.1.3. 
Center Pooling ........................................................................................................... 30 
14.1.4. 
Special Considerations ............................................................................................... 30 
14.1.5. 
Interim Analyses ........................................................................................................ 30 
14.1.6. 
Reports ..................................................................................................................... 30 
14.2. 
Demographics ......................................................................................................... 30 
14.3. 
Primary Objective ................................................................................................... 30 
14.4. 
Secondary Objectives .............................................................................................. 31 
14.4.1. 
Secondary Objective #1 ............................................................................................. 32 
14.4.2. 
Secondary Objective #2 ............................................................................................. 32 
14.5. 
Additional Measures ................................................................................................ 32 
15. 
Ethics ............................................................................................................................. 33 
15.1. 
Statement(s) of Compliance ................................................................................... 33 
16. 
Study Administration ..................................................................................................... 33 
16.1. 
Monitoring ............................................................................................................... 33 
16.2. 
Medtronic Representative Role ............................................................................... 33 
16.3. 
Data Management ................................................................................................... 34 
16.4. 
Direct Access to Source Data/Documents .............................................................. 34 
16.5. 
Confidentiality ......................................................................................................... 34 
16.6. 
CIP Amendments .................................................................................................... 35 
16.7. 
Record Retention .................................................................................................... 35 
16.8. 
Publication and Use of Information ........................................................................ 35 
16.9. 
Suspension or Early Termination ............................................................................ 36 
17. 
References ..................................................................................................................... 37 
18. 
Appendices .................................................................................................................... 39 
 
 
 

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3. Glossary 
Term 
Definition 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CIP 
Clinical Investigational Plan  
eCRF 
Electronic Case Report Form 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
IDE 
Investigational Device Exemption 
IRB 
Institutional Review Board 
LOCF 
Last Observation Carried Forward 
MESA 
Medical, Epidemiological, and Social Aspects of 
Aging 
OAB 
Overactive Bladder 
OABq 
Overactive Bladder Symptom Quality of Life 
Questionnaire 
PGI-I 
Patient Global Impression of Improvement 
PPBC 
Patient Perception of Bladder Condition 
PTNM 
Percutaneous Tibial Neuromodulation 
PTNS 
Percutaneous Tibial Nerve Stimulation 
QoL 
Quality of Life 
Oracle RDC 
Oracle Remote Data Capture 
Reportable Adverse Events 
Serious, device related, procedure related and all 
device deficiencies will be considered reportable for 
this study 
SAGA 
Self-Assessment Goal Achievement Questionnaire 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Events 
TENS 
Transcutaneous Electrical Nerve Stimulation  
USADE 
Unanticipated Serious Adverse Device Effect 
UF 
Urgency Frequency 
UI 
Urinary Incontinence 
UUI 
Urge Urinary Incontinence 
UPS 
Urgency Perception Scale 
US 
United States 
UTI 
Urinary Tract Infection 
 
 

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4. Synopsis 
Title 
PRospective Study to Evaluate EffectivenesS with the NURO™ 
PErcutaneous Tibial Neuromodulation System in Patients with OAB 
(RESET) 
Clinical Study Type 
Post-market, on-label 
Product Name 
Commercially available External Neuromodulation system              
(“NURO System”, model number 3533) 
Sponsor  
Medtronic, Inc. 
Indication under 
investigation  
The NURO External Neuromodulation system is intended to treat 
patients with Overactive Bladder (OAB) and associated symptoms of 
urinary urgency, urinary frequency, and urge incontinence.  There are 
no investigational devices used in this study, all study products will be 
used in accordance with the product labeling. 
Investigation Purpose 
To evaluate the NURO system for the treatment of OAB in drug naïve 
patients. 
Product Status 
The NURO system is commercially released for the treatment of patients 
with OAB and associated symptoms of urinary urgency, urinary 
frequency, and urge incontinence. 
Sample Size 
Up to 120 subjects consented and qualified to participate in the study. 
Primary Objective 
To demonstrate a statistically significant reduction, from baseline 
through 12 percutaneous tibial neuromodulation (PTNM) therapy 
sessions, in the number of urge urinary incontinence (UUI) episodes per 
day 
Secondary Objectives 
• 
Reduction from baseline through 12 PTNM therapy sessions in 
number of voids per day 
• 
Change from baseline through 12 PTNM therapy sessions in patient 
reported quality of life outcomes as measured by the Overactive 
Bladder Symptom Quality of Life Questionnaire (OABq) 
 
 

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Additional Measures 
• 
Incidence of device or therapy-related adverse events 
• 
Nocturia / Nighttime voiding frequency  
• 
Urgency including the Urgency Perception Scale (UPS) 
• 
Patient-reported Outcomes: 
o 
Self-Assessment Goal Achievement Questionnaire (SAGA) 
o 
Patient Perception of Bladder Condition (PPBC) 
o Patient Global Impression of Improvement (PGI-I) 
Study Design 
Prospective, multicenter, single arm study to evaluate changes from 
baseline in OAB symptoms as measured by voiding diaries and patient 
reported outcomes through 12 PTNM therapy sessions.  Safety will be 
evaluated by the collection of reportable adverse events and device 
deficiencies. 
Subjects will be enrolled that have symptoms of OAB and no prior 
treatment with anticholinergics/antimuscarinics or beta 3-agonists 
medications to treat OAB. 
Each subject will complete: an enrollment/baseline visit, 12 therapy 
sessions (each approximately 1 week apart), and a final study visit. 
Inclusion/Exclusion 
Criteria 
Inclusion Criteria: 
1. 18 years of age or older 
2. Diagnosis of OAB with associated symptoms of UUI and qualify 
with at least 3 episodes of mild, moderate, or severe urgency 
demonstrated on a 3-day voiding diary   
3. Experiencing UUI symptoms for at least 3 months  
4. No prior treatment with anticholinergics/antimuscarinics or beta 
3-agonists medications to treat OAB 
5. Willing and able to accurately complete voiding diaries and 
questionnaires, attend visits, and comply with the study protocol  
6. Willing and able to provide signed and dated informed consent   
Exclusion Criteria:  
1. Have received anticholinergics/antimuscarinics or beta 3-
agonists medications to treat OAB or advanced therapy 
treatment options for OAB (botulinum toxin injections, sacral 
neuromodulation, or percutaneous tibial nerve 

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stimulation/neuromodulation) 
2. Have primary stress incontinence or mixed incontinence where 
the stress component overrides the urge component [see 
enrollment/baseline requirements for use of the Medical, 
Epidemiological, and Social Aspects of Aging urinary 
incontinence questionnaire (MESA) questionnaire]  
3. Have implantable pacemakers or implantable defibrillators 
4. Use of transcutaneous electrical nerve stimulation (TENS) in 
pelvic region, back or legs 
5. Women who are pregnant or planning to become pregnant 
during the course of the study (women of child-bearing potential 
must undergo a pregnancy test, with a clear negative result, 
prior to first PTNM session)  
6. Characteristics indicating a poor understanding of the study or 
characteristics that indicate the subject may have poor 
compliance with the study protocol 
7. Nerve damage that could impact either tibial nerve or 
pelvic floor function 
8. Subjects prone to excessive bleeding 
9. Inadequate skin integrity in the area of PTNM needle 
placement 
10. History of diabetes unless the diabetes is well-controlled 
through diet and/or medications 
11. Have symptomatic urinary tract infection (UTI) 
12. Participation in any research study involving or impacting 
gynecologic, urinary or renal function within the 4-week period 
prior to or plans to participate during study enrollment 
Study Procedures and 
Assessments 
Each subject will complete an enrollment/baseline visit, 12 PTNM 
therapy sessions (each approximately 1 week apart), and a final study 
visit for a total of 14 study-related visits.   
Enrollment/Baseline  
Subjects are considered enrolled at the time the study-specific informed 
consent form is signed.  Each subject must meet all of the inclusion and 
no exclusion criteria to be eligible to participate in this study.   At the 
enrollment/baseline visit, data will be gathered from subjects including 

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relevant medical history.  The MESA urinary incontinence questionnaire 
will be used to exclude predominant stress incontinence.  If the 
Investigator’s assessment differs from the results of the MESA 
questionnaire, rationale must be documented to explain the decision to 
enroll the subject.   
Subjects will complete the following required questionnaires: OABq, 
UPS, PPBC, and SAGA at the enrollment/baseline visit.  The 3-day 
urinary baseline voiding diary, pregnancy test (if of childbearing 
potential) must be completed prior to the initial therapy session.   For 
subjects who have dual incontinence (defined as bladder and fecal 
incontinence), a 7-day fecal incontinence diary will be recommended at 
baseline in addition to the 3-day urinary voiding diary.  
Weekly PTNM Therapy Session Visits (PTNM Sessions #1-#12) 
At the weekly follow-up visits, OAB medication(s) and adverse events 
will be collected from the subject.  Following completion of all visit-
specific data collection, subjects will then complete a NURO therapy 
session in accordance with the NURO System Instructions for Use.  
Approximately one day after PTNM therapy sessions #1, #4, #8 and 
#12, subjects will start their 3-day urinary voiding diary.  OABq, UPS, 
and PPBC questionnaires will be completed prior to starting PTNM 
therapy sessions #2, #5 and #9.  Questionnaires must be completed 
prior to the therapy session.   Following completion of all visit-specific 
data collection, subjects will then complete a NURO therapy session.   
Final Study Visit  
At the final study visit, the subject’s 3-day urinary voiding diary will be 
collected.   For subjects who have dual incontinence, a 7-day fecal 
incontinence diary will be recommended in addition to the 3-day urinary 
voiding diary.  Any OAB medication(s) and adverse events will be 
collected from the subject. Subjects will complete the required 
questionnaires associated with the OABq, UPS, PPBC, SAGA and PGI-I.   
Subjects will then be exited from study.    
Safety Assessments 
Safety will be evaluated by the collection of reportable adverse events. 
Statistics 
The sample size estimate is based on a one-sample t-test, with α=0.05 
two-sided, 90% power and an estimated standard deviation of 2.2 UUI 
episodes/day. If the mean reduction in number of UUI episodes is 
expected to be .75 per day after 12 PTNM therapy sessions compared to 
baseline, a sample size of 93 subjects would be required to demonstrate 

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a statistically significant reduction from baseline. To account for subject 
attrition over the period of the study, additional subjects will be enrolled 
for a sample size of up to 120 consented and qualified subjects. 
5. Introduction  
This prospective, open-label clinical study using the NURO System will be conducted in approximately 120 
subjects with UUI, and will include approximately 15 study sites in the United States (US).  The expected 
study commitment for each subject is approximately 14 weeks, including the baseline and final study 
visits.  The study will be conducted in accordance with this protocol, the ethical principles that have their 
origin in the Declaration of Helsinki, all applicable regulatory requirements (21 Code of Federal 
Regulations [CRF] §50 Protection of Human Subjects, and 21CFR§56 Institutional Review Board [IRB] 
and 21CFR§803 Medical Device Reporting), and in accordance with Good Clinical Practice (GCP).  This 
study will be posted on ClinicalTrials.gov as part of Medtronic’s commitment to full disclosure for ongoing 
studies that meet the requirements for public posting. 
Documentation for this study will be produced and maintained to ensure that a complete history of the 
study exists.  Documents created for this study, including all versions and translations of original 
documents, will be identifiable and appropriately stored to assure control and traceability of data related 
to this study.   
5.1. 
Background  
The American Urological Association Guidelines for the diagnosis and treatment of OAB in adults provides 
a clinical framework for the diagnosis and treatment of non-neurogenic OAB. The guidance lists Percuta-
neous Tibial Nerve Stimulation (PTNS), otherwise known as Percutaneous Tibial Neuromodulation 
(PTNM), as an acceptable treatment in a carefully selected patient characterized by moderately severe 
baseline incontinence and frequency and willingness to comply with the PTNM protocol.1 
The most common therapy protocol is the application of 30 minutes of stimulation once per week for 12 
weeks based on early work done by Govier et al. 2 and thus 12 weekly treatment sessions is the duration 
of the majority of published studies.  
The safety of PTNM has been reported extensively in the literature.2-8  These studies range in size from 
35 patients6 to 110 patients7 receiving active treatment over a 12 week period.  The reported treatment-
related adverse events were described as generally mild and transient (such as discomfort at the needle 
site, minor bleeding, bruising, cramping); none needing surgical intervention to resolve.  Published 
randomized controlled trials have been conducted comparing PTNM to sham6,7 or PTNM to 
pharmacological treatment.4,5,8 Overall, PTNM improved key objective efficacy outcomes of incontinent 
episodes and voiding frequency4-8 along with patient’s quality of life compared to baseline.5-8  PTNM was 
observed to be superior to sham regardless of the endpoint definition (objective or subjective)6,7; 
however, no statistically-significant differences were observed between PTNM and medication in terms of 

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voiding symptom improvement and Quality of Life (QOL).5 One study indicated a greater degree of 
efficacy in PTNM compared to medications.8 
Multiple systematic reviews have been published on the performance of PTNS for OAB9-13, and conclude 
that PTNM is safe and effective for treating OAB.  Additionally, PTNM appears in medical treatment 
guidelines in the United States1 and Internationally.14,15  Since the the NURO device delivers identical 
stimulation therapy as the PTNS device evaluated in the literature, a user can expect similar performance 
as that reported in the clinical literature. 
Published literature has primarily focused on OAB drug refractory populations; however, in a study by 
Preyer et al. (2015), 36 treatment naïve subjects were randomized between PTNM and pharmacological 
treatment.16   In this patient population, PTNM reduced incontinence episodes and improved QOL in 
patients with OAB  to a similar degree to those patients receiving pharmacological treatment.  This study 
provided an initial example of how drug naïve patients may respond to PTNM therapy, however additional 
clinical work is needed to characterize drug naïve patients and better understand their treatment 
response to PTNM. 
5.2. 
Purpose 
The purpose of this prospective, multicenter, single arm study is to evaluate the NURO system for the 
treatment of OAB in drug naïve patients.  The study will assess change from baseline through 12 PTNM 
therapy sessions in UUI episodes, voiding episodes, and patient reported outcomes.  Safety will be 
evaluated by the collection of reportable adverse events.  The study is expected to last approximately 14 
weeks per subject following the enrollment visit.  Subjects will be exited from the study after the final 
study visit is complete. 
6. Objectives and Endpoints 
6.1. 
Objectives 
6.1.1. 
Primary Objective(s) 
The primary objective of this study is to assess the efficacy of PTNM on UUI episodes in drug naïve 
patients with OAB. 
6.1.2. 
Secondary Objective 
Secondary objectives of this study are to assess the improvement on number of voids per day and QOL 
measures in drug naïve patients with OAB. 

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6.2. 
Endpoints 
6.2.1. 
Primary Endpoint 
The primary objective of this study is to demonstrate a statistically significant reduction from baseline 
through 12 PTNM therapy sessions in the number of UUI episodes per day. 
6.2.2. 
Secondary Endpoints 
Secondary objectives include: 
• 
Reduction from baseline through 12 PTNM therapy sessions in number of voids per day 
• 
Change from baseline through 12 PTNM therapy sessions in quality of life as measured by the 
Overactive Bladder Symptom Quality of Life Questionnaire (OABq) 
6.2.3. 
Additional Measures 
Additional measures include: 
• 
Incidence of device or therapy-related adverse events 
• 
Nocturia / Nighttime voiding frequency  
• 
Urgency including the Urgency Perception Scale (UPS) 
• 
Patient-reported Outcomes: 
 
Self-Assessment Goal Achievement Questionnaire (SAGA) 
 
Patient Perception of Bladder Condition (PPBC) 
 
Patient Global Impression of Improvement (PGI-I) 
7. Study Design  
This is a prospective, multicenter, open-label study evaluating the use of PTNM in OAB drug naïve 
patients with UUI.  
All eligible subjects will sign a study-specific informed consent form (ICF).  Following qualification using a 
baseline diary, subjects will undergo 12 PTNM therapy sessions, administered weekly,  utilizing the NURO 
system.  Urinary voiding diaries (3-day) to assess efficacy measures and quality of life questionnaires will 
be completed after therapy sessions as required in Figure 1-1: Study Procedures.  The study is expected 
to last approximately 14 weeks per subject following the baseline/enrollment visit.  Subjects will be exited 
from the study after the final study visit is complete.  
The required sample size is 120 consented and qualified subjects; which includes 93 subjects required to 
meet the study endpoint and approximately 20% to account for potential attrition.  
The study will be conducted at approximately 15 sites in the US.  Initial site enrollment is not planned to 
exceed 20% of the total number of subjects enrolled to reduce the possibility that a site with atypical 
results will be overly influential in the overall study results based on pooled data; however this may be 
increased based on the Sponsor’s discretion.   

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This is an on-label, post-market study of an FDA-cleared device that is exempt from Investigational 
Device Exemption (IDE) requirements under 21 CFR 812(c)(2).  All subjects enrolled in the study will 
qualify under the approved indication for the NURO system.  
7.1. 
Duration 
Study subjects will be enrolled and will complete enrollment/baseline requirements to determine 
eligibility.  Subjects that do not qualify for the study prior to the first PTNM therapy session will be exited 
from the study.  All enrolled subjects that qualify for the study (meet all inclusion and no exclusion) will 
receive 12 PTNM therapy sessions, each approximately 1 week apart, prior to completing the final study 
visit.  The visits are expected to occur over a 14 week period.  
7.2. 
Rationale  
While there is extensive literature on the safety and efficacy of PTNM, the majority of published literature 
is on OAB drug refractory patients.  The purpose of this study is to understand the effect of PTNM in a 
OAB drug naïve patient population.  The NURO system is cleared by the Food and Drug Administration 
(FDA) and will be used in accordance with commercially available product labeling.  
8. Product Description 
8.1. 
General 
The NURO system includes: the NURO External Neurostimulator (model 3533), Therapy Sessions (model 
3533S), and single-use Therapy Session Kits (model 3533K) which are provided separately.  The Therapy 
Session Kit includes: two sterile needles, two alcohol wipes, a needle holder, and ground pad. The NURO 
device is a small and portable pulse generator, and should only be used with the single-use items listed 
above. The system also includes a wall charger and USB cable.  Sites will need to ensure technical 
compatibility with the NURO e-commerce site in order to activate the device and download and transfer 
therapy sessions to the NURO External Neurostimulator.  
8.2. 
Manufacturer 
The products used in this study, identified in Section 8.1, are manufactured by Medtronic, Inc. and are 
approved for use in treating patients with OAB.  
8.3. 
Intended Population 
The study will enroll OAB drug naïve patients with a diagnosis of OAB and associated symptoms of UUI 
(see Section 9). 
8.4. 
Product Return 
Since all products are commercially available, product associated with a complaint should be returned 
through commercial processes.  Contact your study team member for return instructions.  

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8.5. 
Product Accountability 
All product used in the study are commercially available; therefore no product accountability will be 
required for the study.  
9. Selection of Subjects 
9.1. 
Study Population 
The intended study population is subjects with UUI who have not tried an OAB medication.  In addition, 
subjects must not have received advanced therapy treatment options for OAB (botulinum toxin injections, 
sacral neuromodulation or PTNS/PTNM).  
9.2. 
Subject Enrollment 
Subjects are considered enrolled at the time the study-specific ICF is signed.  Each subject must meet all 
of the inclusion criteria and no exclusion criteria to be eligible to participate in this study.  Any subject 
meeting an exclusion criterion will be excluded from study participation. 
9.3. 
Inclusion Criteria  
In order to be eligible to participate in the study, a subject must meet all of the following inclusion 
criteria:  
1. 18 years of age or older 
2. Diagnosis of OAB and associated symptoms of UUI and qualify with at least 3 episodes of 
mild, moderate, or severe urgency demonstrated on a 3-day urinary voiding diary  
3. Experiencing UUI symptoms for at least 3 months  
4. No prior treatment with anticholinergics/antimuscarinics or beta 3-agonists medications 
to treat OAB 
5. Willing and able to accurately complete voiding diaries and questionnaires, attend visits, 
and comply with the study protocol  
6. Willing and able to provide signed and dated informed consent 
9.4. 
Exclusion Criteria 
A potential subject who meets any of the following criteria will be excluded from participating in the 
study: 
1. Have received anticholinergics/antimuscarinics or beta 3-agonists medications to treat 
OAB or advanced therapy treatment options for OAB (botulinum toxin injections, sacral 
neuromodulation, or percutaneous tibial nerve stimulation/neuromodulation) 
2. Primary stress incontinence or mixed incontinence where the stress component overrides 
the urge component (see enrollment/baseline requirements for use of the MESA urinary 
incontinence questionnaire) 
3. Have implantable pacemakers or implantable defibrillators 

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4. Use of transcutaneous electrical nerve stimulation (TENS) in pelvic region, back or legs 
5. Women who are pregnant or planning to become pregnant during the course of the 
study (women of child-bearing potential must undergo a pregnancy test, with a clear 
negative result, prior to first PTNM session)  
6. Characteristics indicating a poor understanding of the study or characteristics that 
indicate the subject may have poor compliance with the study protocol 
7. Nerve damage that could impact either tibial nerve or pelvic floor function. 
8. Subjects prone to excessive bleeding 
9. Inadequate skin integrity in the area of PTNM needle placement  
10. History of diabetes unless the diabetes is well-controlled through diet and/or medications 
11. Have symptomatic urinary tract infection (UTI) 
12. Participation in any research study involving or impacting gynecologic, urinary or renal 
function within the 4-week period prior to or plans to participate during study enrollment 
10. Study Procedures  
The study schedule, procedures, and methods of assessment are defined in detail to enable compliance 
with the required activities, and to ensure that the resulting data meet the criteria for evaluability.  See 
Table 1-1 for visit requirements.  Both paper and electronic case report form (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. 
Enrollment/Baseline 
Subjects are considered enrolled at the time the study-specific ICF is signed.  Each subject must meet all 
of the inclusion criteria and no exclusion criteria to be eligible to continue participation in this study.    
As part of the inclusion/exclusion evaluation, the MESA urinary incontinence questionnaire will be used to 
exclude predominant stress incontinence.  If the Investigator’s assessment differs from the results of the 
MESA questionnaire, rationale must be documented to explain the decision to enroll the subject.  
Additionally, prior and ongoing conservative therapies for OAB such as physical therapy, pelvic floor 
muscle training, behavior modification, and dietary programs and relevant medical history will be 
assessed at baseline tracked throughout the duration of the study.  Subjects will be encouraged to 
continue any conservative therapies for OAB they were on at entry through the duration of the study. 
Subjects will complete the following required questionnaires: OABq, UPS, PPBC, and SAGA at the 
enrollment/baseline visit.  The 3-day baseline urinary voiding diary and pregnancy test (women of child-
bearing potential must undergo a pregnancy test, with a clear negative result) must be completed prior 
to the initial therapy session.  For subjects who have dual incontinence, an additional 7-day fecal 
incontinence diary will be recommended at baseline.   
The baseline urinary voiding diary is to be completed and returned to confirm remaining eligibility criteria.  
If the subject does not meet eligibility criteria of at least 3 UUI episodes demonstrated on a 3-day voiding 
diary, the subject must be exited from the study. 
 

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Initial PTNM Therapy Session (PTNM Session #1) 
The baseline urinary voiding diary must be reviewed to confirm eligibility prior to beginning the initial 
PTNM therapy session.  If the subject does not meet eligibility criteria of at least 3 UUI episodes 
demonstrated on a 3-day voiding diary, the subject must be exited from the study.  Any OAB 
medication(s), conservative therapies for OAB and reportable adverse events will be collected from the 
subject.   
If the subject meets the eligibility criteria of at least 3 UUI episodes of mild, moderate, or severe urgency 
demonstrated on a 3-day voiding diary, the subject will then complete a PTNM therapy session using the 
NURO device.  The PTNM therapy sessions will be completed in accordance with the NURO System 
Instructions for Use.  
Weekly PTNM Therapy Sessions: PTNM Sessions #2-#12  (1 Week ± 3 days) 
At the weekly follow-up visits,  any OAB medication(s), conservative therapies for OAB and reportable 
adverse events will be collected from the subject.  Subjects will then complete a PTNM therapy session 
with the NURO device used in accordance with the NURO system Instructions for Use.  
Three-day voiding diaries will be provided to the subjects to be started approximately one day after 
PTNM Session #1, PTNM Session #4, PTNM Session #8, and PTNM Session #12.  
At PTNM Session #2, PTNM Session #5 and PTNM Session #9, and the final visit subjects will return their 
completed 3-day urinary voiding diary and complete OABq, UPS and PPBC questionnaires.  Subjects are 
required to complete the questionnaires prior to the PTNM therapy session. Subjects will then complete a 
PTNM therapy session with the NURO device used in accordance with the NURO system Instructions for 
Use. 
After PTNM Session #12, a 3-day urinary voiding diary will be provided for the subject to start 
approximately one day after the therapy session.  Subjects who have dual incontinence that completed 7-
day fecal incontinence diary at baseline be provided with a final 7-day fecal incontinence diary. 
Final Study Visit (1 Week ± 3 days) 
At the final study visit, the completed final 3-day urinary voiding diary, 7-day fecal incontinence diary (if 
applicable), any OAB medication(s), conservative therapies for OAB and reportable adverse events will be 
collected from the subject. Subjects will complete the following required questionnaires: OABq, UPS, 
PPBC, PGI-I, and SAGA. Following collection of all study-related data, the subject will be exited from the 
study.  
10.1. Schedule of Events 
The start of the study is defined as the date the  subject first signs the informed consent.  The 
completion of the study for each subject is defined as the completion of the final study visit. Subjects that 
do not qualify for the study prior to the first PTNM therapy session will be exited from the study.  The 
completion of the study is defined as the completion of the Final Study Report and closure of all sites.   
 
 

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Qualification
Eligible to 
Participate
Study Discontinuation
If subject does not meet 
all inclusion and no 
exclusion criteria
Enrollment 
Signed Consent
Final Study Visit
Baseline
  Verification of Inclusion/Exclusion Criteria 
  Medical History     Pregnancy Test
 Collect 3-day Voiding Diary  MESA Questionnaire
 Collect 7-day Fecal Incontinence Diary (for dual incontinence)
  Assessment of Conservative OAB Therapy
Questionnaires:
 OABq          UPS      PPBC        SAGA
  Collect 3-day Voiding Diary
Questionnaires Completed Prior to PTNM 
Therapy Session:
 OABq          UPS     PPBC       
  AE Assessment
  OAB Medication Assessment
  Assessment of Conservative OAB Therapy
 Collect 3-day Voiding Diary
 Collect 7-day Fecal Incontinence Diary 
 (for dual incontinence)
Questionnaires:
 OABq       UPS    PPBC
 SAGA     PGI-I
 AE Assessment
 OAB Medication Assessment
 Assessment of Conservative OAB Therapy
  
PTNM Therapy Sessions #1 - #12
Note: Voiding diaries should be 
provided to subjects at PTNM 
sessions 1, 4, 8 and 12 for completion 
1 day after the visit.
Yes
No
PTNM Therapy          
Sessions #2, #5, #9


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A detailed table of the study procedures, presenting the type of procedure required at each visit, is presented in Table 1-1. 
Table 1-1: Study Procedures  
Procedures 
 Enrollment/ 
Baseline Visit 
 
PTNM 
Session 
#1 
PTNM 
Session 
#2 
PTNM 
Session 
#3 
PTNM 
Session 
#4 
PTNM 
Session 
#5 
PTNM 
Session 
#6 
PTNM 
Session 
#7 
PTNM 
Session 
#8 
PTNM 
Session 
#9 
PTNM 
Session 
#10 
PTNM 
Session 
#11 
PTNM 
Session 
#12 
Final 
Study Visit 
Informed Consent Form 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy Test* 
  X* 
 
 
 
 
 
 
 
 
 
 
 
 
 
Reportable Medical History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Distribute Urinary Voiding 
Diary 
X 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
 
Distribute Fecal 
Incontinence Diary** 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Collect Urinary Voiding 
Diary  
 
   X*** 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
Collect Fecal Incontinence 
Diary ** 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
OABq Questionnaire 
X 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
UPS Questionnaire 
X 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
PPBC Questionnaire 
X 
 
X 
 
 
X 
 
 
 
X 
 
 
 
X 
PGI-I Questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
SAGA Questionnaire 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Conservative Therapies for 
OAB 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
AE Review 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
OAB Medication Review 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
*For women of child bearing potential to be completed prior to the first PTNM therapy session  
**Fecal incontinence  Diary (7-day) is recommended for subjects with dual incontinence 
***Qualification diary must be reviewed to confirm eligibility prior to beginning first PTNM therapy session 
 
 
 

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10.2. Subject Screening  
Subjects may be recruited through the investigator’s practice and referring physicians. 
Potential subjects may be identified through chart reviews or as new or existing patients attend clinic 
visits.  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 prior to use.  
Recruited subjects will be screened by the Principal Investigator or authorized site personnel by reviewing 
the study’s inclusion and exclusion criteria.  All subjects must be consented in accordance with the 
protocol prior to any study-specific procedures. 
As part of the inclusion/exclusion evaluation, the MESA urinary incontinence questionnaire will be used to 
exclude predominant stress incontinence.  If the Investigator’s assessment differs from the results of the 
MESA questionnaire, rationale must be documented to explain the decision to enroll the subject.  
10.3. Prior and Concomitant Medications 
Subjects may not be enrolled if they have had any prior treatment with anticholinergic/antimuscarinic or 
beta 3-agonist medications to treat OAB. 
10.4. Subject Consent 
The informed consent process will be performed in accordance with the ethical principles that have their 
origin in the Declaration of Helsinki and with 21CFR§50 Protection of Human Subjects. 
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.  Subjects will be 
given a copy of the IRB-approved ICF and will have 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 date the ICF.  Prior to 
participation in the study, the subject will receive a copy of the signed and dated written informed 
consent and any other written information provided to the subject. 
The Principal Investigator or qualified (delegated) designee will document the informed consent process, 
including the date of consent and name of the person conducting the consent process in the subject’s 
medical record.  A copy of the signed ICF will also be placed in the subject’s medical record. 
10.5. Medication Compliance 
Subjects eligible to participate must be OAB drug naïve.   
If a subject starts an OAB medication prior to starting the PTNM therapy sessions, they should be 
considered ineligible for the study and should be exited. 

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If a subject starts anticholinergic/antimuscarinic or beta 3-agonist medications to treat OAB  following 
their first PTNM therapy session a deviation form will be completed and this medication will be captured 
on the OAB medication form. 
Medications used to treat reportable adverse events will be documented as “interventions” on the 
adverse event case report form.  
10.6. Assessment of Efficacy 
Subject assessments will be performed by appropriately trained, qualified and delegated site personnel 
according to the usual practices of the site. 
Medical History and Demographics 
Assessments will be completed and reported on the eCRF. 
Urinary Voiding Diary 
Symptoms related to OAB will be evaluated using paper voiding diaries.  Subjects will be trained to 
complete the urinary voiding diaries for 3-days as part of the baseline procedures and instructed to 
start the voiding diary approximately 1 day after PTNM Session #1, #4, #8 and #12.  These voiding 
diaries will then be collected at the next following PTNM Session. 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 to baseline for the primary study endpoint of UUI, secondary study 
endpoint of urgency frequency (UF) and additional measures related to urgency, nocturia and 
nighttime frequency. As clinically defined, nocturia will be measured as the number of times the 
subject is woken from sleep to void.17   Nighttime frequency will be defined as number of voids during 
nighttime sleep.17   
Fecal Incontinence Diary 
It is recommended that subjects with dual incontinence complete a 7-day fecal incontinence diary 
during baseline procedures and after 12 PTNM therapy sessions. 
PTNM Therapy Sessions 
Subjects will receive 12 weekly PTNM therapy sessions following the enrollment/baseline visit.   
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 initiation of the PTNM therapy session. Site personnel are encouraged to review 
forms for completeness. 
Overactive Bladder Quality of Life Questionnaire (OABq)  
The Overactive Bladder Quality of Life Questionnaire (OABq) is a 33-item questionnaire that was 
developed to assess symptom bother and the impact of overactive bladder (OAB) on health-related 

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quality of life (HRQL).18  The questionnaire used in the current study includes a 1-week recall for 
symptom assessment.  
Urgency Perception Scale (UPS) 
The Urgency Perception Scale (UPS) is a single item questionnaire measure of perceived urinary 
urgency with three response options.19,20   
Self-Assessment Goal Achievement Questionnaire (SAGA) 
Patient attainment goals have been used throughout the literature in order to determine if patients 
are reaching pre-determined goals.21,22  The Self-Assessment Goal Achievement (SAGA) 
questionnaire is a tool designed to help patients with lower urinary tract symptoms assess goal 
achievement.23  The SAGA questionnaire allows for the patient to rank, in order of importance for 
standard urology symptom goals using a scale of 0-5 and allows for other personal goals to be 
included.  After treatment has been completed, the patient then completes the follow-up 
assessment which includes a scale of -2 to 2 to report on achievement of each symptom goal and 
personal goal(s).   The questionnaire includes an assessment question of “Overall, to what extent 
have you achieved your goals” on a scale of 0-4.  
Patient Perception of Bladder Condition (PPBC)  
The Patient Perception of Bladder Condition (PPBC) is a single-item, 6-point scale that asks patients 
to rate their subjective impression of their current bladder problems.24,25   
Patient Global Impression of Improvement (PGI-I) 
Overall impression for improvement is evaluated using the Patient Global Impression of 
Improvement (PGI-I)26-28  which is a single question asking the patient to rate their urinary 
condition now as compared with prior to beginning treatment on a scale from 1 (very much better) 
to 7 (very much worse). 
10.7. Assessment of Safety 
Subjects will be assessed for potential reportable adverse events that are reportable under the study 
protocol at each study visit. 
10.8. Recording Data 
This study will be conducted using a remote data capture system.  The Oracle Clinical Remote Data 
Capture (RDC) system which allows the study centers to enter study data into the sponsor’s database 
over a secure internet connection, will be used to capture study required Case Report Form (CRF) 
information.  Paper CRFs will be utilized for voiding diaries and subject questionnaires only; however data 
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 

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taken from source documents and directly entered into the study database via the CRFs by the site 
personnel, in accordance with applicable regulations. 
Subject voiding diaries and questionnaires are to be completed only by the subject.  Representatives from 
the research site may not make changes to the diaries or questionnaires with the exception of 
administrative entries and clarification on source documentation.  
The Principal or Sub-Investigator, or an individual delegated by the Principal Investigator on the 
Delegation of Authority and Signature Form, is 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. 
10.9. Deviation Handling 
Protocol deviations are digressions from the written protocol defined as an event where the clinical 
investigator or site personnel did not conduct protocol-required procedures according to the study 
protocol.  Protocol deviations are to be preapproved by Medtronic study personnel and the IRB (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 immediately 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 (as required) after site personnel 
become aware of the deviation.  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 and IRB will be notified in writing of the reasons 
for the termination. 
10.10. 
Subject Withdrawal or Discontinuation  
Subjects are free to voluntarily withdraw from the study at any time and for any reason.  The investigator 
can withdraw a subject from the study at any time and for any reason.  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: 
• 
If the subject does not meet eligibility criteria of at least 3 UUI episodes of mild, moderate, or 
severe urgency demonstrated on a 3-day urinary voiding diary  
• 
Subject death 
• 
Subject lost to follow-up 
• 
Subject voluntarily withdraws from the study 
• 
Subject becomes pregnant 
• 
Investigator terminates the subject’s participation in the study due to lack of compliance, 
violation of/change in eligibility criteria 

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• 
Any clinical laboratory abnormality, inter-current illness, or other medical condition or situation 
occurs such that continued study participation would not be in the best interest of the subject. 
• 
Subject is not a candidate for PTNM therapy  
• 
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 Discontinuation 
eCRF. 
When a subject is withdrawn from the study, the Study Discontinuation 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).  There is no further medical care provided under the study after a 
subject exits from the study. 
11. Risks and Benefits 
11.1. Potential Risks 
11.1.1. 
Health Risks 
The following are known potential health risks associated with the NURO system and PTNM therapy: 
• 
Discomfort and pain (including throbbing pain) at, or near, the stimulation site, including the 
patient's lower leg and foot 
• 
Bleeding at the needle site 
• 
Redness/inflammation at, or near, the stimulation site 
• 
Numbness of toes 
• 
Stomach ache 
11.1.2. 
NURO System Warnings 
To avoid risks to study subjects and system users, Investigators and site personnel should be aware of 
the following. 
1. The provided Instructions for Use is NOT a comprehensive reference to therapeutic techniques 
for the indications noted for the NURO system.  Section 11.1 will only be revised based on 
significant new safety information added to the Instructions for Use.  Refer to the current 
Instructions for Use for complete contraindications, warnings and precautions.  
2. Investigators and site personnel should be familiar with appropriate application and techniques 
involved in the use of the NURO system and needle in the delivery of Percutaneous Tibial 
Neuromodulation. 
3. Do not use the NURO system or needle if the skin in the area of use is inflamed, infected, or 
otherwise compromised. Monitor subjects during therapy session for pain or skin 
irritation/inflammation. Discontinue use of the NURO system if the subject complains about these 
symptoms or any other discomfort. 

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4. Do not use any part of the NURO system to apply stimulation across or through the head, directly 
on the eyes, covering the mouth, on the front of the neck (especially the carotid sinus), or on the 
chest, upper back or crossing over the heart. The application of the ground pad near the thorax 
may increase the risk of cardiac fibrillation. 
5. Subjects should not spend more than 30 minutes in therapy mode during a single therapy 
session. 
6. The subject should remain comfortably seated, or in a supine position, for the duration of the 
therapy session. The subject should not rise or walk until the therapy session is complete, 
because mobility during therapy session has not been assessed. 
7. Do not use the NURO system if any component or accessory is loose or damaged, including the 
rear electrode snap or internal battery. 
8. Do not use the NURO system if its packaging has been opened or altered. If packaging has been 
opened or altered, contact Medtronic. 
9. Do not reuse the single-use needle, needle holder, or ground pad. 
10. Dispose of used needle, needle holder, and ground pad accessories in bio-hazardous material 
disposal container. 
11. Simultaneous connection of a patient to high frequency surgical equipment may result in burns at 
the site of the ground pad and/or needle and possible damage to the NURO device. 
12. Device operation in close proximity (e.g. 1 meter) to short wave or microwave therapy equipment 
may produce instability in the NURO device output. 
13. The NURO device has electric shock protection, type “Internally Powered Equipment” per IEC 
60601-1. 
14. The NURO device enclosure is type IPX0 and does not protect against the ingress of water. Do 
not use the NURO device in or around water. 
15. For recharging, only use the wall charger provided with the NURO device. Use of a different 
charger could result in electrical shock or damage to the device. 
16. Do not operate the NURO device with anything plugged into the USB port. Do not insert the 
needle into the micro USB port. 
17. The following are known potential health risks associated with this type of device and therapy: 
discomfort and pain near needle site, bleeding near needle site, redness/inflammation near 
needle site, numbness in toes, and stomach ache. 
18. The NURO device has no serviceable parts. No modification is allowed. Opening the case could 
lead to electrical shock, device damage, or other risks. 
19. Do not exceed the recommended therapy session time of 30 minutes per session. 
20. Do not excessively bend or kink the device cable. Always inspect device cable for signs of wear or 
damage before use. If wear or damage is found, discontinue use and return the NURO device to 
Medtronic. 
21. No modification of this equipment is allowed. 
22. Use only the ground pad listed in the IFU. This pad is sized to not to exceed 2 mA/cm2 for the 
NURO device. 
 

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11.1.3. 
NURO System Contraindications 
In order for therapy to be effective and to avoid any possible problems or complications, the NURO 
system is contraindicated for use on patients who have the following history or conditions (see study 
exclusion criteria): 
1. Subjects prone to excessive bleeding  
2. Subjects with pacemakers or implantable defibrillators 
3. Subjects with nerve damage that could impact either percutaneous tibial nerve or pelvic floor 
function 
4. Subjects who are pregnant or planning to become pregnant while using this product 
5. The NURO system is not intended for intra-cardiac or trans-thoracic use. 
6. Concurrent use of medical monitoring equipment during stimulation is not recommended. 
7. The NURO system is not suitable for use in the presence of a flammable anesthetic mixture with 
air or with oxygen or nitrous oxide. 
11.1.4. 
NURO System Precautions 
• 
Prior to using the NURO system, read and understand all instructions. 
• 
Caution should be used for patients with suspected or diagnosed heart problems, especially those 
relating to the pacing or electrical functioning of the heart. 
• 
Medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) 
and needs to be installed and placed into service according to EMC guidelines provided. 
a. Portable and mobile radio frequency (RF) communications equipment can affect medical 
electrical equipment. 
b. Investigators and site personnel should assure the NURO system is used in an appropriate 
environment. 
i. Portable and mobile RF Communications equipment (i.e. cell phones) should not be 
used at close distances. 
ii. Power frequency magnetic fields should be at levels characteristic of a typical 
commercial, hospital or clinic environment. 
• 
Always start and restart stimulation at the lowest settings and adjust as necessary. Do not return to 
any previous setting without observing the patient’s responses. 
Reporting of adverse events and device deficiencies should follow the requirements outlined in the 
adverse event assessment section of the study protocol.  
There may be risks or side effects which are unknown at this time. 
If a subject becomes pregnant while using the NURO system, there may be risks to her or her unborn baby.  
These risks are currently unknown.  If the Investigators becomes aware that a subject is pregnant during 
the course of the study, the subject should be exited from the study.   
 

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11.2. Potential Benefits 
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 will not provide greater 
benefit than if the subject was receiving PTNM therapy with the NURO system outside of the study.  
Information from this study might help researchers further understand PTNM therapy.  The benefit to 
subjects participating in this study, and to future patients, resides in the knowledge gained from this 
study related to the safety and efficacy of this therapy when used in OAB drug naïve patients. 
11.3. Risk-Benefit Rationale 
Participation in this study will not expose the subject to greater risks than if he/she were receiving PTNM 
therapy with the NURO system outside of the study. There might be other discomforts and risks related 
to PTNM and/or this study that are not foreseen at this time. 
Subjects may find that some of the questionnaires or completing the urinary voiding and fecal diaries are 
embarrassing.  
12. Adverse Event Assessments 
12.1. Definitions/Classifications 
Any adverse event meeting the definition of: serious, device related, and/or procedure related as well as 
all device deficiencies will be considered reportable for this study.   Adverse events and device 
deficiencies are defined as follows: 
Term 
General  
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other 
persons, whether or not related to the medical device under investigation. 
Adverse Device 
Effect (ADE)* 
Adverse event related to the use of the medical device under investigation. 
Device Deficiency 
(DD)* 
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. 
 
Malfunctions: Failure of the medical device under investigation to perform 
in accordance with its intended purpose when used in accordance with 
the instructions for use or Clinical Investigational Plan (CIP) 
 
Use Error: Act or omission of an act that results in a different medical 
device response than intended by the manufacturer or expected by the 
user 

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SERIOUSNESS  
Serious Adverse 
Event (SAE)*   
An adverse event that 
a) led to a death, 
b) led to a serious deterioration in the health of the subject, that either 
resulted in: 
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function, or 
3. in-patient or prolonged hospitalization, or 
4. medical or surgical intervention to prevent life threatening illness or 
injury or permanent impairment to a body structure or a body 
function. 
c) led to fetal distress, foetal death or a congenital abnormality or birth 
defect. 
 
Note: A planned hospitalization for pre-existing condition, or a procedure required by the 
CIP, without a serious deterioration in health, is not considered to be a serious adverse 
event. 
Serious Adverse 
Device Effect 
(SADE)*    
Adverse device effect that resulted in any of the consequences characteristic of a 
serious adverse event 
Unexpected Serious 
Adverse Device 
Effect (USADE)* 
Serious adverse device effect which by its nature, incidence, severity or outcome 
has not been identified. 
RELATEDNESS 
Relationship of 
Adverse Events 
The relationship of the adverse event to the study treatment (device, therapy) 
will be described using the following terms: 
• 
Not related 
• 
Unlikely 
• 
Possible 
• 
Probable 
• 
Causal relationship 
*Reportable event categories that will be collected during this study 

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12.2. Reporting of Adverse Events 
Any adverse event meeting the definition of serious, device related, and/or procedure related as well as 
all device deficiencies as defined in above will be considered reportable for this study.  The procedure is 
defined as each PTNM therapy session.   
Worsening of OAB symptoms will be collected as part of the efficacy measures and are not considered a 
reportable adverse event.  
All reportable adverse events will be classified using the following responsibility matrix:  
Event Classification Responsibilities 
What is Classified 
Who Classifies 
Classification Parameters 
Relatedness 
Investigator 
Procedure related 
Device related 
Other 
USADE potential 
Medtronic 
USADE 
Seriousness 
Investigator 
SAE/SADE 
Diagnosis 
Investigator 
Based on presenting signs and symptoms and 
other supporting data 
Medtronic 
MedDRA term assigned based on the data 
provided by investigator 
 
All reportable adverse events must be recorded in the subject’s medical record and on the Adverse Event 
and/or Device Deficiency eCRF and promptly reported to Medtronic.  IRB reporting must be completed in 
accordance with the policies of the governing IRB.    
Reports of adverse events and device deficiencies will include the following information, at a minimum: 
• 
Date of event 
• 
Diagnosis or description of the event 
• 
Assessment of the seriousness and relationship to the product(s) under study 
• 
Treatment 
• 
Outcome and date or resolution 
It is the responsibility of the Investigator to identify the occurrence of reportable adverse events and 
device deficiencies and to ensure the required information is accurately documented on the eCRF.  
The clinical course of each adverse event must be followed until resolution or subject discontinuation 
from the study, whichever comes first.  “Ongoing” adverse events and device deficiencies must be 
assessed at each protocol required visit, and new or updated information must be documented on the 
Adverse Event and Device Deficiency eCRF and promptly reported to Medtronic and if applicable to the 
IRB.  
If necessary, the Investigator may report to the sponsor initially by telephone or email and follow-up with 
completed eCRFs and, if possible, copies of source documentation regarding the event (e.g., 
physician/nurse notes or summaries).    
Medtronic study personnel  will promptly review all reported adverse events and device deficiencies  and 
if necessary request clarification and/or additional information from the Investigator.  If Medtronic 

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disagrees with the Investigator’s assessment of the adverse event relationship to device and/or 
procedure, Medtronic study personnel will document the disagreement and report or ensure reporting of 
both opinions to IRB as necessary.  All reported adverse events and device deficiencies will be reviewed 
by a Medtronic Medical Monitor to ensure consistent reporting. 
13. Data Review Committees  
This study will not use a Clinical Events Committee or Data Monitoring Committee.  Instead, all reported 
adverse events  and device deficiencies will be reviewed by a Medtronic Medical Monitor to ensure 
consistent reporting. 
14. Statistical Design and Methods 
14.1. General Statistical Considerations 
14.1.1. 
Study Sample Size Justification 
This study is to evaluate the reduction from baseline in the number of UUI episodes per day after the 
12th PTNM therapy session.  The OrBIT trial by Peters et al (2009)5 compared the effectiveness of PTNS 
to extended-release tolterodine. This study reported an average reduction of UUI at 12 weeks compared 
to baseline in the PTNS arm was 1 episode per day with a standard deviation of 2.2.  The following 
assumptions were used for the sample size calculations: reduction of 0.75 UUI episodes/day from 
baseline, one-sample t-test with two-sided α=0.05, 90% power, and an estimated standard deviation of  
2.2 incontinence episodes/day.   Based on these assumptions, a sample size of 93 subjects would be 
required to demonstrate a statistically significant reduction from baseline. To account for an attrition of 
approximately 20% during the course of the study, a sample size of up to 120 subjects is required for 
this study. 
The sample size requirement of 93 for the primary objective is also adequate to assess the secondary 
objectives of number of voids per day and quality of life measured by OABq. In the OrBIT trial by Peters 
et al (2009)5, the average reduction of voids at 12 weeks compared to baseline in the PTNS arm was 2.4 
voids per day with a standard deviation of 4.0. Based on a one-sample t-test, with α=0.05 two-sided, 
90% power, 44 subjects with UF are required to demonstrate a statistically significant reduction from 
baseline if using a conservative estimate of a reduction of 2.0 voids per day with a standard deviation of 
4.0. In the InSite study, among all implanted subjects 63% of the urinary incontinence (UI) subjects had 
both UI and UF at baseline.29 Therefore, 93 subjects should ensure the sample size needed for the 
secondary objective of UF based on this assumption.    
In the OrBIT trial by Peters et al (2009)5, the average improvement from baseline of HRQL from OABq for 
PTNS  at 12 weeks was 25.3±21.5. Based on a one-sample t-test, with α=0.05 two-sided, 90% power, 
15 subjects are required to demonstrate a statistically significant reduction from baseline when using a 
conservative estimate of average improvement of 20 points at 12 weeks with a standard deviation of 22. 
Therefore, 93 subjects should ensure the sample size need for the secondary objective of OABq. 

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14.1.2. 
Description of Baseline variables 
Summary statistics will be provided for baseline variables. 
14.1.3. 
Center Pooling 
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 15 sites in 
the US.  Initial site enrollment is not planned to exceed 20% of the total number of subjects that are 
qualified for the study; however this may be increased based on the Sponsor’s discretion.  This is 
intended to reduce the possibility that a site with atypical results will be overly influential in the overall 
study results.  
14.1.4. 
Special Considerations 
No adjustments for multiple analyses will be made for this study. 
14.1.5. 
Interim Analyses 
No interim analysis is intended for this study. 
14.1.6. 
Reports 
Periodic reports will be provided to each site’s IRB. A final report will be generated for this study. 
Relevant tables of statistical results and graphs will be generated for inclusion in the final report. Any 
change from the original statistical plan will be summarized. 
14.2. Demographics 
Summary statistics for demographic variables will be presented. 
14.3. Primary Objective 
This study will assess the efficacy of PTNM on UUI episodes collected using a voiding diary. The primary 
objective is to demonstrate a statistically significant reduction between baseline and following the 12th 
PTNM therapy sessions in the number of UUI episodes per day. 
Hypothesis 
Ho: μ12th PTNM therapy session = μbaseline 
Ha: μ12thPTNM therapy session ≠ μbaseline 
Where μbaseline and μ12th  PTNM therapy session are average UUI episodes per day at baseline and 
following the 12th PTNM therapy session respectively. 
Endpoint definition 
The average UUI episodes per day collected at baseline and following the 12th and final PTNM therapy 
session will be used as the endpoint for the primary objective. 

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Sample size methods and assumptions 
This details the sample size justification.  
Data collection and analysis methods 
Diary data collected at baseline and after the 12th PTNM therapy session will be used for the primary 
endpoint analysis. The paired t-test or the Wilcoxon signed-rank test will be used to evaluate the changes 
after testing for data normality. A statistical test is deemed significant if the P value is less than 0.05. 
Primary analysis method will be completers (with no imputation of missing data). Sensitivity analyses will 
be conducted with the adjusted worst-case method and per protocol analysis. 
Determination of subjects for analysis 
Subjects with diary data from both baseline and  the 12th PTNM therapy session will be included in the 
primary analysis for this objective.  
In additional to the primary analysis, two sensitivity analyses will be performed:  
• 
Adjusted worst-case analysis, in which, 
a. For subjects who received the study therapy and withdrew early due to device-related 
adverse events, or treatment unsuccessful, the 12th PTNM therapy session data point 
will be set to subject’s baseline assessment.  
b. For subjects who received the study therapy and exit the study early due to all other 
reasons (i.e. adverse events not related to the device), and for subjects who missed 
the 12th PTNM therapy session or fail to provide the relevant data for 12th PTNM 
therapy session, the Last Observation Carried Forward (LOCF) method will be used to 
impute the missing data. 
c. Subjects who exit the study prior to the initial NURO PTNM therapy session will be 
excluded from this sensitivity analysis 
• 
Per protocol sensitivity analysis which will be based on the completers dataset, but will 
exclude those subjects who take OAB medications in the study. Use of OAB medications will 
be captured as a  protocol deviation. 
Reduction in number of UUI episodes from baseline will be summarized for each follow up visit when the 
diary data is collected with no imputation of missing data (completers analysis). 
14.4. Secondary Objectives 
Secondary objectives are to assess: 
• 
Reduction from baseline through 12 PTNM therapy sessions in number of voids per day 
• 
Change from baseline through 12 PTNM therapy sessions in quality of life as measured 
by the OABq Questionnaire 

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14.4.1. 
Secondary Objective #1 
To assess the reduction in number of voids per day from baseline through 12 PTNM therapy sessions. 
This objective will be assessed in subjects with > 8 voids per day at baseline. Number of voids collected 
from baseline and the 12th PTNM therapy session will be used for analysis of this objective. Subjects with 
diary data from both baseline and 12th PTNM therapy session will be included in the analysis. A paired t-
test or the Wilcoxon signed-rank test will be used to evaluate the changes after 12 PTNM therapy session 
from baseline after testing for data normality.  
In additional to the primary analysis which includes subjects with diary data from baseline and 12th 
PTNM therapy session, the same sensitivity analyses as described in primary objective will be performed 
for secondary objective #1. 
Reduction in number of voids per day from baseline will also be summarized by the PTNM session when 
the diary data is collected.  
14.4.2. 
Secondary Objective #2 
To assess the change from baseline through 12 PTNM therapy sessions in quality of life as measured by 
the OABq Questionnaire. This objective will be assessed in subjects with OABq data at baseline and after 
12th PTNM therapy session. The paired t-test or the Wilcoxon signed-rank test will be used to evaluate 
the changes after the 12th PTNM therapy session from baseline after testing for data normality.  
In additional to the primary analysis which includes subjects with diary data from baseline and 12th 
PTNM therapy session, the same sensitivity analyses as described in primary objective will be performed 
for secondary objective #2. 
Improvement in OABq from baseline will also be summarized at by the PTNM session when this data is 
collected. 
14.5. Additional Measures 
Additional measures include: 
• 
Incidence of device-related and therapy-related adverse events 
• 
Nocturia / Nighttime voiding frequency  
• 
Urgency including the Urgency Perception Scale (UPS) 
• 
Patient-reported Outcomes: 
 
Self-Assessment Goal Achievement Questionnaire (SAGA) 
 
Patient Perception of Bladder Condition (PPBC) 
 
Patient Global Impression of Improvement (PGI-I) 
Nocturia, nighttime voiding frequency and urgency are collected through voiding diaries and patient 
reported outcomes. Reductions in nocturia, nighttime voiding frequency and urgency from baseline will 
be summarized by the PTNM session when the data is collected.  
Additional quality of life measures including PPBC,  UPS, PGI-I and SAGA are collected in this study. 
These data will be summarized  by the PTNM session when data is collected. 

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Reportable adverse events will be summarized for all subjects who receive the therapy. 
Fecal incontinence diaries will be collected for subjects with dual incontinence.  No analysis is pre-
specified for dual incontinence data.  The intent of collecting this information is to inform future study 
designs.  
15. Ethics 
15.1. Statement(s) of Compliance  
The study will be conducted in accordance with this protocol, the ethical principles that have their origin 
in the Declaration of Helsinki, all applicable regulatory requirements (21CFR§50 Protection of Human 
Subjects, 21CFR§56 IRB, and 21CFR§803 Medical Device Reporting), and according to GCP.  The 
principles of the Declaration of Helsinki have been implemented in this study by means of the patient 
informed consent process, IRB approval, risk benefit assessment, study training, clinical trial registration, 
and publication policy.  Study Investigators will be required to sign an Investigator Agreement stating 
their intent to adher to applicable regulations. 
The study will not begin at any site until an IRB letter approving the protocol and the ICF is received by 
Medtronic.   
Details related to stipends provided to study subjects are outlined in the subject ICF.  
16. Study Administration 
16.1. Monitoring  
Medtronic is responsible for ensuring the proper conduct of this study in terms of adherence to applicable 
regulations, protocol compliance, and the validity and accuracy of the study data entered on CRFs.  The 
Principal Investigator and site personnel will provide the Medtronic monitor(s) with complete access to 
primary source data (eg, paper and electronic hospital/clinical charts, appointment books, laboratory 
records) that support the data on the CRFs as well as other documentation supporting the conduct of the 
study.  The monitor will perform source data verification and routine reviews of study-related regulatory 
documents during scheduled monitoring visits and work to secure compliance should any deficiencies be 
observed. The monitoring plan contains the strategy for frequency of monitoring visits and source data 
verification to be performed for this study. 
16.2. Medtronic Representative Role 
Medtronic representatives may participate in the conduct of the study to the extent listed below.   
Medtronic representatives can provide technical support to the investigator and other health care 
personnel as needed during study visits.  This support may include the training of site personnel on use of 
the Medtronic equipment or the protocol-related procedures and forms. 

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In addition, Medtronic personnel can perform certain activities to ensure study quality.  These activities 
may include: 
• 
Observing testing or medical procedures to provide information relevant to protocol completion 
• 
Reviewing collected data and study documentation for completeness and accuracy 
Medtronic personnel will not: 
• 
Practice medicine 
• 
Provide medical diagnosis or treatment to subjects 
• 
Discuss a subject’s condition or treatment with a subject without the approval and presence of 
the health care provider. 
• 
Complete CRFs or make entries in the subject’s medical record 
16.3. Data Management 
Medtronic personnel will perform routine edit and consistency checks for items such as missing data or 
inconsistent data.  Identified data inconsistencies will be resolved by use of data discrepancies; 
investigators and site personnel will review data discrepancies and respond to the discrepancies in a 
timely manner.  The resolved discrepancy will become a part of the eCRF record for the subject. 
The Oracle Clinical Remote Data Capture (RDC) system which is 21CFR§11 Part E compliant controls user 
access, and ensures data integrity. This system is a fully validated system. The RDC system maintains an 
audit trail of entries, changes or corrections in eCRFs. User access will be granted to each individual 
based on his or her delegation of authority and completion of required training. If a person only 
authorized to complete eCRFs makes changes to an already signed eCRF, the system will require the 
Principal Investigator, or authorized delegate, to re-sign the eCRF. 
The Principal Investigator, or designated representative, is responsible for the data submitted and must 
review all data for accuracy and provide his/her approval of the eCRF and sign each form with an 
electronic signature.  
16.4. 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. 
16.5. Confidentiality 
Subject confidentiality is assured through the use of subject identification numbers, use of initials only, 
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.   

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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.  HIPAA language may be included within the ICF template.  
16.6. CIP Amendments 
Protocol amendments may be initiated by Medtronic to address changes to the conduct of the study.  
Protocol amendments must be approved by Medtronic and submitted to the IRBs; protocol amendment 
approval and approval of any associated changes to the informed consent document must be obtained 
prior to implementation of the amendment except: 
• 
When necessary to eliminate an immediate/or apparent immediate hazard to participating  
subjects 
• 
When the change involves purely administrative or logistical aspects of the study  
16.7. Record Retention 
At a minimum the investigator is responsible for the preparation, review, and retention of the records 
listed below: 
• 
Essential correspondence that pertains to the investigation 
• 
Records of each subject’s case history and exposure to the device.  Case histories include the 
CRFs and supporting data (source documentation), such as: 
o 
Signed and dated ICFs 
o 
Medical records, including, for example, progress notes of the physicians, the 
subject’s hospital chart(s) and the nurses notes 
o 
All reportable adverse event information 
o 
Data related to the PTNM therapy session  
• 
Documentation of any deviation to the protocol, including the date and the rationale for such 
deviation 
• 
Signed Investigator Agreement and curriculum vitae for all Investigators 
• 
The protocol and any amendments 
The Principal Investigator is responsible for ensuring that all essential study documentation is retained 
and accessible for a minimum of 2 years following completion of the study.  The Principal Investigator will 
ensure that essential study documents are not destroyed until written permission has been obtained from 
Medtronic.  Medtronic will be notified in writing of any transfer of study documentation.   
16.8. Publication and Use of Information 
Medtronic intends to publish the results from the RESET Study in a timely manner upon study completion.  
These publication activities may include abstracts, presentations/posters to scientific meetings, and 
manuscripts.   

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Investigators who gathered data for this study (ie, enrolled subjects and complied with the protocol) may 
be asked to write or contribute to the writing of abstracts and manuscripts based on the results of this 
study.  Principal investigators who meet the study-specific criteria above will be considered for 
abstract/manuscript authorship if they meet the International Committee of Medical Journal Editors, 
Ethical Considerations in the Conduct and Reporting of Research criteria available via the following link: 
http://www.icmje.org.  Specifically, authorship credit should be based on the following and should meet 
all criteria listed below:   
• 
Substantial contributions to conception or design;or the acquisition, analysis and interpretation of 
data for the work;  
• 
Drafting the article or revising it critically for important intellectual content; and  
• 
Final approval of the version to be published; and.  
• 
Agreement to be accountable for all aspects of the work in ensuring that questions related to the 
accuracy or integrity of any part of the work are appropriately investigated and resolved. 
Medtronic employees who meet the International Committee of Medical Journal Editors criteria for 
authorship will have the right to authorship. 
All contributors who do not meet the criteria for authorship are to be listed in an acknowledgments 
section according to the guidelines of the applicable scientific journal. Examples of those who might be 
acknowledged include a person who provided purely technical help, writing assistance, or a department 
chair who provided only general support. 
16.9. Suspension or Early Termination 
Medtronic reserves the right to suspend or terminate the study at any time.  Reasons may include, but 
are not limited to, the following: 
• 
Insufficient enrollment to complete the study within the expected timeframe 
• 
Identification of unacceptable safety profile; suspicion of an unacceptable risk will result in a 
suspension, confirmation of an unacceptable risk will result in termination 
• 
Product performance/product supply issues  
Medtronic reserves the right to suspend or terminate the study at an individual site.  Reasons may 
include, but are not limited to, the following: 
• 
Noncompliance with the protocol  
• 
Serious or repeated deviations at the site 
• 
Failure to implement required corrective and preventive actions 
• 
Insufficient enrollment to complete the study within the expected timeframe 
• 
Loss of appropriately trained site personnel 
Investigators are required to notify the IRB of study suspension/termination.  Subjects will be notified by 
the investigator of suspension/termination due to unacceptable risk or of termination due to any other 
cause. 

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17. References 
1. Gormley AE, Lightner, DJ Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in 
Adults: AUA/SUFU Guideline Amendment. J Urol. 2015; 193(5) 1572-1580 
2. Govier FE, Litwiller S, Nitti V, et al. Percutaneous afferent neuromodulation for the refractory 
overactive bladder: results of a multicenter study. J Urol. 2001; 165: 1193-1198 
3. van Balken MR, Vandoninck V, Gisolf KW, et al. Posterior tibial nerve stimulation as 
neuromodulative treatment of lower urinary tract dysfunction.  J Urol. 2001; 166: 914-918 
4. Karademir K, Baykal K, Sen B, et al. A peripheric neuromodulation technique for curing detrusor 
overactivity: Stoller afferent neurostimulation. Scand J Urol Nephrol. 2005; 39: 230-233 
5. Peters KM, MacDiarmid SA, Randomized trial of percutaneous tibial nerve stimulation versus 
extended-release tolterodine: results from the overactive bladder innovative therapy trial. J Urol. 
2009; 182(3): 1055-1061  
6. Finazzi-Agro E, Petta F, Sciobica F, et al. Percutaneous tibial nerve stimulation effects on detrusor 
overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo 
controlled trial. J Urol. 2010; 184: 2001-2006 
7. Peters KM, Carrico DJ, Randomized trial of percutaneous tibial nerve stimulation versus Sham 
efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 
2010; 183(4): 1438-1443 
8. Vecchioli-Scaldazza C, Morosetti C, Berouz A, et al. Solifenacin Succinate versus Percutaneous 
Tibial Nerve Stimulation in Women with Overactive Bladder Syndrome: Results of a Randomized 
Controlled Crossover Study. Gynecol Obstet Invest. 2013; 75: 230-234 
9. Burton C, Sajja A, Latthe PM. Effectiveness of percutaneous posterior tibial nerve stimulation for 
overactive bladder: a systematic review and meta-analysis. Neurourol Urodyn. 2012; 31:1206-
1216 
10. Gaziev G, Topazio L, Iacovelli V, et al. Percutaneous Tibial Nerve Stimulation (PTNS) efficacy in 
the treatment of lower urinary tract dysfunctions: a systematic review. BMC Urol. 2013; 13:61 
11. Monga AK, Tracey MR, Subbaroyan J. A systematic review of clinical studies of electrical 
stimulation for treatment of lower urinary tract dysfunction. Int Urogynecol J. 2012; 23:993-1005 
12. Moossdorff-Steinhauser HF, Berghmans B. Effects of percutaneous tibial nerve stimulation on 
adult patients with overactive bladder syndrome: a systematic review. Neurourol Urodyn 2013; 
32:206-214 
13. Schreiner L, Santos TG, Souza AB, et al. Electrical stimulation for urinary incontinence in women: 
a systematic review. Int Braz J Urol 2013; 39:454-464 

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14. Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A., Petri E, Rizk DE, 
Sand PK & Schaer GN. An International Urogynecological Association (IUGA)/International 
Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. 
Neurourology and Urdynamics 2010; 29, 4-20  
15. EAU Guideline on Urinary Incontinence.  http://uroweb.org/guideline/urinary-incontinence.  2014 
16. Preyer O, Umek W, Laml T, Percutaneous tibial nerve stimulation versus tolterodine for 
overactive bladder in women: a randomised controlled trial. European Journal of Obstetrics & 
Gynecology and Reproductive Biology 2015; 191: 51-56 
17. Abrams P, Cardozo L, Khoury S, Wein A.  Incontinence. Fourth Edition. Paris: Health Publication, 
2009.  
18. Coyne KS, Gelhorn H, Thompson C, Kopp ZS, & Guan Z. The psychometric validation of a 1-week 
recall period for the OAB-q. Int Urogynecol J. 2011; 22(12):1555-63 
19. Cardozo, L., Coyne K S and Versi E. Validation of the Urgency Perception Scale.  BJU 
International 2005; 95: 591–596. doi: 10.1111/j.1464-410X.2005.05345.x 
20. Freeman R, Hill S, Millard R, Slack M and Sutherst J.  Reduced Perception of Urgency in 
Treatment of Overactive Bladder with Extended-Release Tolterodine.  The American College of 
Obstetricians and Gynecologists 2003; 103(2): 605-611   
21. Brubaker, L, Piault EC, Tully SE, Evans CJ, Bavendam T, Beach J, Yeh Y, Kopp ZS, Khullar V, 
Kelleher CJ and Trocio J. Validation study of the Self-Assessment Goal Achievement (SAGA) 
questionnaire for lower urinary tract symptoms. International Journal of Clinical Practice 2013; 
67: 342–350. doi: 10.1111/ijcp.12087 
22. Hullfish KL, Bovbjerg VE, Gurka MJ, and Steers WD.  Surgical vs. non-surgical treatment in 
women with pelvic floor dysfunction: Patient-centered goals at one year. J Urol. 2008; 179(6): 
2280–2285 
23. Khullar V, Marschall-Kehrel D, Espuna-Pons M, Kelleher C.J, Tully SE, Piault EC, Brubaker L, 
Fianu-Jonasson A, Weinstein D, Bergqvist A, Kvasz M.  European content validation of the Self-
Assessment Goal Achievement (SAGA) questionnaire in patients with overactive bladder.  
International Urogynecology Journal and Pelvic Floor Dysfunction.  2013; 24(9): 1529-153  
24. Zecca C, Digesu GA, Robshaw P, Puccini F, Khullar V, Tubaro A and Gobbi C.  Motor and sensory 
responses after percutaneous tibial nerve stimulation in multiple sclerosis patients with lower 
urinary tract symptoms treated in daily practice.  European Journal of Neurology 2014; 21: 506–
511 
25. Coyne KS, Matza LS, Kopp Z, Abrams P. The validation of the patient perception of bladder 
condition (PPBC): a single-item global measure for patients with overactive bladder. Eur Urol. 
2006; 49(6):1079-1086 

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26. Vecchioli-Scaldazza C, Morosetti C, Berouz A, Giannubilo W, Ferrara V. Solifenacin succintate 
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 
27. Yalcin I, Bump R. Validation of two global impression questionnaires for incontinence. Am J 
Obstet Gynecol. 2003;189(1):98-101 
28. Tincello D, Owen R, Slack M, Abrams K. Validation of the Patient Global Impression scales for use 
in detrusor overactivity: secondary analysis of the RELAX study. BJOG 2013;120:212–216. 
29. Noblett K, Siegel S, Mangel J, et al. Results of a prospective, multicenter study evaluating quality 
of life, safety, and efficacy of sacral neuromodulation at twelve months in subjects with 
symptoms of overactive bladder. Neurourol Urodyn 2016;35(2):246-51. 
18. Appendices  
None