A Prospective Study to Assess the Efficacy and Safety of the BlueWind RENOVA iStim™ System in the Treatment of Patients Diagnosed With Overactive Bladder (OASIS - OverActive Bladder StImulation System Study)
Phase: NA
Conditions: Treatment of Patients Suffering From Overactive Bladder (OAB)
Sponsor: BlueWind Medical

G02-CLP-0002_US Rev. 08 
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BlueWind Medical OAB Pivotal Study Protocol 
 
  
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CLINICAL INVESTIGATIONAL PLAN 
OVERACTIVE BLADDER STIMULATION SYSTEM (OASIS) 
 
 
 
Document ID:  G02-CLP-0002_US   
 
 
Date: 27July 2021 
 
 
 
 
 
 
 
 
 
Confidentiality Statement 
 
 
This document is confidential and is to be distributed only to investigators, regulatory authorities and relevant 
ethics committees or institutional review boards. The contents of this document shall not be disclosed to others 
without written authorization from BlueWind Medical Ltd. 
 
 

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Revision History 
Version #
Name
Date
Modification Description
1
Karin 
Aharonson-Raz 
01-July-2018
First issue
2
Karin Aharonson-
Raz 
07-Jan-2019
1. Rationale for the study was added to 
section 4.2 
2. Results of Extended Pilot study were 
added to section 6.2 
3. Addition of blood test at baseline, 6 
and 12 months follow up post 
activation 
4. Addition of other endpoints 
5. Concurrent medication section 9.4 was 
added 
6. General update of statistical section 
7. administrative changes throughout the 
document; formatting and wording.  
8. Update of administrative sections 9-22 
9. Addition of coordinating investigators 
10. Including GDPR as a requirement 
3* was 
not 
submitted 
Amit Korner
03-June-2019
1. Updating synopsis visit 3 to align with 
protocol requirements 
2. Update wording on intended use and 
indication for use 
3. Change of wording to secondary 
endpoint 
4. Update of sample size to include 
screen failures 
5. Update of definition of FAS 
6. Update to inclusion criteria #2 – age 
21 for US sites 
7. Update to inclusion criterial # 4 - with 
at least one episode per day for 5 
days 
8.  Update to exclusion criterial # 24 - 
Knowledge of planned MRIs 
9. Re-wording of exclusion criteria #25 
10.  Addition of exclusion criterial #30 – 
history of drug or alcohol abuse 
11. Section 7: reference to the IB for 
information regarding pre-clinical and 
clinical studies 

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12. Section 8 – updated of anticipated 
AE’s 
13.  Addition of usability assessment  
14. Section 10.4.1 – clarification of 
medication documentation and 
requirement to avoid undergoing 
other OAB interventions during the 
study  
15. Section 10.6.1 – clarification that 
patient population should have 
incontinence 
16. Section 11.4.2 addition of alcohol 
wipe after the skin scrub and addition 
of partial physical examination.  
17. Section 11.4.2 Update of wording  
18.  Section 11.4.3 update of parameter 
setting   
19. Section 11.4.5 – deleting the option 
to undergo second implantation in 
case of failure to response.  
20.  Section 11.4.6 Allowing out of 
window visits in case of UTI 
21. Section 13.2.3 change of per protocol 
definition threshold  
22. Section 13.2.4 deletion the definition 
of responder: will be part of the SAP 
23. Section 14.2.1 updating CEC 
responsibilities 
24. Section 18.9 update of contact 
person 
25. Section 18.10 update severity to 
comply with CTCAE common 
terminology 
26. Section 18.11 update of relationship 
to comply with MEDDEV 
27. Section 24 update of the study 
schedule with usability questions 
28. Update of voiding diary version 4 
 
4
Amit Korner
21-July-2019
1. Section 11.4.2
a. 
addition of optional ultrasound 
during implantation visit 
b. 
Changing implantation visit 
window to (-)2 (+)3 weeks 

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c. 
Suture removal after 14 days
d. 
Remove option to remove 
suture by the GP. 
5 
Lori Fein
Amit Korner 
05-Jan-2020
1. Section 1 – update to be applicable to 
the US  
2. Sections 1, 4, 6.1, 10.1 and 13.1 – 
update indication for use to female 
with UUI. 
3. Sections 4, 5.2, 10.2.1, 10.6.2, 13.4 
and 13.5.8 – update sample size 
4. Section 4 and 10.2.1 – update 
number of sites to 35 
5. Sections 4 and 10.3.1 - update 
primary safety endpoint to include all 
AE’s 
6. Sections 4 and 10.7 - updated 
inclusion/exclusion criteria 
7. Section 4 and 11.4 – update time 
window for implantation 
8. Section 4 and 13.5.4 – update 
hypothesis testing method to 
Clopper-Pearson 
9. Section 5.2 – update CE approval for 
OAB 2000 
10. Sections 10 and 14.2.2 – updated for 
staged enrollment provisions 
11. Sections 10.4.3 and 11.4.1 – 
clarification of documentation of 
concurrent medication.  
12. Section 11.4 – updated to allow 
phone visits and addition of device 
usage information 
13. Section 11.4.1 update handling of UTI 
at baseline. 
14. Section 11.4.2 update suture 
technique and material at 
implantation procedure. 
15. Sections 13.3, 13.2.2. and 10.8.1- 
update failure definition. 
16. Section 3 – adding UUI to acronym 
list. 
17. Section 6.3 – adding reference to the 
software version.  

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18. Section 18.9 – update adverse event 
reporting contact details to be 
applicable to the US  
19. Section 24 – adding section on 
“Reporting Results on 
ClinicalTrials.gov”  
20. Wording throughout the document 
21. Administrative changes thought the 
document  
06
Roni Diaz
29-Nov-2020
1. Deleted blood chemistry at 6 and 12 
months follow-up 
2. Added morbid obesity exclusion 
criteria 
3. Added PVR evaluation at baseline 
visit 
4. Removed option for paper diary 
5. Updated SAE definition 
6. Administrative corrections 
throughout 
07
Roni Diaz
14-Jun-2021
1. Update to sample size
2. Update to name of EU 
representative after acquisition 
3. Removal of FAS definition 
4. Reduction of the number of sites 
from 35 to 30 
5. Clarification of exclusion criteria 
14 and 25 
6. Update to patient study duration 
7. Update to minimum retention 
period 
8. Minor administrative changes 
08
Roni Diaz
25-Jul-2021
1. Add 18-, 24-, 30- & 36-month 
visits 
2. Add inclusion/exclusion criteria 
for long-term follow-up 
3. Restate & reorder §10.3.3 
4. Update Figure 1 and add long-
term follow-up chart 
5. Add §13.5.8 Interim Analysis 
6. Update §14.2.1 & §14.2.2 
7. Add §26 long-term follow-up 
schedule 
8. Minor administrative changes 
 
 

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1.  General 
Protocol Number
G02-CLP-0002_US Rev. 08
Revision Date
27 July 2021
NCT #
NCT03596671
Protocol Title
A prospective study to assess the efficacy and safety of the 
BlueWind RENOVA iStim™ System for the treatment of patients 
diagnosed with overactive bladder (OASIS – OverActive bladder 
Stimulation System study) 
Investigational 
Device 
RENOVA iStim™
Manufacturer
BlueWind Medical Ltd.
6 Maskit Street, Herzliya 4614002, Israel 
Phone: +972-74-7218915 
Fax: +972-74-7218999 
Email: info@bluewindmedical.com 
Sponsor’s US Agent
Grant Palmer
1389 Center Drive, Suite 200 
Park City, UT  84098, USA 
Phone: +1-818-859-2406 
EU Legal 
Representative  
IQVIA MedTech nvJustitiestraat 6B
2018 Antwerpen, Belgium  
Tel: +32 3 290 03 06  
https://www.iqvia.com/solutions/industry-segments/medtech/clinical-
solutions 
Coordinating 
Investigators 
Dr.  John Heesakkers
John.Heesakkers@radboudumc.nl 
Dr. Stefan DeWachter 
stefan.dewachter@uantwerpen.be 
Dr. Philip Toozs-Hobson 
P.toozs-hobson@nhs.net  
Medical Monitor 
Dr. Roger Dmochowski
roger.dmochowski@Vanderbilt.Edu 
 
 
 

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2. Protocol Agreement 
I have read the OASIS (Over Active bladder Stimulation System study) protocol G02-CLP-0002, Revision 
08 from 27 July 2021 and agree to adhere to the requirements outlined within. I will provide all pertinent 
information regarding the protocol to the study personnel under my supervision. I will review and discuss 
this material with them and ensure they are fully informed of the requirements of this protocol. I will also 
ensure that this study is conducted in compliance with this protocol, Good Clinical Practice (GCP) E6(R2), 
EN ISO 14155:2011 and any applicable local and/or national regulatory agencies and their requirements. 
 
 
 
 
 
 
 
 
Principal Investigator Name (Capital Letters)
 
 
Investigational Site 
 
 
Principal Investigator Signature 
 
 
Date 
 
 
 
 
 
 
 

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TABLE OF CONTENTS 
 
1. 
General ......................................................................................................................................................... 6 
2. 
Protocol Agreement ..................................................................................................................................... 7 
3. 
Acronym List ............................................................................................................................................... 11 
4. 
Protocol Synopsis....................................................................................................................................... 12 
5. 
Introduction ................................................................................................................................................. 21 
5.1 
Background ............................................................................................................................................. 21 
5.2 
Study Rationale ...................................................................................................................................... 21 
6. 
BlueWind RENOVA iStim™ System Description ....................................................................................... 22 
6.1 
Study Intended Use and Indication for Use ............................................................................................ 22 
6.2 
System Description ................................................................................................................................. 23 
6.2.1 
IMPLANT ................................................................................................................................................... 23 
6.2.2 
WEARABLE UNIT ....................................................................................................................................... 23 
6.2.3 
CLINICIAN PROGRAMMER (CP) .................................................................................................................. 24 
6.3 
System Technical Information ................................................................................................................ 24 
7. 
Pre-Clinical and Clinical Experience with RENOVA iStim™ System ......................................................... 25 
7.1 
Pre-Clinical experience with BlueWind RENOVA iStim™   System ....................................................... 25 
7.2 
Clinical experience with BlueWind RENOVA™ System......................................................................... 25 
8. 
Risks and Benefits...................................................................................................................................... 28 
9. 
Traceability ................................................................................................................................................. 29 
10. 
Protocol Design .......................................................................................................................................... 30 
10.1 
Study Objectives ..................................................................................................................................... 30 
10.2 
Study Design .......................................................................................................................................... 30 
10.2.1 STUDY SCOPE .......................................................................................................................................... 30 
10.3 
Study Endpoints...................................................................................................................................... 30 
10.3.1 PRIMARY ENDPOINT .................................................................................................................................. 30 
10.3.2 SECONDARY ENDPOINTS ........................................................................................................................... 30 
10.3.3 OTHER ENDPOINTS ................................................................................................................................... 31 
10.4 
Medication Usage ................................................................................................................................... 31 
10.4.1 ALLOWED/DISALLOWED MEDICATION .......................................................................................................... 32 
10.4.2 DOCUMENTATION OF CONCOMITANT MEDICATION ........................................................................................ 32 
10.5 
Measurements ........................................................................................................................................ 32 
10.6 
Study Population..................................................................................................................................... 32 
10.6.1 PATIENT POPULATION ............................................................................................................................... 32 
10.6.2 NUMBER OF SUBJECTS .............................................................................................................................. 32 
10.7 
Eligibility Criteria ..................................................................................................................................... 32 
10.7.1 INCLUSION CRITERIA ................................................................................................................................. 32 
10.7.2 EXCLUSION CRITERIA ................................................................................................................................ 33 
10.8 
Patient Withdrawal and Lost to Follow Up .............................................................................................. 35 
10.8.1 DISCONTINUATION OF SUBJECTS ............................................................................................................... 35 
10.8.2 LOST-TO-FOLLOW-UP ................................................................................................................................ 36 
10.8.3 STUDY DISCONTINUATION ......................................................................................................................... 36 
10.9 
Study Duration ........................................................................................................................................ 37 
11. 
Conduct of the Study .................................................................................................................................. 37 
11.1 
General ................................................................................................................................................... 37 
11.1.1 INVESTIGATOR AND SITE QUALIFICATION .................................................................................................... 37 
11.2 
Physician Training .................................................................................................................................. 37 
11.3 
Baseline Evaluation ................................................................................................................................ 38 
11.4 
Study Visits ............................................................................................................................................. 38 
11.4.1 PATIENT ENROLLMENT (BASELINE) – VISIT 1 .............................................................................................. 41 

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11.4.2 BLUEWIND RENOVA ISTIM™ IMPLANTATION – VISIT 2 .............................................................................. 43 
11.4.3 BLUEWIND RENOVA ISTIM™ SYSTEM ACTIVATION  - VISIT 3 ..................................................................... 44 
11.4.4 BLUEWIND RENOVA ISTIM™ SYSTEM TREATMENT................................................................................... 45 
11.4.5 BLUEWIND RENOVA ISTIM™ SYSTEM FOLLOW UP VISITS – VISITS 4-8 ..................................................... 45 
11.4.6 UNSCHEDULED VISIT ................................................................................................................................. 46 
12. 
Monitoring Procedures ............................................................................................................................... 47 
12.1 
Monitoring Procedures and Responsibilities .......................................................................................... 47 
13. 
Statistical Considerations ........................................................................................................................... 47 
13.1 
Introduction ............................................................................................................................................. 47 
13.2 
Analysis Sets .......................................................................................................................................... 48 
13.2.1 SAFETY AND EFFICACY ANALYSIS POPULATION – INTENT TO TREAT (ITT) ................................................... 48 
13.2.2 PER PROTOCOL ANALYSIS SET .................................................................................................................. 48 
13.2.3 ONE-MONTH RESPONDERS ........................................................................................................................ 48 
13.3 
Treatment of Missing Data for Efficacy Analyses ................................................................................... 49 
13.4 
Sample Size Considerations .................................................................................................................. 49 
13.5 
Statistical Analyses ................................................................................................................................. 49 
13.5.1 OVERVIEW ................................................................................................................................................ 49 
13.5.2 SUBJECT DISPOSITION .............................................................................................................................. 50 
13.5.3 SAFETY .................................................................................................................................................... 50 
13.5.4 PRIMARY EFFICACY ................................................................................................................................... 50 
13.5.5 SECONDARY EFFICACY ENDPOINTS ........................................................................................................... 50 
13.5.6 ADDITIONAL EFFICACY ENDPOINTS ............................................................................................................ 51 
13.5.7 COVARIATE ANALYSES .............................................................................................................................. 52 
13.5.8 INTERIM ANALYSIS .................................................................................................................................... 52 
14. 
Data Management ...................................................................................................................................... 53 
14.1 
Electronic Case Report Form (eCRF) .................................................................................................... 53 
14.2 
Safety Monitoring of the Study and Quality Control ............................................................................... 54 
14.2.1 CEC ........................................................................................................................................................ 54 
14.2.2 DSMB ..................................................................................................................................................... 54 
14.3 
Data Collection and Monitoring .............................................................................................................. 54 
14.4 
Data Quality Control and Quality Assurance .......................................................................................... 55 
14.5 
Data Retention ........................................................................................................................................ 55 
15. 
Deviations from Protocol ............................................................................................................................ 55 
16. 
The RENOVA iStim™ System Accountability ............................................................................................ 56 
17. 
Informed Consent Process ......................................................................................................................... 56 
18. 
Safety ......................................................................................................................................................... 57 
18.1 
Adverse Events....................................................................................................................................... 57 
18.2 
Adverse Device Effect ............................................................................................................................ 57 
18.3 
Serious Adverse Events ......................................................................................................................... 57 
18.4 
Serious Adverse Device Effects ............................................................................................................. 58 
18.5 
Anticipated Serious Adverse Device Effects .......................................................................................... 58 
18.6 
Unanticipated Serious Adverse Device Effects ...................................................................................... 58 
18.7 
Device Deficiency /Malfunction / Use Error ............................................................................................ 58 
18.8 
Adverse Events Collection and Recording ............................................................................................. 58 
18.9 
Adverse Events Reporting ...................................................................................................................... 59 
18.9.1 PERIODIC SAFETY REPORT ....................................................................................................................... 60 
18.10 Severity ................................................................................................................................................... 60 
18.11 Relationship ............................................................................................................................................ 61 
19. 
Protocol Amendments ................................................................................................................................ 62 
20. 
Subject Confidentiality ................................................................................................................................ 62 
21. 
Termination of the Clinical Study ............................................................................................................... 63 
22. 
Insurance .................................................................................................................................................... 63 

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23. 
Publication Policy ....................................................................................................................................... 63 
24. 
Reporting Results on ClinicalTrials.gov ..................................................................................................... 63 
25. 
Study Schedule .......................................................................................................................................... 65 
 
 
  
TABLE OF APPENDICES 
Appendix 1 - BSW questionnaire ............................................................................................................................. 67 
Appendix 2 - MESA incontinence questionnaire ...................................................................................................... 68 
Appendix 3 - OAB-q ................................................................................................................................................. 70 
Appendix 4 – PGI ..................................................................................................................................................... 73 
Appendix 5 – PHQ-15 .............................................................................................................................................. 74 
Appendix 6 – References ......................................................................................................................................... 75 
 

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3. Acronym List 
 
AE
Adverse Event
BL
Baseline
BSW
Benefit, Satisfaction and willingness to Continue questionnaire
CEC
Clinical Event Committee
CIP
Clinical Investigation Plan
CP
Clinician Programmer
CRF
Case Report Form
CTCAE
Common Terminology Criteria for Adverse Events
DSMB
Data Safety and Monitoring Board
EC
Ethic Committee
FI
Fecal Incontinence
GCP
Good Clinical Practice
HRQL
Health Related Quality of Life
IRB
Institutional Review Boards
ITT
Intend To Treat
MESA
Medical, Epidemiological, and Social Aspects of Aging
MID
Minimal Important Difference
MS
Multiple Sclerosis
OAB
Over Active Bladder
OAB-q
Over Active Bladder questionnaire
OASIS
Over Active bladder Stimulation System
PCB
Printed Circuit Board
PPIUS
Patient Perception of Intensity of Urgency Scale
PTNS
Percutaneous/Posterior Tibial Nerve Stimulation
PGI-I
Patient Global Impression of Improvement
PHQ-9 (or 15)
Patient Health Questionnaire
PVR
Post Void Residual
QoL
Quality of Life
VD
Voiding Diary
UADE
Unanticipated adverse device effect
UUI
Urinary Urge Incontinence
 
 

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4. Protocol Synopsis  
 
FULL TITLE 
A prospective study to assess the efficacy and safety of the BlueWind RENOVA 
iStim™ System in the treatment of patients diagnosed with overactive bladder 
(OASIS – OverActive bladder StImulation System study). 
RUNNING TITLE 
BlueWind RENOVA iStim™ System for the treatment of OAB. 
STUDY INTENDED 
USE AND 
INDICATION FOR 
USE 
The BlueWind Medical System is intended for peripheral nerve stimulation. 
The RENOVA iStimTM System is indicated for the treatment of women with 
symptoms of urgency incontinence alone or in combination with urinary 
urgency and/or urinary frequency. 
 
STUDY DESIGN  
Prospective, interventional, multi-center, single arm, open label study.  
STUDY PURPOSE 
To demonstrate efficacy and safety of BlueWind RENOVA iStim™ System 
therapy in the treatment of UUI. 
STUDY ARMS  
Single arm. 
Device: RENOVA iStim™ System 
All subjects will receive active RENOVA iStim™ System treatment for the 
duration of the study. 
STUDY CONDUCT 
 
 
 
 
 
 
 
 
 
The study will consist of the following activities:  
 Visit 1 - Screening 
 
Enrollment:  Potential female subjects with UUI, who fulfil basic 
criteria will be informed of the study and will be invited to sign an 
informed consent form. 
 
Enrollment criteria will be verified against medical records and 
subject’s interview. 
 
Baseline: Study candidates will be asked to fill out a 7- consecutive 
day voiding diary and a MESA incontinence questionnaire to 
determine predominant type of incontinence and a PHQ-15 
questionnaire and a quality of life questionnaire (OAB-q). The diary 
and questionnaires will determine eligibility criteria and will serve as 
baseline data. Demographic information (age, race, height and 
weight, leg circumference), medical and surgical history and 
concomitant medication information will be collected. 

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 
Urine sample will be collected, blood will be drawn and a full physical 
examination, including a PVR measurement, will be performed. 
 
Once all eligibility criteria have been met and confirmed, implantation 
procedure will be scheduled.  
 Visit 2 - Implantation 
 
6 ± 4 weeks after starting the diary, eligible subjects will undergo 
unilateral implantation with the BlueWind RENOVA iStim™ System, 
during which intra-operative tibial motor or sensory response test will 
be performed.   
 Visit 3 - Activation 
 After a recovery period of 4-weeks (±2 weeks) post implantation, 
subjects will attend the clinic to undergo physical examination, 
urinalysis and parameter setting according to the individual patient 
sensations and will be trained on the use of the system. Therapy will 
be delivered for a minimum of 30 minutes and a maximum of 2 hours 
per day.  
 Visits 4-8 – Treatment optimization and follow up 
 
Follow-up visits will be performed at 1, 3, 6, 9 and 12-months post 
activation.  
 All follow-up visits will require completion of a voiding diary (a 3-day 
diary at 1, 3 and 9 months post activation and a 7-day diary at 6 and 
12 months post activation) by the patient before coming to the visit. 
During the 6 and 12- months post activation follow-up visits quality of 
life (OAB-q), patient global impression of improvement (PGI-I) and 
Benefit, Satisfaction and Willingness to Continue (BSW) 
questionnaires will be collected.  
 During each visit, stimulation parameters and level of treatment will 
be checked and adjusted as needed. 
 At all follow up visits physical examination and collection of AE and 
concomitant medication will be performed 
 Urine sample will be collected at each follow up visit 
 Patients will be asked to complete usability questions  
 Visits 9-12 – Long term follow-up  
 Long term follow-up visits will be performed at 18, 24, 30, and 36-
months post activation.  
 If a subject already completed the 12-month follow-up visit and exited 
the study, she will be invited for a long-term follow-up consent visit in 
which, following her consent to participate, some eligibility criteria 
will be verified and treatment parameters setting will be performed. 
The subject will enter the visit schedule at the visit that aligns with 
her system activation date. 
 If the subject discontinued treating herself after completion of the 12-
month visit, she will be asked to treat herself for 30 minutes, twice a 
day, for at least 4 weeks before arriving for her closest follow-up visit.  

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During this period, she will be asked to complete modified daily diary 
to capture incontinence episodes, time to treatment effect, and 
symptom improvement questions. Subjects continuing to the long-
term follow-up will be asked to treat themselves per physician 
discretion but not less than twice a week for 30-minutes per 
treatment.  
 All follow-up visits will require completion of 3-day voiding diary by 
the patient before coming to visit.  
 Follow-up visits 9 (18-months) and 11 (30 months) will be performed 
by phone. Questions on treatment satisfaction will be asked, and any 
lifestyle, concomitant medication or OAB related changes from 
previous follow-up as well as any health issues will be addressed and 
documented. Visits may be performed in clinic if needed (i.e. 
treatment parameter adjustment, AE or device malfunction, etc. In 
such cases, the patient will arrive to the clinic and a visit similar to the 
1, 3, and 9- months post activation will be performed. 
 Follow-up visits 10 (24-months) and 12 (36-months) will be performed 
in clinic and will be similar to the 6 and 12- months follow-up visits  
COMMITTEES 
 
Clinical Events Committee (CEC) Members will review and adjudicate 
safety information on an ongoing basis through the 12-month visit. 
 
Data Safety and Monitoring Board (DSMB) will conduct periodic 
independent reviews of the data and the reported adverse events, in 
order to ensure that an ongoing acceptable safety profile is 
maintained. A minimum of semi-annual meetings, or after about each 
new 50 subjects have been recruited is planned until all patients 
complete the 12-month visit and then a minimum of annual meetings 
thereafter until study completion. 
NUMBER OF PATIENTS
150 subjects will be enrolled.
NUMBER OF CLINICAL 
SITES 
Up to 30 sites.

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PRIMARY ENDPOINT
Efficacy
 Proportion of responders at 6 months post system activation as 
demonstrated by ≥50% improvement in average number of urgency 
related incontinence episodes, measured by 7-day Patient Voiding 
Diary. 
- Overall study success criteria are defined as a lower 97.5% 
confidence bound for a single binomial proportion of > 50% 
patient success at 6 months. 
Safety 
 Incidence of adverse events from implantation to 12-months post-
activation. 
SECONDARY 
ENDPOINTS 
 Proportion of subjects with ≥10 points (MID) improvement compared to 
baseline in HRQL (based on OAB-q) at 6 months post system activation 
 Proportion of responders at 12 months post system activation as 
demonstrated by ≥50% improvement in either average number of 
urgency related incontinence episodes or average number of “large” 
(severe) urgency related incontinence episodes, as measured by 7-day 
Patient Voiding Diary. 
 Proportion of responders at 6 months post system activation as 
demonstrated by ≥50% improvement in the average number of 
moderate-severe urgency episodes PPIUS degree 3,4 or <8 voids/day  
OTHER ENDPOINTS
The following endpoints will be assessed as other endpoints for the 6-, 12-, 
24- and 36-months post activation, without formal hypothesis testing and 
type I error control. 
 Incidence of procedure or device related adverse events from 12- to 36-
months post activation. 
 Patient Global Impression of Improvement (PGI-I) score. 
 Treatment Benefit, Satisfaction, and Willingness to Continue (BSW)  
 Reduction in the average number of severe/large urgency related 
incontinence episodes. 
 Improvement in OAB-q (HRQL and symptoms severity). 
  Changes in the following OAB symptoms as measured by voiding diary 
compared to baseline: 
o Reduction in the number of micturition episodes. 
o Reduction in the number of urgency related incontinence episodes. 
o Reduction in degree of urgency prior to void on Patient Perception 
of Intensity of Urgency Scale (PPIUS) from 0-4.  
o Reduction in severity of incontinence episodes (amount leaked). 

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 Proportion of dry subjects following treatment with the RENOVA iStim 
System as measured by 3 consecutive days of a patient voiding diary. 
  Assessment of fecal incontinence symptoms in patients suffering from 
mixed fecal and urine incontinence. 
 Patient compliance with treatment. 
 Duration from treatment initiation to symptoms improvement (in subset 
of patients who stopped treatment after completing the 12 month visit 
and started again when consented for the long term follow-up). 
 Assessment of treatment regimen 
 Device usage 
ESTIMATED STUDY 
DURATION 
Subjects will be followed for 36 months after system activation. Overall study 
duration will be approximately 5 years. 
INCLUSION CRITERIA 
 
1. Signed written informed consent.
2. Female aged 18 or greater (21 or greater in the US), with no plans to 
become pregnant during the trial; if of bearing potential, negative 
pregnancy test and if sexually active, using acceptable contraception. 
3. Subject who is mentally competent with the ability to understand and 
comply with the requirements of the study. 
4. Diagnosis of UUI demonstrated on 7-consecutive days voiding 
diary defined as a minimum of nine (9) leaking episodes 
associated with urgency, with at least one episode per day for 5 
days 
5. More than or equal to 6 months history of UUI diagnosis 
6. Subject with inadequate response to any of the following conservative 
treatments (i.e. dietary restriction, fluid restriction, bladder training, 
behavioral modification, pelvic muscle training, biofeedback, etc.) and 
pharmacologic treatment.  
7. If used, subjects should be on stable dose of antimuscarinics and/or 
beta-3 adrenergic agonists for at least 3 months prior to baseline and 
agree to remain on stable medication consumption until the 12-month 
follow-up visit. 
8. If used, subjects should be on a stable dose of tricyclic antidepressants, 
Selective Serotonin Reuptake Inhibitors (SSRI) and Serotonin-
Norepinephrine Reuptake Inhibitors (SNRI) for at least 3 months prior 
to baseline.  
9. Subjects with positive tibial nerve motor or sensory response tested 
via physical/neurological examination. 
10. Subjects with normal renal function defined by GFR of 50 ml/min or 
more 
11. Leg circumference of no less than 20 cm and no more than 30 cm at 
implantation site (i.e. 5cm above the medial malleolus). 

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12. Subject agrees to attend all follow-up evaluations and is willing and 
capable to completely and accurately fill out voiding diaries and 
questionnaires and is willing to complete required exams and tests. 
The following inclusion criteria will be re-evaluated for patients who 
completed 12-months follow-up and exited the study: 
1. Subject who is mentally competent with the ability to understand and 
comply with the requirements of the study. 
EXCLUSION CRITERIA 
 
 
1. Previous participation in another study with any investigational drug or 
device within the past 90 days. 
2. Subjects who are unable to operate the RENOVA iStim™ System 
3. Deemed unsuitable for enrollment by the investigator based on history 
or physical examination 
4. Subjects at high surgical risk with multiple illnesses or active general 
infections that expose them to excessive bleeding or delayed or non-
healing wounds. This includes patients who need anticoagulation 
therapy that cannot be temporarily stopped for the implantation 
procedure 
5. Any significant medical condition that is likely to interfere with study 
procedures, device operation, or likely to confound evaluation of study 
endpoints 
6. Subject has morbid obesity (>50 BMI) 
7. Any psychiatric or personality disorder at the discretion of the study 
physician 
8. PHQ-15 Patient Somatization Score ≥ 20   
9. Any metal or other implant in the area of BlueWind RENOVA iStim™ 
implantation site (20cm distance). 
10. Variation in diuretics consumption within the last 6 months.  
11. Subjects who have received botulinum toxin injections within the past 
12 months.  
12. Failure to respond to previous neuromodulation therapy for overactive 
bladder. 
13. Subjects who have received neurostimulation in the last 3 months.  
14. Previous urinary incontinence surgery or prolapse surgery using graft 
material within the last 12 months. 
15. Any spinal or genitourinary surgery within the last 6 months. 
16. Previous abdominoperineal resection of the rectum or previous radical 
hysterectomy.  
17. Skin, peripheral edema, orthopedic or neurologic anatomical 
limitations that preclude implantation or/and use of the device. 
18. Diagnosis of interstitial cystitis or bladder pain syndrome as defined by 
either American Urological Association (AUA) or European Association 
of Urology (EAU) guidelines. 

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19. More than minimal level of suspected stress incontinence or mixed 
incontinence with stress component likely to confound study outcome, 
based on a 7-day voiding diary or medical history, or when stress 
incontinence score in the MESA incontinence questionnaire is higher 
than the urgency incontinence score.  
20. Subjects with suspected urinary retention and/or PVR>150ml. 
21. Any neurological disease or disorder including Alzheimer's, Parkinson, 
MS, stroke (CVI), neuropathy or injury resulting in neuropathy and/or 
suspected neurogenic bladder. 
22. Current or recurrent urinary tract infection (3 or more infections in the 
last 6 months), or presence of urinary fistula, or urinary tract 
obstruction such as cancer, urethral stricture or presence of urinary 
stone. 
23. History of chemotherapy or pelvic radiotherapy that might have 
affected bladder control or caused neuropathies (i.e. peripheral 
neuropathy).. 
24. Diabetes with peripheral nerve neuropathy or severe uncontrolled 
diabetes (with HbA1C > 7%). Note: patients with HbA1C in the range of 
7.1-7.5% may be considered eligible based on their complete medical 
record. 
25. Uterine prolapse, cystocele, enterocele or rectocele with pelvic 
prolapse beyond the hymen. 
26. Subjects with a documented history of allergic response to Platinum 
iridium, Titanium, Zirconia, Gold, Silicone or Parylene.  
27. Other active implantable electronic device/s regardless of whether 
stimulation is ON or OFF. 
28. Have a life expectancy of less than 1 year. 
29. Subjects who are breastfeeding. 
30. History of drug or alcohol abuse. 
The following exclusion criteria will be re-evaluated for patients who 
completed 12-months follow-up and exited the study: 
1. Subject whose RENOVA iStim implant has been removed.  
2. Recent participation in another study with an active treatment arm 
within the past 90 days. 
3. Subjects who are unable to operate the RENOVA iStim™ System 
4. Deemed unsuitable for enrollment by the investigator based on history 
or physical examination 
5. Any significant medical condition that is likely to interfere with study 
procedures, device operation, or likely to confound evaluation of study 
endpoints 
6. Any psychiatric or personality disorder at the discretion of the study 
physician 

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7. Subjects who have received botulinum toxin injections within the past 
12 months.  
8. Subjects who have received any neuromodulation therapy in the last 3 
months or implanted with any neuromodulation device  
9. Previous urinary incontinence surgery or prolapse surgery using graft 
material within the last 12 months. 
10. Any spinal or genitourinary surgery within the last 6 months. 
11. Previous abdominoperineal resection of the rectum or previous radical 
hysterectomy.  
12. Diagnosis of interstitial cystitis or bladder pain syndrome as defined by 
either American Urological Association (AUA) or European Association 
of Urology (EAU) guidelines. 
13. Subjects with suspected urinary retention and/or PVR>150ml. 
14. Any neurological disease or disorder including Alzheimer's, Parkinson, 
MS, stroke (CVI), neuropathy or injury resulting in neuropathy and/or 
suspected neurogenic bladder. 
15. Current or recurrent urinary tract infection (3 or more infections in the 
last 6 months), or presence of urinary fistula, or urinary tract 
obstruction such as cancer, urethral stricture or presence of urinary 
stone. 
16. History of chemotherapy or pelvic radiotherapy that might have 
affected bladder control or caused neuropathies (i.e. peripheral 
neuropathy). 
17. Uterine prolapse, cystocele, enterocele or rectocele with pelvic 
prolapse beyond the hymen. 
18. Other active implantable electronic device/s regardless of whether 
stimulation is ON or OFF. 
19. Have a life expectancy of less than 1 year. 
20. Subjects who are breastfeeding. 
 
 
SAMPLE SIZE 
CONSIDERATION 
Sample size calculation, based on the primary endpoint, yields a sample 
size of 114 patients. This calculation assumes an underlying response rate 
of 65%, the null response rate (performance goal) of 50%, with power of 
90% and one-sided significance level of 0.025. To account for up to 15% 
attrition, a total of 134 subjects would be required.  However, the total 
sample size of 150 subjects is driven by an important secondary objective 
that is expected to be evaluable in 70% of enrolled subjects:  The 
proportion of responders at 6 months post system activation as 

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demonstrated by ≥50% improvement in the average number of moderate-
severe urgency episodes PPIUS degree 3,4 or <8 voids/day. 
The assumed underlying response rate is 61%, with performance goal of 
45%, 85% power and one-sided significance level of 0.025 yields a sample 
size of 89 subjects.  To account for up to 15% attrition, 105 subjects are 
required to meet the criteria for this objective.  Assuming 70% of enrolled 
subjects meet the criteria, a total of 150 subjects are required to be 
enrolled. 
STATISTICAL ANALYSIS
For the primary endpoint, the lower 95% Clopper-Pearson confidence 
bound on the overall success rate will be calculated and compared to a 
pre-specified performance goal. Success on the primary analysis will be 
declared if the lower confidence bound is greater than the performance 
goal of 50%. 

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5.  Introduction 
5.1 
Background 
Non-neurogenic lower urinary tract dysfunction or Overactive bladder (OAB) is a common urological chronic 
condition that significantly impairs the quality of life of those affected, with considerable financial costs. OAB 
ranks among the most prevalent and challenging problems in urology [1, 2]. The International Continence Society 
defines OAB as a condition characterized by symptoms of urinary urgency with or without urgency incontinence, 
usually with urinary frequency [3]. In most patients, the etiology of these complaints remains unclear [4]. Earlier 
reports estimated that about one in six adults in the United States and Europe have OAB [5, 6]. The prevalence of 
OAB increases with age [5, 6] thus it is expected that OAB will become more common in the future as the average 
age of people living in the developed world is increasing.  
A European study reports that the prevalence of OAB in Europe has been estimated to be 15.6% and 17.4% for 
men and women respectively, with an overall prevalence of 16.6% [1]. The American Urological Association 
reports studies showing rates as low as 7% to as high as 27% in men and rates as low as 9% to 43% in women. 
Urgency incontinence was reported being higher in women [7]. An estimated 455 million worldwide experienced 
at least one OAB symptom in 2008, with the prevalence expected to increase to 500 million in 2013 and 546 
million in 2018 [8].   
The etiology of non-neurogenic OAB has not been identified, with physiologic abnormalities ruled out by 
diagnostic evaluation. Conservative treatment options for OAB consist of behavioral techniques with or without 
biofeedback, bladder re-education, pelvic muscle exercises or pharmacotherapy [9]. However, for a significant 
proportion of patients, response to treatment is poor and/or may be compromised by troublesome or severe side 
effects [10]. Therefore, other treatment modalities, such as neuromodulation are needed to treat refractory OAB.   
Neuromodulation is a physiological process, which influences the activity in one neural pathway and modulates 
the preexisting activity in another by synaptic interactions [11]. To modulate bladder dysfunction, the stimulator 
signals must be delivered to the neural tissue affecting bladder activity. Different neuromodulative therapies, such 
as stimulation of the pudendal nerve, sacral nerve, and tibial nerve stimulation have been developed with varying 
success rates [12, 13]. 
BlueWind Medical has developed a minimally invasive implantable wireless tibial nerve stimulator for use in the 
treatment of overactive bladder, as described in detail, below.  
5.2 
Study Rationale 
BlueWind obtained CE mark for OAB1000 9 June 2016, certificate 390128DE02. The CE certificate was granted 
among others based on the results from our pilot study described in this protocol. This product is not available on 
the market in Europe or elsewhere. The Investigational Device proposed for this trial is the next generation of the 
system with improvements for increasing patients’ and physicians’ experience in device usability; in addition, this 

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system was designed to improve manufacturability. This model (OAB2000) obtained CE mark approval on 13 Dec 
2019.   
The RENOVA iStim™ is composed of an active implantable unit and an external wearable unit which transmits 
energy via magnetic coupling to the implant, which consequently generates the electrical pulse. It should be noted 
that the sensory reaction associated with the treatment and the intra-operative test performed to ensure proper 
placement of the implant, do not permit blinding of the patients.  
Due to the challenges of maintaining a blinded control arm with the RENOVA iStim™, a “true” RCT using a sham 
control design is not possible, nor is a surgical procedure on a control arm ethical. Taking this into consideration 
and based on prior feedback during the pre-submission process with the FDA, a single arm study design is 
proposed. Each patient serves as her own control and since only refractory OAB patients are included in this study 
there are no expectations that the condition would improve with time without any treatment. The primary and 
secondary endpoints follow-up periods are 6 and 12 months, respectively, to minimize the potential impact of the 
placebo effect and to enable demonstration of durable device effectiveness. 
The proposed OASIS pivotal trial is different from the pilot and the extended studies described in this protocol in 
that, as opposed to the pilot study which was safety oriented, an efficacy primary endpoint was added. Such an 
efficacy-oriented study is essential to gain further medical technology assessment information and hence higher 
scientific value. Several recent studies have raised the awareness to the importance of combining objective and 
subjective results when determining short and long-term efficacy of treatment. Hence, in order to better answer 
a primary efficacy endpoint several validated questionnaires were added and the patient voiding diary was 
modified to allow more accurate capturing of the patients’ reported outcomes.  
An efficacy based single arm study design commonly involves a hypothesis based primary endpoint that includes 
a performance goal. Based on extensive literature review and the pilot and extended follow-up studies’ results, a 
clinically meaningful performance goal was determined which, together is a hypothesis based secondary 
endpoint, result in sample size calculation of 150 patients (see sample size in the statistical section).  
6. BlueWind RENOVA iStim™ System Description 
6.1 
Study Intended Use and Indication for Use 
Intended use: peripheral nerve stimulation. 
Indication for use: treatment of women with symptoms of urgency incontinence alone or in combination with 
urinary urgency and/or urinary frequency. 

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6.2 
System Description 
The BlueWind RENOVA iStim™ System has an implantable wireless neurostimulation component which is 
intended to be placed in the vicinity of the tibial neurovascular bundle.  
The RENOVA iStim™ Implant has no battery; the Wearable Unit transmits energy to the Implant, which sends 
electrical pulses to the tibial nerve. These electrical pulses stimulate the nerve along the leg, reaching the sacral 
plexus - which also contains nerves innervating the bladder, urinary sphincter and pelvic floor. This stimulation 
has the power to modulate the function of these nerves, calming the over-active bladder and relieving OAB 
symptoms. 
The RENOVA iStim™ Wearable Unit is programmed with individual customized Stimulation parameter settings, 
set by the clinician at an initial Treatment Setup visit, having been determined according to the patient’s 
tolerability, sensations and motor thresholds. The patient then receives the personalized Wearable Unit and 
continues Treatment Sessions at home, returning to the clinician periodically for follow-up visits. 
The RENOVA iStim™ System is comprised of the following components: 
• One implantable component - the RENOVA iStim™ Implant 
• Two non-implantable components:  
o RENOVA iStim™ Wearable Unit (with battery charger) 
o RENOVA iStim™ Clinician Programmer (CP) (with battery charger)   
6.2.1 Implant  
The RENOVA iStim™ Implant provides the stimulation current to peripheral nerves in vicinity of the Implant. 
The Implant consists of an electronic assembly within a hermetically sealed encapsulation that is suitable for 
permanent implantation. On the outer surface of the encapsulation there are two ring electrodes which through 
them the stimulation current is delivered to the tissue.  
The Implant is covered by a silicone membrane with suture holes, allowing the surgeon to anchor the Implant to 
the fascia by suturing. 
The implant contains no battery, it is powered and controlled by an external Wearable Unit. Having an external 
power source (see RENOVA iStim™ Wearable Unit, below) increases the implant life time and output capability 
while allowing for a smaller implant size. 
6.2.2 Wearable Unit 
The Wearable Unit wirelessly powers the implant and controls stimulation parameters.  
The RENOVA iStim™ Wearable Unit is designed for two purposes: 
1. Use by the Surgeon — for verifying the Implant's functionality and correct placement in vicinity to the nerve. 
2. Use by the Patient — for delivering routine treatments. 

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The Wearable Device contains an electrical circuit board (which includes the user controls and indications), a 
rechargeable battery and a flexible antenna.  
The Wearable Device communicates with the Clinician Programmer (CP) via Bluetooth Low Energy (BLE). This 
enables the CP to program the Wearable Device and to download the patient’s usage logs.  
The Wearable Unit is paired to a specific Implant and can only communicate (through magnetic coupling) with the 
Implant it is paired with.  
The Wearable Device is supplied with a dedicated charger. 
6.2.3 Clinician Programmer (CP) 
The Clinician Programmer (CP) is the system's interface for treatment control, status evaluation, parameter 
programming and data acquisition. 
The Clinician Programmer which is capable of transferring data to and from the Wearable Unit via a wireless 
connection (via Bluetooth low energy) is designed for two purposes:  
1. During the surgical procedure - when the surgeon wishes to verify the implant position in vicinity to the 
nerve, the CP may be used to monitor the stimulation.  
2. For optimization of therapy for each patient - enables the clinician to set or adjust the stimulation 
parameters of the system as well as to receive treatment logs from the Wearable Unit and present them as 
usage reports. The technician can download this data from the CP to a computer for backup. 
The RENOVA iStim™ Clinician Programmer is comprised of proprietary software that is embedded into a 
commercially available tablet in a single app mode i.e., the tablet can only run the RENOVA iStim™ software. 
Access to the Clinician Programmer is password protected to allow access only to authorized users, namely the 
healthcare professional and the manufacturer. All data transfer does not include any identifying patient 
information. 
6.3 
System Technical Information 
Traceability of clinical investigational systems will be attained during and after the clinical study by assignment of 
serial numbers to each of the system components. The system technical information is specified in the RENOVA 
iStim™ Therapy Clinician User Manual and the components are listed in table 1 below. Software version is 
specified in the Investigator Brochure (G02-CLT-0002).  
Table 1 - BlueWind RENOVA System Components 
Quantity 
Description 
1/patient 
Implant package 

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Quantity 
Description 
 
Implant in sterile pouch; Implant IFU; Patient ID 
card; Patient leaflet;  
1/patient 
Wearable Unit kit 
Wearable Unit with leg band with charger; 
Patient therapy guide 
1/site 
(additional 
back up 
systems can be 
provided to 
site) 
Clinician kit  
Clinician Programmer with charger; Wearable 
Device with charger; Clinician manual; Surgical 
technique guide 
 
7. Pre-Clinical and Clinical Experience with RENOVA iStim™ System1 
7.1 
Pre-Clinical experience with BlueWind RENOVA iStim™   System  
The safety and performance of the system, including assessment of the implant position and technical 
performance, have been examined in an animal trial performed on ovine adult sheep. Eighteen (18) devices were 
implanted in nine (9) animals in the proximity of either the Tibial or Vagal nerves for 2, 30, 90 or 180 days of 
stimulation in order to provide both acute and long-term evidence to the procedure safety and the device 
performance. Stimulation sessions were conducted 5 days a week and up to 3 hours per system per day. Varying 
frequencies, pulse widths, and current amplitudes were used depending on the sheep tolerance.  
The study demonstrated that the RENOVA iStim™ system, including all associated procedures, were found to be 
safe with no effect on animal’s vital signs, well-being and neurological conditions. Minimal adverse events were 
noted following surgery and all were resolved shortly after their identification. Gross pathology as well as 
histopathology revealed no adverse tissue reaction presenting safety concerns. In addition, the implant’s integrity 
was not compromised over time and the implant did not migrate and demonstrated electrical stability.  
7.2 
Clinical experience with BlueWind RENOVA™ System  
The company performed a pilot study to evaluate the use of the BlueWind System in the treatment of patients 
with overactive bladder with or without urgency urinary incontinence. The study was conducted in four European 
sites; two in the Netherlands and two in the UK.  A total of 36 patients were sub-grouped as followed:  
 
1 Previous pre-clinical and clinical testing were performed on the first generation of the device. More detailed information 
is provided in the IB 

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 Patients with no previous treatment with percutaneous tibial nerve stimulation (PTNS) [de novo patient 
group] and  
 Patients with a documented success on PTNS therapy [prior-PTNS group] 
Each subject served as his or her own control and evaluations were performed after 3 and 6-months of 
stimulations, compared to baseline.  
The primary endpoint was safety and the secondary endpoints assessed the performance of the system using 
parameters collected from 3-day voiding diary and a quality of life questionnaire (OAB-q) and were defined as 
follows:  
Primary Endpoints 
The incidence of serious adverse events (system and/or procedure related)  
Secondary Endpoints 
 Six-month clinical improvement compared to baseline was measured by the effect of BlueWind Medical's 
therapy on the treatment of the following symptoms: 
o Number of voids/day 
o Volume voided/void 
o Number of urgency leaks per day 
o Degree of urgency prior to void 
In the presence of urgency incontinence, the following evaluations were performed:  
o Leaking episodes/day  
o Severity of leaking episodes (scale of 0-3; 0-no leak; 1-drops; 2-small amount; 3-large amount) 
o Absorbent pads used due to leaking/day  
 
Quality of Life Questionnaire – OAB-q   
An analysis of 6-months clinical performance success was based on voiding diary parameters, where success was 
defined as a decrease of ≥50% in urgency frequency (UF) and urgency urinary incontinence (UUI) symptoms 
(voids/day or number of episodes with degree of urgency >2 from baseline; or a return to normal voiding 
frequency i.e. <8 voids/day for the UF group; and leaks/day for the UI group). As commonly defined in the 
literature, for the UUI population, dry subjects (no episodes of leakage) were considered as 100% clinical 
improvement. 
Study Procedure 
Subjects were asked to complete voiding diaries and only patients who demonstrated an average urinary 
frequency of at least 8 times/24 hours, and/or patients with urinary urgency leaks of at least 2 leaks on a 3-day 
voiding diary, were eligible to continue to the next enrollment step. Subjects meeting these criteria were tested 
for compatibility with the stimulator system where surface electrodes were placed over the tibial nerve and 
stimulation applied in order to determine whether they experienced a sensory and/or motor response. 

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Subjects who met all enrollment criteria were implanted with the stimulator and returned to the clinic after 2-4 
weeks for activation of the stimulator and parameter setting. Each patient was treated with two different regimens 
employing different stimulation frequencies (6 treatments/week following by 3 treatments/week), with each 
regimen lasting for 3 months. The stimulation parameters for each patient in each treatment regimen were 
customized per patient to ensure a sensory or motor response to the stimulation. Patients were evaluated post 
activation of the stimulation at 1 month, 3 months (end of treatment regimen 1), and 6 months (end of treatment 
regimen 2). All subjects achieving 6-months follow-up remained implanted, without additional follow-ups.  
Safety assessments were based on changes from baseline of clinical signs and symptoms reported by the subject 
or observed by the Investigator.  Performance of the device was assessed using a voiding diary, quality of life 
questionnaire (OAB-q), as well as sensory/motor threshold assessments. 
Subject Demographics 
A total of 36 subjects were implanted with the BlueWind RENOVA™ System where 21 were enrolled into the de 
novo treatment group and 15 subjects in the prior-PTNS treatment group. Thirty-one (31) out of 36 subjects had 
UI at baseline. Twenty-one (21) out of 36 implantation procedures were performed under local anesthesia and 15 
under general anesthesia. The mean surgical operation time was less than 35 minutes. 
Out of the 36 implanted subjects, one subject withdrew from the study due to personal reasons and one device 
was explanted 2 weeks after implantation due to suspected infection, as described further below.  Both of the 
aforementioned subjects exited the study prior to their activation visit. Thus, the safety analysis was performed 
for 36 subjects and performance analysis for 34 subjects (ca. 95% of the population).  
Study Outcomes: 
Safety  
There was a single (1/36, <3%) serious adverse event over the course of the study.  The patient was re-admitted 
approximately 2 weeks' post implantation due to suspected infected implantation site with local pain, skin redness, 
bleeding and fluid discharge from the implanted area. The implant was explanted and the patient was discharged 
from hospital at the following day with a course of antibiotics. The event was resolved without further sequelae 
and culture turned out to be negative. The physician described the SAE as device-related and probably related to 
the procedure.  
Overall 44% of subjects (16/36) experienced adverse events during the study. Surgical procedure-related events 
occurred in approximately 33% of subjects. Device-related adverse event occurred in 36% (13/36) of subjects. The 
most common device-related adverse events were infection (19%; 7/36), implant site pain (14%; 5/36), and 
procedural complications (~8%; 3/36).  
Performance  
Out of 34 subjects in the performance set (one device was explanted due to the SAE and one patient withdrew 
from the study), 70.6% of subjects experienced ≥50% clinical improvement in OAB symptoms at 6-months. In 
subjects suffering from urgency incontinence (UI) at baseline, all UI symptoms (leaks/day, leaks severity and pads 

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change/day) decreased significantly over time. Out of 29 UI subjects, 27.6% became 'dry' (100% improvement) 
after 6-months of treatment. For subjects suffering from urgency frequency (UF), all UF symptoms (void/day, 
volume/void, pads changed) significantly improved during treatment as compared to baseline.   The clinical 
improvement was also supported by an improvement in the quality of life of patients, demonstrated by significant 
improvement in the health-related quality of life and symptoms severity scores following 1,3, and 6-months of 
treatment with the BlueWind Medical system, as well as an increase of all HRQL subscales above the minimal 
important difference (MID) that is considered clinically meaningful. The PTNS group showed similar results as the 
De-novo group. The intensity level during sensation assessments (minimal sensation level and maximal tolerable 
level) did not change significantly at all follow-up visits compared to baseline. 
Extended follow-up study: 
Twenty OAB patients, who were previously implanted with the RENOVA iStim system for the 6-month follow-up 
pilot study, were re-enrolled for an extended, 3-year, follow-up study. No SAEs were reported during the extended 
follow-up. In both the per-protocol analysis as well as the intent to treat analysis (ITT) 75% of the patients 
demonstrated clinical success in OAB symptoms (defined as: ≥50% reduction in urgent voids or leaks or 
normalization of voids) during the long term, 3-year, follow-up. In addition, in the per-protocol population 58% 
and 75% of the wet OAB patients showed >50% reduction in the average number of leaks and large leaks at 3 
years, respectively, and in the ITT population 50% and 80% of the wet OAB patients showed >50% reduction in the 
average number of leaks and large leaks, respectively. This was supported by statistically significant long-term 
sustainable improvement in the overall Health Related Quality of Life (HRQL) score as well as in all subscales 
(coping, sleeping, concern, social) and in the symptoms severity score, with 70% of the patients showing >10 points 
improvement (meaningful important difference) in HRQL. 
Hence, BlueWind Medical RENOVA iStim system demonstrates long term safety and efficacy. The long-term 
success rate is comparable with the 6 months success rate. 
8. Risks and Benefits 
RENOVA iStim™ therapy has been tested in a clinical trial on patients suffering from OAB who did not respond to 
other treatments - such as, a change in diet, biofeedback and medication. 
For 70% of these patients, the therapy succeeded in producing a clinical improvement in their OAB symptoms 
(≥50% reduction in urgency urinary incontinence or voiding episodes or normalization of voids or ≥50% reduction 
in moderate-severe urgency related voids). 
In 51% of patients suffering from urinary urgency leaking episodes, RENOVA iStim™ therapy succeeded in 
producing a ≥50% reduction in this symptom, while almost 30% experienced complete alleviation of this symptom. 
Clinical improvement was also supported by significant improvements in all aspects of Quality-of-Life (concern, 
coping, sleep, and social) and a significant decrease in symptom severity. 

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The potential risks related to this study are the known risks of surgical procedures and electrical stimulation. The 
sponsor and the investigators have determined that this study is justified because of the potential benefit to 
patient’s symptoms relief as a result of the BlueWind RENOVA iStim™ System treatment effect. 
Anticipated adverse events involved with the surgery include: bleeding, pain at stimulator site, ankle discomfort, 
implant site infection, skin irritation, skin erosion, seroma, formation of thrombosis and pulmonary embolism, 
potential temporary or permanent mobility impairment and nerve injury.  
Anticipated adverse events involved with the stimulation include: undesirable changes in stimulation such as 
sensation of transient electric "shock"/sudden radiating sensation/sporadic sensory response, uncomfortable 
heating effects, discomfort, or burn. 
Transient unpleasant sensations noted by subjects which may occur during a programming optimization session 
are not considered adverse events. Stimulation related side effects that persist beyond the programming session 
should be reported as adverse events.  
Anticipated adverse events involved with the treatment include: adverse change in voiding/bowel function, 
transient nausea. 
Anticipated adverse events involved with the device include: spontaneous sensory response (not in association 
with stimulation), implant migration or displacement, allergic reaction and technical device problems. 
Many of the anticipated risks are considered minor, reversible and well tolerated (per studies performed with the 
BlueWind system). 
Risk mitigation will include the selection of experienced, qualified investigators, and their training on proper 
performance of the surgical procedure, as well as on-site attendance by sponsor qualified representatives and 
ongoing safety monitoring by the trial DSMB and CEC. 
When considering the totality of the data, including all risks identified in the risk analysis as well as all AE reported 
in the pilot study and comparing it to the reported benefits for OAB patients, it is apparent that overall the 
potential benefits are higher than the overall risks associated with the implantation procedure and treatment.  
In summary, when considering carefully the risk-benefit ratio for this patient population, the following support the 
further evaluation of the BlueWind RENOVA iStim™ System in a pivotal trial:  
 
The magnitude of healthcare problem attributed to overactive bladder  
 
The low risk associated with tibial nerve stimulation in this and other applications 
 
Population had failed conservative treatments, without many further options left  
 
The positive results of the pilot study  
9. Traceability  
Complete traceability records will be kept of all investigational devices and accessory equipment used during the 
study. 

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10.  Protocol Design 
10.1 
Study Objectives 
 
To demonstrate efficacy of BlueWind RENOVA iStim™ System therapy in females with UUI  
 
To demonstrate the safety of BlueWind RENOVA iStim™ System therapy in females with UUI 
10.2 
Study Design 
10.2.1 Study Scope 
This study is designed as a prospective, interventional, multi-center, single arm, open label study.   
It is expected that 150 evaluable subjects (attempted implanted with the device) overall will be enrolled in 
the study in up to 30 sites. To ensure patient safety, a full report of safety data for up to 30 subjects who 
undergo an implantation of the RENOVA iStim will be reviewed by the DSMB. Screening activities will continue 
during the review of this data; however, no implantations will occur until the DSMB recommends to continue. 
10.3 
Study Endpoints 
10.3.1  Primary Endpoint  
Efficacy 
 Proportion of responders at 6 months post system activation as demonstrated by ≥50% improvement in 
average number of urgency related incontinence episodes, measured by 7-day Patient Voiding Diary. 
- Overall study success criteria is defined as a lower 97.5% confidence bound for a single binomial 
proportion of >50% patient success at 6 months 
 
Safety 
    Incidence of adverse events from implantation to 12-months post-activation. 
10.3.2 Secondary Endpoints 
Bluewind will test three secondary endpoints. In order to control type I error of the family of secondary 
objectives at 5%, secondary objective hypothesis testing will only occur upon rejection of the primary 
objective null hypothesis.   
 
Proportion of subjects with ≥10 points (MID) improvement in HRQL (based on OAB-q) at 6 months post 
system activation 
 
Proportion of responders at 12 months post system activation as demonstrated by ≥50% improvement in 
either average number of urgency related incontinence episodes or average number of severe/large 
urgency related incontinence episodes, as measured by 7-day Patient Voiding Diary. 

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 
Proportion of responders at 6 months post system activation as demonstrated by ≥50% improvement in 
the average number of moderate-severe urgency episodes PPIUS degree 3,4 or <8 voids/day  
10.3.3 Other Endpoints 
The following endpoints will be assessed as other endpoints for the 6-, 12-, 24- and 36-months post activation, 
without formal hypothesis testing and type I error control. 
 
Incidence of procedure or device related adverse events from 12- to 36-months post activation 
 
Patient Global Impression of Improvement (PGI-I) score 
 
Treatment Benefit, Satisfaction, and Willingness to Continue (BSW)  
 
Reduction in the average number of severe/large urgency related incontinence episodes 
 
Improvement in OAB-q (HRQL and symptoms severity). 
 
Changes in the following OAB symptoms as measured by voiding diary compared to baseline: 
o Reduction in the number of micturition episodes. 
o Reduction in the number of urgency related incontinence episodes. 
o Reduction in degree of urgency prior to void on Patient Perception of 
Intensity of Urgency Scale (PPIUS) from 0-4.  
o Reduction in severity of incontinence episodes (amount leaked). 
 
Proportion of dry subjects following treatment with the RENOVA iStim System as measured by 3 
consecutive days of a patient voiding diary 
 
Assessment of fecal incontinence symptoms in patients suffering from mixed fecal and urine incontinence 
 
Patient compliance with treatment 
 
Duration from treatment initiation to symptoms improvement (in subset of patients who stopped 
treatment after completing the 12-month visit and started again when consented for the long-term 
follow-up). 
 
Device usage 
10.4 
Medication Usage 
If used, patients should be on stable dose of OAB related medication (i.e. antimuscarinics and/or beta-3 adrenergic 
agonists for at least 3 months prior to baseline and agree to remain on stable medication consumption until the 
12-month follow-up visit. 
If used, patients should be on a stable dose of tricyclic antidepressants, Selective Serotonin Reuptake Inhibitors 
(SSRI) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRI)) for at least 3 months prior to baseline.  
Type and dosage of OAB related medications as well as any change in consumption during the study will be 
recorded in the CRF. All other medication consumption will be recorded in the CRF during the baseline visit and 
tracked 3 months back.  

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Patients should avoid any OAB intervention (such as PTNS, SNM, or other neuromodulation treatments, Botox 
injections, surgical procedures, etc.) that may have an effect on overall study results throughout the 36 months 
follow-up period.  
10.4.1 Allowed/disallowed medication 
Patients will be administered prophylactic antibiotic and anti-inflammatory medications peri-operative (per 
section 11.4.2).  
10.4.2 Documentation of concomitant medication  
Any of the following concomitant medication consumption and dosages will be recorded in the CRF: Antibiotics, 
diuretics, anti-inflammatory, psychiatric medication, medication used to treat adverse events, cardiac, renal and 
endocrinology medication and any other medication that might affect urine output. 
If there is a medical requirement to change OAB, diuretics or antidepressant medication during the study, these 
changes will be recorded and the patient will continue the study as planned. 
10.5 
Measurements 
The clinical investigation variables will be assessed at baseline and/or at follow up visits using the following 
instruments: 
 
Voiding diary (7 day or 3 day): includes measurements of frequency, urgency, number 
of leaking episodes, leaks severity /amount leaked, and fluid consumed 
 
Quality of life questionnaire (OAB-q) 
 
Patient Global Impression of Improvement (PGI-I) 
 
Treatment Benefit, Satisfaction, and Willingness to Continue (BSW) questionnaire 
10.6 
Study Population 
10.6.1 Patient Population 
Women suffering from overactive bladder (OAB), including symptoms of urinary urgency incontinence (UUI). 
10.6.2 Number of Subjects 
One hundred fifty (150) subjects will be enrolled into the study to test the primary objective hypothesis (taking 
into account for up to 15% attrition). 
10.7 
Eligibility Criteria  
10.7.1 Inclusion Criteria 
1. Signed written informed consent. 

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2. Female aged 18 or greater (21 or greater in the US), with no plans to become pregnant during the trial; 
if of bearing potential, negative pregnancy test and if sexually active, using acceptable contraception. 
3. Subject who is mentally competent with the ability to understand and comply with the requirements 
of the study. 
4. Diagnosis of UUI demonstrated on a 7-consecutive days voiding diary defined as a minimum of nine (9) 
leaking episodes associated with urgency, with at least one episode per day for 5 days.  
5. More than or equal to 6 months history of UUI diagnosis 
6. Subject with inadequate response to any of the following conservative treatments (i.e. dietary 
restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, 
biofeedback, etc.) and pharmacologic treatment.  
7. If used, subjects should be on stable dose of antimuscarinics and/or beta-3 adrenergic agonists for at 
least 3 months prior to baseline and agree to remain on stable medication consumption until the 12-
month follow-up visit. 
8. If used, subjects should be on a stable dose of tricyclic antidepressants, Selective Serotonin 
Reuptake Inhibitors (SSRI) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRI) for at least 3 
months prior to baseline. 
9. Subjects with positive tibial nerve motor or sensory response tested via physical/neurological 
examination. 
10. Subjects with normal renal function defined by GFR of 50 ml/min or more 
11. Leg circumference of no less than 20 cm and no more than 30 cm at implantation site (i.e. 5cm above 
the medial malleolus). 
12. Subject agrees to attend all follow-up evaluations and is willing and capable to completely and 
accurately fill out voiding diaries and questionnaires and is willing to complete required exams and 
tests. 
 
The following inclusion criteria will be re-evaluated for patients who completed 12-months follow-up 
and exited the study: 
1. Subject who is mentally competent with the ability to understand and comply with the 
requirements of the study. 
10.7.2 Exclusion Criteria 
1. Previous participation in another study with any investigational drug or device within the past 90 days. 
2. Subjects who are unable to operate the RENOVA iStim™ System 
3. Deemed unsuitable for enrollment by the investigator based on history or physical examination 
4. Subjects at high surgical risk with multiple illnesses or active general infections that expose them to 
excessive bleeding or delayed or non-healing wounds. This includes patients who need anticoagulation 
therapy that cannot be temporarily stopped for the implantation procedure 

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5. Any significant medical condition that is likely to interfere with study procedures, device operation, or 
likely to confound evaluation of study endpoints 
6. Subject has morbid obesity (>50 BMI) 
7. Any psychiatric or personality disorder at the discretion of the study physician 
8. PHQ-15 Patient Somatization Score ≥ 20   
9. Any metal or other implant in the area of BlueWind RENOVA iStim™ implantation site (20cm distance). 
10. Variation in diuretics consumption within the last 6 months.  
11. Subjects who have received botulinum toxin injections within the past 12 months.  
12. Failure to respond to previous neuromodulation therapy for overactive bladder. 
13. Subjects who have received neurostimulation in the last 3 months.  
14. Previous urinary incontinence surgery or prolapse surgery using graft material within the last 12 months. 
15. Any spinal or genitourinary surgery within the last 6 months. 
16. Previous abdominoperineal resection of the rectum or previous radical hysterectomy.  
17. Skin, peripheral edema, orthopedic or neurologic anatomical limitations that preclude implantation 
or/and use of the device. 
18. Diagnosis of interstitial cystitis or bladder pain syndrome as defined by either American Urological 
Association (AUA) or European Association of Urology (EAU) guidelines. 
19. More than minimal level of suspected stress incontinence or mixed incontinence with stress component 
likely to confound study outcome, based on a 7-day voiding diary or medical history, or when stress 
incontinence score in the MESA incontinence questionnaire is higher than the urgency incontinence score  
20. Subjects with suspected urinary retention and/or PVR>150ml. 
21. Any neurological disease or disorder including Alzheimer's, Parkinson, MS, stroke (CVI), neuropathy or 
injury resulting in neuropathy and/or suspected neurogenic bladder. 
22. Current or recurrent urinary tract infection (3 or more infections in the last 6 months), or presence of 
urinary fistula, or urinary tract obstruction such as cancer, urethral stricture or presence of urinary stone. 
23. History of chemotherapy or pelvic radiotherapy that might have affected bladder control or caused 
neuropathies (i.e. peripheral neuropathy). 
24. Diabetes with peripheral nerve neuropathy or severe uncontrolled diabetes (with HbA1C > 7%). Note: 
patients with HbA1C in the range of 7.1-7.5% may be considered eligible based on their complete medical 
record. 
25. Uterine prolapse, cystocele, enterocele or rectocele with pelvic prolapse to or beyond the hymen. 
26. Subjects with a documented history of allergic response to Platinum iridium, Titanium, Zirconia, Gold, 
Silicone or Parylene.  
27. Other active implantable electronic device/s regardless of whether stimulation is ON or OFF. 
28. Have a life expectancy of less than 1 year. 
29. Subjects who are breastfeeding 
30. History of drug or alcohol abuse. 
 

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The following exclusion criteria will be re-evaluated for patients who completed 12-months follow-up and exited 
the study: 
1. Subject whose RENOVA iStim implant has been removed.  
2. Participation in another study with an active treatment arm within the past 90 days. 
3. Subjects who are unable to operate the RENOVA iStim™ System 
4. Deemed unsuitable for enrollment by the investigator based on history or physical examination 
5. Any significant medical condition that is likely to interfere with study procedures, device operation, or 
likely to confound evaluation of study endpoints 
6. Any psychiatric or personality disorder at the discretion of the study physician 
7. Subjects who have received botulinum toxin injections within the past 12 months.  
8. Subjects who have received any neuromodulation therapy in the last 3 months or implanted with any 
neuromodulation device  
9. Previous urinary incontinence surgery or prolapse surgery using graft material within the last 12 months. 
10. Any spinal or genitourinary surgery within the last 6 months. 
11. Previous abdominoperineal resection of the rectum or previous radical hysterectomy.  
12. Diagnosis of interstitial cystitis or bladder pain syndrome as defined by either American Urological 
Association (AUA) or European Association of Urology (EAU) guidelines. 
13. Subjects with suspected urinary retention and/or PVR>150ml. 
14. Any neurological disease or disorder including Alzheimer's, Parkinson, MS, stroke (CVI), neuropathy or 
injury resulting in neuropathy and/or suspected neurogenic bladder. 
15. Current or recurrent urinary tract infection (3 or more infections in the last 6 months), or presence of 
urinary fistula, or urinary tract obstruction such as cancer, urethral stricture or presence of urinary stone. 
16. History of chemotherapy or pelvic radiotherapy that might have affected bladder control or caused 
neuropathies (i.e. peripheral neuropathy). 
17. Uterine prolapse, cystocele, enterocele or rectocele with pelvic prolapse beyond the hymen. 
18. Other active implantable electronic device/s regardless of whether stimulation is ON or OFF. 
19. Have a life expectancy of less than 1 year. 
20. Subjects who are breastfeeding. 
10.8 
Patient Withdrawal and Lost to Follow Up 
10.8.1 Discontinuation of Subjects 
Each subject who is enrolled and treated should remain in the clinical trial until completion of the required follow-
up period. However, a subject’s participation in any clinical trial is voluntary and the subject has the right to 
withdraw at any time without prejudice. Should this occur, the reason for withdrawal must be documented in the 
subject medical record. A subject may be discontinued from study treatment at any time if the subject or the 
investigator feels that it is not in the subject’s best interest to continue.   
It is recommended not to explant the device unless there is a specific medical need or otherwise deemed 
necessary by the treating physician.  

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Anticipated reasons for discontinuation may include, but are not limited to the following: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
If a subject is withdrawn from treatment due to an adverse event, the subject will be followed and treated by the 
Investigator until the abnormal parameter or symptom has resolved or stabilized. 
10.8.2 Lost-to-Follow-up 
Site personnel should make all reasonable efforts to locate and communicate with subjects at each contact time 
point. If there is difficulty contacting the subject, a minimum of two attempts to contact the subject should be 
documented. If the subject misses two consecutive scheduled study visit time points and the above-mentioned 
attempts at communicating with the subject are unsuccessful, and the subject is known to be alive the subject 
will be considered as “consent withdrawal”. If the patient’s vital status cannot be confirmed the subject will be 
considered “lost-to-follow-up”. If the reason for discontinuation from the study was made clear by the patient, 
then it should be documented in the CRF accordingly. 
10.8.3 Study Discontinuation 
The Study Completion/Discontinuation Form must be completed for all patients and should specify the reason for 
discontinuation or the completion of the study.  
 
The Sponsor shall be notified of the reason for subject discontinuation. The site will provide this information on 
the Study Completion/Discontinuation Form (CRF/e-CRF) and on source documents. Investigators must also 
report this to their EC if defined by their institution’s procedure.  
In case where an implant removal is required in any stage of the clinical study or afterwards, the sponsor will bear 
the costs of having it removed. 
Subject Withdrawal:
Subject participation in a clinical trial is voluntary and the 
subject may discontinue participation (refuse all subsequent 
testing/ follow-up) at any time without loss of benefits they 
would be otherwise entitled to. 
Investigator Termination:
Investigator may terminate the subject´s participation without 
the subject´s consent if the Investigator believes it´s medically 
necessary. 
Lost to Follow-up:
Subject does not complete the scheduled follow-up visits but 
has not “officially withdrawn” from the trial (this does not apply 
to missed visits). 
Failure (lack of effect):
Subject leaves the study due to related AE, device explant, lack 
of effect that results in significant increase of UUI medication 
and the need for other 3rd line therapies for the management of 
UUI. 

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10.9 
Study Duration 
Overall study duration is estimated to be 5 years including about 18 months for enrollment. The study duration 
per patient is 38-42 months and includes; baseline assessments, followed by implantation, activation and 
treatment initiation one-month post implantation and 36 months of follow-up period post system activation.   
11. Conduct of the Study 
11.1 
General 
The study will be conducted according to ISO 14155:2020, Good Clinical Practice guideline E6(R2) form November 
2016, the Declaration of Helsinki (2013), Protection of Human Volunteers (21 CFR 50), Financial Disclosure by 
Investigators (21 CFR Part 54), Electronic Records and Electronic Signatures (21 CFR Part 11), Investigational 
Device Exemption (21 CFR Part 812) and in accordance with local laws and regulations in each of the countries 
participating. All data and information concerning subjects and their participation in this trial are considered 
confidential by the sponsor and its designees. Only authorized investigators and Sponsor or designated personnel 
will have access to confidential records. The EC and other regulatory authorities also have the right to inspect and 
copy records pertinent to the trial. All public reporting of the results of the trial will eliminate identifiable 
references to the subjects. Patients will be identified by a unique ID number. The patient's name and other 
identifying information will be removed from any study document to maintain confidentiality. 
The Ethics Committee approval for the trial is required prior to the beginning of the trial. 
11.1.1 Investigator and Site Qualification 
Urologists and Urogynecologists who have surgical skills applicable for BlueWind system implantation and an 
adequate volume of OAB patients being seen in their clinics will be enrolled as investigators for the trial.  
A pre-study visit (site selection and qualification visit) will take place in order to assess the site’s ability to 
participate in the study. 
11.2 
Physician Training 
Prior to study initiation, the BlueWind Medical team will familiarize the physician (and his/her study staff) on the 
system and the conduct of the study. BlueWind Medical specialists will train the physician on the surgical 
technique as well as the system activation and data collection. Only surgeons trained and qualified by BlueWind 
will be allowed to implant the device during the course of this study. 
Training on the surgical procedure may include a session by a proctor and in some cases, when applicable, by a 
cadaver lab. During the first implantation/s in each site, a proctor may be present in the procedure, and a trained 
BlueWind representative for technical support will accompany all of the implantations. In an event that a new 

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issue related to the use of the system and/or the surgical procedure will be raised in the course of the study, the 
sponsor will perform periodic advanced training sessions, as applicable (for full training instructions, please refer 
to G02-CLI-0002 Rev. 02). 
11.3 
Baseline Evaluation 
Potential female subjects with UUI, who fulfil basic criteria will be informed of the study and will be invited to sign 
an informed consent form. Prior to participating in the study, the investigator will inform the patient orally and in 
writing about the scope, purpose, rights, duties and possible risks of participating in the study. The patient has to 
confirm her consent in writing. Subjects are considered as eligible to undergo device implantation upon signing 
an informed consent, baseline evaluations are successfully completed, and all eligibility criteria are met. 
11.4 
Study Visits  
This study is designed as a single arm interventional study. It consists of baseline assessments, implantation of the 
BlueWind RENOVA iStim™ System, treatment activation and 12 months of follow-up period post activation of the 
device.  
The study will consist of the following activities (see flow chart on Figure 1): 
 
Enrollment and screening: Potential study candidates will sign an informed consent form, complete a 7-
day voiding diary, MESA incontinence questionnaire, PHQ-15 questionnaire and quality of life 
questionnaire (OAB-q) and will undergo a PVR measurement. Data collected will serve for establishing 
eligibility for the study and as a baseline data for purposes of evaluating efficacy. Subjects fulfilling all 
inclusion and none of the exclusion criteria will be enrolled to the trial. 
- 
If a subject already completed the 12-month follow-up visit and exited the study, she will be 
invited for a long-term follow-up consent visit in which, following her consent to participate, 
some eligibility criteria will be verified and treatment parameters setting will be performed.  
 
Implantation – At 6 ± 4 weeks after screening visit, eligible subjects will undergo unilateral implantation 
with the BlueWind RENOVA iStim™ System.  
 
Activation and Treatment: 4 weeks +/- 2 weeks post implantation, subjects will undergo parameter 
setting, and will be trained for system home use treatment. Therapy will be delivered daily for a minimum 
of 30 mins per day and maximum of 2 hours per day.  
 
Follow-ups visits (clinic): will be performed at 1 month ± 2 weeks, 3 months ± 2 weeks, 6 months ± 4 
weeks, 9 months ± 4 weeks,12 months ± 4 weeks, 24 months ± 6 weeks, and 36 months ± 6 weeks post 
system activation. During the follow-up visits a voiding diary will be collected. During the 6,12, 24 and 36 
months follow-up visits quality of life (OAB-q), PGI-I, and BSW questionnaires will be collected.  
Stimulation parameters and level of treatment will be checked and adjusted as needed.  
 
Follow-ups visits (calls): will be performed at 18 months ± 6 weeks and 30 months ± 6 weeks post system 
activation. During the follow-up visits a 3-day voiding diary will be collected.  

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- 
NOTE: Follow-up visits may be performed in clinic if needed (ie. Treatment parameter adjustment, 
AE or device malfunction, etc. 
Prior to each visit, sites will attempt to call the patients to remind them to comply with their treatment regimen 
and complete their voiding diaries.  
Under certain circumstances (e.g. patient is unable to arrive to clinic, device replacement), home visits or limited 
phone visits will be arranged.  Personnel involved in such visits will be those involved in the regular sites’ visits. 
Since patients may not be able to come to the investigational site for follow-up visits, alternative methods such 
as phone contact or a virtual visit will be performed when feasible. NOTE: Baseline, Implantation, and Activation 
cannot be performed.  
 
If a phone or virtual visit is performed, it may not be possible to collect the following study data: urinalysis, 
parameter settings, and leg circumference measurements. The evaluation of these assessments is not 
necessary to ensure patient safety but will result in missing data or will be completed when on-sites visits 
will be allowed.  
 
If a phone or virtual visit is not possible, the visit will be performed out of window or considered a missed 
visit.  
Missed visits, visits performed out of window, or missing data resulting from disruption of the clinical trial during 
the COVID-19 pandemic will be reported as protocol deviations. A listing of all impacted patients and a description 
of how their participation was altered will be described in the clinical study report. 
A full study schedule chart is available in Section 25.  

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Figure 1 -The BlueWind RENOVA iStim™ system Study Design Flowchart 
  

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Subjects who completed the study and are re-entering for long term follow-up: 
 
 
 
11.4.1 Patient Enrollment (Baseline) – Visit 1 
Potential female subjects with wet OAB, who fulfil basic criteria will be informed of the study and will be invited 
to sign an informed consent form. Screening will include the following:  
 
Patient demographics (age, race, height, weight and leg circumference), and medical and surgical 
history review including duration of OAB, type of incontinence (i.e. based on the MESA incontinence 
questions, voiding diary and medical history) and severity of OAB, as well as information on existence 
of mixed fecal and urine incontinence and severity of the fecal incontinence, will be collected 
 
Medication use review (listing of type and doses): Patient who is eligible to enroll, will be asked to 
agree to remain on stable OAB medications until the 12-months follow-up visit. If there is a medical 
requirement to change medication during the study, these changes will be recorded and the patient 
will remain in the study as planned. 
 
Physical examination including abdominal and pelvic examination and neurological exam. Pelvic 
examination will include examination for vaginal abnormalities and pelvic muscles strength.  As part 
of the physical/neurological examination, tibial nerve integrity will be verified by assessing sensory 
and motor response associated with this nerve per physician discretion. The motor function of the 
tibial nerve can be evaluated by testing the strength of the toe flexors. The gastrocnemius and 
abductor hallucis muscles can also be evaluated for the presence of atrophy. The sensory function of 
the tibial nerve can be evaluated by testing touch, pinprick and temperature sensation in the plantar 
aspect of the foot.   

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 
Urinalysis and urine culture – if urinalysis or urine culture suggest the presence of urinary tract 
infection, patient should be treated and should start completing the baseline diary after treatment 
has been completed and urinalysis and culture are negative.  
 
Urine/blood pregnancy test (if bearing potential). 
 
Blood test for Creatinine levels (GFR) and HbA1C will be performed. 
 
A PVR measurement will be performed. 
 
Quality of life questionnaire (OAB-q). 
 
PHQ-15 questionnaire. 
 
Patients will receive a 7-day consecutive voiding diary and will be instructed to begin completing the 
diary immediately after the visit to record, among other things, instances of urgency urinary 
incontinence, number of voids per day, degree of urgency prior to voiding/leaking, severity of leaking 
episodes and number of stress related incontinence episodes per day.  Results will be sent to the clinic 
to complete the eligibility criteria. 
o 
Patients who fail to complete the diaries or fail the inclusion/exclusion criteria, will not be enrolled 
in the study.  
 
All of the above data collected will serve as baseline.  
Subjects who already completed the 12-month follow-up visit and exited the study prior to the addition of the 
long-term study visits will be invited for a consent visit in which, following her consent to participate, some 
eligibility criteria will be verified. Screening will include the following:  
 
New medical and surgical history review since the 12-month visit  
 
Medication use review (listing of type and doses) 
 
Physical and neurological examination and urinalysis will be performed. If the urinalysis suggests 
urinary tract infection, urine sample will be sent for culture and sensitivity. 
 
Urine or blood pregnancy test (if bearing potential). 
 
Subjects will receive a 3-day consecutive voiding diary and will be instructed to begin completing the 
diary immediately after the visit to record, among other things, instances of urgency urinary 
incontinence, number of voids per day, degree of urgency prior to voiding/leaking, severity of leaking 
episodes and number of stress related incontinence episodes per day. 
• 
If the subject discontinued treating herself after completion of the 12-month visit, she will be 
asked to complete a modified daily diary to capture incontinence episodes, time to treatment 
effect, and symptom improvement questions.  
 
Subjects will undergo parameters' setting, and will be re-trained for system home use. Device 
activation, as well as parameter setting will be performed using the Clinician Programmer according 
to the BlueWind Clinician Manual.  

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11.4.2 BlueWind RENOVA iStim™ Implantation – Visit 2 
The implantation of the device is carried out once the patient passed all inclusion/exclusion criteria and at  6 ± 4 
weeks from the first day of the baseline diary. In the case of a patient who has to repeat the baseline diary, the 
window will be 6 ± 4 weeks from the first date of the final baseline diary.   The investigator will perform a partial 
physical examination and confirm that there has not been any change to the medical condition of the patient that 
may necessitate excluding such patient from the study as well as record any changes to concomitant medication 
consumption.  The procedure is performed under local anesthesia. If during the procedure, general anesthesia is 
warranted, the physician may decide to do so per his discretion and CRF should be filled out accordingly.  In order 
to minimize the risk of post-operative infections several steps should be taken: 
o 
In the evening before the surgery and the morning of the surgery patients will be asked to perform a 
scrub of the surgical site with antiseptic soap at home.  
o 
Prophylactic analgesia and intravenous antibiotic (i.e. Cefazolin and/or Clindamycin) should be 
administered 15-60 minutes before the beginning of the procedure to ensure sufficient tissue level.  
o 
A thorough 10-minute skin scrub with antiseptic preparation (i.e. chlorhexidine) must be performed 
followed by alcohol wipe, appropriate draping of the incision area and strict antiseptic technique 
throughout the procedure.  
BlueWind RENOVA iStim™ System implantation will be conducted according to BlueWind Medical Surgical 
Technique Guide and the training and qualification program. Ultrasound may be used as part of the surgical 
preparations for training purposes or per physician discretion to better understand the anatomy. In principal, 
after a 5cm long incision at the appropriate location is made and the crural fascia is exposed and dissected, the 
posterior tibial neurovascular bundle is identified and the site is thoroughly irrigated. The implant is placed over 
the bundle in the appropriate orientation, while ensuring that the implant is parallel to the skin, not deeper than 
3 cm below the skin, and not more than 10 mm from the nerve. The implant is then partially sutured to the fascia 
using non-absorbable suture material. An intra-operative sensory/motor test will be performed to verify proper 
implant location. An optimal result is paresthesia and/or motor response achieved at a low or moderate level of 
stimulation (≤ 5 mA). If results are non-satisfactory, the Implant may need to be re-positioned closer to the tibial 
nerve and the test repeated. The test stimulation shall be repeated after implant is completely secured to the 
fascia. In rare events that the neurovascular bundle is not identified or intra-operative stimulation was not 
successful in provoking a response, the contralateral leg may be attempted per physician’s discretion. For 
subcutaneous tissue closure an absorbable poly-filament suture (such as 4-0 Vicryl) should be used and for the 
skin outer layer, either an interrupted pattern using non-absorbable mono-filament (such as 3-0 nylon) or a 
continuous intradermal pattern using an absorbable monofilament (such as 4-0 Monocryl), should be used. Intra-
operative test will be performed for the last time.  Antibiotic (Cephalexin or Clindamycin) and analgesics should 
be administered for the first 24 hours and may be dispensed longer according to the clinician discretion.  Around 
14 days following the implantation procedure, the patient will be instructed to attend the clinic for sutures 
removal. Patients will be instructed regarding the healing process of the wound, how to treat the wound and what 
to avoid during the two weeks following the procedure (i.e., elevate the operated leg above level of waist when 

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sitting or lying as much as possible during the first 72 hours post operation, avoid rigorous activity, keep the area 
dry and undisturbed).  
Typical symptoms of discomfort related to the surgical procedure (such as incision pain and/or swelling, etc.) are 
expected in this kind of surgical procedure, and may take up to 5 days post procedure for complete resolution. 
Therefore, these symptoms are not considered as adverse events and thus should not be reported unless they 
are clearly related to RENOVA iStim™ system. 
Wound healing in the distal leg region typically takes more time than in wound located more proximal or in the 
trunk, it is therefore normal to see some degree of redness and edema at the time of suture removal and complete 
healing duration of 2-4 weeks post-op.  
Giving antibiotics as a precaution in cases as described above should not warrant automatically classifying them 
as an infection. Implant site infection should be reported when physical evidence of an infection are identified 
(such as described in table 2: Incisional wound classification). 
11.4.3 BlueWind RENOVA iStim™ System Activation  - Visit 3 
After a recovery period of 4-weeks ±2 weeks post implantation, system activation based on sensation and motor 
assessment will be conducted as well as surgical wound inspection, in the outpatient clinic. Subjects will undergo 
an acute stimulation session of the tibial nerve to evaluate their sensory/motor reaction to stimulation. 
Thereafter, subjects will undergo parameters' setting, and will be trained for system home use. Device activation, 
as well as parameter setting will be performed using the Clinician Programmer according to the BlueWind Clinician 
Manual.  
Parameter setting will be individually set for each patient, with stimulation parameters of: 
 
Frequency of up to 30Hz 
 
Peak current of up to 14mA 
 
Pulse width of up to 790µsec 
Sensory and motor thresholds will be assessed and recorded. Tailored patient therapy parameters will be adjusted 
based upon patient tolerability, patient sensation and motor threshold. Stimulation parameters will be modified 
for each patient in a stepwise process, until a sensory response (tingling sensation in the ankle, foot, toes and 
sometimes a radiation sensation in the leg and/or genital area) or a sensory response in combination with a motor 
response (flexion of the big toe, fanning out of digits 2-5, extension of the foot) is elicited. The optimal stimulation 
parameters selected will be comfortable and under the maximal tolerability intensity level. 
Physical and neurological examination and urinalysis, will be performed. If the urinalysis suggests urinary tract 
infection, urine sample will be sent for culture and sensitivity. 
Concomitant medication and AEs will be documented. 

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11.4.4 BlueWind RENOVA iStim™ System Treatment 
Treatment will include a daily stimulation of a minimum of 30 minutes and a maximum of 2 hours, per physician 
discretion.  
Subject therapy parameters (frequency, pulse width and current) will be adjusted according to the individual 
patient sensations and according to the above specified range. Treatment parameters set at each visit will be 
recorded in the CRF.  
11.4.5 BlueWind RENOVA iStim™ System Follow Up Visits – Visits 4-8 
Patients will attend the clinic at 1-, 3-, 6-, 9- and 12-months post system activation. Patients will be asked to fill in 
an electronic voiding diary (a 3-day diary at the 1-, 3- and 9-months post activation visits and a 7-day diary at the 
6- and 12-months visits), immediately prior to every follow-up visit. Only after electronic diary information is 
entered to the EDC the tentatively scheduled visit will be confirmed. 
Patients may receive several treatment programs to choose from based on treatment effect and comfort and 
accordingly may be asked to fill a voiding diary after each change.  
During these visits, patients will be asked about their urinary symptoms, discomforts that might have been felt or 
other physiological or technical problems that might have arisen. Physical examination will be performed and 
patients will be asked to submit a sample of urine for urinalysis at each follow-up visit. If the urinalysis or the 
patient’s symptoms suggest urinary tract infection, urine sample will be sent for culture and sensitivity. If culture 
results suggest urine tract infection, follow-up visit will be re-scheduled for after treatment. 
Adverse events will be recorded in the patient’s CRF, according to specific categories, as defined in section 18 of 
the protocol.  
The device will be inspected, stimulation parameters setting will be re-evaluated and system performance 
parameters and usage information will be recorded  in the CRF. Any change in OAB related medications or dosage 
will be recorded in the patient’s CRF. During the  6- and 12- months follow-up visits quality of life (OAB-q) PGI-I 
and BSW questionnaires will be collected, as well as information on existence of mixed fecal and urine 
incontinence and severity of the fecal incontinence will be collected. 
Sensory and motor thresholds will be assessed and recorded during each follow-up visit and leg circumference 
will be measured and recorded.  
Specific activities and questionnaires associated with each follow-up visit is outlined on section 24; Study 
Schedule. 
At the last visit, 12 months post activation, optimal treatment parameters and treatment regimen will be 
determined and adjusted on the device.  
 

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11.4.6 BlueWind RENOVA iStim™ System Long-Term Follow Up (LTF) Visits – Visits 
9-12 
Long term follow-up visits will be performed at 18, 24, 30, 36-months post activation. 
If a subject already completed the 12-months follow-up and exited the study, she will be invited for a Long-Term 
Follow-Up Consent Visit in which, following her consent to participate in the long-term follow-up study, some 
eligibility criteria will be verified and treatment parameters setting will be performed. Subjects will enter the visit 
schedule using their original system activation date. Any visit that has already passed will not be counted as a 
missed visit. 
If the subject discontinued treating herself when she exited the study and is activated again she will be asked to 
treat herself for 30 minutes, twice a day, for at least 4 weeks prior to completing the first LTF visit. During this 
period, she will be asked to complete a modified daily diary to capture incontinence episodes, time to treatment 
effect, and symptom improvement questions.  
Subjects continuing to the long-term follow-up will be asked to treat themselves per physician discretion but not 
less than two 30-minute treatment per week.  
All follow-up visits will require completion of 3-day voiding diary by the patient before coming to visit.  
Follow-up visits 10 (24-months) and 12 (36-months) will be performed in clinic and will be similar to the 6 and 12- 
months follow-up visits  
Follow-up visits 9 and 11 will be performed over a phone call unless the treatment is not effective enough or 
treatment parameters are not optimal or patient is experiencing an AE or device malfunction.  In such cases the 
patient will arrive to the clinic and a visit similar to the 1, 3, and 9- months post activation will be performed.  
11.4.7 Unscheduled Visit 
An unscheduled visit will be any visit to the clinical site other than the visits specified in the protocol. Unscheduled 
follow-up visits will be allowed as needed to adjust stimulation settings to optimize therapy. The Investigator or 
trained and qualified investigational staff will perform all procedures necessary to evaluate the study participant 
at these visits, and record the visit in the patient’s CRFs. The investigational site Principal Investigator must be 
notified by the patient immediately of any unscheduled visits to any medical facility during the study period. 
At certain circumstances (e.g. UTI) the subject will be requested to attend an additional visit, after the 
circumstance has been resolved. The relevant data will be collected again during this additional visit and used for 
analysis. This additional visit will be considered the formal visit for which the data will be used to evaluate study 
endpoint. At such circumstances the additional visit will be allowed to occur out of the window range.  

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12.   Monitoring Procedures 
12.1 
Monitoring Procedures and Responsibilities 
Monitoring visits will be conducted at the start, during, and at the closure of the clinical study in accordance with 
study Monitoring Plan and in compliance with recognized Good Clinical Practices, FDA's IDE guidance document, 
as outlined in 21CFR§812.43(d) and 21CFR§812.46 and ISO 14155:2011 and per company’s (or company designee) 
standard operating procedure. The Monitoring Plan will be included in a separate document and maintained by 
the study manager or designee. The Monitoring Plan will include detailed descriptions for each type of visit to be 
made during the study, including pre-study visits, site initiation visits, interim monitoring visits and close-out visits. 
It is the responsibility of the study sponsor to ensure that proper monitoring of the investigation is conducted. 
This includes ensuring subject and investigator compliance to the protocol and study agreements, adherence to 
regulations, and accuracy of study data.  
The clinical monitor, as a representative of the sponsor, has the obligation to follow the study closely. In doing so, 
the monitor will visit the principal investigator and/or sub-investigator(s) and study center at periodic intervals, 
in addition to maintaining necessary telephone and letter contact. The monitor will maintain current personal 
knowledge of the study through observation, review of study records and source documentation, and discussion 
of the conduct of the study with the principal investigator and staff. 
All aspects of the study will be carefully monitored for compliance with applicable government regulations, with 
respect to current ISO 14155:2011 and Declaration of Helsinki regulations, and current SOPs. 
The following factors will be taken into account when determining the frequency of monitoring visits at each 
center: implantation rate, total number of subjects enrolled, study phase (e.g., screening, treatment, long-term 
follow-up), center compliance, and monitoring findings from previous visits. The frequency of interim monitoring 
visits will be documented in the monitoring plan and approval from sponsor prior to each interim monitoring visit 
is required. 
13. 
  Statistical Considerations  
This section describes the statistical methods that will be applied to the study’s main endpoints. A detailed 
statistical analysis plan (SAP) will be written and finalized prior to trial initiation.  
13.1 
Introduction 
This is a prospective, single arm, multi-center, open label study whose primary objective is to assess the safety 
and efficacy of the BlueWind RENOVA iStim™ system for the treatment of UUI. The trial's secondary objectives 
are to evaluate device performance, durability of effect and patient reported outcomes (PROs) such as quality of 
life (QoL).  
The trial will be conducted in up to 30 centers.  

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13.2 
Analysis Sets 
13.2.1 Safety and Efficacy Analysis Population – Intent To Treat (ITT) 
The safety and effectiveness endpoints will be evaluated under principles of Intent to Treat (ITT).  The analysis 
set will consist of all subjects for whom the implantation of the BlueWind RENOVA iStim™ system was 
attempted.  Specifically, the analysis set will consist of all subjects for whom skin incision time was not missing. 
Treatment of missing values: 
 Subjects missing data “not in random” will be imputed “failure” on dichotomous endpoints  
 “Failures” (not MAR) include: 
o Subject leaves the study due to related AE  
o Device explant 
o Lack of effect that results in significant increase of UUI medication  
o Need for other 3rd line therapies for the management of UUI 
 Baseline values will not be imputed 
 Missing values in ITT not due to “failure” will be imputed using multiple imputation (MI).  
Because MI assumes missing at random (MAR), sensitivity analyses will, as described below, be conducted to test 
the effects of other patterns of missingness.  See Section 13.3 below for further discussing of how missing data 
will be handled in the efficacy analysis. 
13.2.2 Per Protocol analysis set 
The per protocol analysis set (PP) will be a subset of ITT population without major protocol violations, where 
“major” is defined has having the potential to meaningfully affect outcome. Also excluded will be subjects who 
received treatment on fewer than 50% of days during which they were eligible for therapy delivery. 
Only observed values will be used in the endpoint analyses for the PP. Thus, the primary endpoint will be analyzed 
only on those subjects with an observed primary endpoint. Similarly, a subject will be included in the analysis of 
a secondary endpoint only if she has an observed value on that endpoint. 
13.2.3 One-month Responders 
The one-month responder analysis set will be a subset of ITT of subjects who are classified responders at one 
month. 
All endpoints will also be assessed for this cohort of subjects for qualitative comparisons to treatments utilizing a 
trial period prior to permanent implant. 

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13.3 
Treatment of Missing Data for Efficacy Analyses 
Frequency of missing data and the reasons for the missing data will be presented in the final report. For ITT 
effectiveness endpoints, a multiple imputation procedure will be used to impute missing endpoint data. Any 
patients missing endpoint data due to ”failure” will be considered as a failure for the effectiveness analysis.  
Further sensitivity analyses will include, but may not be limited to, a tipping-point analysis for handling missing 
data.   
Baseline variables included in the multiple imputation procedure may consist of: 
 
Age 
 
Number of UUI episodes per day  
 
OAB duration 
 
Number of prior attempted OAB treatments 
13.4 
Sample Size Considerations 
The sample size was calculated using PASS 2015 software by a one-sided exact test for a single binomial 
population, under the following assumptions: 
  Significance level = 0.025 (one-sided) 
  Power ≥ 90% 
  Assumed treatment success rate = 65%  
  Prespecified performance goal = 50%. 
Given these assumptions, 134 evaluable subjects would be required to participate in the trial, taking into account 
an assumed attrition rate of 15%.   
 
The total sample size for this trial, however, is driven by an important secondary objective:  
 
To demonstrate the proportion of responders at 6 months post system activation, defined by ≥50% 
improvement in the average number of moderate-severe urgency episodes PPIUS degree 3,4 or <8 voids/day, is 
greater than 45%.  A total of 89 evaluable subjects are required.  Assuming 15% attrition rate, a total of 105 
subjects meeting the criteria described above is needed.  With 70% of enrolled subjects meeting the analysis 
criteria, 150 total sample size is sufficient to evaluate the secondary endpoint. 
 
13.5 
Statistical Analyses 
13.5.1 Overview 
Analysis of subject disposition and of safety will be done on the ITT population. The primary efficacy analysis and 
analyses of additional endpoints will be done on ITT. Supportive efficacy analyses will be done for the primary 
efficacy endpoint on the PP population and for other efficacy endpoints in both ITT and PP population. 

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The data will be summarized in tables listing the mean, standard deviation median, minimum, maximum and 
number of subjects for continuous data, or in tables listing count and percentage for categorical data where 
appropriate. Descriptive statistics will be provided by time point both numerically and graphically as appropriate. 
Data listing by subject will be provided.  
All statistical analyses will be performed, and data appendices will be created using the SAS® system. The effects 
of noncompliance, dropouts, and possible covariates such as Age will be assessed to determine the impact on the 
general applicability of results from this study. 
13.5.2 Subject Disposition 
Subject disposition will be tabulated; the number of enrolled, exposed, prematurely terminated and completed 
subjects will be summarized. 
A list of dropouts will be prepared including reason for discontinuation, and time of discontinuation.  
13.5.3 Safety 
The safety analyses will be descriptive and narrative in nature, with AEs, including serious AEs (SAEs), coded and 
tabulated by body system, preferred term, group, severity and relation to device or procedure. Descriptive 
statistics and shift analysis tables will be provided as appropriate. 
13.5.4 Primary Efficacy  
For the primary analysis, the null hypothesis is that the response probability is less than or equal to 50%. We are 
interested in the alternative hypothesis that patients receiving the treatment have above 50% probability to 
achieve clinical improvement: 
H0: πRenova ≤ πPG 
H1: πRenova > πPG, 
where πRenova is the proportion of subjects meeting the pre-defined success criterion with RENOVA therapy (≥ 
50% improvement in average number of urge related incontinence episodes), and πPG is the prespecified 
performance goal (PG) of 50%. 
Though sample size was conservatively calculated under an Exact Binomial test, the hypothesis testing will be 
conducted by constructing a two-sided, 95% Clopper-Pearson confidence interval. We will have succeeded in 
the trial if the lower bound of this confidence interval is above 50%. 
13.5.5 Secondary Efficacy Endpoints 
The following will be assessed as formal secondary efficacy endpoints: 
 Proportion of subjects with ≥ 10 points (MID) improvement compared to baseline in HRQL (measured by 
the OAB-q) at 6 months post system activation 

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 Proportion of responders at 12 months post system activation, defined as ≥ 50% improvement in either 
average number of urgency related incontinence episodes or average number of large (severe) urgency 
related incontinence episodes, as measured by 7-day Patient Voiding Diary. 
 Proportion of responders at 6 months post system activation as demonstrated by ≥ 50% improvement in 
the average number of moderate-severe urgency episodes (PPIUS degree 3,4) or < 8 voids/day 
Durability of effect will be based on 12-month follow-up data and all secondary efficacy endpoints will be 
analyzed in the three efficacy analysis sets—ITT, PP and OR1. 
13.5.6 Additional Efficacy Endpoints 
The following endpoints will be assessed as other endpoints for the 6-, 12-, 24- and 36-months post 
activation, without formal hypothesis testing and type I error control. 
 Incidence of procedure or device related adverse events from 12- to 36-months post activation. 
 Patient Global Impression of Improvement (PGI-I) score. 
 Treatment Benefit, Satisfaction, and Willingness to Continue (BSW). 
 Reduction in the average number of severe/large urgency related incontinence episodes. 
 Improvement in OAB-q (HRQL and symptoms severity) at 6- and 12- months post system activation. 
 Changes in the following OAB symptoms as measured by voiding diary compared to baseline: 
 
Reduction in the number of micturition episodes. 
 
Reduction in the number of urgency related incontinence episodes. 
 
Reduction in degree of urgency prior to void on Patient Perception of Intensity of Urgency Scale 
(PPIUS) from 0-4.  
 
Reduction in severity of incontinence episodes (amount leaked). 
 Proportion of dry subjects following treatment with the RENOVA iStim System as measured by 3 
consecutive days of a patient voiding diary. 
  Assessment of fecal incontinence symptoms in patients suffering from mixed fecal and urine 
incontinence. 
 Patient compliance with treatment. 
 Duration from treatment initiation to symptoms improvement (in subset of patients who stopped 
treatment after completing the 12 month visit and started again when consented for the long term 
follow-up   
 Assessment of treatment regimen 

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 Device usage 
All additional efficacy endpoints will be analyzed in all three efficacy analysis sets—ITT, PP and OR1. 
13.5.7 Covariate Analyses 
Covariate analyses will be done by comparing each endpoint between groups defined by the levels of the 
covariate at baseline, where continuous variables will be coded into two levels by median split. Analyses will 
be done by logistic regression. Covariates will include, but are not limited to: 
 Age  
 BMI 
 OAB duration at baseline 
Additionally, formal subgroup analyses will be conducted to assess the effects on the primary endpoint of 
antidepressant medications, and also to assess the potential impact of COVID-19 on the study outcomes.  
Details of these analyses are outlined in the SAP.   
Finally, a test of homogeneity of effect across investigational center will be conducted.  Descriptive statistics 
(e.g. success rate) will be reported for every participating center.  Any center enrolling fewer than five 
subjects will be excluded from the formal test of homogeneity.  To acknowledge that this test of homogeneity 
is fundamentally underpowered, a significance level of 0.15 will be used to determine whether a potential 
differential effect across centers exists and to trigger additional, exploratory analysis to better understand 
the nature of the difference. 
13.5.8 Interim Analysis 
An administrative interim analysis is will be performed at the time one-month post activation data is available 
on 50 implanted subjects. This analysis is intended to support necessary company financing activities, and 
visibility of the results will be restricted to only those involved in those activities.  Importantly, no person – 
BlueWind employee or consultant – who has interaction with investigational sites will have visibility to interim 
results.  The interim analysis does not require subsequent adjustment of the overall trial significance level 
(0.025) to account for type I error inflation because: 
 
it is administrative in nature only, with limited distribution of the results 
 
it is looking primarily at 1-month data, which may not be reflective of the primary endpoint at 6 
months 
 
the interim analysis is at the time 1/4 to 1/3 of the total number of enrolled subjects is 1/6 of way 
(1 month follow-up) toward the primary effectiveness endpoint (at 6 months follow-up).  This 
represents 1/18th to 1/24th of the total trial information.  Under an O’Brien-Fleming alpha 
spending function, virtually zero alpha would be allocated to the interim analysis  
 
there is no opportunity to terminate the trial early for effectiveness. 

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Only data from the first 50 subjects with one-month post activation data will be reviewed.  Data from enrolled 
subjects that do not yet have 1-month data available will be excluded from the analysis.  All data from the 50 
subjects will be included in the review (i.e. data from follow-up visits subsequent to the 1-month visit will also 
be summarized, if available). 
The analysis will involve, in summary form, results on: 
 
Device and procedure-related adverse events 
 
Percent improvement in the average number of urgency-related incontinence episodes, as 
compared to baseline.    
 
Proportion of subjects with ≥10 points (MID) improvement compared to baseline in HRQL (based 
on OAB-q) at each follow-up post system activation 
 
 Proportion of responders at each follow-up visit post system activation, as demonstrated by ≥50% 
improvement in the average number of moderate-severe urgency episodes PPIUS degree 3,4 or <8 
voids/day  
Other data summaries, such as questionnaires (e.g., PGI-I, BSW), demographics, the proportion of dry subjects, 
and outcomes of interest may  also be summarized  
14.  Data Management 
Data management services will be provided by TechnoSTAT Ltd. Electronic Data Capture and adverse events 
coding will be performed by Axiom Real-Time Metrics. It is the responsibility of the study sponsor to ensure that 
the investigation is conducted and the data is generated, documented (recorded), and reported in compliance to 
the investigational plan and study agreements, adherence to regulations, and accuracy of study data.  
14.1 
Electronic Case Report Form (eCRF) 
The Investigator must maintain required records on all study patients. Data for this study will be recorded in the 
patient's medical records and on eCRFs provided by the Sponsor. The Investigator is responsible for ensuring that 
study data is completely and accurately recorded, including all pertinent study related information. The eCRFs will 
be completed by the authorized study site personnel. The Sponsor’s study monitors or designees will review the 
eCRFs for completeness and accuracy, and instruct site personnel to make any required corrections or additions. 
An electronic version of the final eCRF book for each subject will be forwarded to the study sites for record keeping 
at the study site closure.  
All the source documents and forms used for the trial will be kept in the patient binders and will remain on site 
or will be inserted into the patient’s medical chart as authorized by the local medical facility procedures.  

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14.2 
Safety Monitoring of the Study and Quality Control 
14.2.1 CEC  
Clinical Events Committee is an independent committee with a documented CEC Charter. The Clinical Event 
Committee will adjudicate adverse events in regards to their severity and relationship to the procedure or device. 
Adverse events adjudicated will include: all serious adverse events, and adverse events. The committee will 
include independent physicians, blinded to clinical site, who will adjudicate AEs, UADEs and SAEs. 
All roles and responsibilities and working guidelines of the CEC will be detailed in the CEC charter prior to 
beginning of the adjudication process. CEC will discontinue adjudicating AEs when all patients reach 12 months 
post system activation.  
14.2.2 DSMB 
Data and Safety Monitoring Board is an independent committee with a documented DSMB Charter. Members are 
independent from the sponsor and are not investigators in the study. Its role is to monitor the safety of the study 
and it can recommend to the sponsor to continue or suspend the study due to significant safety or efficacy issues. 
The DSMB receives data directly from the independent statistician or/or sponsor designated study medical 
monitors. The DSMB will conduct independent reviews of the data and the adverse events observed. The actual 
number of DSMB meetings will be finalized in consultation with the committee itself. The DSMB will review the 
safety data of up to 30 patients. Thereafter, the DSMB will convene semi-annually, or every 50 subjects have been 
implanted. Once all patients reach 12-months post system activation, DSMB will continue to convene annually 
until the end of the long-term follow-up (i.e. last patient reaches 36-month follow-up visit). 
14.3 
Data Collection and Monitoring 
Completed e-CRFs will be verified against source data and checked by the study monitor for completeness, 
consistency, and legibility.  
The Research Coordinator will collect and document data in hospital and clinic charts and on source document 
forms prepared for the study.  Data will be entered  with no identifying information, using patient ID only into the 
secure password protected database. Passwords will not be issued by the Sponsor until Site Initiation and 
database training has been conducted for all personnel to whom Investigator has delegated data entry 
responsibilities. Completed final eCRFs in final form may be printed and filed in hardcopy for archiving if required 
by local governing authority.  
The Sponsor will designate and train monitors to review eCRF data against source documents for completeness 
and accuracy. Discrepant data will be queried; the electronic database will maintain audit trails of all queried and 
corrected data. The Investigator is responsible for data integrity at the site and will review and electronically sign 
it to confirm integrity of the data.  

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14.4 
Data Quality Control and Quality Assurance 
All requested information must be entered in the eCRF. If an item is not available or not applicable this fact should 
be indicated.  
Data will be entered into a computer database developed specifically for this trial. A system of computerized data 
validation checks will be implemented and applied to the database on a regular basis. During the course of the 
trial, data queries will be generated for data items that are potentially erroneous and require appropriate 
clarification or correction. All queries will be entered, tracked, and resolved through the eCRF system directly. The 
study database will be updated in accordance with the resolved queries. All changes to the study database will be 
documented. 
14.5 
Data Retention 
The investigator, or an individual designated by the investigator, is responsible for retention of all study related 
documents, including: 
 All correspondence which pertains to the investigation; e.g. Ethic committee’s approvals, device 
information, protocol and subsequent versions, CRFs, financial disclosures, delegation logs, monitoring 
site visit logs, training records, CVs, etc. 
 Documentation of the dates and reasons for any deviation from protocol  
Records are subject to inspection by regulatory authorities and must be retained as required by the applicable 
regulatory requirements or for a period of at least 2 years after a marketing application is approved or from the 
date on which the investigation is terminated or completed and the regulatory authorities have been notified. 
15. Deviations from Protocol 
The investigator is not allowed to deviate from the clinical protocol, except if; 
 Sponsor and EC approval and reports of deviations have been obtained for cases in which the deviation 
affects subject’s rights, safety and well-being, or the scientific integrity of the clinical investigation; 
 Under emergency circumstances, deviations from the clinical protocol to protect the rights, safety and 
well-being of human subjects may proceed without prior approval of the sponsor and the EC. Such 
deviations shall be documented and reported to the sponsor and the EC as soon as possible. 
All study deviations must be recorded. A study deviation is defined as an event within a study that did not occur 
according to the Clinical Investigation Plan. Study deviations should be reported as soon as someone becomes 
aware of them. A waiver from certain criteria may be provided by the sponsor under such circumstances allowed 
by the relevant guidelines. 
Study deviations may be discovered through a variety of sources, such as during the Case Report Form review, 
telephone conversations, and site monitoring.  

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16. The RENOVA iStim™ System Accountability 
The system shall be used only in the clinical investigation and according to the study protocol. 
Complete traceability records will be kept of all systems used during the study, including data recorded during the 
trial by BlueWind Medical Ltd. 
The principal investigator or an authorized designee shall keep records documenting the receipt, use, return and 
disposal of the investigational system. 
17. Informed Consent Process 
Written consent will be obtained from each subject to be involved in the study. Legally incompetent subjects will 
not be enrolled in this study, thus all regulations in relation to this population are not applicable. Potential study 
subjects should be given the opportunity to ask questions and time for consideration. 
The investigator must inform every subject in details and plain language about the nature of the study, its purpose, 
the treatments, those aspects of the study that are experimental, the procedures involved including all invasive 
procedures and the discomfort it may entail, the possible risks, the reasonably expected benefits, the expected 
duration and the approximate number of subjects involved and the subject’s responsibilities. 
The clinical investigation shall be conducted in accordance with the ethical principles that have their origin in the 
Declaration of Helsinki and in compliance with ISO 14155 and 21 CFR Part 50 and/or any regional and/or national 
regulations. 
The clinical investigation shall not begin until the required approvals/ favorable opinions from EC/IRB and/or 
CA/FDA have been obtained. 
After the information contained in the Informed Consent document has been reviewed with each subject, the 
subject must sign the Informed Consent document, indicating willingness to participate in the Clinical 
Investigational Study. A copy of the Informed Consent document should be given to the subject. 
The investigator will indicate that Informed Consent has been obtained by noting so in the appropriate section of 
the Case Report Form. 
A copy of the informed consent form approved by the Ethics Committee / IRB must be maintained in the 
investigator’s study file. A signed copy of the patient information and informed consent form must be given to 
each subject. 

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18. Safety 
18.1 
Adverse Events 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical 
signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device. 
*Disease signs and symptoms that existed prior to study participation are not considered AEs unless the condition 
recurs after the subject has recovered from the pre-existing condition, or the condition worsens during the study. 
18.2 
Adverse Device Effect 
An adverse device effect (ADE) is an AE related to the use of an investigational medical device. 
NOTE 1: This definition includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational medical device. 
NOTE 2: This definition also includes any event from use error or from intentional misuse of the investigational 
medical device. 
18.3 
Serious Adverse Events 
A serious adverse event (SAE) is an AE that: 
a) Led to death 
b) Led to serious deterioration in the health of the subject, that either results in: 
1) A life-threatening illness or injury, or 
2) A permanent impairment of a body structure or a body function, or 
3) Hospitalization 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, 
5) Chronic disease, 
c) led to fetal distress, fetal death or a congenital physical or mental impairment or birth defect 
NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational 
plan, without serious deterioration in health, is not considered a serious adverse event. 

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18.4 
Serious Adverse Device Effects 
A serious adverse device effect (SADE) is an adverse device effect that results in any of the consequences 
characteristic of a serious adverse event. 
18.5 
Anticipated Serious Adverse Device Effects 
An anticipated serious adverse device effect (ASADE) is a serious adverse device effect which by its nature, 
incidence, severity or outcome has been identified in the risk analysis report. 
For list of anticipated AEs see section 8. 
18.6 
Unanticipated Serious Adverse Device Effects 
An unanticipated serious adverse device effect (USADE) is a serious adverse device effect which by its nature, 
incidence, severity or outcome has not been identified in the current version of the risk analysis report. 
18.7 
Device Deficiency /Malfunction / Use Error 
Device deficiency (DD) is the inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety or performance. 
NOTE: Device deficiencies include malfunctions, use errors, and inadequate labeling. 
Device malfunction is the failure of an investigational medical device to perform in accordance with its intended 
purpose when used in accordance with the IFU or CIP. 
Use error is the act or omission of an act that results in a different medical device response than intended by the 
manufacturer or expected by the user. 
NOTE 1: Use error includes slips, lapses, and mistakes. 
NOTE 2: An unexpected physiological response of the subject does not in itself constitute a use error. 
Device malfunction may or may not result in the subject experiencing a harmful effect. All AEs/SAEs associated 
with a device failure are by definition device-related. 
18.8 
Adverse Events Collection and Recording 
Collection of AEs will start after the time that the informed consent form is signed and continue until the subject 
exits the study. AEs will be monitored throughout the study. Investigators must obtain all information available 
to determine the causality and outcome of the AE and to assess whether it meets the criteria for classification as 
a serious adverse event requiring immediate notification to the sponsor or its designated representative. All 
reported AEs will be documented on the appropriate eCRF and will include the event description (sign, symptom, 
and diagnosis), onset, resolution, seriousness, severity, cause and action taken. The investigator or an authorized 
designee must assess the causality and severity for all AEs. All AEs will be followed by the investigator until 

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resolution or until the termination of the subject’s study participation. Any adverse events that remain unresolved 
at the end of the study will be explained in the final report. 
Individual symptoms should not be reported as AE, alternatively a diagnosis should be made based on the 
symptoms and this diagnosis should be entered under the “description/type” column. 
18.9 
Adverse Events Reporting 
Timely, accurate, and complete reporting and analysis of safety information for clinical studies are crucial for the 
protection of the subjects. Reporting and analysis of safety data are mandated by regulatory authorities 
worldwide. Since the safety reporting requirements and classification systems vary for each regulatory authority, 
requirements from all geographies are taken into account for the collection and reporting of safety information. 
Subjects will be carefully monitored during the study for possible AEs. Any AE that occurs after the time of 
informed consent through the end of the study participation will be fully evaluated by the investigator. An 
appropriate treatment will be initiated and the study follow-up will continue as completely as possible. 
The investigator or an authorized designee will document all observations and clinical findings of AEs, including 
the nature, severity and relationship, on the appropriate eCRFs. 
The investigator is required to report all SAEs and ASADEs/USADEs to the Sponsor within 24 hours after first 
learning of the event. Initial reporting may be done by completing the applicable eCRF form or via phone, fax or 
email in case the eCRF is inactive, with as much information as available at that time. In case of urgent questions 
regarding safety reporting, the investigator can contact BlueWind Medical, clinical affairs. Contact details for 
clinical affairs are as follows:  
Europe: 
oasis-group.medtech@iqvia.com 
32.3290.0307 
US: 
Roni.diaz@bluewindmedical.com 
469-423-2015 
 
Furthermore, the investigator must follow their local IRB/EC policy for SAE/ASADE/USADE reporting. If required 
by national regulations or IRB/EC policy, DDs that could lead to a SADE should be reported to the Sponsor and 
IRB/EC within 24 hours of awareness of the event. 
As additional information becomes available, the investigator will record all adverse events (serious or non-
serious), adverse device effects (anticipated and unanticipated) and device deficiencies on the appropriate eCRFs. 
The sponsor, Bluewind Medical Ltd., will ensure to perform expedited SAE reporting to all regulatory authorities 
involved in this study in line with the local reporting requirements.  
In case of SAEs, copies of source documentation which contain significant information related to the event such 
as discharge letters, surgery reports, consultation letters, ECGs, laboratory results etc. are required for evaluation 

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of the event. Copies of such documentation shall be obtained from the investigator, blinded or de-identified as to 
the subjects’ identity, and provided to the Sponsor or designee. 
In case an incisional wound AE is suspected a photograph of the wound should be sent to the chief medical officer 
(see contact above)  who will aid in the classification of the adverse event as per table 3 below. 
Table 2: Incisional wound classification 
AE type – description column 
(*CTCAE) 
Individual symptom - comment column
Reporting
Wound complication 
Localized inflammation (pain or 
tenderness, induration, erythema, 
local warmth of the wound).  
Mild, <4 weeks 
normal 
Moderate, <5 days 
normal 
all other 
define as AE 
Wound infection (surgical site 
infection) 
Localized inflammation (pain or 
tenderness, induration, erythema, 
local warmth of the wound)* together 
with purulent discharge or positive 
culture 
define as AE 
Wound infection with systemic 
symptoms 
Localized inflammation (pain or 
tenderness, induration, erythema, 
local warmth of the wound)* together 
with purulent discharge or positive 
culture and the addition of either 
fever or lymphangitis 
 
define as AE 
Wound Dehiscence 
Incisional separation with device 
exposure 
 
define as AE 
Incisional separation with signs of 
reaction to suture material  
 
define as AE 
 
18.9.1 Periodic Safety Report 
In addition to the expedited reporting of SAEs, the sponsor will submit, at a minimum of once a year throughout 
the clinical study, an annual safety report to the involved ethical committees and regulatory authorities of the 
concerned countries. This periodic safety report can be combined with the annual study report. 
18.10 
Severity 
The investigator will use the following definitions to determine the severity of an AE:  

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 Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not 
indicated.  
 Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental ADL*.  
 Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting selfcare ADL**.  
 Grade 4 Life-threatening consequences; urgent intervention indicated.  
 Grade 5 Death related to AE. 
Activities of Daily Living (ADL) *Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using 
the telephone, managing money, etc. **Self care ADL refer to bathing, dressing and undressing, feeding self, using 
the toilet, taking medications, and not bedridden 
18.11 
Relationship 
The investigator will use the following definitions to assess the relationship to the device (MEDDEV 2.7/3): 
 Not related: relationship to the device or procedures can be excluded when: 
o the event is not a known side effect of the product category the device belongs to or of similar 
devices and procedures; 
o the event has no temporal relationship with the use of the investigational device or the 
procedures; 
o the serious event does not follow a known response pattern to the medical device (if the response 
pattern is previously known) and is biologically implausible; 
o the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible - and reintroduction of its use (or increase of the 
level of activation/exposure), do not impact on the serious event; 
o the event involves a body-site or an organ not expected to be affected by the device or procedure; 
o the serious event can be attributed to another cause (e.g. an underlying or concurrent illness/ 
clinical condition, an effect of another device, drug, treatment or other risk factors); 
o the event does not depend on a false result given by the investigational device used for diagnosis 
17, when applicable; 
o harms to the subject are not clearly due to use error; 
In order to establish the non-relatedness, not all the criteria listed above might be met at the same time, 
depending on the type of device/procedures and the serious event. 
 Unlikely: the relationship with the use of the device seems not relevant and/or the event can be reasonably 
explained by another cause, but additional information may be obtained. 
 Possible: the relationship with the use of the investigational device is weak but cannot be ruled out 
completely. Alternative causes are also possible (e.g. an underlying or concurrent illness/ clinical condition 

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or/and an effect of another device, drug or treatment). Cases were relatedness cannot be assessed or no 
information has been obtained should also be classified as possible. 
 Probable: the relationship with the use of the investigational device seems relevant and/or the event 
cannot be reasonably explained by another cause, but additional information may be obtained. 
 Causal relationship: the serious event is associated with the investigational device or with procedures 
beyond reasonable doubt when: 
o the event is a known side effect of the product category the device belongs to or of similar devices 
and procedures; 
o the event has a temporal relationship with investigational device use/application or procedures; 
o the event involves a body-site or organ that: 
 
the investigational device or procedures are applied to; 
 
the investigational device or procedures have an effect on; 
o the serious event follows a known response pattern to the medical device (if the response pattern 
is previously known); 
o the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious event (when clinically feasible); 
o other possible causes (e.g. an underlying or concurrent illness/ clinical condition or/and an effect 
of another device, drug or treatment) have been adequately ruled out; 
o harm to the subject is due to error in use; 
o the event depends on a false result given by the investigational device used for diagnosis, when 
applicable; 
In order to establish the relatedness, not all the criteria listed above might be met at the same time, 
depending on the type of device/procedures and the serious event. 
19. Protocol Amendments 
An amendment to the protocol may be proposed by an investigator. The amendment will be prepared and 
approved by BlueWind according to the company’s Standard Operating Procedures.  The amendment must be 
submitted to the relevant Ethics committee.  When applicable, the amendment’s implementation will take place 
only once approved by the committee. 
20. Subject Confidentiality 
The Investigator and institution involved in this study will only provide direct access to source data and documents 
to the Sponsor and/or designee, and to appropriate authorities for the purposes of monitoring, audit, EC review 
or regulatory inspection. Each subject taking part in the study will have agreed explicitly to such access in writing. 
All subject data will always be treated with strict adherence to professional standards of confidentiality and 

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according to EU GDPR guidelines effective as of 25- May- 2018. All reports and communications relating to 
subjects in the study will identify the subjects by their subject ID number only. 
21. Termination of the Clinical Study 
The sponsor will notify the involved ethics committees and the competent authorities of the end of the study 
within a period of 90 days or per the EC requirements, whichever is sooner. The end of the study is defined as the 
last patient’s last visit.  
In case the study is ended prematurely, the sponsor will notify the responsible ECs and the competent authorities 
within 15 days, including the reasons for the premature termination. 
At the completion of the last follow-up visit, patient will exit the study. However, the implant will not be explanted 
and the patient will be clinically followed up per physician discretion.  System support will be provided by 
BlueWind Medical for 3 years post activation. 
22. Insurance 
Study subject insurance coverage will be provided according to the laws of the country where the study will be 
conducted.  
In Europe, the insurance company is Newline Syndicate 1218 at Lloyd's and in the US, the insurance company is 
Medmarc Insurance Group. 
23. Publication Policy 
It is BlueWind Medical's policy to publish the results of its Clinical Trials. 
The publication of the common database will be under the direction of the study manager. Publication of the 
complete data set will not be allowed unless approved by the study manager. 
Individual investigators may publish their own data based on the terms and conditions specified in the clinical trial 
agreement. 
All publications will be reviewed by BlueWind Medical in order to assure that no confidential information is 
disclosed. Such confidential information is not allowed for publishing.  
A final study report will be submitted, including any publications/abstracts of the study, to the accredited EC/IRB 
and the Competent Authority within one year after the end of the study. 
24. Reporting Results on ClinicalTrials.gov  
The clinical investigation will be registered on ClinicalTrials.gov. A full report of the pre-specified outcomes, 
regardless of the results, will be made public through the ClinicalTrials.gov website no later than 12 months after 
clinical investigation completion, as required by section 801 of the Food and Drug Administration (FDA) 

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Amendments Act. If this clinical investigation is terminated early, the Sponsor will make every effort to hasten the 
release of the pre-specified outcomes through the ClinicalTrials.gov website. 
 

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25. Study Schedule 
# 
Section name 
Enrollment 
and Screening 
Implantation 
(6 ± 4 weeks) 
Activation 
(4 ± 2 weeks) 
FU 1m 
(±2 weeks) 
FU 3m 
(±2 weeks) 
FU 6m 
(±4 weeks) 
FU 9m 
(±4 weeks) 
FU 12m 
(±4 weeks) 
 
Visit 
1 
2 
3 
4 
5 
6 
7 
8 
1.
Informed consent form 
X 
 
 
 
 
 
 
 
2.
Patient Demographics 
X 
 
 
 
 
 
 
 
3.
Inc/Exc criteria 
X 
 
 
 
 
 
 
 
4.
Medical History 
X 
 
 
 
 
 
 
 
5.
Physical & Neurological Exam (including vital signs) 
*partial physical examination 
X 
X* 
X* 
X* 
X* 
X* 
X* 
X 
6.
Urinalysis 
X 
 
X 
X 
X 
X 
X 
X 
7.
Urine culture (at baseline, *and then pending 
urinalysis results) 
X 
 
* 
* 
* 
* 
* 
* 
8.
Urine/blood pregnancy test (if bearing potential) 
X 
 
 
 
 
 
 
 
9.
Blood – chemistry (Creatinine levels; GFR, and HbA1C) 
X 
 
 
 
 
 
 
 
10.
PVR 
X 
 
 
 
 
 
 
 
11.
Medications 
X 
X 
X 
X 
X 
X 
X 
X 
12.
Quality of Life Questionnaire 
X 
 
 
 
 
X 
 
X 
13.
MESA incontinence questionnaire 
X 
 
 
 
 
 
 
 
14.
PHQ-15 
X 
 
 
 
 
 
 
 
15.
PGI-I 
 
 
 
 
 
X 
 
X 
16.
BSW 
 
 
 
 
 
X 
 
X 
17.
Usage information collection 
 
 
 
X 
X 
X 
X 
X 
18.
Voiding Diary 
X (7-days) 
 
 
X (3-days) 
X (3-days) 
X (7-days) 
X (3-days) 
X (7-days) 
19.
Usability/patient satisfaction questions 
 
X 
X 
X 
X 
 
 
 
20.
Parameter Setting 
 
 
X 
X 
X 
X 
X 
X 
21.
Leg circumference measurements 
X 
X 
X 
X 
X 
X 
X 
X 
22.
Patient Training on wearable unit 
 
 
X 
 
 
 
 
 
23.
Adverse Event 
 
X 
X 
X 
X 
X 
X 
X 
24.
Study completion/discontinuation form 
 
 
 
 
 
 
 
X 
 

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26. Study Schedule – Long-Term Follow-Up 
# 
Section name 
Long Term FU 
Consent Visit 
FU 18m 
(±6 weeks) 
FU 24m 
(±6 weeks) 
FU 30m 
(±6 weeks) 
FU 36m 
(±6 weeks) 
 
Visit 
 
9 
10 
11 
12 
25.
Informed consent form 
X 
 
 
 
 
26.
Inc/Exc criteria (verify new criteria – if exited 
study at 12m FU) 
X 
 
 
 
 
27.
New medical history since 12m FU visit  
X 
 
 
 
 
28.
Physical & Neurological Exam (including vital signs) 
*partial physical examination 
†if in clinic 
X 
X*† 
X* 
X*† 
X* 
29.
Urinalysis  
†if in clinic 
X 
X† 
X 
X† 
X 
30.
Urine culture *pending urinalysis results 
†if in clinic 
X* 
X*† 
X* 
X*† 
X* 
31.
Urine/blood pregnancy test (if bearing potential) 
X 
 
 
 
 
32.
Medications 
X 
X 
X 
X 
X 
33.
Quality of Life Questionnaire 
 
 
X 
 
X 
34.
PGI-I 
 
 
X 
 
X 
35.
BSW 
 
 
X 
 
X 
36.
Usage information collection 
X 
X 
X 
X 
X 
37.
Voiding Diary (3-days) 
X 
X 
X 
X 
X 
38.
Voiding Diary (UUI for ~4 weeks) *only for 
applicable subjects 
X* 
 
 
 
 
39.
Usability/patient satisfaction questions 
 
X 
 
X 
 
40.
Parameter Setting 
†if in clinic 
 
X† 
X 
X† 
X 
41.
Leg circumference measurements  
X 
 
 
 
 
42.
Patient Training on wearable unit 
X 
 
 
 
 
43.
Adverse Event 
X 
X 
X 
X 
X 
44.
Study completion/discontinuation form 
 
 
 
 
X 
 
 
 

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Appendix 1 - BSW questionnaire 
 
 

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Appendix 2 - MESA incontinence questionnaire 
MESA Incontinence Questionnaire 
  
Urge Incontinence Questions 
 
Some people receive very little warning and suddenly find that they are losing, or about to  
lose, urine beyond their control. How often does this happen to you? 
______Often (3) ____Sometimes (2) _____Rarely (1)_____  Never (0) 
 
If you can't find a toilet or find a toilet that is occupied and you have an urge to urinate, how often do you end 
up losing urine and wetting yourself? 
______Often (3) ____Sometimes (2) _____Rarely (1) _____Never (0) 
 
Do you lose urine when you suddenly have the feeling that your bladder is full? 
______Often (3) ____Sometimes (2) _____Rarely (1) _____Never (0) 
 
Does washing your hands cause you to lose urine? 
______Often (3) ____Sometimes (2) _____Rarely (1) _____Never (0) 
 
Does cold weather cause you to lose urine? 
______Often (3) ____Sometimes (2) _____Rarely (1) _____Never (0) 
 
Does drinking cold beverages cause you to lose urine? 
______Often (3) ____Sometimes (2) _____Rarely (1) _____Never (0) 
 
TOTAL URGE SCORE ___________ 
URGE SCORE RATIO ___________ 
 
Stress Incontinence Questions 
 
Does coughing gently cause you to lose urine? 
______Often (3) ____Sometimes (2) _____Rarely (1) _____Never (0) 
 
Does coughing hard cause you to lose urine? 
______Often (3) ____Sometimes (2) _____Rarely (1) _____Never (0) 
 
Does sneezing cause you to lose urine? 
______Often (3) ____Sometimes (2) _____Rarely (1) _____Never (0) 
 
Does lifting things cause you to lose urine? 
______Often (3) ____Sometimes (2) _____Rarely (1) _____Never (0) 
 
Does bending over cause you to lose urine? 
______Often (3) ____Sometimes (2) _____Rarely (1) _____Never (0) 
 
Does laughing cause you to lose urine? 
______Often (3) ____Sometimes (2) _____Rarely (1) _____Never (0) 
 
Does walking briskly cause you to lose urine? 
______Often (3) ____Sometimes (2) _____Rarely (1) _____Never (0) 
 
Does straining, if you are constipated, cause you to lose urine? 
______Often (3) ____Sometimes (2) _____Rarely (1) _____Never (0) 

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Does getting up from a sitting to a standing position cause you to lose urine? 
______Often (3) ____Sometimes (2) _____Rarely (1) _____Never (0) 
 
TOTAL STRESS SCORE ___________ 
STRESS SCORE RATIO ____________ 
 
Add the total score for each category. For urge incontinence, the maximum total score is 18 based on 6 
questions, with a maximum score of 3 for each question. For stress incontinence, the maximum score is 27, 
based on a question with a maximum score of 3 for each question. To determine predominance of either stress 
or urge incontinence, the percent score is obtained (by dividing the score by the maximum total possible 
score, e.g., 9 urge score divided by 18 x 100 = 50% urge vs. 9 stress score divided by 27 x 100 = 33%. Urge is 
considered predominant when the % score of urge is greater than stress.) 
  

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Appendix 3 - OAB-q 
 

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Appendix 4 – PGI 
Patient Global Impression of Improvement 
 
Check the one number that best describes how your urinary tract condition is now compared with 
how it was before you started treatment with the BlueWind RENOVA iStim™ System 
1 
Very much better 
2 
Much better 
3 
A little better 
4 
No change 
5 
A little worse 
6 
Much worse 
7 
Very much worse 
 

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Appendix 5 – PHQ-15 
 
 
 

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Appendix 6 – References 
 
[1] Thom D, “Variation in estimates of urinary incontinence prevalence in the community: effects of differences in definition, population 
characteristics, and study types”, J. Geriatr. Soc. (1998), 46: pp. 473–480. 
 
[2] Rovner E S, Gomes C M, Trigo-Rocha F E, Arap S and Wein A J, “Evaluation and treatment of the overactive bladder: A Review”, Rev. 
Hosp. Clin. Fac. Med. S. Paulo, (2002), 57 (1): pp. 39–48. 
 
[3] Abrams P, Cardozo L and Fall M, et al., “The standardization of terminology of lower urinary tract function: report from the 
Standardization Sub-committee of the International Continence Society”, Neurourol. Urodyn. (2002), 21: pp.167–178.  
 
[4] Hasan ST, Robson WA, Pridie AK et al. Transcutaneous electrical nerve stimulation and temporary S3 neuromodulation in idiopathic 
detrusor instability. J Urol 1996; 155: 2005-2011.  
 
[5] Milsom, I; Abrams, P; Cardozo, L; Roberts, RG; Thuroff, J; Wein, AJ (June 2001). "How widespread are the symptoms of an overactive 
bladder and how are they managed? A population-based prevalence study". BJU Int. 87 (9): 760–6. 
 
[6] Stewart, WF; Van Rooyen, JB; Cundiff, GW; Abrams, P; Herzog, AR; Corey, R; Hunt, TL; Wein, AJ (May 2003). "Prevalence and burden 
of overactive bladder in the United States". World Journal of Urology 20 (6): 327–336. doi:10.1007/s00345-002-0301-4.  
    
[7] Diagnosis and treatment of overactive bladder (Non-Neurogenic) in adults: aua/sufu guideline". American Urological Association. 
Retrieved 25Aug2013.)  
 
[8] Irwin DE, milsom I, Hunskaar S et al: population based survey of urinary incontinence, overactive bladder, and other lower urinary tract 
symptoms in five countries; results of the EPIC study. Eur Urol 2006; 50:1306. 
    
[9] Newman D K, “Urinary incontinence and overactive bladder: a focus on behavioral interventions”, Topics in Advanced Practice Nursing 
eJournal (2001), p. 1. 
 
[10] Yoshimura N and Chancellor M B, “Current and future pharmacological treatment of overactive bladder”, J. Urol. (2002),168: pp. 1,897–
1,913. 
 
[11] Craggs M, McFarlane J , "Neuromodulation of the lower urinary tract". Exp Physiol (1999), 84: 149-60. 
 
[12] Fandel T, Tanagho E."Neuromodulation in voiding dysfunction: a historical overview of neurostimulation and its application", Urol Clin 
North Am (2005), 32:1-10.  
 
[13] van Balken M, Vergunst H, Bemelmans B. "The use of electrical devices for the treatment of bladder dysfunction: a review of methods". 
J Urol (2004), 172:846-51.