Use of the Leva Incontinence System in Treating Bladder Incontinence.
Phase: NA
Conditions: Stress Urinary Incontinence
Sponsor: Renovia, Inc.

NCT 03536923 
Use of Leva Incontinence System in Treating 
Bladder Incontinence 
May 14, 2017 

Protocol Version 2.0 
May 5, 2017 
 
 
 
 
 
 
 
 
 
Project No.: NESCA-Renovia-01 
Sponsor No: POC Trial LV-001 UI 
 
 
 
 
AN OPEN-LABEL STUDY TO ASSESS THE EFFECTIVENESS OF THE LEVA 
INCONTINENCE SYSTEM IN TREATING BLADER INCONTINENCE 
 
 
 
 
 
 
 
 
 
FDA Statement 
leva Incontinence System TM is an FDA-approved Class II medical device. As such it has 
been tested and found to conform with the requirements of IEC 60601-1:2005 (3RD Edition), 
Medical Electrical Equipment-Part 1:  General requirements for basic safety and essential 
performance; 
IEC 
60601-1-2:2007, 
Medical 
electrical 
equipment-Part1-2:General 
requirements 
for 
basic 
safety 
and 
essential 
performance-Collateral 
standard: 
Electromagnetic compatibility-Requirements and tests; and IEC 60601-1-1-11, General 
requirements for basic safety and essential performance-Collateral standard: Requirements 
for medical electrical equipment and medical electrical systems used in the home healthcare 
environment. The results of these tests indicate that the device is safe for its intended use. 
In addition, a biocompatibility evaluation was performed to satisfy ISO 10993-1 and FDA 
requirements. All patient contacting materials have been tested, and passed cytotoxicity, 
sensitization and irritation or intra-cutaneous standards. leva poses little to no risk to the 
patient if used as instructed. 
GCP Statement 
This study is to be performed in full compliance with the protocol, Good Clinical Practices 
(GCP), and applicable regulatory requirements. All required study documentation will be 
archived as required by regulatory authorities. 
 
Confidentiality Statement 
This document is confidential. It contains proprietary information of Renovia, Inc. Any 
viewing or disclosure of such information that is not authorized in writing by Renovia, Inc. is 
strictly prohibited. Such information may be used solely for the purpose of reviewing or 
performing this study. 

leva device  
 
Sponsor No.:  POC Trial LV-001 UI 
Renovia, Inc. 
 
Project No.:  NESCA-Renovia-01 
 
Protocol Version 2.0 
May 5, 2017 
1 
PROTOCOL REVISION HISTORY 
Date/Name 
Description 
17 Feb 2017 
Version 1.0  
05 May 2017 
Version 2.0 
 
 
 

leva device  
 
Sponsor No.:  POC Trial LV-001 UI 
Renovia, Inc. 
 
Project No.:  NESCA-Renovia-01 
 
Protocol Version 2.0 
May 5, 2017 
 
PRINCIPAL INVESTIGATOR AND SPONSOR – SIGNATORIES 
AN OPEN-LABEL STUDY TO ASSESS THE EFFECTIVENESS OF THE LEVA 
INCONTINENCE SYSTEM IN TREATING BLADER INCONTINENCE 
 
 
 
SPONSOR: 
Renovia, Inc. 
99 High Street 
30th Floor 
Boston, MA 02110 
 
SPONSOR’S 
REPRESENTATIVES: 
Ramon J. Iglesias, MD 
Chief Medical Officer 
Tel.:  +1 386 747 8293 
E-mail: rjiglesias@renovia.com  
 
 
 
 
 
Signature 
 Date 
 
 
 

leva device  
 
Sponsor No.:  POC Trial LV-001 UI 
Renovia, Inc. 
 
Project No.:  NESCA-Renovia-01 
 
Protocol Version 2.0 
May 5, 2017 
AN OPEN-LABEL STUDY TO ASSESS THE EFFECTIVENESS OF THE LEVA 
INCONTINENCE SYSTEM IN TREATING BLADER INCONTINENCE 
 
PRINCIPAL INVESTIGATOR AND CLINICAL SITE: 
Robert Rosenberg, MD 
799 Concord Avenue 
Cambridge, MA 02138 
Tel.: (781) 979-0140 
Fax: (617) 547-7165 
E-mail: rrosenberg@nespinecare.com 
 
 
Signature 
 Date 
 
 
 
SUB INVESTIGATOR: 
Peter Rosenblatt, MD 
Urogynecology Study Consultant 
725 Concord Avenue 
Suite 1200 
Cambridge, MA 02138 
Tel.: (617)354-5452 
E-mail:plrosen@comcast.net 

leva device  
 
Sponsor No.:  POC Trial LV-001 UI 
Renovia, Inc. 
 
Project No.:  NESCA-Renovia-01 
 
Protocol Version 2.0 
May 5, 2017 
2 
TABLE OF CONTENTS 
1 
PROTOCOL REVISION HISTORY .................................................................................... 2 
PRINCIPAL INVESTIGATOR AND SPONSOR – SIGNATORIES......................................... 3 
2 
TABLE OF CONTENTS ..................................................................................................... 5 
3 
SYNOPSIS .......................................................................................................................... 7 
4 
STUDY EVENTS FLOW CHART ....................................................................................... 9 
5 
ABBREVIATIONS ............................................................................................................ 10 
6 
BACKGROUND ................................................................................................................ 11 
7 
STUDY OBJECTIVE AND ENDPOINT ........................................................................... 12 
7.1 Study Objective ........................................................................................................ 12 
7.2 Study Endpoint(s) ..................................................................................................... 12 
8 
INVESTIGATIONAL PLAN .............................................................................................. 13 
8.1 Overall Study Design and Plan ................................................................................ 13 
8.1.1 
Confinement and Return Visits .................................................................. 13 
8.2 Risks and/or Benefits to Subjects ............................................................................ 13 
8.3 Selection of Study Population .................................................................................. 14 
8.3.1 
Inclusion Criteria ........................................................................................ 14 
8.3.2 
Exclusion Criteria ....................................................................................... 14 
8.3.3 
Removal of Subjects from the Study ......................................................... 15 
8.3.4 
Prohibitions and Concomitant Therapy ..................................................... 15 
8.3.5 
Meals .......................................................................................................... 15 
8.3.6 
Activity ........................................................................................................ 15 
8.4 Treatments ............................................................................................................... 16 
8.4.1 
Treatment Administered............................................................................. 16 
8.4.2 
Treatment Compliance ............................................................................... 16 
9 
STUDY PROCEDURES ................................................................................................... 17 
9.1.1 
Adverse Events .......................................................................................... 19 
9.1.1.1 Monitoring .................................................................................... 19 
9.1.1.2 Serious Adverse Event ................................................................ 19 
10 DATA ANALYSIS ............................................................................................................. 21 
10.1 Statistical Methods ................................................................................................... 21 
10.1.1 
Determination of Sample Size ................................................................... 21 
10.1.2 
Subjects to Analyze.................................................................................... 21 
10.2 Safety Evaluation ..................................................................................................... 21 
11 STUDY ADMINISTRATION ............................................................................................. 22 
11.1 Ethics ........................................................................................................................ 22 

leva device  
 
Sponsor No.:  POC Trial LV-001 UI 
Renovia, Inc. 
 
Project No.:  NESCA-Renovia-01 
 
Protocol Version 2.0 
May 5, 2017 
11.1.1 
Institutional Review Board ......................................................................... 22 
11.1.2 
Ethical Conduct of the Study ..................................................................... 22 
11.1.3 
Subject Information and Consent .............................................................. 22 
11.2 Termination of the Study .......................................................................................... 22 
11.3 Data Quality Assurance ........................................................................................... 22 
11.4 Direct Access to Source Data/Documents .............................................................. 22 
11.5 Study Device Supplies, Packaging and Labeling .................................................... 23 
11.6 Data Handling and Record Keeping ........................................................................ 23 
11.7 Publication Policy ..................................................................................................... 23 
12 REFERENCES ................................................................................................................. 24 
 
 
 
 

leva device  
 
Sponsor No.:  POC Trial LV-001 UI 
Renovia, Inc. 
 
Project No.:  NESCA-Renovia-01 
 
Protocol Version 2.0 
May 5, 2017 
 
3 
SYNOPSIS 
Device: 
leva Incontinence SystemTM 
Clinical Indication: 
Urinary Incontinence 
Study Objective: 
The objective of this study is to assess the effectiveness of the 
leva Incontinence SystemTM in treating bladder incontinence. 
Summary of Study 
Design: 
An open-label study.  
Screening of subjects will occur over 1-2 study visits to 
determine study eligibility. 
Up to 25 subjects meeting inclusion/exclusion criteria at 
Screening will complete about 6-8 weeks of training and testing 
with a device to improve the strength of their pelvic floor 
muscles.  
Weekly during the study the subjects will complete tests using 
the leva device to assess changes in their pelvic floor muscle 
strength. Subjects will also complete surveys to assess 
improvements in the symptoms of their urinary incontinence. 
 
The FSFI and PISQ-IR surveys will be provided to subjects to 
complete at the Screening visit and upon study completion and 
will be returned in a sealed envelope for review after conduct is 
completed. Completion of the FSFI and PISQ-IR surveys is 
optional.  
 
Subjects that complete the study will be asked to participate in 
an optional post study interview with the Study Director and a 
marketing professional to better understand the subjects’ 
experience using the device. The interview is optional. 
Blinding: 
Unblinded 
Number of Subjects: 
Up to 25 subjects meeting inclusion/exclusion criteria at 
Screening visit will return to the clinic to participate in the 
treatment phase of the study.  
Study Treatment: 
leva Incontinence SystemTM 
Key Assessments: 
The following analyses will be performed: 
Efficacy: 
• 
leva device angle measurements 
• 
Survey evaluations of incontinence including: 
o 
Urinary Incontinence Distress Inventory (UDI-6)  
o 
Incontinence Impact Questionnaire (IIQ-7) 

leva device  
 
Sponsor No.:  POC Trial LV-001 UI 
Renovia, Inc. 
 
Project No.:  NESCA-Renovia-01 
 
Protocol Version 2.0 
May 5, 2017 
o 
Patient’s Global Impression of Severity (PGI-S) 
o Revised Urinary Incontinence Scale (RUIS) 
o Patient’s Global Impression of Improvement 
(PGI-I) 
o Clinician’s Global Impression of Improvement 
(CGI-I) 
o Voiding diary 
Safety and Tolerability: 
o 
Subjects will be monitored for adverse events and 
serious adverse events.  

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Project No NESCA-Renovia-01 
Protocol Version 2.0 
May 5, 2017 
4 
STUDY EVENTS FLOW CHART 
Study Procedures 
Screen 
Training 
Visits 
Week 3 
 
Week 6 
Visit 
 
End of 
Study/Early 
Termination 
Visit → 
1** 
2-30 
11 
26 
 
31 
Inclusion/Exclusion Criteria 
X 
 
 
 
 
Informed Consent 
X 
 
 
 
 
Demographic data 
X 
 
 
 
 
Medical History 
X 
 
 
 
 
Height/Weight 
X 
 
 
 
 
Urine Pregnancy Test 
X 
 
 
 
 
Oral alcohol/Urine Drug Screen 
X 
 
 
 
 
AE Monitoring 
 
X 
X 
X 
X 
Concomitant Medication 
X 
X 
X 
X 
X 
Survey: MESA 
X 
 
 
 
 
Surveys: UDI-6, IIQ-7, PGI-S, RUIS  
X 
X 
weekly 
X 
X 
X 
Surveys: FSFI, PISQ-IR (optional) 
X 
 
 
 
X 
Patient’s & Clinical Global Impression-
Improvement 
 
 
X 
X 
X 
Voiding Dairy 
X 
 
X 
 
X 
leva Training 
X  
X 
X 
X 
 
leva Testing/Angle Measurements 
X 
X* 
visits 6, 16 & 21 
 
X* 
 
 
X* 
 
X* 
Interview subject about experience 
using the device (optional) 
 
 
 
 
X 
 
*Preferably on Mondays                   ** Screening activities can be conducted over 1-2 visits

leva device 
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Renovia, Inc. 
 
Project No.:  NESCA-Renovia-01 
 
Protocol Version 2.0 
May 5, 2017 
5 
ABBREVIATIONS 
AE 
Adverse event 
CFR 
Code of Federal Regulations 
CGI-I 
Clinical Global Impression of Improvement 
CRF 
Case Report Form 
CRU 
Clinical Research Unit 
EOS 
End of Study 
FDA 
FSFI 
Food and Drug Administration 
Female Sexual Function Index 
GCP 
Good Clinical Practice 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IIQ-7 
Incontinence Impact Questionnaire 
IRB 
Institutional Review Board 
MESA 
Medical, Epidemiologic and Social Aspects of Aging 
N 
Number of subjects 
PGI-I 
Patient’s Global Impression of Improvement 
PGI-S 
Patient’s Global Impression of Severity 
PI 
PISQ-IR 
Principal Investigator 
Pelvic Organ Prolapse/Incontinence Sexual Questionnaire 
QA 
Quality Assurance 
RUIS 
Revised Urinary Incontinence Scale 
SAE 
Serious adverse event 
SAP 
Statistical analysis plan 
SD 
Standard deviation 
UAE 
Unexpected adverse event 
UDI-6 
Urinary Incontinence Distress Inventory 
US 
United States 
 
 
 
 
 
 
 
 
 
 
 

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Project No.:  NESCA-Renovia-01 
 
Protocol Version 2.0 
May 5, 2017 
6 
BACKGROUND  
Injury or weakening of the pelvic floor muscles can lead to pelvic floor disorders including 
urinary incontinence, pelvic organ prolapse, fecal incontinence or sexual dysfunction.  These 
conditions affect 1 in 4 women of all ages and can make a significant impact on quality of 
life.  Pelvic Floor Muscle Exercises, also known as Kegel’s, are the first-line conservative 
treatment for pelvic floor disorders and specifically for urinary incontinence. Studies have 
shown that performing pelvic floor muscle exercises and/or pelvic floor physical therapy is 
the most effective non-invasive treatment for urinary incontinence. Pelvic Floor Muscle 
Therapy is advocated as the first-line of treatment for urinary incontinence by the American 
College of Obstetrics and Gynecology, the American Urogynecological Society, the Agency 
for Healthcare Research and Quality. 
 
Pelvic Floor Muscle Exercises was first described by Arnold Kegel almost 60 years ago. 
Most women have trouble identifying and contracting the correct muscles when performing 
these exercises. The novel device that is an intravaginal system, leva Incontinence System 
TM allows women to have real-time visual verification that the exercises are performed 
correctly and consistently. leva Incontinence SystemTM also measures and records the 
results of every session performed while using the device thus assuring patient compliance. 
In the proposed study we aim to clinically show improvement of incontinence symptoms with 
use of leva Incontinence SystemTM for performing Pelvic Floor Muscle Exercises. 
The association between urinary incontinence and female sexual dysfunction has been 
described in the literature. The relationship is reported by Salonia et al (2004) however, 
overall there is a paucity of research in this area. We will evaluate if women who show 
improvement in incontinence symptoms with the use of the leva Incontinence SystemTM and 
who complete the optional FSFI and PISQ-IR surveys have changes in their responses to the 
survey questions and will then determine if further research is warranted. 

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Renovia, Inc. 
 
Project No.:  NESCA-Renovia-01 
 
Protocol Version 2.0 
May 5, 2017 
7 
STUDY OBJECTIVE AND ENDPOINT 
7.1 
Study Objective 
The objective of this study is to assess the effect of the leva device on signs and symptoms 
of urinary incontinence as measured by the endpoints descried below. 
7.2 
Study Endpoint(s) 
Efficacy: 
1. leva device angle measurements 
2. Survey evaluations of incontinence including: 
a. Urinary Incontinence Distress Inventory (UDI-6)  
b. Incontinence Impact Questionnaire (IIQ-7) 
c. Patient’s Global Impression of Severity (PGI-S) 
d. Revised Urinary Incontinence Scale (RUIS) 
e. Patient’s Global Impression of Improvement (PGI-I) 
f. 
Clinician’s Global Impression of Improvement (CGI-I) 
g. Voiding diary 
 
Safety and Tolerability: 
1. Reported Adverse Events (AEs) and Serious Adverse Events (SAEs) 
 
 

leva device 
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Renovia, Inc. 
 
Project No.:  NESCA-Renovia-01 
 
Protocol Version 2.0 
May 5, 2017 
8 
INVESTIGATIONAL PLAN 
8.1 
Overall Study Design and Plan 
An open-label study in adult women with urinary incontinence.  
Screening of subjects will occur in one to two visits to determine study eligibility. 
Up to 25 subjects meeting inclusion/exclusion criteria at screening will participate in 6 (up to 
8 weeks) of twice daily training sessions using the leva device. Subjects will be allowed up 
to 8 weeks to complete the study to accommodate scheduling issues, menstrual periods or 
planned vacations. 
Training sessions last 2.5 minutes with alternating 15 seconds of voluntary contraction of the 
pelvic floor muscles and 15 seconds of rest.  
Changes in urinary incontinence will be assessed by symptoms of incontinence, leva angle 
measurements and patient’s and clinician’s assessment of global improvement over the 
study period.  
All subjects enrolled in the study will be asked to complete the FSFI and PISQ-IR surveys 
upon enrollment and at study end. Completion of the FSFI and PISQ-IR is optional, and 
completed surveys will be returned in a sealed envelope and reviewed following study 
completion. 
All subjects who complete this study will be invited to participate in an optional interview with 
the Study Director and a marketing professional to better understand their experiences 
using the device. The interview will last up to one hour at the final visit. 
 
8.1.1 Confinement and Return Visits 
The screening visit may take up to 1 hour and the return visits will last about 15 minutes. 
See Study Events Flow Chart (Section 4).  
For each visit, the subjects will report to the clinic at the time indicated by the Clinical 
Research Unit (CRU) and remain confined until completion of the training/testing with the 
female leva Trainer who is a licensed healthcare professional. 
At the discretion of study staff, a female leva Trainer therapist may be sent to a subject’s 
home for training/testing. There will be no additional charge for an at-home visit. 
There are no overnight stays required for this study. At all times, a subject may be required 
to remain at the CRU for longer at the discretion of the Principal Investigator (PI). 
8.2 
Risks and/or Benefits to Subjects 
leva Incontinence System TM is an FDA-approved Class II medical device. As such it has 
been tested and found to conform with the requirements of IEC 60601-1:2005 (3RD Edition), 
Medical Electrical Equipment-Part 1:  General requirements for basic safety and essential 
performance; 
IEC 
60601-1-2:2007, 
Medical 
electrical 
equipment-Part1-2:General 
requirements 
for 
basic 
safety 
and 
essential 
performance-Collateral 
standard: 
Electromagnetic compatibility-Requirements and tests; and IEC 60601-1-1-11, General 
requirements for basic safety and essential performance-Collateral standard: Requirements 

leva device 
Page 14 
 
Renovia, Inc. 
 
Project No.:  NESCA-Renovia-01 
 
Protocol Version 2.0 
May 5, 2017 
for medical electrical equipment and medical electrical systems used in the home healthcare 
environment. The results of these tests indicate that the device is safe for its intended use. 
In addition, a biocompatibility evaluation was performed to satisfy ISO 10993-1 and FDA 
requirements. All patient contacting materials have been tested, and passed cytotoxicity, 
sensitization and irritation or intra-cutaneous standards. leva poses little to no risk to the 
patient if used as instructed. 
The risks of use of the leva device are minimal to none however, there may be some 
unknown or infrequent or unforeseeable risks associated with the use of the device.  The 
potential risks may include embarrassment with use of the intravaginal device; however the 
use of this should not conceptually differ from use of a tampon. Risks of course will be 
monitored throughout the entirety of the study. 
 
8.3 
Selection of Study Population 
8.3.1 Inclusion Criteria 
Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the 
study, unless otherwise specified: 
1. Subjects must be female. 
2. Subjects must be capable of giving informed consent. 
3. Subjects should be between at least 18 years of age. 
4. Subjects must have a diagnosis of or symptoms of predominant mild to moderate urinary 
incontinence based on the results of the completed urinary incontinence surveys.  
8.3.2 Exclusion Criteria 
Subjects must not be enrolled in the study if they meet any of the following criteria: 
1. Absence of a vagina. 
2. Positive drug or alcohol test at the Screening visit. 
3. Post-menopausal defined as absence of a period for over 12 months. 
4. Pregnancy or being less than 12 months post-partum. 
5. Greater than 3 vaginal deliveries or prior operative delivery (e.g. use of vacuum, forceps 
or abdominal pressure). 
6. Symptoms of stage II or greater pelvic organ prolapse. 
7. BMI >31 kg/m2. 
8. Diagnosis of any neurological disorder. 
9. Prior lower back or pelvic surgery, including prior surgery for SUI. 

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Project No.:  NESCA-Renovia-01 
 
Protocol Version 2.0 
May 5, 2017 
10. Prior pelvic radiation. 
11. Current or recurrent vaginal infections (>3 per year). 
12. Painful bladder syndrome, active or chronic pelvic pain. 
13. Concurrent PFME under a supervised therapeutic plan of care. 
14. Previous supervised pelvic floor muscles rehabilitation in the past 12 months for the 
treatment for urinary incontinence or any other pelvic floor disorder. 
15. Currently taking medication to treat incontinence. 
16. Impaired cognitive function. 
17. Unable to tolerate use of the leva vaginal device. 
8.3.3 Removal of Subjects from the Study 
Subjects are free to withdraw from the study at any time for any reason.  
In addition, subjects may be withdrawn from the study by the PI in consultation with the 
Sponsor for the following reasons: 
• 
Subject is unable to use the leva device; 
• 
Subject experiences a SAE; 
• 
Protocol violation. 
The clinical report will include reasons for subject withdrawals. 
8.3.4 Prohibitions and Concomitant Therapy 
There are no prohibited therapies, activities or medications except as described in the 
exclusion criteria. All medications taken by subjects during the course of the study will be 
recorded. 
8.3.5 Meals 
Due to the short duration of confinement for each study period, subjects will not be provided 
with a meal.  
8.3.6 Activity 
The subjects will be required to remain standing while performing training and in weekly 
tests using the leva device. The subjects are allowed to be ambulatory (i.e., no restrictions 
for standing, walking, sitting, or lying down) at all other times. 

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Renovia, Inc. 
 
Project No.:  NESCA-Renovia-01 
 
Protocol Version 2.0 
May 5, 2017 
8.4 
Treatments 
8.4.1 Treatment Administered 
Subjects will train twice daily for 6 (up to 8 weeks) using the leva device. The female leva 
Trainer will assist the subject five days a week with the training session by helping to assure 
that the subject is performing the training using the correct muscle movements.  
 
8.4.2 Treatment Compliance  
The leva device retains results from the subject’s previous training sessions. Therefore, 
when the subject trains at home or when a session is missed the female leva Trainer will be 
able aware of the data and can counsel the subject if no session data is recorded due to a 
missed session. 

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Renovia, Inc. 
 
Project No.:  NESCA-Renovia-01 
 
Protocol Version 2.0 
May 5, 2017 
9 
STUDY PROCEDURES 
The Study Events Flow Chart (Section 4) summarizes the procedures to be performed at 
each visit. Individual procedures are described in detail below. Additional evaluations/testing 
may be deemed necessary by the PI and/or the Sponsor for reasons related to subject 
safety. 
Any nonscheduled procedures required for urgent evaluation of safety concerns take 
precedence over all routine scheduled procedures. 
Screening visit:  
This visit may be conducted in one to two visits, as needed. The study will be explained by 
the Study Director and the consent will be reviewed with prospective participants.  The 
consent will be obtained by the licensed Physician Investigator or his Study Director. The 
study participation will be entirely voluntary. 
Each subject will provide samples for drug screening, pregnancy testing, and buccal swabs 
for alcohol screening. 
The following surveys will be administered: 
• 
Medical, Epidemiologic and Social Aspects of Aging (MESA) 
• 
Urinary Distress Inventory questionnaire, short version (UDI-6) 
• 
Incontinence Impact Questionnaire, short form (IIQ-7) 
• 
Patient Global Impression of Severity (PGI-S) Scale 
• 
Revised Urinary Incontinence Scale (RUIS) 
• 
Voiding diary – 24 hours intake and output and symptoms diary - to be taken home  
and completed within the first week of participation 
• 
Female Sexual Function Index (FSFI) (optional) 
• 
Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-IR) (optional) 
 
Medical History will be obtained to include: 
• 
Demographic data 
• 
Height/weight 
• 
Concomitant medication 
• 
Latex allergy (for selection of disposable probe cover)   
 
The female leva Trainer therapist will familiarize the subject with the leva Incontinence 
SystemTM  and instruct on the technique of contraction. 
The female leva Trainer will conduct baseline leva testing and measurements will include: 
Baseline angle; angle with Valsalva (or bear down maneuver); highest angle with pelvic floor 
muscles contraction; ability to sustain contraction and contractions in timed 15 seconds. 
This series is called the leva Test. 
The subject will train for 2 ½ minutes using the leva device (leva Training) – each cycle will 
have 15 seconds of contraction with 15 seconds of relaxation. Participants will perform 5 
alternating repetitions. 
The female leva Trainer will record leva device measurements.  

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Renovia, Inc. 
 
Project No.:  NESCA-Renovia-01 
 
Protocol Version 2.0 
May 5, 2017 
Study visits 2-30 (with the female leva Trainer): 
Frequency: once a day 5 days a week. The female leva Trainer will supervise the 
participants on performing 2 1/2 minutes of 5 repetitions of pelvic floor exercises using the 
leva Incontinence System TM (leva Training) 
Once a week, preferably Mondays, during the about 6-8 week study period: 
The subjects will be asked to perform a series of 5 exercises “leva Test” to test the effect of 
the daily training and follow the test with the 2 ½ minutes of training (leva Training). The 
female leva Trainer will record leva device measurements. 
The study participants will be given the following surveys:  
• 
UDI-6 
• 
IIQ-7 
• 
PGI-S 
• 
RUIS 
 
At 3 weeks: 
The subjects will be asked to perform a series of 5 exercises (leva Test) to test the effect of 
the daily training and follow the test with the 2 ½ minutes of training (leva Training). The 
female leva Trainer will record leva device measurements.  
The study participants will be given the following questionnaires: 
• 
UDI-6 
• 
IIQ-7 
• 
PGI-S 
• 
PGI-I 
• 
RUIS 
• 
Voiding diary completion 
 
The Study Director or PI will complete the Clinician’s Global Impression of Improvement 
(CGI-I) evaluation. 
At 6 weeks: 
The subjects will be asked to perform a series of 5 exercises (leva Test) to test the effect of 
the daily training and follow the test with the 2 ½ minutes of training (leva Training). The 
female leva Trainer will record leva device measurements.  
The study participants will be given the following questionnaires: 
• 
UDI-6 
• 
IIQ-7 
• 
PGI-S 
• 
PGI-I 
• 
RUIS 
 
The Study Director or PI will complete the Clinician’s Global Impression of Improvement 

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Protocol Version 2.0 
May 5, 2017 
(CGI-I) evaluation. 
At the End of Study/ Early Termination visit: 
The subjects will be asked to perform a series of 5 exercises (leva Test) to test the effect of 
the daily training. The female leva Trainer will record leva device measurements.  
The study participants will be given the following questionnaires: 
• 
UDI-6 
• 
IIQ-7 
• 
PGI-S 
• 
PGI-I 
• 
RUIS 
• 
Voiding diary completion 
• 
FSFI (optional) 
• 
PISQ-IR (optional) 
 
The Study Director or PI will complete the Clinician’s Global Impression of Improvement 
(CGI-I) evaluation. 
 
9.1.1 Adverse Events  
9.1.1.1 Monitoring 
Subjects will be monitored at each study visit for adverse events. A specific enquiry will be 
made at the time of each check-in. The subjects will be queried with an open-ended 
question such as “How are you feeling?” or “How have you been feeling since your last 
visit?”  
9.1.1.2 Serious Adverse Event 
Any SAE will be reported to the Sponsor and the Institutional Review Board (IRB), as 
required. All SAEs will be reported to the Sponsor via fax or e-mail within one working day of 
becoming aware of the event, whether or not the serious events are deemed study 
treatment-related and within 5 working days to the IRB (24 hours of discovery if the event 
involves a death), as required. 
An SAE is any AE or suspected adverse reaction that in the view of either the PI or Sponsor, 
results in any of the following outcomes:  Death, a life-threatening adverse event, inpatient 
hospitalization or prolongation of existing hospitalization, a persistent or significant 
incapacity or substantial disruption of the ability to conduct normal life functions, or a 
congenital anomaly/birth defect. Important medical events that may not result in death, be 
life-threatening, or require hospitalization may be considered serious when, based upon 
appropriate medical judgment, they may jeopardize the subject and may require medical or 
surgical intervention to prevent one of the outcomes listed in the above definition.  
Life-threatening is defined as an AE or suspected adverse reaction that in the view of the PI 
or Sponsor, its occurrence places the patient or subject at immediate risk of death. It does 
not include an adverse event or suspected adverse reaction that, had it occurred in a more 
severe form, might have caused death. 

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Treatment of SAEs will be performed by a physician, either at the site or at a nearby hospital 
emergency room. Where appropriate, medical test(s) and/or examination(s) will be 
performed to document resolution of event(s). Outcome may be classified as resolved, 
improved, unchanged, worse, fatal, or unknown (lost to follow-up). 
If a SAE occurs to a subject on this study, contact the Sponsor’s Representative listed in 
Section 2. 

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10 DATA ANALYSIS 
Data will be handled and processed according to Operating Procedures, which are based on 
the principles of GCP. 
10.1 Statistical Methods 
Detailed methodology for summary and statistical analyses of the data collected in this study 
will be documented in the Clinical Study Report. 
10.1.1 Determination of Sample Size 
This is an open-label study where subjects serve as their own control. The sample size was 
selected without statistical considerations.  
10.1.2 Subjects to Analyze 
Safety Population: All subjects who were administered at least one training session will be 
included in the safety evaluations. 
 
Efficacy Population: All subjects who had at least one leva testing administration and 
measurement of any of the efficacy assessments post Screening Visit. 
 
10.2 Safety Evaluation 
Safety data will be populated in individual CRFs. All safety data will be listed by subject. 
AEs and SAEs will be monitored throughout the study. All SAEs will be recorded and 
reported. Concomitant medications and medical history will be listed by subject. 

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11 STUDY ADMINISTRATION 
11.1 Ethics 
11.1.1 Institutional Review Board  
This protocol will be reviewed by Chesapeake Research Review, Inc., an IRB and the study 
will not start until the IRB has approved the protocol or a modification thereof. The IRB is 
constituted and operates in accordance with the principles and requirements described in 
the US Code of Federal Regulations (21 CFR Part 56). The IRB is compliant to International 
Conference on Harmonisation (ICH) guidelines, and may be reached at: 
Chesapeake IRB 
6940 Columbia Gateway Drive, Suite 110 
Columbia, MD 21046 
Tel.:  +1 410 884 2900 
11.1.2 Ethical Conduct of the Study 
This research will be carried out in accordance with the protocol, US Code of Federal 
Regulations, GCP, 21 CFR Parts 50 and 56, the ethical principles set forth in the 
Declaration of Helsinki, and the ICH harmonized tripartite guideline regarding 
GCP (E6 Consolidated Guidance, April 1996). 
11.1.3 Subject Information and Consent 
The purpose of the study, the procedures to be carried out and the potential hazards will be 
described to the subjects in non-technical terms. Subjects will be required to read, sign and 
date an ICF summarizing the discussion prior to Screening, and will be assured that they 
may withdraw from the study at any time without jeopardizing their medical care. 
Subjects will be given a copy of their ICF. 
11.2 Termination of the Study 
The Principal Investigator reserves the right to terminate the study in the interest of subject 
welfare. The Sponsor may terminate the study for administrative reasons. 
11.3 Data Quality Assurance 
The Principal Investigator will designate personnel responsible for implementing and 
maintaining quality assurance and quality control systems to ensure that the study is 
conducted, and that data are generated, documented and reported in compliance with the 
study protocol, GCP and Good Laboratory Practice requirements as well as applicable 
regulatory requirements and local laws, rules and regulations relating to the conduct of the 
clinical study. 
 
11.4 Direct Access to Source Data/Documents 
The Principal Investigator will ensure that the Sponsor, IRB and domestic and foreign 
regulatory authorities will have direct access to all study sites, source data/documents, and 

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reports for the purpose of monitoring and auditing. In the event that other study-related 
monitoring should be done by other parties, those parties will be required to sign a 
confidentiality agreement prior to any monitoring or auditing. 
11.5 Study Device Supplies, Packaging and Labeling 
The Sponsor will supply sufficient quantities of devices to allow completion of this study. 
Each subject will be provided with her own device and can retain the device at the end of 
the study. The device has a value of about $700. If the subject does not already own an 
iPhone to run the leva software they will be provided at no charge an iPOD touch ($250 
value) to use. It will be up to the discretion of the Sponsor if the iPOD touch needs to be 
returned to the study site or can be retained by the subject at the end of the study.  Records 
will be made of the receipt and dispensing of devices supplied. This accountability record 
will be available for inspection at any time. At the completion of the study, the original 
accountability record will be available for review by the Sponsor upon request. 
11.6 Data Handling and Record Keeping 
All raw data generated in connection with this study, together with the final report, will be 
retained for at least 5 years after completion of the final report. These documents should be 
retained for a longer period however if required by the applicable regulatory requirements or 
by an agreement with the Sponsor. It is the responsibility of the Sponsor to inform the 
PI/Institution as to when these documents no longer need to be retained. 
11.7 Publication Policy 
All unpublished information given to the Principal Investigator by the Sponsor shall not be 
published or disclosed to a third party without the prior written consent of the Sponsor. 
The data generated by this study are considered confidential information and the property of 
the Sponsor. This confidential information may be published only in collaboration with 
participating personnel from the Sponsor or upon Sponsor’s written consent to publish the 
article.  

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12 REFERENCES 
1 
Svatek R, Roche V, Thornberg J, Zimmern P. NormativeValues for the American 
Urological Association Symptom Index (AUA-7) and Short Form Urogenital Distress 
Inventory (UDI-6) in Patients 65 and Older Presenting for Non-Urological Care. 
Neurourol Urodyn. 2005;24(7):606-10. 
 
2 
Herzog AR, Diokno AC, Brown MB, Normolle DP, Brock BM. Two-year incidence, 
remission, and change patterns of urinary incontinence in noninstitutionalized older 
adults. J Gerontol 1990;45:M67-M7. 
 
3 
Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. 
Am J Obstet Gynecol. 2003 Jul;189(1):98-101. 
 
4 
Salonia A, Zanni G, Nappi R, Briganti A, Deho F, Fabbri F, Columbo R, Guazzoni G, Girolamo V, 
Rigatti P, Montorsi F. Sexual Dysfunction is Common in Women with Lower Urinary Tract 
Symptoms and Urinary Incontinence: Results of a Cross-Sectional Study. European Urology. 
2004; 45: 642-648. 
 
5 
Rogers RG, Rockwood TH, Constantine ML, Thakar R, Kammerer-Doak DN, Pauls RN,  Parekh 
M, Ridgeway B, Jha S, Pitkin J, Reid F, Sutherland SE, Lukacz ES, Domoney C, Sand P, Davila 
GW, Espuna Pons ME.  A new measure of sexual function in women with pelvic floor disorders 
(PFD): the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). 
International Urogynecology Journal 2013, 24:1091-1103.