A Prospective Efficacy Study Comparing FREquency of Use and Efficacy of a Personalized Surgery-free Wearable and Personalized Bladder Modulation System With Objective Confirmation of Nerve Activation for Use in the Home by Subjects With OverActive Bladder Syndrome
Phase: NA
Conditions: Overactive Bladder, Urinary Frequency, Urinary Incontinence, Urge, Urinary Urgency
Sponsor: Avation Medical, Inc.

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Avation Medical 
...Empowering Subjects. Empowering lives. 
 
 
 
 
 
 
A prospective efficacy study comparing FREquency of use and 
Efficacy of a personalized surgery-free wearable and 
personalized bladder modulation system with objective 
confirmation of nerve activation for use in the home by 
subjects with OverActive Bladder syndrome 
 
FREEOAB Study 
 
 
 
 
Protocol 
Number 
AMHOAB2001 
Version 
Number 
V 2, February 15, 2021 

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Notice of Confidentiality 
 
The confidential information in the following document is provided to you as an 
Investigator, potential Investigator, or Consultant for review by you, your staff and an 
appropriate Institutional Review Board or Independent Ethics Committee. By 
accepting this document, you agree that the information contained herein will not be 
disclosed to others without written authorization from Avation Medical except to the 
extent necessary to obtain informed consent from those persons to whom the 
products may be administered 

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Contact Details 
 
 
 
Sponsor 
Avation Medical, Inc. 
1375 Perry St 
Columbus, Ohio 43201 
United States 
System Manufacturer 
Avation Medical, Inc. 
1375 Perry St 
Columbus, Ohio 43201 
United States 

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Protocol Signature Page 
 
Study Title: A prospective efficacy study comparing frequency of use of a surgery-free 
wearable and personalized bladder modulation system with objective confirmation of nerve 
activation for use in the home by subjects with overactive bladder syndrome. 
Protocol Number: AMHOAB2001 
Version: V 2.0, February 15, 2021 
Investigator’s Statement 
I agree to conduct this clinical investigation in accordance with the design and specific 
provisions of this protocol; modifications to the study are acceptable only with a 
mutually agreed upon protocol amendment as approved by the Sponsor and ethics 
review board. I agree to await ethics review board approval of the protocol and 
informed consent before initiating the study, to obtain consent from participants 
prior to their enrollment in the study, to collect and record data as required by the 
protocol and case report forms, and to maintain study documents for the period of 
time required. 
 
Confidential 
This document contains confidential information belonging to Avation Medical 
except as may be otherwise agreed to in writing, by accepting or reviewing these 
materials, I agree to hold such information in confidence and not to disclose it to 
others (except where required by applicable law), nor use it for unauthorized 
purposes. 
 
 
 
 
 
 
 
Investigator’s Signature 
       Date of Signature 

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Table of Contents 
1. 
Abbreviations and Definitions .............................................................................................................. 6 
2. 
Protocol Summary ................................................................................................................................ 7 
3. 
Introduction ........................................................................................................................................ 11 
4. 
Objectives ........................................................................................................................................... 12 
5. 
Study Design ....................................................................................................................................... 12 
6. 
Subject Selection ................................................................................................................................ 14 
7. 
Methods and Procedures ....................................................................................................................16 
8. 
Long-Term Follow-Up Phase ............................................................................................................. 22 
9. 
Outcome Variables ............................................................................................................................ 25 
10. 
Test Article ......................................................................................................................................... 26 
11. 
Regulatory Status .............................................................................................................................. 28 
12. 
Safety and adverse events ................................................................................................................. 28 
13. 
Data Analysis, Evaluation and Statistical Plan .................................................................................... 29 
14. 
Withdrawal of Subjects from Study ..................................................................................................... 31 
15. 
Modification of Protocol ..................................................................................................................... 31 
16. 
Discontinuation of Study..................................................................................................................... 31 
17. 
Identified Risks .................................................................................................................................... 31 
18. 
Administrative Requirements and Quality Assurance ......................................................................... 33 
19. 
Publications ....................................................................................................................................... 36 
20. 
References ......................................................................................................................................... 36 
21.  
Protocol Amendment Summary of Changes ....................................................................................... 37 
21. 
Appendix A- Case Report Forms .........................................................................................................38 

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1. Abbreviations and Definitions 
 
Term 
Definition 
BOTOX 
Botulinum toxin 
CRF 
Case Report Form 
DCF 
Data Clarification Form 
EMG 
Electromyography 
IIQ-7 
Incontinence Impact Questionnaire – Short Form 
I-QOL 
Incontinence Quality of Life 
ISF 
Investigator Site File 
OAB 
Overactive Bladder 
OAB-q 
Overactive Bladder questionnaire 
OHQ 
Oxford Happiness Questionnaire 
PGIC 
Patient’s Global Impression of Change 
PTNS 
Percutaneous Tibial Nerve Stimulation 
SAE 
Serious Adverse Event 
SNS 
Sacral Nerve Stimulation 
UUI 
Urge Urinary Incontinence 
WiFi 
Wireless Fidelity 

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2. Protocol Summary 
 
Title 
A prospective efficacy study comparing frequency of use and efficacy of a 
surgery-free wearable personalized bladder modulation system with 
objective confirmation of nerve activation for use in the home by subjects 
with Overactive Bladder syndrome. 
Test Article 
Avation Medical’s surgery-free wearable and personalized bladder 
modulation system that provides objective confirmation of nerve activation, 
can be used in a home environment, and is controlled with a tablet-based 
application 
Protocol 
Number 
AMHOAB2001 
Objectives 
• To compare the effectiveness of 1 treatment session per week to 3 
treatment sessions per week on OAB symptoms using the Test 
Article. 
• To evaluate the overall effectiveness. 
• To evaluate any side effects of the Test Article. 
• To evaluate the tolerability, usability, and satisfaction of the Test Article. 
• To evaluate the compliance of subjects using the Test Article. 
Subject 
Population 
Subjects diagnosed with OAB. 
Population 
Size 
80 completed subjects 
Number of 
Centers 
Up to 12 sites 
Structure 
Prospective open label study, 12-week treatment duration with an optional  
additional 21-month long-term follow-up period, for a total participation 
time of 24 months. 
Method of 
Assignment 
All subjects who meet the inclusion/exclusion criteria and sign the 
informed consent will be enrolled. Subjects will be randomized to 
once a week or three times a week of stimulation for a twelve-week 
period. Eligible subjects that elect to enroll in the long-term follow 
up study will sign a new informed consent and then be instructed to 
slowly taper down their treatment frequency stepwise from three 
treatment sessions per week, to two per week, to one per week, 
and finally one session every other week. The subjects that were 
assigned to one treatment session per week in the lead-in portion 
of the study will move directly to twice monthly treatment 
sessions. Subjects will then be instructed to perform treatments as 
needed or a minimum of twice per month. 
 
 
 
 

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Randomization 1:1, 1 treatment session per week: 3 treatment sessions per week 
Selection 
Criteria 
Inclusion Criteria: To be eligible for study entry, subjects must satisfy all of 
the following inclusion criteria: 
1. Male or female and 18 years of age or older at the time of enrollment 
2. Willing and capable of giving informed consent 
3. Willing and able to comply with study-related requirements 
and procedures 
4. Are an appropriate candidate for the study Test Article based on the 
clinical judgment of the Investigator. 
5. Have been diagnosed or have symptoms of OAB for at least 3 
months prior to enrollment 
6. Have an average of 10 or more frequency events per day in a 3-Day 
Bladder Diary 
7. Able to provide clear, thoughtful responses to questions 
and questionnaires 
8. Able to toilet self and have and maintain personal hygiene 
9. Able to don and doff the bladder modulation garment on their 
ankle area, replace Gel Pads and use the controller 
10. Have ankle and foot anatomy that allows the garment to fit 
properly, including having the hook and loop closures close and 
without excessive gapping and allowing the electrodes to fit  
firmly on the skin. 
11. Able to sense and tolerate stimulation for the entire 30-minute 
therapy session 
12. Has detectable EMG signal in response to modulation system 
stimulation during an investigator supervised screening session 
13. If currently on medications that may affect their OAB symptoms, is 
on a stable dose (no new, discontinued, or change in dose) of all 
prescribed medication for at least 4 weeks prior to enrollment 
14. Female subjects of child-bearing potential must have a negative 
urine dip stick pregnancy test at baseline 
15. Have access to Wi-Fi at least weekly 
16. Are capable of using the tablet-based controlling app 

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Exclusion Criteria: Subjects will be excluded from the study if 1 or more of 
the following exclusion criteria are applicable: 
1. Have evidence of an active disruptive psychological or psychiatric 
disorder or other known condition significant enough to impact 
perception of pain, compliance of intervention and/or ability to 
evaluate treatment outcomes, in the opinion of the investigator. 
2. Allergic, or have shown hypersensitivity, to any materials of the 
system which come into contact with the body 
3. Have a pacemaker or implanted defibrillator 
4. Have a documented current or reoccurring Urinary Tract Infection (3 
or more in the 12months prior to enrollment) 
5. Current use of a marketed device for treatment of their OAB or 
incontinence (including but not limited to Interstim®) 
6. Have had Botox treatment for their OAB in the previous 8 months 
7. Current use of TENS in pelvic region, back or legs 
8. Had PTNS treatment within 6 months prior to enrollment 
9. Use of investigational drug/device therapy within past 12 weeks 
10. Current participation in another clinical study 
11. Had within 6 months of enrollment a significant untreated substance 
abuse disorder or polysubstance abuse disorder stemming from 
dependency producing medications, alcohol, and/or illicit drugs 
12. Pregnant or planning to become pregnant within the next 12 weeks 
13. Has scar tissue, metal, or other implant in the target ankle that would 
interfere with stimulation 
14. Has a neurological disorder that causes abnormal sensations in the 
lower leg (loss of sensation or allodynia) 
15. Has a neurological disorder that affects the bladder or a diagnosis of 
interstitial cystitis, radiation cystitis, or fistulas. 
16. Has a skin condition in the area of the ankle stimulation location that 
would preclude them from using surface stimulation 
17. Has been diagnosed with incontinence due to neurogenic bladder 
18. Have failed a third line treatment for their OAB because of lack of 
effectiveness in the last 2 years (PTNS, Botox, or SNS) 
19. Urge incontinence due to stress predominant mixed urinary 
incontinence (greater that 60% of the time) 
20. Have polyuria (>2500 cc urine output per day) 
21. Has urinary retention or incomplete bladder emptying 
22. Has symptoms of benign prostatic hyperplasia (weak stream, straining, 
hesitancy, or intermittency) 
 

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Study design 
Subjects that have signed the Informed Consent Form and meet all 
applicable eligibility criteria will be randomized 1:1 to 30-minute 
stimulation treatments either once a week or three times a week over a 
treatment period of 12 weeks. 
Subjects will return to the clinic at 1-, 4-, 8-, and 12-weeks post-baseline for 
visit assessments listed in the Schedule of Activities. Investigative sites may 
elect to have some visits completed remotely via use of ePRO for visit 
questionnaires.  On weeks where a subject does not have an in-clinic visit, 
they will be contacted by phone and queried for health and medication 
changes and any device issues. At the end of the first 12 weeks of 
stimulation, subjects will return to the clinic for final assessments, then will 
either enroll in the long-term follow up phase, if eligible, or exit from the 
study. 
Statistical 
Methods 
Analyses will be performed within both the intent-to-treat (ITT) population 
of all enrolled patients and among the subset of patients who complete the 
study. Patients may be missing endpoint data at one or more, or possibly all,
post-screening time points, at which endpoint data will be provided by 
carrying forward the most recent observation.  Enrollment will continue 
until 80 patients complete the study. Expecting 15% dropout, the 
anticipated total enrollment will be approximately 94 patients. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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3. Introduction 
Overactive bladder is a stressful and disruptive chronic disorder that affects more than 
16% of the adult population [1], an estimated 42 million adults in the just the United 
States alone. The symptoms of OAB cause millions of individuals to suffer with a 
decrease in their quality of life and put them at increased risk of falls, bone fractures due 
to falls and higher rates of anxiety and depression 
OAB is characterized by four symptoms; urgency, frequency, nocturia, and urge 
incontinence[2]. Urgency is the complaint of a sudden, irresistible desire to pass urine 
which often is difficult to resist. Frequency is the number of voids per day. In OAB, there 
are usually 8 or more voiding episodes during waking hours. Nocturia is the number of 
voids per night. In OAB, the complaint of sleep interruption due to the need to void is 
1+ times, per night. Urge incontinence is the involuntary leakage of urine, associated 
with sudden compelling desire to void. In order to be diagnosed, these symptoms or a 
combination of them, must be present without a pathologic or metabolic component 
causing them[3]. 
According to the American Urological Association, the first line of treatment is 
behavioral therapy. These therapies include the use of exercises, timed voiding, and 
fluid monitoring. This approach may be effective for some, but many patients are not 
compliant, and they do not see consistent relief of symptoms [2]. The next line of 
treatment is medications. Medication can be effective in around 70% of patients but 
they can produce significant side effects and are cost prohibitive[4] . Further, more than 
70% of patients quit drug therapy within 6 months making longer term compliance an 
issue [5]. Third line therapies include Botulinum toxin (BT), PTNS, and SNS. BT can also 
be effective in up to 70% of cases; however, 39.8% of all who discontinued therapy, did 
so because of the side effects, including the risk or urinary retention [2]. The full effect 
of BT treatment is temporary and requires additional procedures every 4 to 9 months. 
PTNS is found to be around 55-70% effective, minimally invasive, and has very little side 
effects, but is temporary and requires frequent visit to the clinic (once a week) which 
may be difficult for patients who work full time or those who must travel a long distance 
to reach a provider [6] [7]. SNS is typically regarded as the most effective treatment at 
85%, but it is also the most invasive[8]. SNS requires a surgical implant which may cause 
a series of adverse events. Further, the currently available neuromodulation options are 
open-loop and do not provide objective confirmation that the target nerve is being 
reached. 
In summary, while there are many treatment options available to manage symptoms 
associated with OAB, each carry with it considerable drawbacks for patients. Patients 
drop out of the treatment pathway for OAB in great numbers. Further, of the 42 million 
adults in the United States estimated to have OAB, fewer than 500,000 have opted for 
neuromodulation treatment due to the need for surgery or temporary insertion as well 
as inconvenience, despite demonstrated clinical evidence. 

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There is a compelling clinical need for better treatment options that are not only 
effective and safe but also convenient, accessible, and have a minimal side effect 
profile. There is a need for a surgery-free and drug-free easy-to-use wearable system 
that allows patients to treat their chronic OAB symptoms when and where it is 
convenient for them and one that offers an objective confirmation that the 
neuromodulation target has been reached and one that automatically adjusts based 
on the patient’s anatomy and movement during treatment sessions.
This study will evaluate the clinical efficacy, subject compliance, side-effects, and 
subject satisfaction of a surgery-free wearable and personalized bladder modulation 
system that provides personalized treatment through objective confirmation of nerve 
recruitment and can used in the home by subjects suffering from the symptoms of 
OAB. 
 
4. Objectives 
• To compare the effectiveness of 1 treatment session per week to 3 
treatment sessions per week on OAB symptoms using the Test Article. 
• To evaluate the overall effectiveness 
• To evaluate any side effects of the Test Article. 
• To evaluate the tolerability, usability, and satisfaction of the Test Article. 
• To evaluate the compliance by subjects using the Test Article. 
5. Study Design 
This is a prospective, multicenter study comparing the effectiveness of 1 treatment 
session per week to 3 treatment sessions per week using the Test Article on subjects 
diagnosed with OAB in a home environment. 
After subjects have signed informed consent, they will undergo two screening 
evaluations. The first evaluation will involve examining the data collected during a 3-
day bladder diary. The second evaluation will involve evaluation of the EMG signal 
produced while using the Test Article. Once the subject has met all eligibility and  
screening criteria, they will be enrolled in the study. Subjects will be randomized to once 
a week or three times a week of therapy. Demographic and baseline measurements will 
be taken including quality of life questionnaires and OAB questionnaires. All subjects 
will be given the Test Article and instructed on its use. All stimulation parameters will 
be personalized for the subject and within the commercially approved levels. 
Subjects will be asked to use the Test Article either once (1) or three (3) times a week 
for thirty (30) minutes each time over a 12-week period. Subjects will either return to 
the clinic or have a remote visit (via phone/video conferencing) after one (1) week ± 2 
days, four (4) weeks ± 4 days, eight (8) weeks ± 4 days, and twelve (12) weeks ± 4 days 
for evaluations. Subjects will be called by the site on the weeks they do not have a study 
visit and queried for any changes to health and medications, as well as address any 
questions or issues. If a subject needs additional training on use of any Test Article 
components, they will be asked to either return to the clinic or undergo troubleshooting 

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instructions over the phone. At the end of the twelve (12) weeks ± 4 days of stimulation 
treatments, eligible subjects will be offered the opportunity to participate in the long-
term follow up portion of the study. Ineligible subjects and those that decline 
participation in the long-term portion will exit from the study and the Test Article will 
be collected by the site. Subjects electing to enroll in the follow up study will sign a new 
informed consent and then be instructed to taper down their treatment frequency 
stepwise from three treatment sessions per week, to two per week, to one per week, 
and finally one session every other week. The subjects that were assigned to one 
treatment session per week in the lead-in portion of the study will move directly to twice 
monthly treatment sessions. Subjects will then be instructed to perform treatments as 
needed or a minimum of twice per month. 
 
5.1. Purpose 
The purpose of this study is to compare the efficacy, usability, safety, and 
comfort of 1 treatment session per week to 3 treatment sessions per week 
using the Test Article on subjects with OAB. This study will also help to 
evaluate the dose response of two different dose levels to aid in the 
development of a larger scale study to evaluate the safety and effectiveness 
of the Test Article. 
5.2. Study Rationale 
Electrical stimulation has been used to treat chronic pain for several 
decades. This includes placing electrodes over the spinal cord, in deep brain 
structures, and over nerves in the periphery. Stimulation has also been used 
to treat disorders that are not pain related such as Parkinson’s disease, 
epilepsy, and depression. Recently, SNS and PTNS have been used to 
modulate bladder function and treat subjects with OAB and provided some 
relief of OAB symptoms. However, currently commercial options for bladder 
modulation are invasive and have significant drawbacks that have limited 
their appeal to patients. SNS requires a major surgery, is costly and results 
in a permanent foreign body implant and, frequently, additional surgeries to 
replace batteries or address other issues PTNS requires a skin puncture and 
requires the Subject to travel to a physician’s office weekly for therapy. Of 
the estimated 42 million adults in the United States with OAB, fewer than 
500,000 are estimated to have been treated with commercially available 
neuromodulation options despite evidence of clinical efficacy. 
The Test Article can be used in the home and offers personalized treatment 
through objective confirmation of nerve activation. It is noninvasive, 
eliminating the risk of surgery, and minimizes the inconvenience of frequent 
visits to the physician’s office. This study will evaluate the tolerability, 
usability and satisfaction of the Test Article on subjects with OAB. Further, 
the study will also evaluate the use of evoked EMG signals to help control 
the Test Article and customize the stimulation experience for each subject. 

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6. Subject Selection 
 
Selection 
Criteria 
Inclusion Criteria: To be eligible for study entry, subjects must satisfy all of the 
following inclusion criteria: 
1. Male or female and 18 years of age or older at the time of enrollment 
2. Willing and capable of giving informed consent 
3. Willing and able to comply with study-related requirements 
and procedures 
4. Are an appropriate candidate for the system required in this study 
based on the clinical judgment of the Investigator. 
5. Have been diagnosed or have symptoms of OAB for at least 3 
months prior to enrollment 
6. Have an average of 10 or more frequency events per day in a 3-Day 
Bladder Diary 
7. Able to provide clear, thoughtful responses to questions and 
questionnaires 
8. Able to toilet self and have and maintain personal hygiene 
9. Able to don and doff the bladder modulation garment on their ankle 
area, replace Gel Pads and use the controller 
10. Have ankle and foot anatomy that allows the garment to fit properly, 
including having the hook and loop closures close and without excessive 
gapping and allowing the electrodes to fit firmly on the skin. 
11. Able to sense and tolerate stimulation for the entire 30-minute therapy 
session 
12. Has detectable EMG signal in response to modulation system 
stimulation during an investigator supervised screening session 
13. If currently on medications that may affect their OAB symptoms, is on a 
stable dose (no new, discontinued, or change in dose) of all prescribed 
medication for at least 4 weeks prior to enrollment 
14. Female subjects of child-bearing potential must have a negative urine 
dip stick pregnancy test at baseline 
15. Have access to Wi-Fi at least weekly 
16. Are capable of using the tablet-based controlling app 

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 Exclusion Criteria: Subjects will be excluded from the study if 1 or more of the 
following exclusion criteria are applicable: 
1. Have evidence of an active disruptive psychological or psychiatric              
disorder or other known condition significant enough to impact       
perception of pain, compliance of intervention and/or ability to evaluate 
treatment outcomes, in the opinion of the investigator. 
2. Allergic, or have shown hypersensitivity, to any materials of the system 
which come into contact with the body. 
3. Have a pacemaker or implanted defibrillator. 
4. Have a documented current or reoccurring Urinary Tract Infection                           
(3 or more in the 12 months prior to enrollment). 
5. Current use of a marketed device for treatment of their OAB or 
incontinence (including but not limited to Interstim®). 
6. Have had botulinum toxin treatment for their OAB in the previous 8 months. 
7. Current use of TENS in pelvic region, back or legs. 
8. Had PTNS treatment within 6 months prior to enrollment. 
9. Use of investigational drug/device therapy within past 12 weeks. 
10. Current participation in another clinical study. 
11. Had within 6 months of enrollment a significant untreated substance                    
abuse disorder or polysubstance abuse disorder stemming from                  
dependency-producing medications, alcohol, and/or illicit drugs. 
12. Pregnant or planning to become pregnant within the next 12 weeks. 
13. Has scar tissue, metal, or other implant in the target ankle that would        
interfere with stimulation. 
14. Has a neurological disorder that causes abnormal sensations in the lower 
 leg (loss of sensation or allodynia). 
15. Has a neurological disorder that affects the bladder or a diagnosis of  
interstitial cystitis, radiation cystitis, or fistulas. 
16. Has a skin condition in the area of the ankle stimulation location that  
would preclude them from using surface stimulation. 
17. Has been diagnosed with incontinence due to neurogenic bladder. 
18. Have failed a third line treatment for their OAB because of lack of  
effectiveness in the last 2 years (PTNS, botulinum toxin, or SNS). 
19. Urge incontinence due to stress-predominant mixed urinary incontinence 
(greater that 60% of the time) 
20. Have polyuria (>2500 cc urine output per day) 
21. Has urinary retention or incomplete bladder emptying 
22. Has symptoms of benign prostatic hyperplasia (BPH) - weak stream,  
straining, hesitancy or intermittency. 

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6.1. Subject Assignment to Treatment and Masking 
Each subject complying with the inclusion/exclusion criteria who is willing to 
participate in the study, and signs the informed consent, will be enrolled. At 
baseline subjects will be randomized to use the system for 30 minutes either 
one (1) time per week or three (3) times per week for a total of 12 weeks. All 
subjects will independently complete stimulation treatment sessions; no 
blinding will occur 
7. Methods and Procedures 
7.1. Informed Consent 
Written Informed Consent will be obtained from each subject prior to any 
study procedures being performed. All potential subjects will be properly 
informed as to the purpose of the study and the potential risks and benefits 
known or that can be reasonably predicted or expected. The Investigator will 
retain the original copy of the Informed Consent Form signed by the subject; 
a duplicate will be provided to the subject. Only the consent form approved 
by the ethics committee will be used. 
 
7.2. Visit Schedule 
Study Visit 
Tele-visit 
Screening 1 
Visit 0 
Screening 2/ Baseline 
Visit 1 
Week 1 
Visit 2 
optional 
Week 2 
 
X (Weekly Phone Call) 
Week 3 
 
X (Weekly Phone Call) 
Week 4 
Visit 3 
optional 
Week 5 
 
X (Weekly Phone Call) 
Week 6 
 
X (Weekly Phone Call) 
Week 7 
 
X (Weekly Phone Call) 
Week 8 
Visit 4 
optional 
Week 9 
 
X (Weekly Phone Call) 
Week 10 
 
X (Weekly Phone Call) 
Week 11 
 
X (Weekly Phone Call) 
Week 12 
Visit 5 
 

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7.3. Pre-Screening 
Potential study candidates will be initially pre-screened by the investigator 
prior to screening and enrollment according to the Inclusion and Exclusion 
criteria. 
 
7.4. Visit 0 - Screening 1 (Informed Consent and Diary Distribution) 
This visit involves the review and signing of the Informed Consent, 
eligibility criteria review, and distribution of a 3-day Bladder Diary.  
Step 
Action 
1. 
Subjects will be informed of the study and review the informed 
consent. 
2. 
Subjects will be given a 3-day Bladder Diary to take home 
and complete within 3 days leading up to their scheduled 
Visit 1. 
Note 
Only subject that sign the informed consent will be given the      
3-day Bladder Diary. 
 
7.5. Visit 1 - Screening 2 (EMG evaluation) 
This procedure will evaluate if EMG signals can be recorded during 
stimulation of the tibial nerve with the wearable bladder modulation 
system. 
Step 
Action 
1. 
Screening evaluations will be collected including (using a 3-day 
Bladder Diary): 
1. Number of daytime voids 
2. Number of urge events 
3. Number of nighttime voids 
4. Number of urge incontinence events 
Note 
Only subjects that meet the inclusion/exclusion criteria with regard 
to the Bladder Diary will proceed to EMG testing. 
2. 
Only delegated, qualified, site personnel will instruct the subject 
on how to place the Test Article on the foot and ankle area. 
3. 
Once the Test Article is placed, site personnel will use the Test 
Article to stimulate the tibial nerve, evaluate EMG signals and 
instruct the subject how to use the Test Article. 
4. 
The subject will be asked to rate various sensations 
experienced during the stimulation therapy. 
5. 
Subject will be enrolled in the study and given a subject ID. 
Note 
Only subjects that have a detectable EMG and find the stimulation 
sensation tolerable will be eligible for enrollment. 

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7.6. Visit 1- Baseline Evaluations 
These evaluation procedures outline the baseline evaluation that will take 
place before a subject begins stimulation therapy. These procedures can also 
be done during the Screening 2 / Baseline visit. 
Step 
Action 
1. 
The inclusion and exclusion criteria will be confirmed as being met 
2. 
Demographic information will be collected. 
3. 
OAB questionnaires will be completed including: 
1. OAB-q 
2. IIQ-7 (only for those with incontinence) 
3. I-QoL 
4. and OHQ 
4. 
Subjects will be randomized 1:1 to perform 30-minute stimulation 
sessions once per week or three times per week for the 12-week 
treatment period. 
 
7.7. Visit 1- System fitting and training 
This procedure outlines the training that will take place before the subject 
begins stimulation.
Step 
Action 
1. 
The subject will be fitted for the Test Article. 
2. 
The subject be given instruction by site personnel as to how 
to use the Test Article. 
3. 
Once the Test Article is placed, the subject will use the controller to 
start the stimulator to activate the tibial nerve (trial session should 
not exceed 15 minutes). 
4. 
The subject will be asked questions regarding the feeling of Test 
Article during use and the ease of use of the Test Article. 
5. 
Subjects will be given a new 3-day Bladder Diary to complete in the 
days leading up to the next scheduled study visit. 

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7.8. Visit 2 - Week 1 ± 2 days 
This visit will be scheduled after 1 week of therapy for evaluations. This 
visit may be performed remotely via ePRO. 
 
Step 
Action 
1. 
Subjects will be queried for AE/SAE or concomitant medication 
changes. 
2. 
The 3-day Bladder Diary dispensed at Visit 1 will be collected and 
reviewed.  
3. 
Applicable visit forms and questionnaires will be completed. 
4. 
The subject will be asked questions regarding the feeling of the 
therapy and ease of use of the Test Article. 
6. 
Subjects will be given a new 3-day Bladder Diary to complete in the 
days leading up to the next scheduled study visit. 
 
7.9. Visit 3 - Week 4 ± 4 days 
This visit will be scheduled after 4 weeks of therapy for evaluations. This 
visit may be performed remotely via ePRO. 
 
Step 
Action 
1. 
Subjects will be queried for AE/SAE or concomitant medication 
changes. 
2. 
The 3-day Bladder Diary dispensed at Visit 2 will be collected and 
reviewed. 
3. 
Applicable visit forms and questionnaires will be completed:  
1. OAB-q 
2. IIQ-7 
3. I-QoL 
4. PGIC 
4. 
The subject will be asked questions regarding the feeling of the 
therapy and ease of use of the Test Article. 
5. 
Subjects will be given a new 3-day Bladder Diary to complete in the 
days leading up to the next scheduled study visit. 

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7.10. Visit 4 - Week 8 ± 4 days 
This visit will be scheduled after 8 weeks of therapy for evaluations. This 
visit may be performed remotely via ePRO. 
 
 
Step 
Action 
1. 
Subjects will be queried for AE/SAE or concomitant medication 
changes. 
2. 
The 3-day Bladder Diary dispensed at Visit 3 will be collected and 
reviewed. 
3. 
Applicable visit forms and questionnaires will be completed 
4. 
Subjects will be given a new 3-day Bladder Diary to complete in the 
days leading up to the next scheduled study visit. 
 
7.11. Visit 5 – Week 12 ± 4 days 
This visit will be scheduled after 12 weeks of stimulation for final 
evaluations.  
 
 
 
 
 
 
 
 
 
 
 
 
Step 
Action 
1. 
Subjects will be queried for AE/SAE or changes to concomitant 
medications. 
2. 
The 3-day Bladder Diary dispensed at Visit 4 will be collected and 
reviewed. 
3. 
 Applicable visit forms and questionnaires will be completed, 
including the Study Exit Form. 
4. 
The subject will be asked questions regarding the feeling of the 
therapy and ease of use of the Test Article. 
5. 
Subjects will either exit from the study or be given the option to 
enroll in the long-term follow-up study, if eligible. 

 
 
 
7.12. Visit Schedule for Lead-in Phase 
 
  
Visit 0  
Visit 1  
Visit 2 
Week 2 
Week 3 
Visit 3 
Week 5 
Week 6 
Week 7 
Visit 4 
Week 9 
Week 10 
Week 11 
Visit 5 
Informed Consent 
X 
3-day Bladder Diary (a,b) 
X 
X 
X 
X 
X 
X 
EMG Detection Trial 
X (c) 
Inclusion/Exclusion Check 
X 
Medical History 
X 
  
Test Article Assessment 
Form 
X 
Device Training 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
OAB-q 
X 
X 
X 
IIQ-7 
X 
X 
X 
I-QoL 
X 
X 
X 
PGIC 
X 
X 
X 
X 
OHQ 
X 
X 
Study Visit Form 
X 
X 
X 
X 
Exit Form 
X 
Weekly Phone Call 
X 
X 
X 
X 
X 
X 
X 
X 
a - 3-Day Bladder Diary to be dispensed at Visit 0, Visit 1, Visit 2, Visit 3, and Visit 4. 
b - 3-Day Bladder Diary to be collected at Visit 1, Visit 2, Visit 3, Visit 4, and Visit 5. 
c - EMG Detection trial to be performed after review of Bladder Diary from Visit 0, and before any other visit procedures 
 

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8. Long-Term Follow-Up Phase 
8.1. Subject Selection 
 
Selection 
Criteria 
Inclusion Criteria: To be eligible for entry into the long-term 
follow-up portion of the study, subjects must satisfy all the 
following inclusion criteria: 
1. Successful completion of the lead-in portion of the FREEOAB 
study 
2. A rating of 5 or greater on the PGIC questionnaire at Visit 5 
3. A minimum compliance of 90% with diary and 
questionnaire completion 
4. A minimum compliance of 80% with stimulation sessions 
during the lead-in portion of the FREEOAB study. 
 
Exclusion Criteria: Subjects will be excluded from participation 
if the following exclusion criteria are met: 
1. Any change in health status that might affect the subject’s 
ability to comply with the visit schedule, assessments, 
and/or stimulation session completion.   
8.2. Informed Consent 
Written Informed Consent will be obtained from each subject before recruitment into 
the long-term follow-up portion of the FREEOAB trial. All potential subjects will be 
properly informed as to the purpose and the potential risks and benefits known or that 
can be reasonably predicted or expected. The Investigator will retain the original copy of 
the Informed Consent Form signed by the subject; a duplicate will be provided to the 
subject. Only the consent form approved by the ethics committee will be used.  
8.3. Visit Schedule 
 
Study Visit 
(in-clinic) 
Remote/Tele-visit 
 
Enrollment 
Visit 6 
 
Month 6 
 
Visit 7 
Month 9 
 
Visit 8 
Month 12 
Visit 9 
Optional 
Month 18 
 
Visit 10 
Month 24 
Visit 11 
 
8.4. Visit 6 - Enrollment 
This procedure will occur at the completion of Visit 5/Week 12 of the lead-in portion of 
the FREEOAB study. Eligible subjects will sign a new Informed Consent Form. (Visit 5 
and 6 may occur on the same day) 
 
 
 
 

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Step 
Action 
1. 
 
Eligible subjects that elect to enroll in the long-term follow 
up study will sign a new informed consent form. 
2.  
Subjects will be given detailed instructions to begin an 
augmented treatment schedule, based on original 
treatment group assignment in the lead-in portion of the 
study.  
• Subjects will be instructed to slowly taper down their 
treatment frequency stepwise from three treatment 
sessions per week, to two per week, to one per week, 
and finally one session every other week.  
• Subjects that were assigned to one treatment 
session per week in the lead-in portion will move 
directly to twice monthly treatment sessions.  
 
3. 
 
Subjects will be given a new 3-day Bladder Diary to complete within 3 
days leading up to their next scheduled visit. 
 
8.5. Visit 7 - (Month 6 ± 14 days of stimulation) 
Visit 7 will occur after 6 months of treatment (including lead-in portion of  
the FREEOAB study). This visit may be conducted remotely, via ePRO. 
 
1. 
Subjects will be queried for AE/SAE or concomitant medication 
changes. 
2. 
The 3-day Bladder Diary dispensed at Visit 6 will be collected and 
reviewed. 
3. 
Applicable visit forms and questionnaires will be completed 
4. 
Subjects will be given a new 3-day Bladder Diary to complete within 3 
days leading up to their next scheduled visit. 
8.6. Visit 8 – (Month 9 ± 14 days of stimulation) 
Visit 8 will occur after 9 months of treatment (including lead-in portion of  
the FREEOAB study) . This visit may be conducted remotely, via ePRO. 
1. 
 
Subjects will be queried for AE/SAE or concomitant medication 
changes. 
2.  
The 3-day Bladder Diary dispensed at Visit 7 will be collected and 
reviewed 
3. 
 
Applicable visit forms and questionnaires will be completed 
Step 
Action 
Step 
Action 

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4.  
Subjects will be given a new 3-day Bladder Diary to complete within 3  
days leading up to their next scheduled visit. 
8.7. Visit 9 – (Month 12 ± 14 days of stimulation) 
Visit 9 will occur after 12 months of treatment (including lead-in portion of  
the FREEOAB study).This visit may be conducted remotely via ePRO. 
 
Step 
Action 
 
1. 
 
Subjects will be queried for AE/SAE or concomitant medication 
changes. 
2. 
 
The 3-day Bladder Diary dispensed at Visit 8 will be collected and 
reviewed. 
3. 
 
Applicable visit forms and questionnaires will be completed. 
4. 
 
Subjects will be given a new 3-day Bladder Diary to complete within 3 
days leading up to their next scheduled visit. 
8.8. Visit 10 – (Month 18 ± 14 days of stimulation) 
Visit 10 will occur after 18 months of stimulation (including lead-in portion of  
the FREEOAB study). This visit may be conducted remotely via ePRO. 
 
Step 
Action 
1. 
 
Subjects will be queried for AE/SAE or concomitant medication 
changes. 
2. 
 
The 3-day Bladder Diary dispensed at Visit 9 will be collected and 
reviewed. 
3. 
 
Applicable visit forms and questionnaires will be completed 
4. 
Subjects will be given a new 3-day Bladder Diary to complete within 3 
days leading up to their next scheduled visit. 
8.9. Visit 11 – (Month 24 ± 14 days of stimulation) – End of Study 
Visit 11 will occur after 24 months of stimulation.  
 
Step 
Action 
1. 
 
Subjects will be queried for AE/SAE or concomitant medication 
changes. 
2. 
 
The 3-day Bladder Diary dispensed at Visit 8 will be collected and 
reviewed 
3. 
 
 Applicable visit forms and questionnaires will be completed 
4. 
 
Subjects will return their study equipment and supplies to the site staff 
and exit the from the study. 

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8.10. Unscheduled Visits 
Unscheduled visits are permitted to occur as needed, for the purposes of resolving 
issues, AE/SAE follow up, and may be performed remotely or in-clinic, depending on 
the reason for the visit. 
 
 
8.11. Visit Schedule for Long-Term Follow-Up Phase 
 
Visit 6 
Visit 7 
Visit 8 
Visit 9 
Visit 10 
Visit 11 
Study Phase 
enrollment 
Month 6 
Month 9 
Month 12 
Month 18 
Month 24 
Informed Consent 
X 
 
 
 
 
 
3-day Bladder Diary 
(a,b) 
X 
X 
X 
X 
X 
X 
Inclusion/Exclusion 
Check 
X 
 
 
 
 
 
OAB-q 
 
 
 
X 
 
X 
IIQ-7 
 
 
 
X 
 
X 
I-QoL 
 
 
 
X 
 
X 
PGIC 
 
X 
X 
X 
X 
X 
OHQ 
 
 
 
X 
 
X 
Study Visit Form 
X 
X 
X 
X 
X 
X 
Exit Form 
 
 
 
 
 
X 
a - 3-Day Bladder Diary to be dispensed at Visit 6, Visit 7, Visit 8, Visit 9, and Visit 10. 
b - 3-Day Bladder Diary to be collected at Visit 7, Visit 8, Visit 9, Visit 10, and Visit 11. 
 
9. Outcome Variables 
All outcome variables will be collected by the investigator. 
9.1. Demographics 
Basic subject demographics will be collected  such as height, weight, race, and ethnicity.  
9.2. Study Visit Form 
This form asks questions regarding comfort, tolerability, and satisfaction of the Test 
Article as well as comfort and tolerability of the therapy. 
9.3. Test Article Assessment Form 
The subject will be asked several questions regarding the Test Article, specifically ease 
of use and comfort. 
9.4. IIQ-7 
The IIQ-7 questionnaire asks subjects about areas of their life that may have been 
influenced or changed by incontinence. It looks at its effect on activities, relationships, 
and feelings. 
9.5. I-QOL 
The incontinence quality of life questionnaire is used to assess the quality of life in 
subjects with urinary incontinence due to neurogenic detrusor overactivity [5]. 
9.6. OAB-q 
This questionnaire asks about how much you have been bothered by selected bladder 
symptoms during the past 4 weeks. 
 
 

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9.7. PGIC 
The Subject global impression of change evaluates all aspects of Subjects’ health and 
assesses if there has been an improvement or decline in clinical status. 
9.8. OHQ 
This questionnaire assesses the level of happiness experienced by the Subject by asking 
them to rate a series of statements based on their level of agreement. 
 
10. Test Article 
The Test Article consists of a garment, a stimulator, gel pads, a controller, and charging system.  
10.1. Garment , Stimulator, Charger,  and Gel Pads 
The Garment is worn on the foot and ankle area to provide a comfortable and 
convenient method of holding the electrodes in the desired location and a place to hold 
the stimulator. The stimulator unit can be easily removed to allow recharging. 
Replaceable gel pads are located inside the Garment to improve skin contact.  Gel Pads 
can be replaced. The stimulator will have and on/off button and LED’s to indicate 
Bluetooth connection status and battery level. 
10.2. Material 
Article 
Material 
Garment 
Neoprene 
Stimulator and Charger 
3D Printed Plastic (ABS-Like)  
Gel Pads 
Hydrogel 
10.3. Stimulation Specifications 
Parameters 
Technical Description 
Pulse Type 
Charged balanced biphasic  
Output 
Current-controlled 
Number of stimulation electrodes 
2 (one cathode, one anode) 
Figure 1   Wearable tibial nerve stimulation garment with built-in stimulating and sensing 
electrodes, fits left & right ankles 

Page 27 of 38 
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Number of recording electrodes 
3 ( two differential inputs, one reference input) 
Maximum current amplitude 
40 mA 
Maximum output voltage 
200 V 
Maximum pulse width per phase 
800 us 
Maximum pulse frequency 
20 Hz 
Worst-case current density per 
phase 
7.8 mA/ cm 2 
Worst-case charge density per 
phase 
3.1 uC/cm 2 
Power Source 
Lithium-ion battery 
Connection to mains power 
None 
10.4. Controller  
The Stimulator will be controlled using an application on a tablet. This tablet will be 
supplied by the Sponsor and will only be enabled as a controller for the stimulator.  
The controller application will have screens which will allow both the physician and 
subject to easily interact with the stimulator. Data collected by the stimulator will be 
transmitted to a HIPAA-compliant cloud to allow the investigators and Sponsor to 
easily review the subject’s usage of the system while completing their treatment 
sessions at home. This will also allow troubleshooting to take place without a visit to the 
office.  
 

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11. Regulatory Status 
The Test Article is not approved for sale in any country.  
 
12. Safety and adverse events 
12.1. Definitions 
Adverse Events 
(AE) 
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users, or other persons, whether or not related to the 
investigational medical device. 
Serious Adverse 
Events (SAE) 
A current adverse event that worsened or the occurrence of a new 
adverse event that: 
a) led to death 
b) led to serious deterioration in the health of the subject, that either 
resulted in: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body 
function, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body structure or 
a body function 
 c) led to fetal distress, fetal death or a congenital abnormality or birth  
defect 
Unanticipated 
Adverse Device 
Effect (UADE) 
Adverse device effect which by its nature, incidence, severity or 
outcome has not been identified in the current version of the risk 
analysis report. 
Unanticipated 
Serious Adverse 
Device Effect 
(USADE) 
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. 
12.2. AE Recording 
All AEs or UADEs volunteered by the subjects or elicited by the Investigator must be 
recorded on the appropriate AE CRF. In accordance with the medical device incident 
reporting and investigation scheme (IRIS) (in the US follow 21 CFR 812.150(a)(l)), an 
Investigator shall submit to the Sponsor and IRB a report of any UADE occurring during 
the investigation as soon as possible, but no later than 10 days after the Investigator first 
learns of the event. Unanticipated Serious Adverse Device Effect (USADEs) will be 
reported to the regulatory authorities as required. This report must be confirmed by 
using the AE source documentation and eCRF data. 
 
 

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12.3. Reporting AEs 
Qualified investigators and research staff will closely and carefully monitor study 
participants for all anticipated and any unanticipated adverse events. All serious and 
device related adverse events or device deficiency should be recorded on the appropriate 
case report form. All adverse events will be reported from the moment a consented 
participant is in contact with the study device, through to participant study exit.  
Investigational sites will be asked to report the final medical diagnosis as an AE, rather 
than reporting all signs and symptoms as separate events. 
It is the responsibility of the investigator to decide when an adverse event has occurred. 
Adverse event information will be collected throughout the study. Adverse events will be 
recorded on the appropriate CRF by the investigator or study coordinator. Event, date of 
onset, severity, duration and relationship to the procedure or device will be recorded. 
In case of a serious adverse event (whether or not related to the investigational device), 
or an unanticipated adverse device effect, the investigator should complete the 
applicable SAE CRF pages within 24 hours of being made aware of the event and begin 
the reporting process. If the case report form cannot be completed within 24 hours, the 
Investigator should advise the Sponsor by other means, within 24 hours. 
The Sponsor will assist the site with reporting any SAEs to the reviewing ethics 
committee, according to their requirements and timelines.  
All SAEs and UADEs must be reported to and reviewed by the Sponsor. 
NOTE: As applicable, reports must only identify participants using the study’s unique 
identifier to protect confidentiality. 
Non-serious AEs should be reported at the next routine contact. 
12.4. Anticipated Adverse Events and Complications 
The anticipated AEs associated with using the Test Article include: 
1. 
Pain at the stimulation site. 
2. 
Allergic reaction.  
3. 
Changes in skin color (reddening) under the electrode. 
12.5. AE Classification 
The Investigator will classify each AE according to the Adverse Event Form. If the AE is 
serious or the Investigator feels that the device contributed in any way to the AE, the 
Investigator must report the event to the Sponsor. 
13. Data Analysis, Evaluation and Statistical Plan 
13.1. Analysis Populations 
Analyses will be performed within both the intent-to-treat (ITT) population of all 
enrolled patients and among the subset of patients who complete the study. Patients 
may be missing endpoint data at one or more, or possibly all, post-screening time 
points, at which endpoint data will be provided by carrying forward the most recent 
observation. Enrollment will continue until 80 subjects complete the study.  Expecting 
15% dropout, the anticipated total enrollment will be approximately 94 patients. 
 
 

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13.2. Analysis of Efficacy and Sample Size 
Using data collected at each of Study Visits 2, 3, and 4, percent change from screening 
at each time point will be calculated for each patient with respect to frequency of OAB 
symptoms, including 3-day daily averages of daytime voids, urge events, nighttime 
voids, and urge incontinent events.  The maximum percent improvement across the 
four symptoms will also be calculated at each time point as a composite endpoint. 
Percent improvement in daily average total voids relative to an upper normal limit of 
8, will also be calculated, and will be bounded below at 0% for patients not achieving 
improvement and bounded above at 100% for patients achieving or surpassing the 
upper normal limit of 8. Longitudinal analyses will be performed using repeated 
measures models to assess and describe trends over time with respect to these 
endpoints.  At individual time points, the one-sample T-test will be performed at 
significance level α=0.05 within each treatment group and for the pooled study groups 
to assess the mean percent improvements, with 95% confidence intervals for mean 
percent improvements also calculated. The percent change endpoints are not likely to 
have approximately normal distributions, but the sample size is considered sufficient 
such that mean values will be approximately normally distributed, justifying the use of 
the T-tests.  If there is concern with the distributions, then the Wilcoxon signed rank 
test will be used as an alternative to the one-sample T-test. 
Sample size is evaluated by the performance of the 95% confidence interval for mean 
percent improvement percent improvement in daily average total voids relative to an 
upper normal limit of 8.  Log ratios of daily average event frequencies at post-
screening time points relative to the daily average event frequencies at baseline, 
which are mathematically related to the percent changes from baseline, are more 
likely than percent changes to have approximately normal distributions.  If such log 
ratios are normally distributed so that in both treatment groups the median percent 
improvement (toward zero) in daily average total voids is 15% and so that 25% of 
patients will achieve a 50% improvement, then with a total evaluable sample size of 80 
patients completing the study, there is an estimated 95.6% power to conclude that 
the mean percent improvement in daily average total voids relative to an upper 
normal limit of 8 is 25% or larger using the 95% confidence interval.  Within each 
treatment group of size n=40, there is an estimated 90.8% power to conclude that the 
mean percent improvement in daily average total voids relative to an upper normal 
limit of 8 is 20% or larger using the 95% confidence interval. 
Two-sample T-tests performed at a significance level α=0.05 will be used to compare 
the treatment groups with respect to mean percent improvements in frequency of 
QAB symptoms, and with respect to results of OAB questionnaires.  If there is concern 
with the non-normality of the distributions of these endpoints, then the Wilcoxon rank 
sum test will be used as an alternative to the two-sample T-test.  Linear models will be 
constructed as extensions of the one-sample and two-sample T-tests to allow for 
assessments of mean percent improvements and group comparisons with covariate 
adjustments.   
Frequencies of responders at individual time points and over all time points will also be 
calculated, where a responder for a given OAB symptom is defined as a subject 
achieving 50% improvement in frequency, and a responder for the composite 
collection of OAB symptoms is defined as a subject achieving 50% improvement in 
frequency for at least one symptom frequency.  The treatment groups will be 

Page 31 of 38 
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compared with respect to response frequencies using chi-square of Fisher’s exact 
tests, and exact 95% binomial confidence intervals will be calculated. 
13.3. Analyses of Tolerability, Usability, and Satisfaction 
Subject responses to questions regarding tolerability, usability, and satisfaction, will be 
tabulated. 
13.4. Analyses of Safety 
All adverse events will be collected as they occur and tabulated. 
 
 
14. Withdrawal of Subjects from Study 
Subjects may be discontinued from the study for non-treatment-related reasons only when no other 
option is possible. Reasons for discontinuation include, but are not necessarily limited to: 
1. Voluntary withdrawal from the study by the subject. 
2. Subject is unwilling or unable to cooperate with study requirements. 
3. Subject has an adverse event such that they can no longer continue with stimulation. 
The reason for discontinuation will be recorded on the appropriate subject Withdrawal form. 
Discontinued subjects may not be replaced in the study. 
Prior to discontinuing a subject, every effort should be made to contact the subject in an effort either to 
get the subject back into compliance with the protocol, or to obtain as much follow-up data as possible. 
15. Modification of Protocol 
Any amendments to this protocol must be prepared by the Study Monitor and approved by Avation 
Medical, the Investigator, and the central or local authority (IRB/IEC) before implementation. 
16. Discontinuation of Study 
Avation Medical reserves the right to discontinue any study for administrative reasons at any time, such 
as but not limited to, a decision to discontinue further clinical investigations with the Test Article, 
improper conduct of the Study by the Investigator, inability to obtain the number of subjects required by 
the protocol, etc. Reimbursements for reasonable expenses will be made if such action is necessary. 
17. Identified Risks 
The Avation Medical Risk Management Procedure was used during the development of the protocol. 
This procedure complies with ISO 14971:2012 and ensures hazards are identified for which risks are 
assessed, designed out, mitigated, or labeled. Where residual risks remain high, risk/benefit analysis has 
been conducted. 
All identified risks have been designed out, mitigated or disclosed with labeling. 
 
 
 

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17.1. Justification for study given risk/benefit outcomes 
PTNS has been used to treat patients with OAB. It requires that a needle electrode be 
inserted through the patient’s skin to provide stimulation to the tibial nerve near the 
inner ankle. PTNS therapy is performed in a doctor’s office one time a week for a 30-
minute session for 12 weeks in a doctor’s office. Successful patients are then required 
to continuing therapy at least once a month to maintain success. There have been 
recent studies that have indicated that stimulating more often may be beneficial. PTNS 
protocols rely on a toe twitch to confirm the correct placement of the needle at the 
beginning of the session. Once the therapy session begins stimulation is typically 
reduced below toe twitch. Thus, in most cases there is no means of objectively 
confirming nerve recruitment during the therapy session. In those patients where 
stimulation cannot be increased to the level of a toe twitch, there is no objective 
confirmation of tibial nerve stimulation.  
The current study involves testing a surgery-free and non-invasive wearable bladder 
modulation system in the home by subjects with OAB. In addition, the System, 
through sensors incorporated into the modulation garment, provide objective 
confirmation of tibial nerve activation at the beginning and through the modulation 
therapy which provides personalized treatment for each patient. The Test Article 
provides several benefits over PTNS. First, it is wearable eliminating any risks 
associated with a needle puncture. Second, it allows the patient to perform their 
therapy in their home, eliminating the need for weekly and monthly travel to a 
physician’s office. Third, it will provide objective confirmation that the active tibial 
nerve stimulation is automatically adjusting the personalized stimulation level for 
each subject. The study will involve stimulating for 30 minutes transcutaneously over 
the tibial nerve, either 1 day or 3 days per week for a total of 12 weeks. The main risks 
to subjects participating in this study is the potential for skin irritation at the electrode 
site.  We anticipate that the risk of pain in this study to be minimal. In the event of 
pain, the subject can stop the stimulation or continue at a reduced level. As a result of 
participating in this study, subjects may experience a temporary reduction in their 
OAB symptoms. Data collected from this study will help in the development of a new 
therapy to treat their OAB which may benefit them in the future 
This study will compare two treatment frequencies, one session a week or three 
sessions a week for a 12-week treatment period, followed by an optional additional 21-
month long-term follow-up phase. Pre-validation and pre-verification testing were 
done to ensure system functionality and safety for this study. There were no cadaver 
or animal model testing done with the Test Article. Voltage tests were done to ensure 
that the Stimulator would stay within the set voltage parameters. Testing was done to 
ensure the Test Article could run properly for the full 30-minute treatment duration.  
 
 

Page 33 of 38 
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Biocompatible materials were chosen for this system to reduce any allergic reactions.  
The risks to subjects participating in this study are minimal. Although subjects may 
see some temporary improvement, there is minimal benefit in participating in this 
study. The data collected in this study will be used to support the 510K clearance of 
the Test Article. 
17.2. Justification of study design 
Electrical stimulation of peripheral nerves has been used to manage chronic pain, 
Parkinson’s disease, epilepsy, and other neurological disorders. These treatments 
include placing electrodes over the spinal cord, in deep brain structures, and over 
nerves in the periphery, etc. Recently, PTNS has been used to treat subject with OAB. 
PTNS is thought to modify the signals from the bladder to achieve it effect, it usually 
takes 5-7 weeks for symptoms to change. However, patients respond at different 
rates. In a review of about 100 patients who responded to PTNS, onset of symptom 
relief began anywhere between 2-12 weeks after starting treatment. For about 20% of 
these patients, some symptoms didn't improve until after 8 weeks [1]. However, PTNS 
therapy is performed only in a doctor’s office during weekly visits and requires that a 
needle-electrode is blindly inserted through the patient’s skin near their inner ankle. A 
non-invasive transcutaneous system that can be used at home will make treatment 
more accessible and convenient for patients, will help to improve treatment 
compliance and subject satisfaction and may contribute to better outcomes.  
Once subjects meet all eligibility and screening criteria, they will be enrolled in the 
study. Subjects will be randomized to therapy once a week or three times a week for 
12 weeks.  Unlike PTNS, the Test Article is fully non-invasive and can be done 
completely at home, eliminating the need for weekly visits to a medical office This 
study is designed to minimize patient and site contact to help reduce possible 
exposure to COVID 19. The only required in-person office visit would be to  conduct 
EMG screening to confirm eligibility for enrollment and to set up the System for home 
use, and end of study assessments. To further minimize COVID19 exposure, this 
protocol enables sites to combine Screening Visit 2 and Visit 1/Baseline in a single 
office visit.  
18. Administrative Requirements and Quality Assurance 
18.1. Institutional Review Board (IRB) / Ethics Committee (EC) 
Before study enrollment can begin, the Investigator must provide the Sponsor with a 
copy of the approval notice for the protocol and informed consent forms, signed by 
the committee Chairperson. 
18.2. Informed Consent 
Written Informed Consent must be obtained from all subjects or their legally 
authorized representative before recruitment into the study.  All potential subjects 
must be properly informed as to the purpose of the study and the potential risks and 
benefits known or that can be reasonably predicted or expected.  

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 The Investigator will retain the original copy of the Informed Consent form signed by 
the subject and a duplicate will be provided to the subject.  Only the consent form 
approved by the IRB/EC must be used. 
18.3. Clinical Supplies 
All System components will be labeled as investigational and bear the following 
statement: 
“For Investigational Use Only” 
18.4. Data Management 
All study data will be recorded on the eCRF EDC system or by using sponsor generated 
paper CRFs.  When applicable, deidentified copies of all paper CRFs must be made 
available to the Sponsor so that the validity and completeness of the forms can be 
determined.  Where possible all paper CRF and EDC data should originate from a 
verifiable medical record in source documentation for each subject. 
Any corrections to paper CRFs should be made by scoring through the original value 
with a single line and writing the new value next to the original entry with the 
designated study staff initialing and dating the new entry.  Only the designated study 
staff may amend or otherwise alter any data entered onto the paper CRF or site source 
documents. Once a change has been made on the paper CRF and the CRF has been 
submitted to the data department, no change may be made on the original CRF. All 
corrections must be made with a Data Clarification Form (DCF) for submission to 
Avation data management. Significant changes to eCRF EDC data entries are to be 
captured on a DCF and will require PI approval or approval by designated study 
personnel prior to submission to Avation. 
If the reason for the correction is not obvious then, when appropriate, a brief 
explanation of the reason for the correction should be made. Correction fluids should 
never be used on any document.  Before forwarding copies of completed paper CRFs 
to Avation Medical the Investigator or designated study staff should review their 
completeness, accuracy, and legibility. The Investigator/site must always retain a copy 
of all completed CRFs in his/her ISF.  
Study centers will record all study information in an appropriate source document. 
The data will then be entered directly into an electronic data capture (EDC) system by 
completing the eCRF via a secure internet connection. Data entered into the eCRF 
must be verifiable against source documents at the study center. Any changes to the 
data entered in the EDC system will be recorded in the audit trail. 
The Sponsor will be responsible for activities associated with the data management of 
this study.  
 
 
 

Page 35 of 38 
Version 2.0 dated February 15, 2021 
 
18.5. Monitoring 
The Investigator will permit the Study Monitor to visit the Investigational Site at 
regular intervals to review all the CRFs, study related adjunctive data, and study 
management.  These reviews are for the purpose of verifying the adherence to the 
protocol and the completeness and exactness of the data being entered as per local 
requirements. The Study Monitor must be kept informed of all issues pertinent to the 
study.  The Study Monitor will be available to discuss questions regarding adverse 
events, removal of subjects from the study, conduct of the study or any other 
questions that should arise.  At the final monitoring visit the Study Monitor must 
resolve any outstanding data deficiencies and retrieve all used and unused Test 
Articles if applicable. 
A detailed monitoring plan will be provided separately from the protocol.  
 
18.6. On-site Audits 
The various national regulatory authorities and the Sponsor in the person of a 
scientifically trained and properly authorized employee may request access to all 
study records, including source documents, for inspection and copying. 
Study centers and study documents may be subject to Quality Assurance audits 
during the study by the sponsor or its representative. In addition, inspections may be 
conducted by regulatory authorities at their discretion. 
18.7. Record Storage and Retention 
Federal laws and GCP requires that a copy of all study records (e.g., Informed Consent 
documents, source documents, study records, etc.) which support CRFs of this study, 
must be retained in the ISF of the responsible Investigator for a minimum of two years 
in accordance with local regulations following notification by Avation Medical that all 
Investigations (not merely the Investigators portion) are completed, terminated, or 
discontinued, or that the Food and Drug Administration or the non-U.S regulatory 
authority has approved the submission.   
If the Principal Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person 
who will accept responsibility. Avation Medical or its local sponsor must be notified in 
writing of the name and address of the new custodian. 
18.8. Clinical Monitors 
The name, title, address, phone, and fax number of the Study Monitor should be provided to 
the Investigator and Sponsor and kept in the respective Investigator and Regulatory Binders. 
 
 
 

Page 36 of 38 
Version 2.0 dated February 15, 2021 
 
19. Publications 
Investigator agrees, and will ensure that its Agents likewise agree, that neither shall, without Sponsor’s 
prior written consent, independently publish, publicly disclose, present, or discuss any results of, or 
information pertaining to, Investigator’s activities conducted under this protocol until such multi-center 
publication is released or twelve months after completion of the Study, whichever is the sooner. 
After the events recited in the above paragraph of this protocol, the Investigator and/or its Agents shall 
then be free to publish or publicly present the results of the Study Subjects enrolled solely at Facilities, 
provided that the manuscript or abstract proposed to be published or presented shall be submitted to 
Sponsor at least ninety (90) days prior to submission for publication or presentation. Sponsor retains 
the right to direct removal of any Confidential Information provided by Sponsor and contained therein 
other than as required to communicate a scientifically appropriate description of the methods and 
results of the Study, to protect its rights to any patentable inventions set forth therein and to ensure the 
accuracy of the information contained in the publication or presentation. The Investigator agrees, and 
will ensure that its Agents likewise agree, to delete any Confidential Information provided by Sponsor 
that Sponsor directs should not be published pursuant to this paragraph. 
Sponsor supports the authorship criteria established by the International Committee of Medical 
Journal Editors (ICMJE). According to these guidelines, authorship credit is based only on substantial 
contributions to: (i) conception and design, or acquisition of data, or analysis and interpretation of data; 
(ii) drafting of the article or revising it critically for important intellectual content; and (iii) approving of 
the final version to be published. Neither Investigator nor its Agents qualify to be an author if its 
contribution consists solely of arranging funding, collecting data or supervising the research group. The 
Sponsor reserves the right to assign a co-author to any publication or public presentation. 
 
20. References 
 [1] I. Milsom, P. Abrams, L. Cardozo, R. G. Roberts, J. Thüroff, and A. J. Wein, “How 
widespread are the symptoms of an overactive bladder and how are they managed? A 
population-based prevalence study,” BJU Int., vol. 87, no. 9, pp. 760–766, 2001. 
[2] P. Abrams, C. J. Kelleher, L. A. Kerr, and R. G. Rogers, “Overactive bladder significantly 
affects quality of life,” Am J Manag Care, vol. 6, no. 11 Suppl, pp. S580–S590, 2000. 
[3] C. R. Chapple et al., “Total urgency and frequency score as a measure of urgency and 
frequency in overactive bladder and storage lower urinary tract symptoms: TUFS as 
measure of storage symptoms in LUTS and OAB,” BJU Int., vol. 113, no. 5, pp. 696–703, 
May 2014. 
[4] S. Herschorn et al., “A Phase III, Randomized, Double-blind, Parallel-group, Placebo-
controlled, Multicentre Study to Assess the Efficacy and Safety of the β3 Adrenoceptor 
Agonist, Mirabegron, in Subjects With Symptoms of Overactive Bladder,” Urology, vol. 82, 
no. 2, pp. 313–320, Aug. 2013. 
[5] M. B. Chancellor, K. Migliaccio-Walle, T. J. Bramley, S. L. Chaudhari, C. Corbell, and D. 
Globe, “Long-Term Patterns of Use and Treatment Failure With Anticholinergic Agents for 
Overactive Bladder,” Clin. Ther., vol. 35, no. 11, pp. 1744–1751, Nov. 2013. 
[6] K. M. Peters et al., “Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus 
Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results From the SUmiT 
Trial,” J. Urol., vol. 183, no. 4, pp. 1438–1443, Apr. 2010. 

Page 37 of 38 
Version 2.0 dated February 15, 2021 
 
[7] Peters K.M. et al., “Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus 
Extended-Release Tolterodine: Results From the Overactive Bladder Innovative Therapy 
Trial,” J. Urol., vol. 182, no. 3, pp. 1055–1061, 2009. 
[8] K. Noblett et al., “Results of a prospective, multicenter study evaluating quality of life, 
safety, and efficacy of sacral neuromodulation at twelve months in subjects with 
symptoms of overactive bladder: 12 Month Outcomes of Sacral Neuromodulation for 
OAB,” Neurourol. Urodyn., vol. 35, no. 2, pp. 246–251, Feb. 2016. 
 
21. Protocol Amendment Summary of Changes 
 
 
 
 
 
 
 
Summary of Changes for 
Protocol Version 1 Dated: 06 JUL 2020 to Version 2 Dated: 07 DEC 2020 
SECTION 
DESCRIPTION OF CHANGE 
RATIONALE 
GLOBAL 
THROUGHOUT 
DOCUMENT 
Formatting changes and other minor 
edits, including changes to references for 
consistency/correction, throughout the 
protocol, without change to meaning or 
substance. 
Improve document consistency, 
accuracy, readability, and 
adherence to necessary style. 
TITLE PAGE 
Version / Date change. 
To reflect the current version of 
the protocol 
TABLE OF 
CONTENTS 
Modified to include addition of Section 8  
Long-Term Follow-Up. 
To Provide necessary information 
relating to the long-term follow-up 
phase of the AMHOAB2001 trial. 
SECTION 2 – 
Protocol Summary 
Structure, Method of Assignment, and 
Study Design sections updated to include 
information related to the long-term 
follow-up phase of the AMHOAB2001 
study. 
To provide information regarding 
the long-term follow-up phase of 
the AMHOAB2001 study. 
Section 5 – Study 
Design 
Updated to include information related to 
the long-term follow-up phase of the 
AMHOAB2001 study. 
To provide information regarding 
the long-term follow-up phase of 
the AMHOAB2001 study 
Section 7 – 
Methods & 
Procedures 
Updated to include information related to 
the long-term follow-up phase of the 
AMHOAB2001 study. 
To provide information regarding 
the long-term follow-up phase of 
the AMHOAB2001 study 
Section 8 – Long-
Term Follow-Up 
Phase 
Section added to provide information 
related to the long-term follow-up phase 
of the AMHOAB2001 study. 
To provide information regarding 
the long-term follow-up phase of 
the AMHOAB2001 study 
Section 10 – Test 
Article 
Updated pictures for the Stimulator and 
controller app 
To reflect latest design of Test 
Article 
Section 21 – 
Protocol 
Amendment 
Summary of 
Changes 
Section added to Protocol 
To provide information regarding 
changes between Protocol Version 
1.0 and Protocol Version 2.0. 

Page 38 of 38 
Version 2.0 dated February 15, 2021 
 
 
 
21. Appendix A- Case Report Forms 
 
 
 
 
 
 
 
 
 
 
 
[This Page is left intentionally blank] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Page 1 of 2 
Version 2.0 dated February 15, 2021 
 
 
3-Day Bladder Diary Visit # 
 
Subject ID:   
 
Subject Initials:    
 
 
 
1. Choose 3 days (entire 24 hours) to complete this record - they do not have to be in a row. Pick days during 
which it will be convenient to measure every void. 
2. Begin recording when you wake up in the morning and continue for a full 24 hours. 
3. Make a separate entry each time you void, leak or have anything to drink. 
4. Record each time you notice a leak - please indicate how much using a scale from 1-3 
(1=drops/damp, 2=wet/soaked, 3=bladder emptied/voided). Record if you felt an "urge" with the 
leak (yes or no). 
 
 
 
Time of Day 
Fluid Intake 
(oz) 
Leak Amount 
(1-3) 
Activity with 
Leak 
Urge with Leak 
(yes or no) 
Comments 
7:15 am 
7:45 am 
2 oz 
9:00 am 
2 
Yes 
10:30 am 
3 oz 
1 
Sneezing 
No 

Date 
Authorized Signature 
Version 2.0 dated February 15, 2021 
Page 2 of 2 
 
 
I have reviewed the recorded information for this visit and verified that it is complete and accurate. 
SIGNATURE 
 
3-Day Bladder Diary Visit #   
Subject ID:     
 
Subject Initials: 
 
 
Number of Pads for full 24 hours: 
 
 
 
 
 
Time of Day 
Fluid Intake 
(oz) 
Leak Amount 
(1-3) 
Activity with 
Leak 
Urge with Leak 
(yes or no) 
Comments 

Page 1  of 3 
Version 2.0 dated February 15, 2021 
 
 
 
OAB-q (HQL) Form- Visit   
 
 
 
Subject ID:  
 
Subject Initials:   
 
 
This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 
weeks. Please mark the box that best describes the extent to which you were bother by each symptom during the past 4 
weeks. There are no right or wrong answers. Please be sure to answer every question. 
During the past 4 weeks, how 
bothered were you by… 
(1) 
(2) 
(3) 
(4) 
(5) 
(6) 
1. Frequent urination during 
day-time hours 
 
Not at all 
A little bit 
Somewhat 
 
Quite a bit 
 
A great deal 
A very 
great deal 
2. An uncomfortable urge to 
urinate 
 
Not at all 
A little bit 
Somewhat 
 
Quite a bit 
 
A great deal 
A very 
great deal 
3. A sudden urge to urinate 
with little or no warning 
 
Not at all 
A little bit 
Somewhat 
 
Quite a bit 
 
A great deal 
A very 
great deal 
4. Accidental loss of small 
amounts of urine 
 
Not at all 
A little bit 
Somewhat 
 
Quite a bit 
 
A great deal 
A very 
great deal 
5. Nighttime urination 
 
Not at all 
A little bit 
Somewhat 
 
Quite a bit 
 
A great deal 
A very 
great deal 
6. Waking up at night 
because you had to urinate 
 
Not at all 
A little bit 
Somewhat 
 
Quite a bit 
 
A great deal 
A very 
great deal 
7. An uncontrollable urge to 
urinate 
 
Not at all 
A little bit 
Somewhat 
 
Quite a bit 
 
A great deal 
A very 
great deal 
8. Urine loss associated with a 
strong desire to urinate 
 
Not at all 
A little bit 
Somewhat 
 
Quite a bit 
 
A great deal 
A very 
great deal 
This questionnaire asks about how much you have been bothered by selected bladder symptoms during the past 4 
weeks. Please circle what best describes the extent to which you were bothered by each symptom during the past 4 
weeks. There are no right or wrong answers. Please be sure to answer every question. 
During the past 4 weeks, how 
often have your bladder 
symptoms… 
(1) 
(2) 
(3) 
(4) 
(5) 
(6) 
9. Made you carefully plan your 
commute? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the time 
Most of 
the time 
All of 
the time 
10. Caused you to feel drowsy 
or sleepy during the day? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the time 
Most of 
the time 
All of 
the time 
11. Caused you to plan 'escape 
routes’ to restrooms in public 
places? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the time 
Most of 
the time 
All of 
the time 

Page 2  of 3 
Version 2.0 dated February 15, 2021 
 
 
 
OAB-q (HQL) Form- Visit   
 
 
Subject ID:  
 
Subject Initials:    
 
 
12.Caused you distress? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of 
the time 
13.Frustrated you? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of 
the time 
14. Made you feel like there is 
something wrong with you? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of 
the time 
15. Interfered with your ability 
to get a good night’s rest? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of 
the time 
16. Caused you to decrease 
your physical activities 
(exercising, sports, etc.) ? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of 
the time 
17. Prevented you from feeling 
rested upon walking in the 
morning? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of 
the time 
18.Frustrated your family or 
friends? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good 
bit of the 
time 
Most of 
the time 
All of 
the time 
19. Caused you anxiety or worry? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of 
the time 
20. Caused you to stay home 
more often than you 
would prefer? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of 
the time 
21.Caused you to adjust your 
travel plans so that you are 
always near a restroom? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of 
the time 
22 Made you avoid activities 
away from restrooms (i.e., 
walks, running, hiking)? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of 
the time 
23. Made you frustrated or 
annoyed about the amount 
of time you spend in the 
restroom? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
 
All of 
the time 
24. Awakened you during sleep? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
 
All of 
the time 
25. Made you worry about odor 
or hygiene? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of 
the time 

Page 3  of 3 
Version 2.0 dated February 15, 2021 
 
 
 
OAB-q (HQL) Form- Visit   
 
 
Subject ID:  
 
Subject Initials:    
 
 
26. Made you uncomfortable 
while traveling with others 
because of needing to stop for 
a restroom? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of the 
time 
27. Affected your relationships 
with family and friends? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of the 
time 
28. Caused you to decrease 
participating in social 
gatherings, such as parties or 
visits with family or friends? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of the 
time 
29. Caused you embarrassment? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of the 
time 
30. Interfered with getting the 
amount of sleep you 
needed? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of the 
time 
31.Caused you to have 
problems with your 
partner or spouse? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of the 
time 
32.Caused you to plan activities 
more carefully? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of the 
time 
33.Caused you to locate the 
closes restroom as soon as 
you arrive at a place you 
have never been? 
None of 
the time 
A little of 
the time 
Some of 
the time 
A good bit 
of the 
time 
Most of 
the time 
All of the 
time 
2001 Pharmacia & Upjohn, a subsidiary of Pharmacia Corporation. Contact K. Coyne for 
permission to use 
 
 
D D M M M Y Y Y Y 
Date 
Authorized Signature 
I have reviewed the recorded information for this visit and verified that it is complete and accurate. 
SIGNATURE 

Page 1 of 1 
Version 2.0 dated February 15, 2021 
 
 
 
IIQ-7 SF Form- Visit    
 
Subject ID:  
 
Subject Initials:   
 
 
Some people find that accidental urine loss may affect their activities, relationships, and feelings. The 
questions below refer to areas in your life that may have been influenced or changed by your problem. For 
each question, circle the response that best describes how much your activities, relationships, and feelings 
are being affected by urine leakage. 
 
Has urine leakage affected your: 
Not at 
all 
Slightly Moderately Greatly Subject Score 
1. Ability to do household chores 
(cooking, housecleaning, laundry)? 
 
0 
 
1 
 
2 
 
3 
 
2. Physical recreation such as walking, 
swimming, or other exercise? 
 
0 
 
1 
 
2 
 
3 
 
3. Entertainment activities (movies, 
concerts, etc.)? 
 
0 
 
1 
 
2 
 
3 
 
4. Ability to travel by car or bus more 
than 30 minutes from home? 
 
0 
 
1 
 
2 
 
3 
 
5. Participation in social activities 
outside your home? 
 
0 
 
1 
 
2 
 
3 
 
6. Emotional health (nervousness, 
depression, etc.)? 
 
0 
 
1 
 
2 
 
3 
 
7. Feeling frustrated? 
0 
1 
2 
3 
 
TOTAL 
 
 
Reference. Uebersax, J.S., Wyman, J. F., Shumaker, S. A., McClish, D. K., Fantl, J. A., & the Continence Program for Women 
Research Group. (1995). Short forms to assess life quality and symptom distress for urinary incontinence in women: The 
incontinence impact questionnaire and the urogenital distress inventory. Neurourology and Urodynamics, 14, 131-139. 
 
 
D D M M M Y Y Y Y 
Date 
Authorized Signature 
I have reviewed the recorded information for this visit and verified that it is complete and accurate. 
SIGNATURE 

Page 1 of 1 
Version 2.0 dated February 15, 2021 
 
 
 
PGIC – Visit #  
 
 
Subject ID:   
 
Subject Initials:   
 
 
 
Chief Complaint:   
 
Since beginning treatment how would you describe the change (if any) in ACTIVITY LIMITATIONS 
SYMPTOMS, EMOTIONS and OVERALL QUALITY OF LIFE, related to your condition? (tick ONE box) 
1. No change (or condition has got worse) 
 
2. Almost the same, hardly any change at all 
 
3. A little better, but no noticeable change 
 
4. Somewhat better but the change has not made any real difference 
 
5. Moderately better, and a slight but noticeable change 
 
6. Better, and a definite improvement that has made a real and worthwhile difference 
 
7. A great deal better and a considerable improvement that has made all the difference 
 
In a similar way, please circle the number below, that matches your degree of change since beginning 
care at this clinic: 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
Much 
No 
Much 
Better 
Change 
Worse 
Reference: Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome 
measures. J Manipulative Physiol Ther 2004;27:26-35. 
 
 
D D M M M Y Y Y Y 
Date 
Authorized Signature 
I have reviewed the recorded information for this visit and verified that it is complete and accurate. 
SIGNATURE 

Page 1 of 2 
Version 2.0 dated February 15, 2021 
 
 
 
I-QoL – Visit #   
 
Subject ID:   
 
Subject Initials:    
 
 
ALB Domain 
1. I worry about not being able to get to 
the toilet on time 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
2. I worry about coughing/sneezing 
because of my incontinence 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
3. I have to be careful standing up from 
sitting 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
4. I worry about where toilets are in new 
places 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
5. It’s important to me to make frequent 
trips to the toilet 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
6. It’s important to plan every detail in 
advance because of my incontinence 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
7. I have difficulty getting a good night’s 
sleep because of my incontinence 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
8. I have to watch how much I drink 
because of my incontinence 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
PSI Domain 
9. I feel depressed because of my 
incontinence 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
10. I don’t feel free to leave home for long 
periods of time because of my 
incontinence 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
11. I feel frustrated because my 
incontinence prevents me doing what I 
want 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
12. My incontinence is always on my mind 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
13. My incontinence makes me feel 
unhealthy 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
14. My incontinence makes me 
feel helpless 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
15. I get less enjoyment out of life because 
of my incontinence 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
16. My incontinence limits my choice 
of clothing 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
17. I worry about having sex because of 
my incontinence 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 

Page 2 of 2 
Version 2.0 dated February 15, 2021 
 
 
Date 
Authorized Signature 
I have reviewed the recorded information for this visit and verified that it is complete and accurate. 
SIGNATURE 
 
I-QoL – Visit #   
 
Subject ID:   
 
Subject Initials:   
 
 
SE Domain 
18. I worry about others smelling urine 
on me 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
19. I worry about my incontinence 
getting worse as I get older 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
20. I worry about being embarrassed or 
humiliated by my incontinence 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
21. I worry about wetting myself 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
22. I feel I have no control over my bladder 
Extremely 
Quite a bit 
Moderately 
A little 
Not at all 
 
 
 
 
 
 
 
D  D   M  M M Y Y Y Y 

Page 1  of 2 
Version 2.0 dated February 15, 2021 
 
 
 
OHQ– Visit #  
 
 
Subject ID:    
 
Subject Initials:   
 
 
 
Instructions 
Below are a number of statements about happiness. Please indicate how much you agree or disagree with 
each by entering a number in the blank after each statement, according to the following scale: 
 
1 = strongly disagree 
2 = moderately disagree 
3 = slightly disagree 
4 = slightly agree 
5 = moderately agree 
6 = strongly agree 
 
Response # 
 
1. I don’t feel particularly pleased with the way I am. 
2. I am intensely interested in other people. 
3. I feel that life is very rewarding. 
4. I have very warm feelings towards almost everyone. 
5. I rarely wake up feeling rested. 
6. I am not particularly optimistic about the future. 
7. I find most things amusing. 
8. I am always committed and involved. 
9. Life is good. 
10. I do not think that the world is a good place. 
11. I laugh a lot. 
12. I am well satisfied about everything in my life. 
13. I don’t think I look attractive. 
14. There is a gap between what I would like to do and what I have done. 
15. I am very happy. 
16. I find beauty in some things. 
17. I always have a cheerful effect on others. 
18. I can fit in (find time for) everything I want to do. 
19. I feel that I am not especially in control of my life 
20. I feel able to take anything on. 
21. I feel mentally alert. 
22. I often experience joy and elation. 

Page 2  of 2 
Version 2.0 dated February 15, 2021 
 
 
 
OHQ– Visit #  
 
 
Subject ID:   
 
Subject Initials:    
 
 
23. I don’t find it easy to make decisions. 
24. I don’t have a particular sense of meaning and purpose in my life. 
25. I feel I have a great deal of energy. 
26. I usually have a good influence on events. 
27. I don’t have fun with other people. 
28. I don’t feel particularly healthy. 
29. I don’t have particularly happy memories of my past. 
 
 
D D M M M Y Y Y Y 
Date 
Authorized Signature 
I have reviewed the recorded information for this visit and verified that it is complete and accurate. 
SIGNATURE 

Page 1 of 1 
Version 2.0 dated February 15, 2021 
 
 
 
Paresthesia Map 
 
 
Subject ID:   
 
 
Subject Initials:   
 
 
 
 
 
 
 
 
 
 
 
Paresthesia Map 
Turn the stimulator to the maximum tolerable level. Mark on the figure below where the Subject feels stimulation. 
 
 
 
R 
L 
 
 
R 
L 

Version 2.0 dated February 15, 2021 
Date  
Paresthesia Rating 
Page 1 of  1 
 
D 
D 
M M M Y Y Y Y 
Date 
Authorized 
S
I have reviewed the recorded information for this visit and verified that it is complete 
d
SIGNATURE 
Subject ID:   
  
 
 
Subject Initials:   
_______ 
 
Ask the patient to rate each of the following words from 0 to 4 how well each 
describes the feeling of paresthesia. (0 does not at all describe the feeling --- 4 very 
much describes the feeling) 
 
Warm 
0 
1 
2 
3 
4 
Fluttering 
0 
1 
2 
3 
4 
Tingling 
0 
1 
2 
3 
4 
Unpleasant 
0 
1 
2 
3 
4 
Aching 
0 
1 
2 
3 
4 
Tickling 
0 
1 
2 
3 
4 
Massaging 
0 
1 
2 
3 
4 
Jabbing 
0 
1 
2 
3 
4 
Prickly 
0 
1 
2 
3 
4 
Tapping 
0 
1 
2 
3 
4 
Aggravating 
0 
1 
2 
3 
4 
Vibrating 
0 
1 
2 
3 
4 
Gentle 
0 
1 
2 
3 
4 
Gentle Pressure 
0 
1 
2 
3 
4 
Cramping 
0 
1 
2 
3 
4 
Calming 
0 
1 
2 
3 
4 
Throbbing 
0 
1 
2 
3 
4 
Pulsing 
0 
1 
2 
3 
4 
Shocking 
0 
1 
2 
3 
4 
Sharp 
0 
1 
2 
3 
4 
Soothing 
0 
1 
2 
3 
4 
Pleasant 
0 
1 
2 
3 
4 
Buzzing 
0 
1 
2 
3 
4 
Numbing 
0 
1 
2 
3 
4 
Relaxing 
0 
1 
2 
3 
4 
Natural 
           0   1 
2 
3 
4 
Comfortable 
0 
1 
2 
3 
4 
Pins and Needles 
0 
1 
2 
3 
4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Version 2.0 dated February 15, 2021 
Date  
Paresthesia Rating 
Page 1 of  1 
 
D 
D 
M M M Y Y Y Y 
Subject ID:   
  
 
 
Subject Initials:   
               
 
General Information 
1. How likely would you be willing to use 
a system like this for treating your 
OAB? 
Not 
likely 
A little 
likely 
Moderately 
likely 
Very 
likely 
Extremely 
likely 
Please comment on the willingness to use this System to treat OAB: 
2. How easy was it to use the overall 
System? 
Not easy 
A little 
easy 
Moderately 
easy 
Very easy 
Extremely 
easy 
Please comment on the ease of use of the System: 
3. How satisfied were you with the 
Avation System app? 
Not 
satisfied 
A little 
satisfied 
Moderately 
satisfied 
Very 
satisfied 
Extremely 
satisfied 
What in particular did you like about the 
App? 
What, if anything, can be improved 
about the App? 
4. How satisfied were you with the 
Garment? 
Not 
satisfied 
A little 
satisfied 
Moderately 
satisfied 
Very 
satisfied 
Extremely 
satisfied 
What in particular did you like about 
the Garment? 
What, if anything, can be improved 
about the Garment? 
5. How satisfied were you with the system 
overall? 
Not 
satisfied 
A little 
satisfied 
Moderately 
satisfied 
Very 
satisfied 
Extremely 
satisfied 
What in particular did you like about the 
system overall? 
What, if anything, can be improved 
about the overall system? 
 
 
 

Version 2.0 dated February 15, 2021 
Date  
Paresthesia Rating 
 
 Page 2 of 2 
 
 
 
D 
D 
M M M Y Y Y Y 
  
       Subject ID:   
  
 
 
Subject Initials:   
                          
 
 
General Information 
6. How easy was it to fit this 
stimulation therapy into 
your routine? 
 
 
Not easy 
 
 
A little easy 
 
Moderately 
easy 
 
 
Very easy 
 
 
Extremely easy 
Please comment on ease of fitting 
this modulation therapy into your 
routine. 
7. What type of activities were you 
doing when you used this system? 
[ ] Reading 
[ ] Watching TV 
[ ] On the Computer 
[ ] Eating 
[ ] Other:   
 
8. What positions were you in 
while using the system? 
[ ] Sitting 
[ ] Standing 
[ ] Lying 
[ ] Other:   
 
9. What positions were you in 
most often while using the 
system? 
[ ] Sitting 
[ ] Standing 
[ ] Lying 
[ ] Other:   
 
10. What did you like about the 
stimulation sessions? 
11. What did you dislike about the 
stimulation sessions? 
12. How easy was it to change the 
Gel Pads? 
Not easy 
A little easy 
Moderately 
easy 
Very easy 
Extremely 
easy 
13. Did you use the subject 
manual? 
[ ] Yes 
[ ] No 
If yes, why did you use the subject 
manual? Was the information clear 
and easy to locate?