Efficacy of a Non-invasive Pelvic Floor Muscle Trainer for Treatment of Stress Urinary Incontinence
Phase: NA
Conditions: Stress Urinary Incontinence, Urinary Incontinence, Pelvic Floor Disorders
Sponsor: Pelex

  
CLINICAL STUDY PROTOCOL 
 
Study evaluating efficacy of a non-invasive pelvic floor muscle 
trainer for treatment of stress urinary incontinence 
 
 
 
Protocol #: PLX-001 
 
jeremy@pelex-med.com 
 
19-Feb-2021 
 
 
PROTOCOL VERSION HISTORY 
Version 
Date (01-Feb-2021) 
Initial 
19-Feb-2021 
Amendment 
21-Feb-2021 
 
ETHICS AND REGULATORY COMPLIANCE STATEMENT 
The procedures set forth in this protocol are designed to ensure that the sponsor(s) and 
principal investigator(s) abide by the International Conference on Harmonization (ICH) 
current Good Clinical Practice (cGCP) guidelines, current Good Laboratory Practice (cGLP) 
guidelines, the Declaration of Helsinki, and applicable local regulatory requirements and 
laws in the conduct, evaluation, and documentation of this study. 

 
  
 
Protocol Name 
Study evaluating efficacy of a non-invasive pelvic floor 
muscle trainer for treatment of stress urinary 
incontinence 
Protocol Number 
PLX-001 
Investigational Product 
Name 
Pelex Upp 
Date: (dd-mmm-yyyy) 
19-Feb-2021 
Author 
Jeremy Wiygul, MD 
 
PROTOCOL HISTORY 
Version 
Date (dd-mmm-yyyy) 
Description 
V1  
19-Feb-2021 
Initial Release 
V2 
21-Feb-2021 
 
 
PROTOCOL APPROVALS 
Name 
Signature 
Date 
(dd-mmm-yyyy) 
Department 
 
eSignature 
eDate 
 
 
eSignature 
eDate 
 
 
eSignature 
eDate 
 
 

 
  
CONTACT INFORMATION 
Sponsor 
Pelex, Inc.  
info@pelex-med.com 
Primary Study Contact, Principal 
Investigator 
Dr. Jeremy Wiygul 
jeremy@pelex-med.com 
Project Team Lead 
Regulatory Affairs 
Rohit Joshi 
Pelex, Inc. 
rohit@pelex-med.com 
Russ Olsen 
HPA 
rolsen@healthpolicyassociates.com  
Study Monitor 
Unanticipated Adverse Device Events 
Rohit Joshi 
Pelex, Inc. 
rohit@pelex-med.com 
Dr. Glennis Mehra 
Pelex, Inc. 
glennis@pelex-med.com 
Legal Affairs 
Protocol Author:  
Chris Simpson 
Polsinelli LLC 
csimpson@polsinelli.com  
Dr. Jeremy Wiygul 
Pelex, Inc. 
jeremy@pelex-med.com 
Sub-investigators: 
 
 
Coordinating Investigator and Principal Investigators   
An updated list of Principal Investigators (PI), investigation sites, and institutions will be 
maintained separately. The definitive list will be provided in the clinical study report. 
 

 
  
PROTOCOL SIGNATURE PAGE 
 
 
 
Protocol #: PLX-001  
 
Study evaluating efficacy of a non-invasive pelvic floor muscle 
trainer for treatment of stress urinary incontinence 
 
As an Investigator for this Study, I have read the Clinical Trial Protocol. I agree to make 
available to the Sponsor, Pelex, Inc. (or its designee), original source documents and all 
regulatory documents pertaining to this Study. I agree to cooperate fully with the Sponsor 
with the conduct of study-related audits. 
 
By my signature below, I agree to conduct this Study in accordance with the Clinical 
Trial Protocol, current Good Clinical Practice (cGCP) and Good Laboratory Practice 
(cGLP) guidelines, obligations as set forth in Title 21 CFR Parts 812, 54, 56 and 11 (as 
applicable), and any applicable regulatory laws. I will make no changes to protocol-
defined procedures without written permission from the Sponsor.   
 
I understand that Investigational Use Products may be used only for the purposes explicitly 
described in this protocol.  
 
I further agree to treat the results of this Study as confidential information and will not 
submit the results of the Study for publication without prior written authorization from the 
Sponsor.  
 
 
 
Jeremy Wiygul 
  
 02/19/2021 
PRINTED NAME 
 SIGNATURE 
 DATE 
 
 

 
  
SYNOPSIS 
Title of Study 
Study evaluating efficacy of a non-invasive pelvic floor muscle 
trainer for treatment of stress urinary incontinence. 
Objectives 
 
Evaluate efficacy of Pelex Upp in treatment of patients with 
stress urinary incontinence. 
Planned Number of 
Subjects and Duration 
of Involvement 
5 study subjects will be enrolled for a total of 4 weeks. 
Patient Population 
 
Women > 18 years of age with symptoms of stress urinary 
incontinence 
Investigational 
Product Name 
Pelex Upp 
Methodology 
Overview 
 
This will be a prospective cohort study of women > 18 years of 
age with symptoms of stress urinary incontinence, recruited via 
an online recruitment tool.   
 
After screening, patients meeting inclusion criteria will be given 
a study brochure, and then given instructions on how to indicate 
desire to participate in the study.  The patient will then be 
contacted for study participation, including explanation of study 
and details and completion of Informed Consent. Participants 
will then complete a pre-treatment urinary incontinence 
symptom questionnaire(ICIQ).  
 
After completion of the above, the participants will then be given 
a Pelex Upp study, in addition to educational materials on use of 
the device, and a treatment schedule.  Participants will perform 
a standardized biofeedback-mediated pelvic floor muscle 
training program with the study device 10 minutes a day, five 
times a week for 4 weeks.  There will be a mid-study check in to 
assure all devices are functioning appropriately.  At the end of 
the study, participants will complete a post-treatment urinary 
incontinence symptom questionnaire(ICIQ). 
 
Endpoint of the study will be change in stress urinary 
incontinence symptoms as measured by the ICIQ.  The ICIQ will 
be collected at 2 time points: before study entry, and at study 
close. 
 
 
 

 
  
ABBREVIATIONS 
PFMT  
Pelvic floor muscle training 
SUI 
Stress urinary incontinence 
OAB 
Overactive bladder 
UI 
Urinary incontinence 
PFM 
US/USA 
Pelvic floor muscles 
United States of America 

 
  
TABLE OF CONTENTS 
1 
INTRODUCTION ...................................................................................................... 11 
2 
DESCRIPTION OF THE INVESTIGATIONAL PRODUCT ................................. 11 
2.1 
Overview ............................................................................................................. 11 
2.2 
Proposed Intended Use Statement ........................................................................ 11 
3 
STUDY OBJECTIVES .............................................................................................. 11 
4 
STUDY OVERVIEW ................................................................................................. 12 
4.1 Study Approach .......................................................................................................... 12 
4.3 Study Duration .......................................................................................................... 13 
5 
STUDY POPULATION ............................................................................................. 14 
5.1 
Sample Size and Target Study Population ............................................................ 14 
5.1.1 
Sample size ................................................................................................................ 14 
5.1.2 
Study population ........................................................................................................ 14 
5.1.3 
Alignment with intended study population .................................................................. 14 
5.1.4 
Alignment with intended use of the device.................................................................. 14 
5.2 
Recruitment Methods ........................................................................................... 14 
5.2.1 
Recruitment for Study ................................................................................................ 14 
5.2.2 
Duration of study activities ......................................................................................... 14 
5.3 
Patient Selection .................................................................................................. 15 
6 
STUDY MATERIALS ............................................................................................... 15 
6.1 
Investigational Product......................................................................................... 15 
6.1.1 
Identity of the investigational product and accessories ................................................ 15 
6.1.2 
Safety issues ............................................................................................................... 16 
6.1.3 
Handling, storage, accountability ................................................................................ 16 
6.1.4 
Required training ........................................................................................................ 16 
6.1.5 
External studies .......................................................................................................... 17 
6.2 
Other Study Materials .......................................................................................... 17 
6.2.1 
Materials to be provided by study site ......................................................................... 17 
6.2.2 
Materials to be provided by external testing facilities .................................................. 17 
7 
STUDY PROCEDURES ............................................................................................ 17 
7.1 
Workflow............................................................................................................. 17 
7.2 
Study Data ........................................................................................................... 18 
7.2.1 
Collection of data ....................................................................................................... 19 
7.3 
Randomization and Blinding ................................................................................ 20 
7.4 
Procedures for Study Closure ............................................................................... 20 

 
  
7.4.1 
Routine study close-out .............................................................................................. 20 
7.4.2 
Suspension or premature termination of the study ....................................................... 20 
8 
DATA QUALITY ASSURANCE .............................................................................. 20 
9 
STATISTICAL METHODS ...................................................................................... 21 
9.1 
Determination of Sample Size .............................................................................. 21 
9.2 
Bias Minimization................................................................................................ 21 
9.3 
Planned Analyses ................................................................................................. 21 
10 ADVERSE EVENT REPORTING ............................................................................ 22 
10.1 
Non-Device-Associated Adverse Events .............................................................. 22 
10.2 
Device-Associated Adverse Events ...................................................................... 22 
10.2.1 Definition of an unanticipated adverse device effect (UADE) event ............................ 22 
10.2.2 Reporting of device-associated adverse events ............................................................ 22 
10.3 
Sponsor Contact for Serious Adverse Event Reporting ......................................... 23 
11 RISK ANALYSIS ....................................................................................................... 23 
11.1 
Potential Risks of the Investigational Product and Clinical Investigation .............. 23 
11.2 
Potential Benefits of the Investigational Product and Clinical Investigation .......... 23 
11.3 
Minimization of Risks .......................................................................................... 24 
12 INVESTIGATOR RESPONSIBILITIES .................................................................. 24 
12.1 
Site Qualification and Study Oversight ................................................................ 24 
12.2 
Case Report Forms/Electronic Data Records ........................................................ 24 
12.3 
Access to Source Documents ............................................................................... 25 
12.4 
Financial Disclosure ............................................................................................. 25 
12.5 
Deviations from the Study Protocol ...................................................................... 25 
12.6 
Record Retention ................................................................................................. 25 
12.7 
Publication Policy ................................................................................................ 26 
13 ETHICS AND COMPLIANCE ................................................................................. 26 
13.1 
Investigational Device Exemption ........................................................................ 26 
13.2 
Informed Consent and De-Identification .............................................................. 26 
13.2.1 Prospectively collected data ........................................................................................ 27 
13.3 
IRB Review ......................................................................................................... 27 
13.4 
Confidentiality of Data and Patient Records ......................................................... 27 
13.4.1 Provisions to Protect the Privacy Interests of Participants ............................................. 27 
14 REFERENCES ........................................................................................................... 28 
 

 
  
 
 

 
  
LIST OF TABLES 
Table 1: Study Materials 
Page 18 
LIST OF FIGURES 
FIGURE 1: Study Workflow 
Page 18 

 
  
1 INTRODUCTION 
Pelex, Inc. is a medical device company that is dedicated to addressing pelvic health 
disorders. The company is developing a non-invasive medical device that uses 
electromyography and neurostimulation to treat incontinence and other pelvic floor disorders.  
In support of its research and development efforts, Pelex is conducting a clinical study to 
assess the efficacy and usability of the electromyography component of the company’s pelvic 
health product. Five patients suffering from stress urinary incontinence, a form of pelvic 
floor disorder, will be recruited to participate and the duration of participation is expected to 
be four weeks. The result of this study will be used to verify that the underlying technology 
functions as expected, identify subject preferences for device form factor and other design 
decisions, and capture other patient feedback. 
2 DESCRIPTION OF THE INVESTIGATIONAL PRODUCT  
2.1 Overview 
The Pelex Upp is a non-invasive device that is designed to guide a user through personalized 
pelvic floor strengthening exercises. The device consists of a patient contact interface 
approximately 12” x 6” whose upper surface is embedded with disposable electrodes which 
by a short cable is linked to an enclosed circuit board component. When a patient interacts 
with the patient contact interface by sitting upon it, the electrodes of the sensor array are able 
to detect and measure the patient’s muscle contractions. The circuit board component 
analyzes the collected data and provides feedback to the patient on sensor array placement 
and strength of muscle contractions via a user interface panel consisting of LEDs that is 
located on a handheld piece that is connected to the hardware component by a fixed cable.  
The handheld component also houses a cadence LED, which prompts the user through a 
series of standardized pelvic floor contraction and relaxation exercises. 
2.2 Proposed Intended Use Statement 
The Pelex Upp is a non-invasive electromyography device designed to treat stress urinary 
incontinence in adults. 
3 STUDY OBJECTIVES 
The principal objective of this study is to demonstrate efficacy of the Pelex Upp in treatment 
of stress urinary incontinence.  The secondary objective will be to determine ease of use of 
the Pelex Upp by patients at home. 

 
  
4 STUDY OVERVIEW 
4.1 Study Approach 
Urinary incontinence (UI), as defined by the International Continence Society as any 
involuntary loss of urine, is among the most prevalent of all medical conditions, affecting one 
in four adult women and increasing in incidence with age (1).  Stress urinary incontinence 
(SUI), which is the involuntary loss of urine during exertion, sneezing or coughing, is the 
most common form of UI (2) and is estimated to be responsible for over $12 Billion in health 
care expenditures annually (3).  SUI is typically the result of weakening of the pelvic floor 
muscles and atrophy of vaginal tissues, both of which occur increasingly with age and after 
childbirth(4). 
         Therapies for SUI primarily revolve around restoring the strength and function of the 
pelvic floor muscles (PFM), and can be understood as lying on a spectrum between more 
conservative and more invasive options.  First line (conservative) therapy for SUI typically 
consists of behavioral modification, such as more frequent urinating to avoid larger bladder 
volumes, in addition to some form of pelvic floor muscle training (PFMT)(2), while more 
invasive options, such as surgery to reconstruct the pelvic floor, are reserved for patients who 
have failed first line therapy. 
The goal of PFMT is to increase the strength, coordination and endurance of PFM, 
which allows for stabilization of the urethra and pelvic organs during rises in intra-abdominal 
pressure(5), thereby avoiding loss of urine during these pressure rises.  PFMT in the form of 
Kegel exercises is a well-established form of treatment for urinary incontinence (6), and 
success rates with PFMT for UI approach 84% in selected patients (7; 8), which, combined 
with their relative simplicity, make them a highly desirable and often-used treatment option.  
Most simply, PFMT is performed in the form of daily timed contractions and relaxations of 
the pelvic floor, typically after being coached about appropriate muscle use by a trained 
professional during a clinic visit (9).  While this has been proven to improve SUI symptoms 
over behavioral therapy alone, PFMT with biofeedback, where a device is used to record the 
biological signal of contraction of the PFM and then present that signal to the user in audio or 
visual form, has been proven to offer even greater benefit that PFMT alone(10).  Biofeedback 
in the setting of PFMT is accomplished by placement of surface electrodes on the skin 
overlying the pelvic floor muscles, or an intravaginal device sensitive to pressure changes, 
both of which can detect contraction and relaxation of the pelvic floor muscles and allows the 
user to then gain greater awareness of their PFM.  Patients undergoing PFMT plus 
biofeedback typically do so under the guidance of weekly visits to a physical therapist, 
usually over the course of four to six weeks. 
         There is a robust body of evidence supporting use of biofeedback during PFMT in the 
treatment of all forms of urinary incontinence.  In a systematic review in 2011, Herdershee et 
al(10) evaluated all randomized controlled trials (RCT) that compared PFMT alone to PFMT 
plus various types of feedback, including biofeedback, in treatment of urinary incontinence in 
women, and found across all studies, patients treated with PFMT plus biofeedback were 
significantly more likely to report improvement or resolution of their urinary incontinence, 

 
  
though the authors pointed out that the results also could be partially attributable to more 
contact with health care providers (10).  In another recent analysis, Glazer et al (11), using 
more inclusive inclusion criteria, also found a general benefit to biofeedback for treatment of 
urinary incontinence when compared not only to PFMT alone, but also medications and 
electrical stimulation.  However, a more recent meta-analysis was more equivocal in its 
findings, with significantly better objective results, such as pad tests, in patients undergoing 
PFMT plus biofeedback, but with not as clear a difference in subjective quality of life (QoL) 
measures as compared to PFMT alone (12). 
         While PFMT plus biofeedback has traditionally been performed in a medical facility, 
whether it be a clinician’s office or physical therapist’s, more recent research has looked to 
leverage the ability to perform biofeedback at home to improve outcomes.  This movement 
has been aided by the development in recent years of several medical devices designed to 
help patients perform biofeedback for PFM exercises at home, and thus avoid the need for 
recurrent trips to the physical therapist or physician’s office.  In a recent study, use of a home 
biofeedback device was found to be as efficacious as a standard twelve week PFMT program 
with four weekly visits to a physical therapist in treating women with predominantly SUI 
symptoms (13).  In pilot studies, other devices have also shown promising rates of 
improvement in urinary incontinence when used at home and without other PFMT training 
(14).  The use of medical devices to perform biofeedback at home is not only much more 
convenient than typical PFMT plus biofeedback, it has the potential to increase access to 
treatment overall.  In a study by Washington et al, over one third of patients referred to a 
physical therapist for PFMT did not ultimately undergo treatment, with lack of insurance 
being the variable most associated with non-participation in treatment (15).  Considering that 
the out-of-pocket cost of an initial physical therapist visit for PFMT is $500 (15), while most 
of the devices designed for home biofeedback use are priced several hundred dollars less 
(13), these devices could greatly expand treatment capability. 
         However, despite the advantages these devices provide, there are still significant 
barriers to use.  Due to the way biofeedback in conjunction with PFMT must be performed, 
specifically capture of the contraction and relaxation of the PFM, devices designed for use in 
these setting are either invasive (inserted into the vagina or rectum) or require placement by a 
trained professional (surface EMG electrodes).  This presents a barrier to use for patients, and 
an opportunity for innovation.  Specifically, the product under investigation, the Pelex Upp is 
designed for use at home for biofeedback plus PFMT sessions.  It has a non-invasive patient 
interface that takes advantage of the unique anatomical properties of the perineum, the skin 
between the anus and vagina or scrotum, allowing the patient to perform PFMT plus 
biofeedback without the need for invasive devices or professionally placed electrodes.  
         The aim of the present pilot study is to determine efficacy of our product in the 
treatment of SUI in a home setting.  Since PFMT plus biofeedback is considered standard of 
care in patients with SUI who are therapy-naïve, the study subjects will be exposed to no 
greater than normal risk associated with treatment.  Study subjects will undergo evaluation 
by a treating physician and will have prescribed a treatment regimen typical for the disease 
process. 
  
4.3 Study Duration 
The study will last approximately a total of four weeks. 

 
  
5 STUDY POPULATION 
5.1 Sample Size and Target Study Population 
5.1.1 
Sample size 
The total number of individual subjects is expected to reach approximately 5. This estimate is 
based on this being a pilot study, with the primary goal of determining efficacy of the Pelex 
Upp in treatment of stress urinary incontinence in adult women.   
5.1.2 
Study population  
The study population will be representative of adults at least 18 years of age with symptoms 
of stress urinary incontinence. It is anticipated that Pelex will enroll approximately 5 
qualifying adults in total.  
5.1.3 
Alignment with intended study population  
The study population includes patients likely to benefit from pelvic floor muscle training plus 
biofeedback. It may also include other patients who may provide controls. 
5.1.4 
Alignment with intended use of the device 
The device under investigation is intended as a biofeedback device to be used during PFMT. 
5.2 Recruitment Methods 
5.2.1 
Recruitment for Study 
Eligible patients will be invited to participate in the study on a first-come, first-serve basis, 
subject to Pelex weekly recruitment goals. They will be informed of the possible risks of the 
procedure and will be required to give informed consent before study-specific procedures can 
proceed. A minimal financial inducement will not be offered, and subject recruitment 
materials will be used. Each subject will be informed that no personally relevant clinical 
information will be derived from the collected data, and that the only possible benefit to the 
subject is the improvement in their stress urinary incontinence. Medications will be 
documented. Each subject’s involvement in the study will be limited to the period between 
signing of the informed consent form (ICF) and the end of the study, which is expected to be 
four weeks after study initiation.   
5.2.2 
Duration of study activities 
The study is anticipated to continue for approximately four weeks, excluding study 
enrollment period. In the event that additional studies are going to be conducted, new 
protocols will be developed specifically for those studies. 
 

 
  
5.3 Patient Selection 
The eligibility criteria for prospective enrollment of subjects are shown in Table 1.  
Table 1. 
Inclusion/Exclusion Criteria for Enrollment of Subjects  
Inclusion criteria 
Female 
18 years of age or older 
Documented symptoms of predominantly stress urinary 
incontinence as determined by the ICIQ questionnaire 
 
Exclusion criteria 
History of pelvic or lower back surgery 
Pregnancy or less than 12 months post partum 
History of physician-supervised PFMT  
History of Kegel exercises greater than once a month 
History of prior operative delivery 
Self-reported history of pelvic organ prolapse stage II or greater 
Participant 
Withdrawal 
Criteria 
Inability to demonstrate correct use of product 
Inability to devote sufficient time necessary to fulfill study goals 
Worsening of stress urinary incontinence symptoms 
 
6 STUDY MATERIALS 
6.1 Investigational Product 
6.1.1 
Identity of the investigational product and accessories 
The Pelex Upp is intended to allow a patient to perform biofeedback-augmented PFMT non-
invasively and at home. It is comprised of a patient contact interface, a connected handheld 
device, and disposable sensor arrays.  The sensor array is a flexible circuit array holding a 
pair of sensing electrodes and a reference electrode which are connected to a male connector 
at one end.  The patient contact interface, upon which the user sits after disrobing, has the 
sensor array embedded along the upper surface.  A housing compartment within the patient 
contact interface will hold signal processing equipment, which will be connected to the 
sensor array externally via a female connector in the front of the patient contact interface.  
The signal processing equipment will also be separately connected via a cord on the side of 
the patient contact interface to the handheld device.  The handheld device will have two LED 
systems, a power switch and battery compartment for housing of the power source.  The two 
LED systems will include a “cadence” LED, which flashes in a pre-set pattern for the user to 
follow with contractions of their own pelvic floor muscles.  It will also include a “response” 
LED, which allows the user to visualized the contraction of their pelvic floor muscles.  The 
sensor array is disposable, and several replacement sensor arrays will be included, and can be 
changed at the user’s discretion. 
The Pelex Upp is completely non-invasive and made of hypoallergenic, non-latex materials.  

 
  
 
 
6.1.2 
Safety issues 
The device under investigation is completely non-invasive, and qualifies as a non-significant 
risk device based on Title 21 CFR 812.2 (c).  Safety issues would include skin abrasions and 
contact allergic reactions from contact of bare skin with the flexible circuit array, which has a 
mild adhesive applied to it 
6.1.3 
Handling, storage, accountability 
The Sponsor will provide the Investigator with a supply of study devices for conduct of the 
study. All devices will be logged into the device accountability log. If a device is used in the 
investigation it will be documented in the device accountability log. Devices returned to the 
Sponsor will be noted as such in the device accountability log. A final accounting of devices 
will be being presented in the final clinical study report. 
The Investigator shall permit an investigational device to be used only in subjects enrolled in 
the study. The Investigator shall not supply an investigational device to any person not 
authorized to receive it.  
The Investigator or designee shall document receipt, use, and disposition of the device as it 
relates to:  
• The quantity of the device, dates of receipt, catalogue and lot numbers;  
• The names of all persons who received each device; and  
• Why and how many units of the device have been returned to Sponsor or otherwise 
have left the possession of the Investigator.  
The devices must be stored separately from other clinical supplies. Opened, unused devices 
must be returned to the Sponsor or destroyed on site as directed by the Sponsor.  
The use of the study device outside of this protocol is prohibited. Each investigational site will 
identify a designee who will be held responsible for controlling the devices and ensuring that 
a device is dispensed only for the purposes of this study. This designee will be expected to 
retain all unused study supplies until the completion of the study and/or until a representative 
of the Sponsor has inventoried and made arrangements to return the supplies to the Sponsor. 
Upon completion or termination of this investigation or the Investigator’s part of this 
investigation, or at the request of the Sponsor, the Investigator shall return any remaining 
supply of the device or otherwise dispose of the device as directed by the Sponsor. 
 
 
6.1.4 
Required training 
Each study participant will be given instruction materials to guide use of the investigational 
device. 

 
  
6.1.5 
External studies 
In the event that plans are made to conduct additional studies, new protocols describing the 
relevant handling, storage, accountability, and training procedures will be prepared 
specifically for those studies.  
6.2 Other Study Materials 
6.2.1 
Materials to be provided by study site 
● Study notebooks to maintain study documents, including signed ICFs, all applicable 
information, and additional forms to be collected and retained by the study institution 
during the course of the study.  
● Example spreadsheets for tracking patient information. 
6.2.2 
Materials to be provided by external testing facilities  
No materials from external testing facilities will be given. 
7 STUDY PROCEDURES 
7.1 Workflow  
The study design is a prospective cohort that enrolls adult female patients identified as having 
stress urinary incontinence via an online enrollment form to evaluate the effectiveness of the 
Pelex Upp in treatment of stress urinary incontinence.  The treatment group will enroll 5 
subjects. Following the granting of Informed Consent, subjects will be enrolled in the study 
within the prospective cohort and will complete a four-week course of biofeedback augmented 
PFMT using the Pelex Upp.  Patients will complete a pre- and post-study urinary incontinence 
quality of life evaluation tool to assess response to the investigational device. 
 Subsequent treatment and work up will be dictated by the reported persistence of symptoms. 
Follow-up with care providers will be as needed, as determined by the patient. 

 
  
 
Figure 1: Study Workflow 
 
Table 1: Study Materials 
7.2 Study Data 
Eligible subjects will be invited to participate in the study on a first-come, first-serve basis. 
Potential donors must provide informed consent to participate. To be eligible for 
participation, subjects must be at least 18 years of age.  
 

 
  
At the discretion of the Investigator and subject to Pelex requirements, urinary incontinence 
data will be collected from each eligible subject providing signed informed consent.  
7.2.1 
Collection of data  
Source data is all information, original records of clinical findings, observations or other 
activities in a clinical trial necessary for the reconstruction and evaluation of the trial.  Source 
data are contained in source documents.  Examples of source documents in this study include 
medical records, memoranda, evaluation checklists, CRF worksheets, and Data Capture 
An Electronic Data Capture (EDC) system using an electronic Case Report Form (eCRF) that 
is compliant with 21 CFR part 11 is the primary data collection instrument for the study. All 
data requested on the eCRF should be recorded. The EDC system will only allow for data to 
be collected based on specified fields. The EDC system also generates an audit trail for any 
corrected data. All data entered on an eCRF must be traceable to a source document.  
eCRFs will be completed for each subject enrolled into the clinical study.  The Investigator 
will review, approve, and electronically sign the completed eCRF for each subject; the 
Investigator’s electronic signature will serve as a testament of the Investigator’s responsibility 
for ensuring that all clinical data entered on the eCRFs are complete, accurate, and authentic.  
Subjects will be identified in the EDC by a numeric code used for study purposes.  Subjects 
are not identified by name.  Data entry staff are expected to follow data protection practices.  
All procedures for the handling and analysis of data will be conducted using good computing 
practices meeting FDA guidelines for the handling and analysis of data for clinical trials. 
 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  
Those regulations require a signed subject authorization informing the subject of the following:  
 
 
1. 
What protected health information (PHI) will be collected from subjects in this study; 
2. 
Who will have access to that information and why; 
3. 
Who will use or disclose that information; and 
4. 
The rights of a research subject to revoke their authorization for use of their PHI. 
In the event that a subject revokes authorization to collect or use PHI, the Investigator, by 
regulation, retains the ability to use all information collected prior to the revocation of subject 
authorization.  For subjects that have revoked authorization to collect or use PHI, attempts 
should be made to obtain permission to collect at least vital status (i.e., that the subject is alive) 
at the end of their scheduled study period. 
 
 
The accountability procedure will consist of Pelex, Inc., the principal investigator and project 
team lead, respectively, being responsible for upkeep of the secured database and the only 
people with access, except for the IRB. The IRB will be allowed to access site, records, etc. 

 
  
 
 
 
7.3 Randomization and Blinding   
No randomization nor blinding will occur. 
7.4 Procedures for Study Closure 
7.4.1 
Routine study close-out 
The study will end when Pelex has obtained all data necessary to complete its studies of 
the test product. Study close-out will follow Pelex standard procedures and may include, 
but is not limited to, review of regulatory documents, collection of completed case report 
forms, reconciliation of study records, removal or destruction of ancillary study supplies, 
and informing the Investigator of remaining obligations (e.g., record retention, final 
report submission to the IRB, financial disclosure updates, etc.).  
7.4.2 
Suspension or premature termination of the study 
 
This study may prematurely terminate at any time because of a regulatory authority decision, 
a change in opinion of the IRB, or at the discretion of the Investigator or Sponsor. If this trial 
is temporarily suspended or prematurely discontinued, Pelex will promptly notify the 
Investigator(s) and provide instructions. If the study is temporarily suspended, Pelex will 
provide guidance on timing and procedures for resuming the study. If the study is prematurely 
discontinued, all study materials must be collected and all study forms completed to the extent 
possible. All such materials must be returned to Pelex upon request.  Reasons for termination 
of the study or a study site may include, but are not limited to, the following: 
 
● The risks and benefits of continuing the study have been reassessed, and the risks 
outweigh any potential benefits. 
● The incidence of AEs constitutes a potential health hazard to the subjects. 
● New scientific data do not justify a continuation of the study. 
● The investigator or study site exhibit serious and/or persistent non-adherence to the 
clinical study protocol and/or applicable regulatory requirements. 
● The Sponsor decides to terminate the study at any time for any other reason. 
 
8 DATA QUALITY ASSURANCE  
The study screening questionnaire, pre-study survey, post-use survey, and post-study survey 
are all forms requiring input from subjects. Pelex will endeavor to use electronic forms of 
data capture whenever possible. Possible forms of electronic data capture include Google 

 
  
forms and SurveyMonkey. These forms will be configured such that only Dr. Wiygul has 
access to the raw information in order to protect patient health information. 
While obtaining the informed consent, Dr. Wiygul will ask the subject whether she is able to 
use electronic data forms. In the event that the subject indicates that she is unable to use 
electronic data forms, then the study team will include a paper journal in the study package. 
The study package will be returned to Dr. Wiygul who will be responsible for converting the 
paper form to an electronic format, anonymizing the electronic version, and archiving or 
destroying the paper form. 
Beyond subject input, the study device are intended to collect physiological parameters and 
store this data on the device.  The data will be salvaged when the study materials are returned 
to the study team. The device data will only be stored using the anonymous subject identifier.  
Data stored on the device hardware that is returned to the study team will be recovered by Dr. 
Wiygul following a protocol that has been established with the primary device manufacturer, 
Arduino. Anonymized recovered data will be collectively stored in a password protected data 
server or database. The raw data will be backed up at least once to local storage. 
The data will be processed through reproducible measures, such as by writing start-to-finish 
code. When data processing is complete, this code will be applied to a copy of backed-up raw 
data to confirm the reproducibility of the analysis and integrity of the raw data. 
9 STATISTICAL METHODS 
9.1 Determination of Sample Size 
This study is exploratory and not designed to establish non-inferiority or superiority. 
Therefore, determining a sample size for the purposes of statistical significance is not 
necessary. 
9.2 Bias Minimization 
All subjects meeting the specified eligibility criteria will be enrolled on a first-come, first-
serve basis.  
9.3 Planned Analyses 
Specific study parameters to be analyzed will be the maximum pelvic floor contraction at 
study entry and exit, as well as maximum sustained contraction at study entry and exit.  
Objective clinical response to use of device in improving SUI symptoms will also be 
captured per the symptom questionnaires, which will be entered into an electronic record, 
and then all responses will be aggregated. 

 
  
10 ADVERSE EVENT REPORTING 
10.1 Non-Device-Associated Adverse Events 
Adverse events occurring during the enrollment period should be documented by the 
Investigator in progress notes, but will not be collected or analyzed by Pelex unless 
considered serious by the Investigator.  
 
Serious adverse events (SAEs) encountered during study enrollment will be documented by 
the Investigator and reported to Pelex immediately upon discovery. SAEs are defined under 
current Good Clinical Practice (cGCP) guidelines as events that result in one or more of the 
following: 
● life-threatening illness or injury;  
● permanent impairment of a body structure or a body function;  
● medically necessary in-patient hospitalization;  
● medical or surgical intervention necessary to prevent permanent impairment 
to body structure or function; or  
● fetal distress, fetal death, or congenital abnormality. 
 
10.2 Device-Associated Adverse Events  
10.2.1 
Definition of an unanticipated adverse device effect (UADE) event 
A UADE event, as defined by cGCP guidelines, is any SAE, life-threatening problem, or 
death caused by or associated with a device (or with the process of evaluating a device) if 
that SAE, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan or application (including a supplementary plan or 
application), or any other unanticipated, serious, device-associated problem that relates to the 
rights, safety, or welfare of subjects or operators using the investigational product system or 
the comparator product system. 
10.2.2 
Reporting of device-associated adverse events 
Any adverse event that results in serious injury or death and any type of unanticipated 
adverse device effect, regardless of seriousness or severity, must be reported to the 
Investigator once when site becomes aware of the event. Initial reports may be partial and 
should be updated as additional information becomes available. All unanticipated adverse 
device effects and all serious adverse events should be reported to the Investigator’s IRB in 
accordance with the IRB reporting requirements. 
 
SAEs will be reported using an Unanticipated Adverse Device Effects (UADE) form, which 
serves the dual role of capturing pertinent SAE information per industry guidelines and 
capturing device information pertinent to medical device standards. Other serious events that 
affect the rights, safety, or welfare of subjects must also be documented on the UADE form 
and must be reported immediately to Pelex and to the Investigator’s IRB according to that 
IRB’s policies. 

 
  
 
All SAEs that occur during the study period, whether considered to be related to the 
investigational product or not, will be reported within 24 hours of knowledge of the event to 
the sponsor contact below via an EDC notification. 
 
Although all information required for completion of an SAE report form may not be 
available within the specified time period, the following minimal initial information should 
be reported: Subject ID #, Site #, an identifiable reporting source name and contact 
information (e.g. investigator/study coordinator), which of the 6 SAE criteria identified 
above resulted in the event being deemed “serious”.  IRB reporting requirements may also 
apply for SAEs. 
 
 
10.3 Sponsor Contact for Serious Adverse Event Reporting 
Rohit Joshi 
718-404-7152 
rohit@pelex-med.com 
11 RISK ANALYSIS 
11.1 Potential Risks of the Investigational Product and 
Clinical Investigation 
Study device is currently seeking 510(k) approval with the FDA and has been identified as a 
non-significant risk medical device under FDA regulations and guidance documents, 
specifically Title 21 CFR 812.2(c). Importantly, subjects will experience no greater risk than 
that associated with standard pelvic floor muscle training plus biofeedback treatment.  
 
The types of risk associated with Pelex Upp align with those associated with biofeedback 
devices used for PFMT. These risks are all stated in the consent form.  
11.2 Potential Benefits of the Investigational Product and 
Clinical Investigation 
Subjects may benefit from this study through the possible improvement in their stress urinary 
incontinence symptoms. The benefits of the study will also be to the larger population of 
patients with stress urinary incontinence who would potentially benefit from a non-invasive 
device for usage at home in treatment of stress urinary incontinence. 
The studies made possible by the data collected in this study are expected to lead to 
confirmation of the clinical efficacy of biofeedback-augmented PFMT performed at home.  

 
  
11.3 Minimization of Risks 
Although the risk to subjects participating in the study is anticipated to be minimal, the 
clinician, at his/her discretion, will not collect data from those individuals for whom 
collection is judged to pose an unusually high risk of physical or mental harm or discomfort. 
 
Participation in this study poses no risk to study personnel other than that normally 
encountered during standard practice. These risks will be minimized by adherence to the 
following guidelines: 
 
● Personnel should wear appropriate personal protective equipment to avoid contact of 
the eyes or skin with hazardous materials or products derived from biological sources.  
12 INVESTIGATOR RESPONSIBILITIES 
12.1 Site Qualification and Study Oversight 
The PI is responsible for general administration of the study.  
Before the study, the PI must: 
● Obtain approval to conduct the study from the study site’s IRB; 
● Sign the Protocol PLX-001 Signature Page him/herself and have all sub-investigators 
sign the Protocol PLX-001 Signature Page and return it to Pelex; 
● Provide financial disclosures to Pelex for themselves and all sub-investigators 
participating in study conduct, per Title 21CFR 54 (see Section 12.4 below).  
 
During the study, the PI must ensure that: 
● The study is conducted ethically;  
● Case report forms (CRFs), including Subject ICFs, are provided with each transfer of 
data requiring informed consent; and 
● All other study forms are completed as instructed by Pelex. 
 
In the case of completion or termination of the study or an Investigator's role in the study, or 
at Pelex request, all study materials must be returned to Pelex. 
12.2 Case Report Forms/Electronic Data Records 
As used in this protocol, the term CRF should be understood to refer to either a paper form or 
an electronic data record or both, depending on the data collection method(s) used. 
 
Original CRFs are the sole property of Pelex and should not be made available in any form to 
third parties, except for authorized representatives of Pelex or appropriate regulatory 
authorities, without written permission from Pelex. 
 
It is the PI's responsibility to ensure completion, review, and approval of all CRFs. CRFs 
must be signed by the PI or by an authorized staff member. These signatures serve to attest 

 
  
that the information contained on the CRFs is true. At all times, the PI has final personal 
responsibility for the accuracy and authenticity of all clinical and laboratory data entered on 
the CRFs.  
12.3 Access to Source Documents 
Pelex or its agents and appropriate regulatory authorities shall be granted direct access to all 
study-related documents to perform verification that the protocol and all applicable current 
Good Laboratory Practices (cGLPs), Good Clinical Practices (GCPs), and regulations are 
being followed and to confirm that study documents are complete and accurate. It is 
important that Investigator(s) and their relevant personnel be made available during 
monitoring visits and any audits or inspections, and that sufficient time is allotted for the 
process.  
12.4 Financial Disclosure 
Investigators must provide Pelex with sufficient, accurate financial information in 
accordance with local regulations to allow Pelex to submit complete and accurate financial 
certification or disclosure statements to the appropriate health authorities. Investigators are 
responsible for providing information to Pelex concerning their relevant financial interests 
during the course of the study and for 1 year after completion of the study. Conflicts of 
interest should be disclosed as required by law.  
 
Financial support for this project is provided by Pelex, Inc.  Specifically, Pelex, Inc. is 
providing all investigational devices and device-associated materials, including instructional 
material.  Pelex, Inc will also provide all documentation for the study. 
12.5 Deviations from the Study Protocol 
An Investigator may not deviate from the study protocol without prior approval by Pelex 
unless the deviations are necessary under emergency circumstances to protect the rights, 
safety, or well-being of human subjects or the scientific integrity of the clinical investigation. 
These deviations must be documented and promptly reported to Pelex and, if applicable, to 
the IRB providing oversight of the study. Protocol deviations may result in corrective and 
preventive actions and/or disqualification of the Investigator. 
12.6 Record Retention 
To enable evaluations and/or audits from regulatory authorities or Pelex, the PI and all sub-
investigators agrees to retain all study records, including copies of all CRFs, UADE forms, 
and source documents, for 3 years following completion of the project dependent upon the 
study data. The Investigator must obtain the Pelex written permission before disposing of any 
records, even if retention requirements have been met. 
 
If an Investigator relocates, retires, or for any other reason withdraws from the trial, Pelex 
must be notified in advance, and study records must be transferred to a designee acceptable 
to Pelex. This designee might be another Investigator, another institution, or Pelex itself. 

 
  
12.7 Publication Policy 
The results of this study may be submitted for publication to a medical journal.  The PI 
agrees that any publication of data from this study will comply with Pelex publication policy, 
the instructions to authors outlined by the editor of the journal or conference proceedings 
where the data is to be published, and the spirit of recommendations made in the good 
publication practice guidelines (GPP3) of the International Society of Medical Publication 
Professionals. Pelex has the right to review any manuscripts, presentations, or abstracts that 
originate from this study or that utilize these data before they are submitted for publication or 
other means of communication.  
13 ETHICS AND COMPLIANCE 
13.1 Investigational Device Exemption 
Although exempt from IDE regulations as noted in Title 21 CFR 812.2(c), the conduct and 
performance of this study will be in accordance with applicable Sponsor and Investigator 
responsibilities as described in Title 21 CFR 809 and Title 21 CFR 812. 
13.2 Informed Consent and De-Identification  
Informed consent will be obtained in accordance with the Declaration of Helsinki, International 
Council for Harmonisation (ICH) guidelines for GCP, US Code of Federal Regulations (CFR) 
for Protection of Human Subjects (21 CFR 50.25[a,b], CFR 50.27, and CFR Part 56, Subpart 
A), and General Data Protection Regulation if applicable, and local regulations. All subjects 
for this study will be provided an informed consent form (ICF) describing this study and 
providing sufficient information for subjects to make an informed decision about their 
participation in this study. The consent form will be submitted with the protocol for review 
and approval by the IRB/EC for the study. A blank copy of the IRB/EC-approved form must 
be kept on-site and by the Sponsor and Investigator (see Attachment – Informed Consent 
Form). 
 
The ICF will be reviewed with the prospective study subject by the Investigator or qualified 
designee who will be available to answer questions about procedures, risks, and alternatives. 
Appropriate essential information will be provided, and the procedure fully explained, to allow 
the subject’s legal guardian to make an informed decision about study participation.  The 
subject will be informed that study participation is voluntary and the decision not to participate 
will not result in penalty and they can still receive standard of care.  If the subject consents, 
he/she and the qualified designee reviewing the consent will sign and date the IRB-approved 
paper ICF. The subject will receive a copy of the signed ICF. The original signed and dated 
ICF will be kept in the site’s regulatory file. Documentation of informed consent for 
participation in this trial will be noted in the subject’s medical record at the site.  
 
 

 
  
13.2.1 
Prospectively collected data 
All subjects will be given a copy of the IRB-approved ICF to review before their study 
participation begins. The Investigator will explain all aspects of the study in lay language and 
answer all of the potential participant’s questions regarding the study. If the participant 
decides to participate in the study, s/he will be asked to sign and date the ICF. Subjects who 
refuse to participate or who withdraw from the study will be treated without prejudice. 
13.3 IRB Review 
The PI is required to obtain IRB oversight of the research study. The IRB must be provided 
with the Pelex-approved study protocol. Performance of the study may not begin until written 
evidence of IRB approval has been provided to Pelex.  
 
The conduct and performance of this study will be in accordance with applicable Sponsor 
and Investigator responsibilities as described in Title 21 CFR 812 and other Good Clinical 
Practice guidance.  
 
IRB/Ethics Committee oversight will be required as human subjects or data from humans are 
being used. This protocol and the associated informed consent document(s) (if applicable) 
must be submitted to the IRB for review and approval. Performance of the study at a given 
site may not begin until written evidence of IRB oversight has been provided to Pelex study 
manager. IRB Review and approval must comply with Title 21 CFR 812 Subpart D. 
13.4 Confidentiality of Data and Patient Records 
The study institution shall keep all records associated with this study for at least 3 years, as 
specified in Section 12.6. Investigators will keep all records associated with this study for at 
least 3 years. 
13.4.1 Provisions to Protect the Privacy Interests of Participants 
The PI and/or study institution shall provide sufficient information to allow the IRB to 
evaluate the researcher’s provisions to maintain the confidentiality of data. 
 
Privacy data will be maintained in accordance with HIPAA and other applicable policies and 
local law.  
 

 
  
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