Pippa Fitness Pessary Device Effectiveness and Safety Study
Phase: NA
Conditions: Stress Urinary Incontinence
Sponsor: Liv Labs Inc.

 
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Clinical Investigational Plan 
 
Pippa Fitness Pessary 
Device Effectiveness and Safety Study 
 
Unique Protocol Identification Number: LL101 
National Clinical Trial (NCT) Identified Number: NCT05611970 
 
 
 
Sponsor:  
Liv Labs, Inc. 
332 S Michigan Ave 
Suite 121 # 5595 
Chicago, IL 60604 
 
www.livlabsfitness.com 
630-373-1471 
 
Funded by: NICHD 
Version: 5.0 
October 2, 2023 
 
 
 
 
The information contained in this document is  
confidential and proprietary property of Liv Labs, Inc.   
 

 
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Table of Contents 
Statement of Compliance 
6 
1 Protocol Summary 
7 
1.1 Synopsis 
7 
1.2 Schema 
9 
1.3 Schedule of Activities (SoA) 
12 
1.4 Subject Follow-up and Allowed Windows 
12 
2 Introduction 
13 
2.1 Study Rationale 
13 
2.2 Background 
14 
2.3 Risk/Benefit Assessment 
14 
2.3.1 Known Potential Risks 
14 
2.3.2 Known Potential Benefits 
15 
2.3.3 Assessment of Potential Risks and Benefits 
15 
3 Objectives and Endpoints 
16 
4 Study Design 
17 
4.1 Overall Design 
17 
4.2 Scientific Rationale for Study Design 
21 
4.3 End of Study Definition 
22 
5 Study Population 
23 
5.1 Inclusion Criteria 
23 
5.2 Exclusion Criteria 
23 
5.4 Screen Failures 
24 
5.5 Strategies for Recruitment and Retention 
24 
6 Study Intervention 
25 
6.1 Study Intervention(s) Administration 
25 
6.1.1 Study Intervention Description 
25 
6.2 Preparation/Handling/Storage/Accountability 
27 
6.2.1 Acquisition and accountability 
27 
6.2.2 Formulation, Appearance, Packaging, and Labeling 
27 
6.2.3 Product Storage and Stability 
27 
6.2.4 Preparation 
28 
6.3 Measures to Minimize Bias: Randomization and Blinding 
28 

 
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6.4 Study Intervention Compliance 
28 
6.5 Concomitant Medication 
28 
7 Study Intervention Discontinuation and Participant Discontinuation/Withdrawal 
28 
7.1 Discontinuation of Study Intervention 
28 
7.2 Participant Discontinuation/Withdrawal from the Study 
29 
7.3 Lost to Follow-Up 
29 
8 Study Assessments and Procedures 
30 
8.1 Effectiveness Assessments 
30 
8.2 Safety and Other Assessments 
30 
8.3 Adverse Events and Serious Adverse Events 
31 
8.3.1 Definition of Adverse Events (AE) 
31 
8.3.2 Definition of Serious Adverse Events (SAE) & Unanticipated Adverse Device Effect
 
31 
8.3.3 Classification of an Adverse Event 
32 
8.3.3.1 Severity of Event 
32 
8.3.3.2 Relationship to Study Intervention 
32 
8.3.3.3 Expectedness 
32 
8.3.4 Time Period and Frequency for Event Assessment and Follow-Up 
32 
8.3.5 Adverse Event Reporting 
33 
8.3.6 Serious Adverse Event Reporting 
33 
8.3.7 Reporting Events to Participants 
34 
8.3.8 REPORTING OF PREGNANCY 
34 
9 Statistical Considerations 
34 
9.1 Statistical Hypotheses 
34 
9.2 Sample Size Determination 
35 
9.3 Populations for Analyses 
36 
9.4 Statistical Analyses 
37 
9.4.1 General Approach 
37 
9.4.2 Analysis of the Primary Effectiveness Endpoint(s) 
37 
9.4.3 Analysis of the Secondary Endpoint(s) 
37 
9.4.4 Safety Analyses 
37 
9.4.5 Baseline Descriptive Statistics 
37 
9.4.6 Planned Interim Analyses 
38 

 
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9.4.7 Sub-Group Analyses 
38 
9.4.8 Tabulation of Individual Participant Data 
38 
9.4.9 Exploratory Analyses 
38 
10 Supporting Documentation and Operational Considerations 
38 
10.1 Regulatory, Ethical, and Study Oversight Considerations 
38 
10.1.1 Informed Consent Process 
38 
10.1.1.1 Consent/assent and Other Informational Documents Provided to participants 39 
10.1.2 Study Discontinuation and Closure 
39 
10.1.3 Confidentiality and Privacy 
39 
10.1.4 Future Use of Stored  Data 
40 
10.1.5 Key Roles and Study Governance 
41 
10.1.6 Safety Oversight 
41 
The sponsor will contact the independent medical reviewer, to assist in assessing any safety 
concerns, if needed. The Investigator should be able and willing to provide further 
information on the specific event when requested by the study Sponsor. Details on the roles 
and responsibility of the medical monitor can be found in the Medical Monitoring Plan. 
10.1.7 Clinical Monitoring 
41 
10.1.8 Quality Assurance and Quality Control 
41 
10.1.9 Data Handling and Record Keeping 
41 
10.1.9.1 Data Collection and Management Responsibilities 
41 
10.1.9.2 Study Records Retention 
42 
10.1.10 Protocol Deviations 
42 
10.1.11 Publication and Data Sharing Policy 
42 
10.1.12 Conflict of Interest Policy 
43 
10.3 Abbreviations 
44 
10.4 Protocol Amendment History 
44 
11 Appendices 
45 
Appendix A – Instructions for Use 
45 
Appendix B – Screeners and Questionnaires 
47 
Appendix C – Pad Weight Test Preparations Worksheet 
57 
Appendix D – Pre-Enrollment Clinic Visit Invitation 
59 
Appendix E – Study Participant Guide 
60 
Appendix F – 21-Day Leakage Episodes Record 
65 
Appendix G – Daily Communications 
66 

 
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STATEMENT OF COMPLIANCE 
 
The trial will be carried out in accordance with International Council on Harmonisation Good Clinical 
Practice (ICH GCP) and United States (US) Code of Federal Regulations (CFR) applicable to clinical studies 
(21 CFR Part 50, 21 CFR Part 54, 21 CFR Part 56, and 21 CFR Part 812). 
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are responsible 
for the conduct, management, or oversight of NIH-funded clinical trials have completed Human Subjects 
Protection and ICH GCP Training. 
 
The protocol, informed consent form, recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval prior to use. Approval of both the protocol and the 
consent form must be obtained before any participant is consented. Any amendment to the protocol 
will be reviewed and approved by the IRB, if needed, before the changes are implemented to the study. 
All changes to the consent form(s) will be IRB approved; a determination will be made regarding 
whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form. 
 
I agree to ensure that all staff members involved in the conduct of this study are informed about their 
obligations in meeting the above commitments. 
 
Principal Investigator:   
 
Name of Investigator (printed) __________________________ 
 
Signed _____________________________________ 
 
Date: ______________________________________ 
 

 
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1 PROTOCOL SUMMARY 
1.1 SYNOPSIS  
 
Title: 
Pippa Fitness Pessary Device Effectiveness and Safety Study  
Short Title: 
Pippa Pessary Study 
Study Description: 
This is an open label, interventional, single arm, multi-clinic study where each 
adult female participant with stress urinary incontinence (SUI) serves as her 
own control (vaginal pessary use vs. no vaginal pessary).  Approximately 90 
adult women with stress urinary incontinence from 3 distinct clinics in 
ethnically and economically diverse settings will be recruited for the study. 
Participants will undergo clinical assessments, comparative pad weight testing 
(with and without intervention), and at-home device use (as compared to a 
control phase without device use). This study is deemed non-significant risk 
and this status has been confirmed with FDA. 
Objectives: 
The overall objectives of this clinical study are to demonstrate the 
effectiveness and safety of the Pippa Fitness Pessary (device) when self-
administered and used in a home environment.  Specifically, this study will 
evaluate the effectiveness of the Pippa Fitness Pessary by assessing reduction 
in urine leakage in approximately 57 women with SUI.  Up to ninety women 
will be recruited to ensure that leakage reduction can be assessed in 
approximately 57 women. Effectiveness will be assessed by percentage 
reduction in 1-hour pad weight gain, reduction of stress urinary incontinence 
episodes per day, and a quality-of-life questionnaire. The safety of the Pippa 
Fitness Pessary will be evaluated by assessing all adverse events, including the 
results of urinalysis and vaginal examination. 
 
Primary 
Objectives: 
The primary objectives are to demonstrate 
safety of the Pippa Fitness Pessary for over the 
counter (OTC) use and effectiveness of the Pippa 
Fitness Pessary in reducing urinary leakage 
and/or frequency of leakage episodes. 
Secondary 
Objectives: 
The secondary objective is to demonstrate 
improved quality of life. 

 
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Endpoints: 
Primary 
Effectiveness 
Endpoint: 
Composite endpoint consisting of >50% reduction in 
urine pad weight gain in 1-hour pad weight test 
and/or >50% reduction in mean daily episodes of leak 
episodes (pre/post pessary use). 
Primary Safety 
Endpoint: 
Collection and evaluation of all adverse events, 
analyzed by seriousness, severity and device-
relatedness, including the results of urinalysis and 
vaginal examination. 
Secondary 
Endpoints: 
Change in Quality of Life as Measured by the IIQ-7 
Questionnaire.  
 
Study Population: 
Approximately 90 women will be recruited, ages 18 and up, who suffer from 
objectively-diagnosed Stress Urinary Incontinence (SUI); have a >3 month 
history of experiencing more than 3 episodes of SUI per week; and have not 
been diagnosed with any other form of urinary incontinence. 
Phase: 
Pivotal trial (non-significant risk status) 
Description of 
Sites/Facilities  
Enrolling  
Participants: 
The study will be conducted at 3-6 clinical centers within the United States, 
that specialize in treating SUI. Investigators will be selected based on training 
and experience in Female Pelvic Medicine and Reconstructive Surgery. The 
centers will be geographically distinct to allow access to a verity of ethnic and  
socio-economic populations.  
Description of  
Study Intervention: 
A reusable vaginal pessary for stress urinary incontinence worn daily. 
Endpoint Classification:   Effectiveness and Safety Study 
Interventional Model:      Single Group, Open Study 
Masking:                             Open Label 
Primary Purpose:              Effectiveness and Safety 
Study Duration: 
8 - 18 months 
Participant Duration: 
< 4 weeks of activity      
 
 
 
 
 

 
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1.2 SCHEMA 
 
 
Figure 1.: Clinical Trial Schema 
 
 
Recruiting 
New patient study candidates will be recruited through physician referral, flyers, and 
web posting that may be shared across social networks. Existing patients will be 
contacted by the clinical team at the sites. 
Pre-Assessment 
New patient study candidates will be pre-screened via the web for self-reported 
frequency and likely stress urinary incontinence, based on the Three Incontinence 
Questions questionnaire (3IQ). If responses suggest SUI with leaking episodes at least 
three times weekly, or if the candidate is an existing patient whose symptoms are 
known, an appointment will be scheduled for informed consent.  
 

 
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Informed Consent 
Potential Study candidates will be consented using the process described in Section 
10.1.1. of this protocol.  Potential study candidates may be consented electronically if 
site has current access to a 21 CFR part 11 compliant platform.   
1-Hour Baseline Pad Weight Test (PWT1,2 ) 
Study candidates will execute a standardized 1-hour baseline PWT in a telehealth visit 
staffed by a licensed healthcare provider (such as a Doctor of Physical Therapy or a 
Registered Nurse) who has been trained on the study protocol and certified in Good 
Clinical Practice (GCP). Incontinence pads used in the test will either be provided at the 
consenting visit or express shipped to the study site for blinded weighing and collection 
of baseline pad weight data. If results indicate at least mild incontinence (pad weight 
gain of >1g3), the study candidate will be invited to the clinic for an in-person 
assessment.  
Clinical Assessment 
The in-person clinic visit will include 1) obtain and document medical history, 2) conduct 
a Cough Stress Test (CST) to confirm an SUI diagnosis, 3) perform a vaginal examination 
and symptom evaluation to ensure the participant has no active urinary or vaginal 
infection requiring treatment, 4) perform lab tests (urine culture, urinalysis and, for 
women of childbearing potential, a pregnancy test), 5) screen potential participants by 
remaining inclusion and exclusion criteria, and 6) perform human factors and fit 
assessments. 
Enrollment 
Results of the clinical assessment will determine who may be formally enrolled in the 
study. The SUI diagnosis assessment and fit assessment may deem the participant 
ineligible for enrollment due to a diagnosis of urgency urinary incontinence or mixed 
(stress and urgency) urinary incontinence or inadequate pessary fit. To simulate OTC 
use, study candidates will be asked to perform self-selection and assess device fit based 
on the product labeling (prior to confirmation by the PI). 
 
Nota bene: Results of the laboratory tests from the screening visit (any pregnancy test, 
vaginal examination, urine culture and urinalysis) may deem a participant ineligible for 
enrollment due to positive pregnancy result, positive vaginal infection requiring 
treatment, or positive urinary infection requiring treatment, respectively. Thus, due to a 
laboratory test result, a provisionally enrolled study participant may need to be treated 
for infection and retested after a period of recovery, or she may need to be disenrolled 
from the study. 
 
1P. Abrams, J.G. Blaivas, S.L. Stanton, J.T. Anderson. The standardization of terminology of lower urinary tract function. Scand J 
Urol Nephrol Suppl, 1988, 114:5-19. 
2A. Tubaro, W. Artibani, C. Bartram, et al., “Imaging and other investigations,” in Incontinence: Basics and Evaluation, edited by 
P. Abrams, L. Cardozo, S. Khoury, and A. Wein A., vol. 1, Paris: Health Publication Ltd., 2005, pp. 775. 
3Ibid, pp. 779. 
 

 
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Questionnaires 
Consented study participants will complete several surveys including: a baseline Quality 
of Life Questionnaire (IIQ-7), Patient Global Impression of Severity (PGI-S),  the 
Questionnaire for Urinary Incontinence Diagnosis (QUID), and the Pelvic Floor Disability 
Index (PFDI-20).  After completing these surveys, study participants will be provided 
with materials for the in-home portion of the study. 
Start Study 
Enrolled study participants will receive for home use: a Study Participant Guide; a 
packaged Pippa Fitness Pessary kit (two differently sized pessaries, one applicator, and 
Instructions for Use); water-based lubricant; water-based cleanser; and a 1-Hour 
Treatment Pad Weight Test kit. They will be given an opportunity to ask questions and 
provided with a number to call as needed, throughout the study. For women of child-
bearing potential, the study may be scheduled to not overlap with menstruation, 
according to the preference of the study participant. 
7-Day Control Phase 
Study participants will perform the control phase of the study at home. They will track 
leaking episodes for 7 consecutive days. During this time, they will go about their 
normal daily routines and will use no treatments or interventions (neither the 
investigational Pippa Fitness Pessary nor any other leak preventative). Study participants 
will receive daily text message reminders to track their leak episodes.  
14-Day Treatment Phase 
Study participants will begin using the investigational Pippa Fitness Pessary in the 
second week of the home use study. Participants will be instructed to wear the device 
during waking hours, but to remove and clean it before bedtime. Study participants will 
receive a daily text message reminder to wear their Pippa Fitness Pessary and track their 
leak episodes.  
1-Hour Treatment Pad Weight Test 
After using the Pippa Fitness Pessary for two weeks, study participants will complete the 
1-Hour Treatment Pad Weight Test in a televisit staffed by a licensed healthcare 
provider who has been trained on the study protocol and certified in Good Clinical 
Practice (GCP). The test will be identical to the baseline test, except that the study 
participant will perform the test while wearing the investigational device.  
Final Clinic Visit 
The final clinic visit will take place after the in-home protocols have been completed. 
The device and associated materials will be collected from participants. The visit will 
include final safety evaluation via vaginal examination and urinalysis. Study participants 
will repeat the Pelvic Floor Disability Index (PFDI-20), Quality-of-Life Questionnaire (IIQ-
7), Patient Global Impression of Severity (PGI-S), and the Questionnaire for Urinary 
Incontinence Diagnosis (QUID). Participants will also complete the Patient Global 
Impression of Change (PGI-C) and surveys measuring user satisfaction and likelihood to 

 
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recommend the device. Participants will undergo an exit interview and provide written 
comments.  
1.3 SCHEDULE OF ACTIVITIES (SOA) 
 
Procedure 
Screening 
(2 hrs) 
Day 1 
(1 hr) 
Days 2-8 
(1 wk) 
Days 9-23 
(2 wks) 
Day 24 
(1 hr) 
Final Visit 
Day 25 
(1 hr) 
Recruitment 
X 
 
 
 
 
 
Questionnaires/ Survey 
- 3IQ 
- Severity self pre-screening 
- Inclusion criteria self pre-screening 
X 
 
 
 
 
 
Informed Consent 
X 
  
  
  
 
 
1-Hour PWT 
X 
 
 
 
X 
 
Demographics 
X 
  
  
  
 
 
Medical History 
X 
  
  
  
 
 
Physical Exam 
X 
  
  
  
 
X 
Urinalysis 
X 
  
  
  
 
X 
Pregnancy Test (if needed) 
X 
 
 
 
 
 
Cough Stress Test 
X 
  
  
  
 
 
HF & Fit Assessments 
X 
  
  
  
 
 
Concomitant Medications Case Report Form 
(ConMeds CRF) 
X 
 
 
 
 
X 
Pre-Study Questionnaires 
- PGI-S 
- QUID 
- IIQ-7 
- PFDI-20 
 
 X 
  
  
 
X 
Leak Tracking w/o Pessary  
 
  
X 
 
 
 
Leak Tracking w/Pessary 
 
 
 
X 
 
 
Post-Study Questionnaires 
- PGI-C 
- PGI-S 
- QUID 
- IIQ-7 
- PFDI-20 
- Likelihood to recommend 
- User satisfaction 
- User experience 
- Observational study interest 
 
 
 
 
 
X 
Exit Interview 
 
  
  
  
 
X 
Adverse Event Collection 
 
 X 
 X 
 X 
X 
X 
Complete CRFs 
 
 X 
 X 
 X 
X 
X 
1.4 SUBJECT FOLLOW-UP AND ALLOWED WINDOWS 
 

 
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Study-related follow-up assessments occur between Study Days 2-8, Days 9-23, and at 
Study Exit (Day 25), with windows shown below. The study’s schedule of assessments is 
shown above in section 1.3. 
Follow-Up Contact 
Allowed Window 
Control Phase Follow-Up* 
Day 2-8 
Treatment Phase Follow-Up* 
Day 9-23 
Day 24 - Treatment PWT 
Day 22-25 
Final Clinic Visit 
Day 25-30 
*Phone follow-up. 
** If day lands on a weekend or holiday, the subject may be scheduled on the next business day. 
2 INTRODUCTION 
2.1 STUDY RATIONALE 
 
This study seeks to evaluate the effectiveness and safety of the Pippa Fitness Pessary, a pessary 
intended for temporary management of urine leakage caused by stress urinary incontinence (SUI) in 
women, 18 years and older. The study design has been guided by a review of the literature and co-
authored by subject matter experts engaged in daily clinical care and numerous clinical research studies 
of the study population. 
 
SUI can present as a daily concern or, for many women, only in the context of specific physical activities, 
be they chosen (as with jogging) or involuntary (as with a sneeze). The Pippa Fitness Pessary is designed 
to be self-managed and used on an as-needed basis, i.e.: for a trip to the gym, during a hike, or all-day. 
Thus, effectiveness must justify the per-use effort. Although dryness is the logically ideal outcome, some 
women may find leak reduction meaningful.  
 
The selection of a within-subject pad weight study design aligns with the intended use of the device as a 
situational self-treatment option for women with varying degrees of symptom severity. The primary and 
secondary endpoints incorporate both objective measures of leak reduction and a validated quality-of-
life assessment. The statistical analysis plan of safety and effectiveness draws upon available data from 
testing of a predicate pessary device (Revive, K183468). 
 
The recruitment of adult women with suspected SUI will involve three distinct, geographically-dispersed 
clinics, enabling recruitment of a diverse study population. The sample size for the study (recruiting up 
to 90 participants to meet a goal of 57 completions) is based on power calculations with summary data 
from predicate studies.  
 
Finally, the safety analysis for this study will include results of urinalysis, vaginal examination, and 
evaluation of adverse events, as is recommended in the FDA Guidance (Guidance for Industry and Food 
and Drug Administration Staff -- Clinical Investigations of Devices Indicated for the Treatment of Urinary 
Incontinence (Issued March 8, 2011).   
 

 
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The protocol utilizes daily digital reminders that should improve the accuracy of participants’ self-report 
on leaking episodes, adherence to the study protocol, and the reporting of any adverse events. 
2.2 BACKGROUND 
 
Urinary incontinence is a common issue for women. It is estimated that one in three women leak urine 
involuntarily, and that approximately 25 percent of women will seek medical advice for the condition at 
some point, typically after suffering with it for several years. The most common form of incontinence is 
stress urinary incontinence (SUI). SUI is the involuntary leaking of urine that occurs during exercise, 
sneezing, coughing, and laughing. During these activities, the abdominal muscles apply pressure to the 
bladder and urethra, and a combination of weakened pelvic floor muscles and urethral hypermobility 
allows urine leakage to occur. Stress incontinence affects adult women, particularly after vaginal 
childbirth when the muscles of the pelvic floor are stretched and weakened. Other causes include aging 
into menopause, high-impact sports, chronic cough and obesity.  
 
Market research suggests that most women manage their SUI day-to-day with a combination of activity 
avoidance and incontinence pads. Too often women who do seek medical treatment only consider 
surgery, discounting the restorative potential of physical therapy and shying away from vaginal 
pessaries. Physician-inserted, prescription-only fitted pessaries, while proven effective and safe, are 
inconvenient to maintain because they require both clinicians and patients to engage in an indefinite 
routine of follow-up visits. Many physicians are reluctant to recommend fitted pessaries for this reason.    
 
Women suffering from SUI lack direct access to an Over-the-Counter (OTC) pessary that can be reused 
without replacing at least one component.  Currently marketed OTC pessaries are either disposable after 
a single use or include disposable components that may only be used once. All such devices include a 
cotton string for device retrieval. The multi-use device requires that any old string be removed, and a 
new cotton string be threaded and attached by the user, for each instance of device re-use.  A significant 
number of adverse events reported in the FDA’s MAUDE database relate to breakage of the string and 
the subsequent need for professional medical attention to remove the pessary. 
 
The Pippa Fitness Pessary was designed to address barriers to pessary trial, adoption, and use. It is 
intended to offer users device effectiveness and safety that is on par with currently marketed OTC 
disposables, in a handy, fully reusable, engineered form without the need to change a string, that both 
patients will find comfortable and that doctors will find credible. 
2.3 RISK/BENEFIT ASSESSMENT 
2.3.1 KNOWN POTENTIAL RISKS 
 
Potential risks include the following short-term risks: 
● 
Sensitivity to the materials used in the device; however, the probability is low due to the high 
purity, medical-grade silicone in use and testing demonstrating biocompatibility of the device 
● 
Irritation to the vaginal area, cramping or other discomfort 

 
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● 
Vaginal bleeding/spotting or excess discharge 
● 
Urinary Tract Infection (UTI) 
● 
Vaginal infection 
● 
Toxic Shock Syndrome (TSS) 
● 
Urine retention 
● 
Infection if the device is not used as indicated 
● 
Breach of confidentiality 
 There are no known long-term risks associated with this study. 
2.3.2 KNOWN POTENTIAL BENEFITS 
  
Patients undergoing successful intravaginal pessary treatment for SUI have been shown to have 
improvement in quality of life, so long as the device is being used. The quality of life improvement seen 
in patients undergoing successful SUI treatment include physical mitigation of symptoms which results 
in potential increase in social interaction, increased confidence, reduced anxiety, and increase in 
physical activity. 
 
Non-surgical treatment options are important to the subject population. SUI device interventions that 
demonstrate effectiveness and safety could significantly improve the quality of life for a condition that 
most patients do not like to discuss, even with their physicians. Surgical options are typically used as a 
last resort. For this reason, the potential benefits associated with this study outweigh the risks involved. 
 
The potential benefits to participants during this study include treatment of their SUI, increased quality 
of life, increased social activity (including exercise), psychological improvement, and increased 
confidence due to decreased urinary leakage. 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
 
The risk profile of the Pippa Fitness Pessary (investigational device) is considered to be low. Risks to 
participants in this study are comparable to those routinely encountered with using commercially 
available vaginal pessaries. 
 
The device is not intended as an implant or for use in supporting or sustaining human life and does not 
present serious risk to the health, safety, or welfare of a subject.  Thus, this study is a non-significant risk 
study under the criteria in 21 CFR 812.3(m). In a meeting with FDA regarding the proposed study, FDA 
stated agreement that the study qualified as a non-significant risk device study.  
 
The materials used in the manufacturing of this device are medical-grade. During the screening process, 
a vaginal examination and urinalysis will be performed to rule out vaginal infection or UTI, respectively. 
For pre-menopausal women of childbearing potential, a urine pregnancy test will be administered. The 
device will be tested at the screening visit to ensure fit. Each of the participants will receive an 

 
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identification number during enrollment. This number will be the only identifying information on the 
Case Report Form. The PI will maintain the participant information in a secure location. The Sponsor 
shall have access to the study data after it has been de-identified to analyze the data to determine the 
success of the study. Patient names will only be seen during monitoring by the study sponsor or 
inspections by regulatory authorities. 
 
Each of the devices used in this study will be labeled “Caution: Investigational device. Limited by United 
States law to investigational use”. If manufacturing lots differ for the study devices, this will be recorded. 
 
Patients undergoing successful intravaginal pessary treatment for SUI have been shown to have 
improvement in quality of life. The quality-of-life improvement in patients undergoing successful SUI 
treatment with an intravaginal pessary include mitigation of physical symptoms (leaking) which result in 
potential social and psychological benefit. Successful pessary treatment for SUI could also lead to 
greater ability to enjoy exercise and increased confidence due to decreased urinary leakage. The 
potential benefits to participants thus outweigh potential risks. 
3 OBJECTIVES AND ENDPOINTS 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
Effectiveness of the device in 
reducing urinary leakage in adult 
women with SUI 
- 
percentage reduction in 1-
hour pad weight gain 
- 
reduction of episodes of 
incontinence 
 
 
Safety for over the counter 
(OTC) use 
A composite primary endpoint 
comprising of subjects achieving 
>50% reduction in pad weight gain 
and/or achieving 50% reduction in 
episodes of leaking - treatment vs. 
control  
 
Collection of all adverse events, 
analyzed by seriousness, severity 
and device-relatedness, including 
the results of urinalysis, and vaginal 
examination 
Reviewed with FDA  
Secondary 
Demonstrate improved quality  
of life 
Reduction in scores on the IIQ-7 
from control by > 3.7. 
Use of IIQ-7 conforms to 
FDA guidance  

 
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4 STUDY DESIGN 
4.1 OVERALL DESIGN 
 
The purpose of the pivotal study is to gather clinical data to support applications for marketing 
authorization from the U.S. FDA and regulatory health agencies outside the U.S., with the objectives of 
evaluating the effectiveness and safety of the Pippa Fitness Pessary in a home environment, comparing 
standardized 1-hour baseline and treatment pad weight studies as well as reduction in leaking episodes 
during 7 days at home without use of the Pippa Fitness Pessary to 7 days at home with use of the Pippa 
Fitness Pessary (within the 14-day period of device use). This is an open label, interventional, single arm, 
multi-clinic study where each adult female participant with stress urinary incontinence (SUI) serves as 
her own control (vaginal pessary use vs. no vaginal pessary). Up to 90 adult women with stress urinary 
incontinence served by 3 distinct clinics in ethnically and economically diverse settings will be recruited 
for the study so that treatment may be evaluated in approximately 57 women.  
The study will comprise three distinct elements: 
1. Clinic Visits: to evaluate patient health, confirm SUI diagnosis, confirm eligibility via inclusion 
and exclusion criteria, assess human factors and device fit, collect baseline and treatment 
data on symptom severity, urinary symptom distress, daily life impact, and user experience; 
and 
2. Comparative Pad Weight Testing (with and without intervention): to establish objective data 
on device effectiveness using a standardized method; and 
3. At-Home Device Use (compared to a control phase): to establish objective data on device 
effectiveness under realistic conditions that will vary by study participant. 
The study will follow a standardized process for each participant lasting 4-5 weeks from recruitment 
to participant completion, as follows: 
 
Pre-Assessment Process 
Recruiting materials will provide links to an online survey. Interested participants who are not existing 
patients will first be screened for likelihood of study eligibility. If a candidate’s responses suggest 
eligibility, she will be provided with summary information about the study and scheduled for informed 
consent. 
 
Informed Consent Process 
Voluntary informed consent will be given by every study candidate prior to the initiation of any study-
related procedures. The Investigator/designee will explain the study to each study candidate and they 
must indicate voluntary consent by signing and dating the approved informed consent form. The 
Investigator must provide the study candidate with a copy of the consent form in a language the 
participant understands. The Investigator will maintain documentation that informed consent was 
obtained prior to the initiation of any study-specific procedures.   
 
1-Hour Baseline Pad Weight Test 

 
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Consented study candidates will execute a 1-Hour Baseline Pad Weight Test at a telehealth visit with a 
healthcare provider based on guidelines developed by the International Continence Society (ICS)4. Study 
participants will follow a timed process that includes emptying their bladders, drinking 500 milliliters of 
water, resting, walking, climbing up and down a flight of stairs, and performing a set of physical activities 
as follows:  
● 
Standing up from sitting (10 times) 
● 
Jumping jacks (10 times) 
● 
Picking up a small object from the floor (5 times) 
● 
Running in place (1 minute) 
● 
Low-hopping in place (20 seconds) 
● 
Coughing vigorously while sitting (10 times) 
 
Test facilitation will be standardized across study sites by means of tools, training, and practice. Study 
participants will wear activity trackers to enhance comparative data analysis. 
 
Study participants will be provided an initial pad weight test kit. It will include: 
● a reusable water bottle with a 500 mL marking;  
● an activity tracking device with digital display; 
● two (2) incontinence pads bagged in odor- and leak-proof, resealable 4 mil zipper bags that have 
been pre-labeled and pre-weighed for de-identified data collection; and 
● a pre-addressed, postage-paid FedEx return mailer suitable for shipping exempt human 
specimens.  
 
Healthcare providers conducting each session will use the following standardized tools: 
● a facilitation guide for the complete session, and 
● a data collection tool for recording test participant behavior. 
 
Upon completing the PWT, study candidates will return-ship the used and re-bagged incontinence 
pad(s), and the activity tracking device in a provided FedEx mailer. Incontinence pads used in the test 
will then be weighed and baseline pad weight data recorded at the clinical sites. If a candidate meets the 
baseline inclusion criteria for SUI and severity, an appointment will be made for her to come to the clinic 
for the clinical stage of assessment. The appointment will be timed to avoid a menstruating study 
candidate’s monthly cycle. 
 
Clinical Assessment & Enrollment 
Consented study candidates will be evaluated in clinic for the purposes of confirming a diagnosis of SUI 
and for ensuring proper fit of the Pippa Fitness Pessary.  The procedure is outlined below in Figure 2. 
 
4Krhut J, Zachoval R, Smith PP, Rosier PF, Valanský L, Martan A, Zvara P. Pad weight testing in the evaluation of urinary 
incontinence. Neurourol Urodyn. 2014 Jun;33(5):507-10. doi: 10.1002/nau.22436. Epub 2013 Jun 24. PMID: 23797972. 
 

 
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       Figure 2. Protocol for the in-clinic SUI diagnosis, human factors, and device fit procedures. 
  
Human Factors and Fit Assessments:  As part of the screening process, and following a positive diagnosis 
of SUI using a CST,5 a human factors assessment will be performed, followed by a fit assessment. The 
human factors portion will assess self-administration and device placement accuracy. Proper device fit 
will be evaluated first through study candidate perception and then through expert confirmation by a 
clinician. 
  
Self-Administration Assessment:  Each study candidate will be provided with a packaged Pippa Fitness 
Pessary kit and instructed to proceed as she would at home. She will be further instructed to inform the 
clinician when she believes she has finished the process. The study candidate will perform self-selection 
and device self-administration using only the labeling and without any training by study staff. She may 
or may not remove and reinsert the first selected Pippa Fitness Pessary. She may or may not swap out 
the first selected Pippa Fitness Pessary for the other one. The observing clinician will document any 
issues with device assembly, insertion, and removal. Once the study candidate announces she has 
finished the process, the clinician will elicit the candidate’s feedback on perceived fit. The study 
candidate will then remove the device without clinician assistance. If the study candidate chooses on 
 
5The cough stress test (CST) is recommended in the evaluation of female patients to identify the signs of SUI and is used as an 
outcome measure following SUI treatment. The patient coughs and is observed for urine loss synchronous with the cough. If 
the patient leaks with the onset of the cough and terminates with its cessation, the test is positive and confirms the presence of 
SUI. The International Continence Society (ICS) has provided guidance on the CST with the introduction of the ICS Uniform 
Cough Stress Test (ICS-UCST), and an ICS education module has been developed to standardize the performance and reporting 
of the CST used in the clinical and outcome assessment of women with urinary incontinence.  When compared with 
multichannel urodynamic evaluations, the CST demonstrates good sensitivity and specificity for SUI.  
https://onlinelibrary.wiley.com/doi/epdf/10.1002/nau.23519# 
 

 
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her own to try the other Pippa Fitness Pessary, she will again be asked to provide feedback regarding her 
perception of fit.   
  
Proper Fit Assessment: If the study candidate does not think either device fits, she will be excluded from 
the study. Otherwise, she will be instructed to reinsert the Pippa Fitness Pessary she prefers, again 
without assistance. The clinician will then verify proper device placement and confirm fit. In the absence 
of confirmed fit, the study candidate will be excluded from the study. If the study candidate has passed 
all other inclusion and exclusion screens, then proper fit of the Pippa Fitness Pessary will confirm the 
candidate’s eligibility for the home-based study, and she will be enrolled.  
 
Start Study 
Enrolled study participants will complete three questionnaires to provide baseline symptom severity, 
urinary symptom distress, and daily life impact data. These questionnaires are the validated 
Questionnaire for Urinary Incontinence Diagnosis (QUID), the Incontinence Impact Questionnaire Short 
Form (IIQ-7),  Patient Global Impression of Severity (PGI-S), and the Pelvic Floor Disability Index (PFDI-
20). They will then be provided with all at-home study materials.  
 
Home-Based Study Protocol 
Enrolled study participants will be sent home from the clinic with a Pippa Fitness Pessary Kit, a PWT kit 
and a Study Participant Guide. In broad strokes, the home-based study will include one week of 
monitoring urine leakage episodes during normal routines (the 7-day control phase) and two weeks of 
monitoring urine leakage episodes during normal routines and while wearing the investigational device 
(the 14-day treatment phase).  Reminders will be sent by text message every morning and evening.   
 
Week 1 will constitute the control phase and will require participants to simply go about their ordinary 
lives. Twice-daily (morning and evening) text messages will be sent to each subject to remind her to 
track her leaks, which will be the only study task for this phase.  
 
Weeks 2 and 3 together are the treatment phase and will require participants to wear the Pippa Fitness 
Pessary during waking hours, while going about their ordinary lives. Daily reminders by text message will 
continue throughout the 14-day period. 
 
1-Hour Treatment Pad Weight Test 
A telehealth visit will be scheduled with a healthcare provider after week 3 to repeat the original pad 
weight test, but with investigational device treatment. Each study participant’s actual baseline test 
activity will have been documented and retained for reference. To ensure comparable within-subject 
baseline vs. treatment test conduct, any modification for participant ability will be replicated. (For 
example, if a participant ceases running in place at 45 seconds in the baseline test, she will only be asked 
to run in place for 45 seconds on the treatment test.) As before, this test requires the study participant 
to return-ship the pad weight test materials via FedEx for pad weight data collection and analysis by the 
centralized research team.  
 
Final Clinic Visit 
After completing the period of treatment, participants will return to the clinic with the Pippa Fitness 
Pessary (for subsequent reconciliation against Device Accountability Logs by the Site Monitor and 
disposed of per the site’s biohazard protocol). Participants will be debriefed with the same four 

 
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validated questionnaires used in the pre-study period, namely:  QUID, IIQ-7, PFDI-20 and PGI-S. 
Additionally, they will complete the Patient Global Impression of Change (PGI-C); a user experience 
satisfaction questionnaire; a likelihood to recommend question; an open-ended request for any 
additional comments; and a brief exit interview. 
 
4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
This study is an interventional, open label, single-arm, clinical study in which participants will serve as 
their own controls. This study will enroll participants deemed eligible per the Inclusion/Exclusion Criteria 
listed.  These criteria were informed by relevant FDA guidance and predicate device studies.  
 
This study will evaluate the effectiveness of the Pippa Fitness Pessary (device) by assessing percentage 
reduction in urine leakage and/or frequency in approximately 57 women with SUI (up to 90 will be 
recruited). Effectiveness will be assessed by percentage reduction in 1-hour pad weight gain, frequency 
of stress urinary incontinence episodes, and a quality-of-life questionnaire.  
 
We used a precision approach to determine the appropriate sample size and power for the study. For 
our primary composite endpoint (>50% reduction in pad weight gain on the 1-hour pad weight test 
and/or on mean daily leak reports) we estimated a response rate of at least 70% based on our own 
earlier work and on the Poise Impressa study (Ziv et al.). With the desired precision of this estimated 
response rate set to 0.10 and a confidence level of 0.90, the estimated sample size would be 57. 
 
For the primary composite endpoint, the null hypothesis is that the responder proportion (percentage of 
participants with >50% reduction in pad urine weight and/or >50% reduction in mean daily number of 
leakage events) is <=70%. The alternative is that it is >70%. 
 
For the analysis of our primary composite outcome, the dichotomous subject success in 
pad leakage reduction of greater than 50% and/or a reduction in mean daily leakage episodes greater 
than 50%, a binomial proportion test will be used. In analyzing the individual components, a comparison 
of the mean percent reduction in leakage compared to zero will be performed using a 1-sample t test. 
 
To also ensure that our 1-hr pad weight differences between baseline and pessary treatment would be 
statistically significant, we checked that a sample size of 57 with a type 1 error rate (alpha) of 0.05, one-
sided, would provide sufficient power. We based our estimates of a standard deviation in pad weight 
change to be 18% (conservative estimate based on the Poise Impressa study, Ziv et al.) and found that 
we would only need 50 subjects to have at least 90% power to see at least a 50% reduction in pad urine 
weight as an exploratory single endpoint. 
 
Thus, to be conservative, we will recruit up to 90 participants to ensure a sample size of completers of 
57 participants. 
 
This sample size should also be sufficient for the analysis of self-report measures of leak frequency, 
quality-of-life, and our other exploratory endpoints. 
 

 
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The primary safety endpoint was adopted from the FDA’s guidance for urinary incontinence studies.  
Safety analysis will include results of urinalysis, vaginal examination, and evaluation of adverse events. 
The study site will contact each subject at least twice during the study to check compliance with the 
study protocol and record any adverse events the subject may have experienced. At the final study visit, 
the investigator will inquire about the occurrence of AE/SAEs since the initial visit. All adverse events will 
be characterized according to their relatedness to the device and their seriousness and severity. The 
safety analysis will include a descriptive assessment of the types and frequency of adverse events 
observed, with comparison to those observed during the control phase. 
4.3 END OF STUDY DEFINITION 
 
A participant is considered to have completed the study if she has completed all phases of the study 
including the last visit shown in the Schedule of Activities (SoA), Section 1.3. 
  
The end of the study is defined as completion of the last visit by the last participant. 

 
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5 STUDY POPULATION 
5.1 INCLUSION CRITERIA 
Inclusion Criteria:  To be eligible to participate in this study, an individual must meet all of the following 
criteria: 
1. Female, ≥18 years of age 
2. Diagnosed with SUI by a physician using a cough stress test (positive test) 
3. Confirmed Pippa Fitness Pessary fit in clinic by a physician or qualified clinician (e.g., Nurse 
Practitioner, Registered Nurse)  
4. Have a >3 month history of experiencing more than 3 episodes of SUI per week 
5. English literacy sufficient to understand the nature of the study and sufficient to read and 
understand  the informed consent form 
6. Provision of a signed and dated informed consent form 
7. Willingness to use the Pippa Fitness Pessary during the study and comply with study procedures 
8. Willingness to forego use of any vaginal insert (e.g.: vaginal pessaries, bladder supports, 
estrogen rings, tampons, and menstrual cups) while the Pippa Fitness Pessary is in place 
9. Willingness to cease use of any other form of urinary incontinence treatment for the duration of 
the study  
10. Willingness and ability to interact with study staff by email, phone, text message and video 
conferencing software throughout study 
5.2 EXCLUSION CRITERIA 
Exclusion Criteria:  An individual who meets any of the following criteria will be excluded from 
participation in this study: 
1. Known urethral stricture, bladder neck contracture, spastic bladder, vesicoureteral reflux, 
bladder stones, and/or bladder tumors  
2. Concurrent bladder specific medications (including beta agonists or anticholinergics) that affect 
urination and the use of any other prescription medication and/or over-the-counter medication 
and/or dietary supplements (including herbal supplements and those taken as teas) that affect 
urination, except in those instances where they are medically necessary and can be actively 
supported at a stable dosage throughout the active study period 
3. Known prolapse beyond hymen or any POP-Q point > 0 
4. Known hypersensitivity to silicone rubber 

 
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5. Pelvic floor surgery including anterior bladder repair and urethral slings 
6. Vaginal, perineal, or uterine surgery, or abortion (spontaneous or induced) within the past 3 
months 
7. Any injectable treatments, or prior surgeries for incontinence 
8. Class III Obesity (BMI > 40.0 kg/m2) 
9. Currently suffering from urinary tract or vaginal infection 
10. Pregnant or planning to become pregnant within 3 months, or within 3 months postpartum 
11. History of Toxic Shock Syndrome or consistent symptoms 
12. Previously diagnosed with urge-predominant or mixed predominant urinary incontinence, 
functional incontinence, incontinence due to a central or spinal cord neurological condition (such as 
multiple sclerosis, neurogenic bladder, Parkinson's, spina bifida), insensate incontinence, or overflow 
incontinence 
13. Screening laboratory values outside the reference range considered significant by the 
investigator which might impact the safety of the participant or outcome of the study 
14. Unsuccessful fit assessment during screening 
15. Any other reason the investigator decides the potential participant should not participate in the 
study 
16. Self-reported difficulty emptying bladder 
17. Difficulty inserting or wearing an intra-vaginal device 
5.4 SCREEN FAILURES 
 
Participants will be pre-screened prior to calendaring an appointment.  If they fail the pre-assessment, 
they will be thanked for their interest but told that they are not eligible for the study. If they fail the 1-hr 
PWT, they will not be scheduled for an in-clinic screening visit, but will be provided with the stipend, as 
outlined in the Informed Consent Form (ICF). If participants fail the screening procedure during the clinic 
visit, they will be thanked for their participation and be provided with the stipend, as outlined in the ICF 
5.5 STRATEGIES FOR RECRUITMENT AND RETENTION 
 
The study staff will recruit women with stress urinary incontinence from 3-6 distinct clinics in ethnically 
and economically diverse settings. 
An ethnically and racially diverse mix of participants will be recruited.  
 
A mix of methods will be used to facilitate recruiting, ranging from flyers in clinics and nearby facilities to 
physician referrals and emails and Web news to patient networks. This information will be replicated in 
substantially similar Web and email forms. Existing clinic patients with a diagnosis of SUI will not 

 
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undergo pre-assessment. Instead they will be instructed to call directly for an informed consent call and 
will be shipped the first pad weight test kit, or they will be scheduled for an office visit for informed 
consent review and signature. Up to 90 participants will be recruited to ensure that approximately 57 
are able to complete the study. 
● 
Participants will receive reminders by mobile text messages each morning and evening of the 
leak-tracking study phase. 
● 
Subjects will be contacted via phone call at least once during each phase of the study, to ensure 
that the subject is compliant and does not have any concerns. During these calls, the site staff 
will remind the subject to complete her leak diary each day.  
6 STUDY INTERVENTION 
6.1 STUDY INTERVENTION(S) ADMINISTRATION 
6.1.1 STUDY INTERVENTION DESCRIPTION 
 
A pessary is an intravaginal prosthetic that, in the case of stress 
urinary incontinence (SUI), seeks to affect mechanical changes 
to restore proper urethral function.  
 
The subject device, the Pippa Fitness Pessary, is a system of 
reusable device components comprising a stress urinary 
incontinence pessary and vaginal applicator (Figure 3). The 
device is single patient, multi-use, and self-administered 
without training.  The device is intended for both over-the-
counter (OTC) and prescription use. 
 
The Pippa Fitness Pessary is made of flexible medical-grade 
silicone with no attachments to irritate vaginal tissue and no 
sharp edges to cause injury or discomfort. It is engineered to 
compress and expand intravaginally. The device package 
includes two diameters: 42mm and 50mm, to serve most 
women in need. It will require no precise sizing, fitting, patient 
training or clinic visits. Both sizes should be effective and safe 
for most women, but one size may be more comfortable or 
easy to position for a given user. It will be recommended that 
users try both sizes (starting with the 42 mm size) and select 
the one they prefer for regular use. When placed intravaginally, the device presses longitudinally along 
the urethra to reduce or prevent involuntary urine loss while also preventing involuntary expulsion. 
Placed correctly, it will not impede intentional urination. The hollow form allows vaginal excretions to 
pass through and prevents the vaginal sealing found with some SUI pessaries.  Figure 4, below, shows an 
anatomical cross section both with and without the Pippa Fitness Pessary. 
 
Figure 3:  
Pippa Fitness Pessary System  

 
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Figure 4: Anatomical cross section without (L) and with (R) Pippa Fitness Pessary    
 
The reusable Pippa Fitness Pessary is shaped as a hollow silicone ovoid, comprising a tapered leading 
end from which extend radially four elongate surface elements that reconnect at a base, from which 
further extends a loop, by which the device may be pulled (out of one’s body) or hung (as if to dry on a 
wall hook). The Pippa Fitness Pessary was carefully designed for comfort and ease of use. A reusable 
vaginal applicator is required to assist with correct self-administration of the device. The applicator 
comprises injection-molded plastic cylinders, assembled for use. Figure 5 below shows the Pippa Fitness 
Pessary in its expanded form and Figure 6 below shows it in its compressed form. 
 
 
Figure 5: Design Features (expanded)    Figure 6: Design Features (compressed)   
 
  
 
The user-contacting materials used in the Pippa Fitness Pessary are listed in Table A below. 
 
Table A - Pippa Fitness Pessary Materials 

 
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Component 
Material 
Tissue Contact 
Duration 
Pessary 
medical-grade 
silicone 
mucosal membrane 
Less than 24 hours at 
a time. 
Applicator 
(two pieces) 
polypropylene 
mucosal membrane 
Less than 24 hours.  
The applicator should 
be in contact with the 
vagina for only a few 
seconds during 
placement. 
6.2 PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY 
6.2.1 ACQUISITION AND ACCOUNTABILITY 
 
All participant study materials will be provided by Liv Labs. Materials will include printed participant 
study guides; packaged Pippa Fitness Pessary kits (two differently sized pessaries, one applicator, and 
Instructions for Use); water-based lubricant; water-based cleanser; pad weight test kits (instructions, 
activity monitor (pedometer), pre-weighed incontinence pads, FedEx mailers); a commercial-grade 
electronic balance; and a proper balance calibration mass. These study materials will be stored securely 
at each of the clinics at which study candidates and participants will be seen. All pads will be mailed back 
by participants to a central location. Pads will be weighed upon return and then disposed of. 
6.2.2 FORMULATION, APPEARANCE, PACKAGING, AND LABELING 
 
The Pippa Fitness Pessary is a system of reusable device components comprising a stress urinary 
incontinence pessary and vaginal applicator. The Pippa Fitness Pessary is constructed of medical-grade 
silicone and the applicator is constructed of polypropylene.  The device is single patient, multi-use, and 
self-administered without training. The device is intended for over-the-counter (OTC) and prescription 
use.  It will be provided to participants in a box that contains 2 pessaries (42mm and 50 mm), an 
applicator, a plunger, and instructions for use.  Participants will also be provided with water-based 
cleanser and lubricant to be used as needed. The instructions for use (IFU) are provided in Appendix A. 
 
6.2.3 PRODUCT STORAGE AND STABILITY 
 
The IFU in Appendix A instructs the participant to wash the device with a water-based cleanser and to 
store the Pippa Fitness Pessary in a cool dry place. 
 
 

 
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6.2.4 PREPARATION 
 
The materials for the treatment period of the study will be provided to each participant during the initial 
clinic visit. The investigational device and applicator are described in the IFU (Appendix A). Participants 
will be provided with a tailored Study Participant Guide that describes what to do on each day of the at-
home study phase. Participants will also be provided with a pad weight testing kit that includes 
instructions, an activity monitor (pedometer), pre-weighed incontinence pads, and a pre-addressed 
FedEx mailer. Participants will receive daily text reminders. Advice about pessary use will not be 
provided. 
6.3 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
 
Although the participants will know when they are in the treatment period (using the Pippa Fitness 
Pessary), the study personnel weighing the pads after use will be blinded with regard to participant 
name or what phase of the trial they are in. The pads will be labeled with coding that de-identifies each 
study participant. Therefore, research analysts will not associate participant scores between all the 
tests, reducing expectations about results based on prior assessments. Analysts may only associate 
results for individual participants after completion of all statistical analyses. 
6.4 STUDY INTERVENTION COMPLIANCE 
 
Participant compliance will be monitored throughout the study by follow-up telephone calls made by 
the site during the at-home phase of the study. 
 
6.5 CONCOMITANT MEDICATION  
 
Prescription medications taken during study participation will be recorded on the case report forms 
(CRFs). For this protocol, a prescription medication is defined as a medication that can be prescribed 
only by a properly authorized/licensed clinician. Only prescription medications are to be reported in the 
ConMeds CRF. Over-the-counter medications will be documented if they are taken for the purpose of 
resolving an Adverse Event that occurs during the study. This information shall also be collected during 
the medical history evaluation. There are no known concomitant medications for the treatment of SUI.  
7 STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 DISCONTINUATION OF STUDY INTERVENTION 
 
Adverse event monitoring will begin upon study enrollment (not during screening phase). Potential 
adverse events will be monitored during the follow-up telephone calls made by the site during the at-
home phase of the study. All adverse events will be reported to the Sponsor within 48 hours. The study 
will be suspended or discontinued if required by an evaluation of the severity and possible causality of 
the adverse events. This study may be temporarily suspended or prematurely terminated if there is 

 
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sufficient reasonable cause. Written notification, documenting the reason for study suspension 
or termination, will be provided by the suspending or terminating party to the investigator, funding 
agency, the sponsor and regulatory authorities. If the study is prematurely terminated or suspended, the 
PI will promptly inform the IRB and will provide the reason(s) for the termination or suspension and the 
study sponsor will inform the FDA if the study was terminated due to an unanticipated adverse device 
effect that presents an unreasonable risk to subjects. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
 
• Determination of unexpected, significant, or unacceptable risk to participants 
 
• Insufficient compliance to protocol requirements 
 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed and 
satisfy the Sponsor, IRB and FDA. 
7.2 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Participants will be clearly informed that they are free to withdraw from the study at any time.  Study 
personnel will work with each participant having problems to determine if they should continue the 
study.  If any participant discontinues the study, the reasons for termination will be recorded. Every 
attempt will be made to complete the study exit visit and collect all study-related products.  
7.3 LOST TO FOLLOW-UP 
 
If for some reason a participant cannot be reached after three (3) attempts (using a combination of 
phone calls, emails, and/or MyChart) and pad shipments or device return requests go unanswered, then 
she will be considered lost to follow-up. Attempts to contact such a participant by mail, to determine a 
reason for this, and any reasons reported, will be recorded for later analysis.  
 
 

 
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8 STUDY ASSESSMENTS AND PROCEDURES 
8.1 EFFECTIVENESS ASSESSMENTS 
 
The primary effectiveness endpoint is a composite endpoint used to describe responders to the use of 
the Pippa Fitness Pessary to reduce urinary leakage. The two component endpoints defining a responder 
are: 
1. >50% reduction in pad weight gain for the 1-hour pad weight test with vs without the pessary.  
This component outcome is defined as: 
(1-hr PWT urine weight without pessary) – (1-hr PWT urine weight with pessary) 
-------------------------------------------------------------------------------------------------------- > .50 
  
                             (1-hr PWT urine weight without pessary) 
and/or 
2. >50% reduction in the average daily reports of number of urine leaks per day during periods 
with and without the pessary. This component outcome is defined as: 
(Mean # of leaks/day without pessary) - (Mean # of leaks/day with pessary) 
---------------------------------------------------------------------------------------------------- > .50 
                              
(Mean # of leaks/day without pessary) 
  
Our secondary endpoint will be Change in Quality of Life as measured by the Incontinence Impact 
Questionnaire Short Form (IIQ-7) measured at baseline and at the end of the treatment phase. 
 
Other effectiveness data to be analyzed include:   
(1) Net Promoter Score (likelihood that participant would recommend the device) 
(2) Patient Global Impression of Severity (PGI-S) 
(3) Patient Global Impression of Change (PGI-C) 
(4)  Pelvic Floor Disability Index (PFDI-20) 
8.2 SAFETY AND OTHER ASSESSMENTS 
 
The clinician's initial physical exam and screening procedure will ensure that all participants are 
appropriate for the study. 
 
Daily reminders will be sent to participants via text message. These text messages will include a routine 
reminder for the participant to contact the site in the case of questions or concerns. Such questions or 
concerns may range from confusion on logistical procedures associated with the study, to mild 

 
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discomfort or vaginal discharge, or to a possible serious adverse event. Study participants will be 
encouraged to call the study coordinator immediately if she has a serious concern. The study guide will 
also indicate that the participant should call 911 in the event of a medical emergency. 
  
Serious adverse events will be communicated to the Data Safety Monitor for the study within a 48-hour 
period, with the exception of deaths and immediately life-threatening events. Deaths and immediately 
life-threatening events, whether related or unrelated to the study device, shall be recorded on the SAE 
form and submitted to the Data Safety Monitor, IRB and the Sponsor, Liv Labs, Inc., within 24 hours of 
site awareness.  The study sponsor will report the UADE to FDA. 
 
Unanticipated adverse device events (UADEs) will be reported to the Sponsor and Data Safety Monitor 
within 24 hours of site awareness. 
  
Safety analysis will also include results of urinalysis and vaginal examination taken at the end of the 
study.   
8.3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 DEFINITION OF ADVERSE EVENTS (AE) 
 
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the investigational medical device and whether anticipated or unanticipated. (ISO 
14155:2020(E)) 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) & UNANTICIPATED ADVERSE DEVICE EFFECT 
 
A Serious Adverse Event (SAE) is defined as an AE or suspected adverse reaction that, in the view of 
either the Investigator or Sponsor, results in any of the following outcomes (ISO 14155:2020(E)):  
(1) death; 
(2) serious deterioration in the health of the subject, users, or other persons as defined by one or 
more of the following: (a) a life-threatening illness or injury, (b) a permanent impairment of a 
body structure or a body function including chronic diseases, (c) in-patient or prolonged 
hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury, or 
permanent impairment to a body structure or a body function;  
(3) fetal distress, fetal death, a congenital abnormality, or birth defect including physical or mental 
impairment. 
 
An Unanticipated Adverse Device Effect (UADE) is defined as any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, 
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 problem associated with a device that relates to the rights, safety, or welfare of 
subjects (21 CFR 812.3(d)). 

 
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8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
 
All AEs will be assessed by the PI using a protocol-defined grading system. The following guidelines will 
be used to describe severity: 
 
• Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities. 
 
• Moderate – Events result in a low level of inconvenience or concern with the therapeutic measures. 
Moderate events may cause some interference with functioning. 
 
• Severe – Events interrupt a participant’s usual daily activity and may require systemic drug therapy or 
other treatment. Severe events are usually potentially life-threatening or incapacitating. 
8.3.3.1 SEVERITY OF EVENT 
 
The PI will record all reportable events with start dates occurring any time after enrollment occurs 
through the last day of study participation. At the end-of-study clinic visit, the investigator will inquire 
about the occurrence of AE/SAEs throughout the home study. Events will be followed for outcome 
information until resolution or stabilization. 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION 
 
The PI’s assessment of an AE's relationship to the study device is part of the documentation process, but 
it is not a factor in determining what is or is not reported in the study. All AEs must have their 
relationship to the study device assessed. To help assess, the following guidelines are used: 
 
• Related – The AE is known to occur with the study device type, there is a reasonable possibility that 
the study device caused the AE, or there is a temporal relationship between the study device and the 
event. Reasonable possibility means that there is evidence to suggest a causal relationship between the 
study device and the AE. 
 
• Not Related – There is not a reasonable possibility that the administration of the study device caused 
the event, there is no temporal relationship between the study device and event onset, or an alternate 
etiology has been established. 
8.3.3.3 EXPECTEDNESS 
 
The PI will be responsible for determining whether an AE is expected or unexpected. An AE will be 
considered unexpected if the nature, severity, or frequency of the event is not consistent with the risk 
information previously described for the study device.  Potential risks are noted in Section 2.3.1. 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
 

 
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Adverse event assessments will be noted by the study clinician for the initial clinic visit and for the end-
of-study final clinic visit. .  If any of the adverse events are serious, these will be noted, followed up with 
phone contact with the participant, and arrangements made for care.   
 
All AEs including local and systemic events will be captured on the appropriate CRF. Information to be 
collected includes event description, time of onset, clinician’s assessment of seriousness and severity, 
relationship to study product (assessed only by those with the training and authority to make a 
diagnosis), and time of resolution/stabilization of the event. All AEs occurring while on study must be 
documented appropriately regardless of relationship to the study device. All AEs will be followed to 
adequate resolution or stabilization. Any medical condition that is present at the time that the 
participant is screened will be considered as baseline and not reported as an AE. However, if the study 
participant’s condition deteriorates at any time during the study, it will be recorded as an AE. 
8.3.5 ADVERSE EVENT REPORTING 
 
AEs will be documented using the Case Report Form. This will include assessments from the two (2) 
clinic visits as well as the two follow-up telephone calls..   
 
The PI will record all reportable events with start dates occurring any time after enrollment occurs 
through the last day of study participation. At the final study visit, the investigator will inquire about the 
occurrence of AE/SAEs since the last visit. Events will be followed for outcome information until 
resolution or stabilization. 
8.3.6 SERIOUS ADVERSE EVENT REPORTING 
 
The study clinician will complete a SAE Form within the following timelines: 
 
● All deaths and immediately life-threatening events, whether related or unrelated, will be 
recorded on the SAE Form and submitted to the Data Safety Monitor, IRB and the Sponsor, Liv 
Labs, Inc. within 24 hours of site awareness. See Section 10.1.5, Key Roles for contact 
information. 
 
● Other SAEs, regardless of relationship, will be submitted to the Sponsor and Data Safety Monitor 
within 48 hours of site awareness. 
 
● All UADEs will be reported to the Sponsor and the Data Safety Monitor within 24 hours of site 
awareness. 
 
● The Sponsor will notify the IRB of any device-related SAE and the IRB and FDA of any UADE as 
soon as possible, but in no case later than 10 working days after the Sponsor first receives notice 
of the UADE. 
. 
● UADEs will be reported to study participants as soon as possible, but in no case later than 10 
working days after the Sponsor first receives notice of the UADE. Participants will also be 
informed of their right to discontinue the study at any time. 

 
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All SAEs and UADEs will be followed until satisfactory resolution or stabilization. Other supporting 
documentation of the event may be requested by the Sponsor and should be provided as soon as 
possible.  The Sponsor will be responsible for notifying the FDA of any UADE as soon as possible but in 
no case later than 10 working days after the Sponsor's initial receipt of the information. 
 8.3.7 REPORTING EVENTS TO PARTICIPANTS 
 
If any serious adverse events are associated with the study logistics or treatment phase of the study, 
study personnel will pause the trial and notify all participants within 72 hours of the Sponsor or PI 
determining that a serious adverse event is likely associated with the study logistics or treatment. 
8.3.8 REPORTING OF PREGNANCY 
 
If any study candidate tests positive for pregnancy at the clinic visit, she will be informed of the test 
result as the basis for her exclusion from the study. 
9 STATISTICAL CONSIDERATIONS 
9.1 STATISTICAL HYPOTHESES 
● 
Primary Effectiveness Endpoints: 
The primary effectiveness endpoint is a composite endpoint used to describe responders to the use of 
the Pippa Fitness Pessary to reduce urinary leakage.  The two component endpoints defining a 
responder are: 
1. >50% reduction in pad weight gain for the 1-hour pad weight test with vs without the pessary.  
This component outcome is defined as: 
(1-hr PWT urine weight without pessary) - (1-hr PWT urine weight with pessary) 
-------------------------------------------------------------------------------------------------------- > .50 
  
                             (1-hr PWT urine weight without pessary) 
and/or  
2. >50% reduction in the average daily reports of number of urine leaks per day during periods 
with and without the pessary.  This component outcome is defined as: 
(Mean # of leaks/day without pessary) - (Mean # of leaks/day with pessary) 
---------------------------------------------------------------------------------------------------- > .50 
                              
(Mean # of leaks/day without pessary) 
 
We plan to ensure that our study is powered to be able to show a significant difference between 
baseline and treatment measures for each component outcome, but primarily we will ensure that our 

 
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study is powered to show a responder rate of success of at least 70%. A responder in this case would be 
a participant who showed a greater than 50% reduction in 1-hour pad weight gain between baseline and 
pessary use and/or a greater than 50% reduction in mean daily reported leakage episodes between 
baseline and pessary use. 
 
For the primary composite endpoint, the null hypothesis is that the responder proportion (percentage of 
participants with >50% reduction in pad urine weight gain and/or >50% reduction in mean daily number 
of leakage episodes) is <=70%.  The alternative is that it is >70%. 
 
To investigate the component endpoints of our composite endpoint: 
1. The null hypothesis for the 1-hour pad weight test is that the reduction in urine weight gain due 
to use of the Pippa Fitness Pessary is <=50%, and the alternative hypothesis is that it is >50%. 
2. For the daily reports of leakage episodes, the null hypothesis is that the reduction in leakage 
episodes due to use of the Pippa Fitness Pessary is <=50%, and the alternative hypothesis is that 
it is >50%. 
 
Our additional primary endpoint relates to safety. Safety reporting using urinalysis, vaginal examination, 
and evaluation will be descriptive and narrative in nature. Additionally, the participants' self report of 
AEs will be descriptive and later classified into relative groupings and quantitatively summarized.  
 
Secondary Endpoint: 
Our secondary endpoint will be change in quality of life (QoL) as measured by the IIQ-7 Quality of Life 
Questionnaire at baseline and post-treatment.  Although we also will measure changes in the Patient 
Global Impression of Severity (PGI-S), the Pelvic Floor Disability Index (PFDI-20) and the Questionnaire 
for Urinary Incontinence Diagnosis (QUID) as exploratory measures, the secondary endpoint analysis will 
be based on changes in the IIQ-7 scores. 
The IIQ-7 Questionnaire is to be completed at baseline and after the treatment period.  The 
questionnaire contains 7 questions regarding areas which may have been influenced or changed by 
accidental urine loss.  These questions are assigned a value of 0 = Not at All; 1 = Slightly; 2 = Moderately; 
and 3 = Greatly.  The Questionnaire is scored by taking the average score of items and then multiplying 
that value by 33 1/3 to put scores on a scale from 0 to 100. A lower score is considered less impact to 
quality of life and a higher score reflects more impact to quality of life. In the same manner, a reduction 
in scores from control reflects improved quality of life. A reduction in score of > 3.7 is considered the 
Minimum Clinically Important Difference (MCID).  The IIQ-7 score reduction of > 3.7 will be our 
secondary outcome. 
9.2 SAMPLE SIZE DETERMINATION 
 
We used a precision approach to determine the appropriate sample size and power for the study. For 
our primary composite endpoint (>50% reduction in pad weight gain on the 1-hour pad weight test 
and/or on mean daily leak reports) we estimated a response rate of at least 70% based on our own  
 
 

 
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earlier work and on the Poise Impressa study (Ziv et al.). With the desired precision of this estimated 
response rate set to 0.10 and a confidence level of 0.90, the estimated sample size would be 57. 
 
Estimated Proportion 
0.70 
Desired precision of estimate 
0.10 
Confidence level 
0.90 
Population size 
Large 
Sample Size 
57 
 
To also ensure that our 1 hour pad weight differences between baseline and treatment would be 
statistically significant, we checked that a sample size of 57 with a type 1 error rate (alpha) of 0.05, one-
sided, would provide sufficient power.  We based our estimates of a standard deviation in pad weight 
change to be 18% (conservative estimate based on the Poise Impressa study, Ziv et al.) and found that 
we would only need 50 subjects to have at least 90% power to see at least a 50% reduction in pad urine 
weight for an exploratory analysis of just pad weight differences. 
 
Thus, to be conservative, we will recruit up to 90 participants to ensure a sample size of completers of 
57 participants. 
 
This sample size should also be sufficient for the analysis of self-report measures of leak frequency, 
quality of life, and our other exploratory endpoints. 
9.3 POPULATIONS FOR ANALYSES 
 
The effectiveness and safety analyses will be based on the Intent to Treat (ITT) population.  We will also 
do comparative analyses for the Modified Intent to Treat and Per Protocol populations. 
 
Intent to Treat Population (ITT): Any subject enrolled who receives a pre-weighed pad for the control 
phase. Enrollment is expected to be 70 subjects. Enrolled study participants are those who meet all 
inclusion and exclusion criteria and who are issued pads and a device. An ITT approach is possible if at 
least partial primary endpoint outcome data are available (in this case, either a 1-Hour Treatment Pad 
Weight Test or at least one treatment leak report). We will handle missing data due to dropouts by using 
the last observation carried forward (LOCF) method, whereby the last available measurement for each 
individual at the time point prior to withdrawal from the study is retained in the analysis (in our case, all 
data up to the time of withdrawal).6 The ITT population will be used for the primary effectiveness 
analysis. 
 
Modified Intent to Treat Population (mITT): Any subject enrolled who remains in the study through the 
control phase, has started the treatment phase, has taken the 1-Hour Treatment Pad Weight Test and 
has at least 1 leak report data point. We will analyze the mITT data as an exploratory analysis. 
 
6Gupta SK. Intention-to-treat concept: A review. Perspect Clin Res. 2011;2(3):109-112. doi:10.4103/2229-3485.83221. 
 

 
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Per Protocol Population (PP): Any subject getting through the entire treatment period and having 
complete data (baseline and treatment 1-hour pad weight data as well as complete leak report data). 
We will also analyze the PP data as an exploratory analysis. 
  
Safety Population (SP): Same as ITT. 
9.4 STATISTICAL ANALYSES 
9.4.1 GENERAL APPROACH 
 
De-identified data will be combined into analysis data sets using an electronic database that is validated, 
secure, password-protected and has an audit trail of all changes made to the data after initial entry. 
9.4.2 ANALYSIS OF THE PRIMARY EFFECTIVENESS ENDPOINT(S) 
 
For the analysis of our primary composite outcome, the dichotomous subject success in 
pad leakage reduction of greater than 50% and/or a reduction in mean daily leakage episodes greater 
than 50%, a binomial proportion test will be used. In analyzing the individual components, a comparison 
of the mean percent reduction in leakage compared to zero will be performed using a 1-sample t test. 
The ITT population will be used for the primary effectiveness analysis. We will handle missing data due 
to dropouts by using data up to the last observation carried forward (LOCF) method, whereby the last 
available measurement for each individual at the time point prior to withdrawal from the study is 
retained in the analysis (in our case, all data up to the time of withdrawal).6 For the composite primary 
endpoint, this means that the 1-hour Treatment Pad Weight Test will be required. For the daily reported 
leak episodes, we will consider data up until the time of withdrawal during the treatment period. We 
will also conduct sensitivity analyses for missing data, using various methods, to evaluate the whole 
spectrum of the treatment effect. 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
Similarly, a 1-sample t test will be used to investigate change in the quality-of-life measure (IIQ-7) with 
versus without use of the Pippa Fitness Pessary. 
9.4.4 SAFETY ANALYSES 
 
No formal testing of adverse events or their characteristics will be performed.  Reporting is described 
above. Analyses will include a summary table and tables for relationship to the study treatment and 
seriousness and severity.  
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
 
Demographic variables, questionnaire data and physical exam / medical history findings taken at 
baseline will be summarized with descriptive statistics. 

 
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End-of-study data on safety outcomes, overall satisfaction with the Pippa Fitness Pessary, Net Promoter 
Score (indication of how likely one is to recommend the device to others), PGI-C, QUID, PFDI-20 and PGI-
S will also be summarized with descriptive statistics. 
9.4.6 PLANNED INTERIM ANALYSES 
 
None planned.  
9.4.7 SUB-GROUP ANALYSES 
 
None planned. 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
 
A spreadsheet will be used to consolidate and store the study data.   
9.4.9 EXPLORATORY ANALYSES 
 
None planned. 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
 
Consent forms describing in detail the study device, study procedures, and risks will be given to the 
participant, and documentation of informed consent is required prior to starting 
intervention/administering the study device. The following consent materials are submitted with this 
protocol: Pippa Fitness Pessary Device Effectiveness and Safety Study Informed Consent. 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Extensive discussion of risks and 
possible benefits of participation will be provided to the participants and their families. Consent forms 
will be IRB-approved, embody the elements of informed consent required by 21 CFR 50.25, and the 
participant will be asked to read and review the document. A research team member will explain the 
research study to the participant and answer any questions that may arise. All participants will receive a 
verbal explanation in terms suited to their comprehension of the purposes, procedures, and potential 
risks of the study and of their rights as research participants. Participants will have the opportunity to 
carefully review the consent form and ask questions prior to signing. 
 
The participants will have the opportunity to discuss the study with their surrogates or think about it 
prior to agreeing to participate. The participant will sign and date the informed consent document prior 
to any procedures being done specifically for the study. The participants may withdraw consent at any 

 
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time throughout the course of the trial. A copy of the signed informed consent document will be given 
to the participants for their records. The rights and welfare of the participants will be protected by 
emphasizing to them that the quality of their medical care will not be adversely affected if they decline 
to participate in this study. 
 
Original informed consent forms will be maintained in the study participant’s case history.  In addition, 
the study participant’s case history will document that the participant provided consent prior to 
participation in the research. 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO PARTICIPANTS 
 
Candidates for the study will be provided with the Pippa Fitness Pessary Device Effectiveness and Safety 
Study Informed Consent; the IFU for the device; and the Study Participant Guide. 
 
 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
 
The study will be discontinued after at least 57 participants have completed all phases of the trial and 
we have analyzed the resulting data.   
 
The study will be suspended or discontinued if required by an evaluation of the severity and possible 
causality of adverse events. This study may be temporarily suspended or prematurely terminated if 
there is sufficient reasonable cause. Written notification, documenting the reason for study suspension 
or termination, will be provided by the suspending or terminating party to the investigator, funding 
agency, the sponsor and regulatory authorities. If the study is prematurely terminated or suspended, the 
PI will promptly inform the IRB and will provide the reason(s) for the termination or suspension and the 
study sponsor will inform the FDA if the study was terminated due to an unanticipated adverse device 
effect that presents an unreasonable risk to subjects. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• Determination of unexpected, significant, or unacceptable risk to participants 
• Insufficient compliance to protocol requirements 
 
The study may resume once concerns about safety, protocol compliance, and data quality are addressed 
and satisfy the Sponsor, IRB and FDA. 
10.1.3 CONFIDENTIALITY AND PRIVACY 
 
Participant confidentiality is strictly held in trust by the participating investigators, their staff, and the 
sponsor(s) and their agents. This confidentiality is extended to cover testing of biological samples in 
addition to the clinical information relating to participants. Therefore, the study protocol, 
documentation, data, and all other information generated will be held in strict confidence. No 
information concerning the study or the data will be released to any unauthorized third party without 
prior written approval of the Sponsor. 
 

 
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The study monitor, other authorized representatives of the Sponsor, representatives of the IRB or 
company supplying study materials or regulatory health authorities may inspect all documents and 
records required to be maintained by the investigator, including but not limited to, medical records 
(office, clinic, or hospital) and pharmacy records for the participants in this study. The clinical study site 
will permit access to such records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by local IRB and Institutional regulations, but at least for a period of 2 years 
after the latter of the following two dates: The date on which the investigation is terminated or 
completed, or the date that the records are no longer required for purposes of supporting a marketing 
application. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted to and stored in a secure server in the investigator’s clinic. This will not include the 
participant’s contact or identifying information. Rather, individual participants and their research data 
will be identified by a unique subject identification number. Any electronic study data entry and study 
management systems used by clinical sites will be secured and password protected. At the end of the 
study, all study databases will be de-identified and archived at the clinic and at the Sponsor 
organization. 
10.1.4 FUTURE USE OF STORED  DATA 
 
Data collected for this study will be stored at the clinical site and Sponsor facilities. After the study is 
completed, the de-identified, archived data that is stored at the Sponsor’s facility under the supervision 
of the CEO may be used by other researchers, including those outside of the study. Permission to 
transmit data to the Sponsor will be included in the informed consent. 
 
 

 
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10.1.5 KEY ROLES AND STUDY GOVERNANCE 
 
Sponsor 
Liv Labs, Inc. 
332 S Michigan Ave 
Suite 121 #5595 
Chicago, IL 60604 
Melody Roberts, CEO 
melody@liv-labs.com  
Medical Monitor 
SEE STUDY CONTACT LIST 
Data Safety Monitor 
SEE STUDY CONTACT LIST 
10.1.6 SAFETY OVERSIGHT 
 
THE SPONSOR WILL CONTACT THE INDEPENDENT MEDICAL REVIEWER, TO ASSIST IN ASSESSING ANY SAFETY CONCERNS, IF 
NEEDED. THE INVESTIGATOR SHOULD BE ABLE AND WILLING TO PROVIDE FURTHER INFORMATION ON THE SPECIFIC EVENT 
WHEN REQUESTED BY THE STUDY SPONSOR. DETAILS ON THE ROLES AND RESPONSIBILITY OF THE MEDICAL MONITOR CAN BE 
FOUND IN THE MEDICAL MONITORING PLAN. 10.1.7 CLINICAL MONITORING 
 
Clinical site monitoring shall be conducted to ensure that the rights, safety and welfare of human 
participants are protected, that the reported trial data are accurate, complete, and verifiable, and that 
the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, 
and with applicable regulatory requirement(s). Any required onsite monitoring for this study will be 
performed by a qualified Sponsor representative. Details of clinical site monitoring are documented in a 
Clinical Monitoring Plan (CMP). The CMP will describe in detail who will conduct the monitoring, at what 
frequency monitoring will be done, at what level of detail monitoring will be performed, and the 
distribution of monitoring. 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
Following written SOPs, the monitors will verify that the clinical trial is conducted and data are 
generated, documented (recorded), and reported in compliance with the protocol, GCP, and the 
applicable regulatory requirements. The investigational site will provide direct access to all trial-related 
sites, source data/documents, and reports for the purpose of monitoring and auditing by the Sponsor, 
and inspection by local and regulatory authorities. 
10.1.9 DATA HANDLING AND RECORD KEEPING 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site 
PI. The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of 
the data reported. 
 

 
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Consenting records may be captured in electronic forms via REDCap (or similar software), which is a 
secure web application for managing online databases. Any software used for consenting will be 
compliant with 21 CFR Part 11, FISMA, HIPAA and GDPR. 
 
Study data will be collected using standardized paper Case Report Forms. CRFs will be printed on 2-part 
NCR paper (or equivalent) so that both the site and Sponsor will have copies of the CRFs. Each CRF will 
be designed to accommodate the specific features of the trial design.  Modification of a CRF will only be 
made if deemed necessary by the study sponsor. A CRF is required and should be completed for each 
included subject. The Investigator has ultimate responsibility for the collection and reporting of all data 
entered on the CRFs and any other data collection forms (source documents) and ensuring that they are 
accurate, authentic/original, attributable, complete, consistent, legible, timely (contemporaneous), 
enduring and available when required. The CRFs must be signed by the investigator to attest that the 
data contained therein are true. The site will be provided with general CRF Completion Guidelines that 
can be located in the Study Operations Manual, which will assist in data entry and data issues/questions. 
All persons allowed to enter or change CRF data must appear on the Delegation of Responsibilities Log.  
 
During the at-home phase of the study, a digital messaging service (such as Twilio or Slick Text) will be 
used to automatically send daily  reminders 
 
A representative of the Sponsor will monitor CRFs to identify possible data errors. Data queries that 
arise on CRFs that have been retrieved from the site, will be resolved using a Data Clarification Form 
(DCF). All data discrepancies will be resolved prior to database lock. 
10.1.9.2 STUDY RECORDS RETENTION 
 
Study documents (including device disposition, informed consents, source documents, correspondence, 
regulatory documents, contracts etc.) should be retained for a minimum of 3 years after the 
investigation is completed or terminated or the records are no longer required to support a marketing 
application (whichever date is later). No records will be destroyed without the written consent of the 
Sponsor, Liv Labs. It is the responsibility of the Sponsor to inform the investigator when these 
documents no longer need to be retained.   
10.1.10 PROTOCOL DEVIATIONS 
  
A protocol deviation is any noncompliance with the clinical trial protocol or GCP requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly.  
 
It is the responsibility of the site to use continuous vigilance to identify and report deviations within 3 
working days of the scheduled protocol-required activity. All deviations must be addressed in study 
source documents and reported to the Sponsor. Protocol deviations must be sent to the IRB per their 
guidelines. The site PI/study staff is responsible for knowing and adhering to IRB requirements.  
10.1.11 PUBLICATION AND DATA SHARING POLICY 
 
The study will be registered on ClincialTrials.gov before the first participant is enrolled. 

 
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10.1.12 CONFLICT OF INTEREST POLICY 
 
The independence of this study from any actual or perceived influence, such as by the medical device 
industry, is critical. Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a 
way that is appropriate to their participation in the trial. 
 
 

 
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10.3 ABBREVIATIONS 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CMP 
Clinical Monitoring Plan 
CRF 
Case Report Form 
CST 
Cough Stress Test 
DCF 
Data Clarification Form 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
ICH 
International Conference on Harmonisation 
ICS 
International Continence Society 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
ITT 
Intention-To-Treat 
NIH 
National Institutes of Health 
PI 
Principal Investigator 
PWT 
Pad Weight Test 
SAE 
Serious Adverse Event 
SOA 
Schedule of Activities 
SUI 
Stress Urinary Incontinence 
US 
United States 
10.4 PROTOCOL AMENDMENT HISTORY 
Version Date 
Description of Change  
Brief Rationale 
1.0 
December 21, 2021 Original submission 
 
1.1 
April 20, 2022 
Change to data management 
Ease of study execution 
2.0 
July 14, 2022 
Update for independent IRB 
Northwestern ceding to Advarra 
3.0 
May 16, 2023 
Removing Northwestern Lab, 
eICF and subject payment 
details. Adding numbers to 
Eligibility Criteria and Visit 
Windows. Increasing the 
maximum number of sites to 6. 
Changing investigational device 
disposal policy.  
Adapting protocol for Site 
Variation and Flexibility. 
Adding clarity to eligibility 
criteria and assessment time 
points. To have the ability to 
replace one site that was initiated 
but never enrolled. 
4.0 
July 11, 2023 
Remove automated daily surveys 
during the at-home phase; 
including Appendix H – Daily 
Assessments. Better define 
exclusion criteria 5 and 7. 
Over-complicated and 
unnecessary. Add clarity to the 
current exclusion criteria. 

 
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5.0 
October 2, 2023 
Add PFDI-20 questionnaire to 
baseline and final clinic visits. 
Remove contact information for 
Medical and Data Safety 
Monitors.  
Collect additional information 
on secondary symptoms. Allow 
for contact information to be 
maintained outside of the 
protocol for ease of updating as 
needed.  
11 APPENDICES 
• 
Appendix A – Instructions for Use 
• 
Appendix B – Screeners and Questionnaires 
• 
Appendix C – Pad Weight Test Preparations Worksheet 
• 
Appendix D – Pre-Enrollment Clinic Visit Invitation 
• 
Appendix E – Study Participant Guide 
• 
Appendix F – 12-Day Leakage Episodes Record 
• 
Appendix G – Daily Communications 
APPENDIX A – INSTRUCTIONS FOR USE 
 
Instructions are provided in the device package. This large-format document folds out to display two 
sections: a written section detailing device benefits and risks and an illustrated section providing 
instructions for use. This document is the result of formal human factors testing. Full-scale version 
uploaded under Device Description Document. 
 

 
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APPENDIX B – SCREENERS AND QUESTIONNAIRES 
 
A. PRE-ASSESSMENT SCREENER 
Hello! 
Thank you for your interest in our study. Please answer the following questions honestly and to your 
very best knowledge, so that we can learn if you may qualify for further screening.  
Thank you! 
3IQ Screening Questionnaire 
Q1: During the last three months, have you leaked urine (even a small amount)? 
A1: 
Yes No  
If no, end survey. 
 
Q2:  During the last three months, did you leak urine… 
A2:  (check all that apply): 
□ 
a. When you were performing some physical activity, such as coughing, sneezing, lifting, or 
exercise? 
□ 
b. When you had the urge or feeling that you needed to empty your bladder, but you could 
not get to the toilet fast enough? 
□ 
c. Without physical activity and without a sense of urgency? 
 
Q3: During the last three months, did you leak urine most often  
A3: 
(check only one): 
□ 
a. When you are performing some physical activities, such as coughing, sneezing, lifting, or 
exercise? 
□ 
b. When you had the urge or feeling that you needed to empty your bladder, but you could 
not get to the toilet fast enough? 
□ 
c. Without physical activity or a sense of urgency? 
□ 
d. About equally as often with physical activities as with a sense of urgency? 
 
 
If the answer to question 3 is “a,” then continue. If not, disqualify candidate. 
 
End Message: Thank you for answering the questionnaire. You do not currently qualify for our 
study. 
Frequency Confirmation 
Q1: How many times in a week do you leak urine? 
A1: 
0, 1-2, 3 or more 
If not “3 or more,” end survey and disqualify candidate. 
 
Q2: For how long have you leaked at least 3 times a week? 
A2: 
less than 3 months, more than 3 months  
If less than 3 months, disqualify candidate. Otherwise, move forward to inclusion and exclusion pre-
screening questionnaires.  

 
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End Message: Thank you for answering the questionnaire. You do not currently qualify for our study. 
 
Additional Criteria Self-Certification. 
Q1: Are ALL of the following statements true for you? 
● I am at least 18 years old. 
● I am anatomically female. (I have a vagina.) 
● I am willing and able to interact with study staff by email, phone, text message and video 
conferencing software. 
● I have reliable home internet connectivity. 
● I am willing and able to wear a vaginal insert that is similar in size to a tampon. 
● I am willing to halt the use of other vaginal inserts (such as vaginal pessaries, bladder supports, 
estrogen rings, tampons, and menstrual cups) while the study device is in place. 
● I am willing to stop the use of any other form of urinary incontinence treatment for the duration of 
the study. 
● My BMI is less than <40.0 (If you do not know your BMI you may calculate it here: 
https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm ) 
 
A1a: If every statement above is true for you, click here: “All are true” (Continue to Exclusion Criteria 
Questions) 
A1b: If one or more of the statements above are not true for you, click here: “Some are not true” (End 
screening Questionnaire and disqualify candidate)  
 
 
End Message: Thank you for answering the questionnaire. Unfortunately, you do not currently 
qualify for our study. 
 
Q2: Are ANY of the following statements true for you? 
● 
I have been diagnosed with pelvic organ prolapse beyond the hymen 
● 
I have hypersensitivity to silicone rubber 
● 
I have recently been diagnosed with bladder stones and/or bladder tumors 
● 
I have had pelvic floor surgery (Cesarean section is OK) 
● 
I have had an abortion within the past three months  
● 
I have had vaginal, perineal, or uterine surgery within the past 3 months 
● 
I have had surgery for incontinence 
● 
I have symptoms of a potential urinary tract or vaginal infection 
● 
I am pregnant  
● 
I am planning to become pregnant within the next 3 months 
● 
I do have a history of Toxic Shock Syndrome 
● 
I have been diagnosed with urgency urinary incontinence 
● 
I have been diagnosed with mixed incontinence (both urgency and stress types) 
● 
I have been diagnosed with overflow incontinence 
● 
I have been diagnosed with functional incontinence 
● 
My incontinence is related to a central or spinal cord neurological condition such as multiple 
sclerosis, neurogenic bladder, Parkinson’s, or spina bifida 
● 
I have difficulty emptying my bladder on a regular basis 
● 
I have difficulty inserting or wearing an intra-vaginal device  

 
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A2a: If none of the above statements are true for you, click here: “None of these statements are true for 
me.” (Continue: Move forward to Informed Consent process.) 
A2b: If any of the above statements are true for you, click here: “At least one statement is true for me.” 
(End screening Questionnaire and disqualify candidate) 
 
End Message: Thank you for answering the questionnaire. Unfortunately, you do not currently 
qualify for our study. 
 
Q3: Check this box if you are currently within 3 months post-partum.  
All inclusion and exclusion criteria will be evaluated and confirmed at the clinical visit. 
 
B. PRE-STUDY QUESTIONNAIRES 
Hello! 
Thank you for enrolling in our study. Please answer the following questions honestly and to the best of 
your knowledge. The full questionnaire will take less than 10 minutes of your time. Your answers will 
help us understand your current experience of living with Stress Urinary Incontinence. 
Thank you for your time and effort! 
PGI-S: Patient Global Impression Scales 
Check the one number that best describes how your urinary tract condition is now.  
□ 
0 – normal 
□ 
1 – mild 
□ 
2 – moderate 
□ 
3 – severe 
Baseline measurement. No exclusion. 
QUID Questionnaire  
Q1: Do you leak urine (even small drops), wet yourself, or wet your pads or undergarments when you 
cough or sneeze?   
A1:  Rarely, once in a while, often, most of the time, all of the time, none of the time 
 
Q2: Do you leak urine (even small drops), wet yourself, or wet your pads or undergarments when you 
bend down or lift something up? 
A2:  Rarely, once in a while, often, most of the time, all of the time, none of the time 
 
Q3: Do you leak urine (even small drops), wet yourself, or wet your pads or undergarments when you 
walk quickly, jog or exercise?  
A3:  Rarely, once in a while, often, most of the time, all of the time, none of the time 
 
Q4: Do you leak urine (even small drops), wet yourself, or wet your pads or undergarments while you 
are undressing in order to use the toilet?  
A4:  Rarely, once in a while, often, most of the time, all of the time, none of the time 
 

 
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Q5: 
Do you get such a strong and uncomfortable need to urinate that you leak urine (even small 
drops) or wet yourself before reaching the toilet?  
A5:  Rarely, once in a while, often, most of the time, all of the time, none of the time 
 
Q6: Do you have to rush to the bathroom because you get a sudden, strong need to urinate?  
A6:  Rarely, once in a while, often, most of the time, all of the time, none of the time 
 
Each item scores 0 (None of the time), 1 (Rarely), 2 (Once in a while), 3 (Often), 4 (Most of the time) or 5 
(All of the time). Responses to items 1, 2 and 3 are summed for the Stress score; and responses to items 
4, 5, and 6 are summed for the Urge score.  
IIQ-7 Questionnaire 
Q1: Has urine leakage affected your ability to do household chores (cooking, cleaning, laundry)? 
A1: 
Not at all, a little bit, moderately, greatly 
 
Q2: Has urine leakage affected your physical recreation such as walking, swimming, or other exercise? 
A2: 
Not at all, a little bit, moderately, greatly 
 
Q3: Has urine leakage affected your entertainment activities (movies, concerts, etc.)? 
A3: 
Not at all, a little bit, moderately, greatly 
 
Q4: Has urine leakage affected your ability to travel by car or bus more than 30 minutes from home? 
A4: 
Not at all, a little bit, moderately, greatly 
 
Q5: Has urine leakage affected your participation in social activities outside your home? 
A5: 
Not at all, a little bit, moderately, greatly 
 
Q6: Has urine leakage affected your emotional health (nervousness, depression, etc.)? 
A6: 
Not at all, a little bit, moderately, greatly 
 
Q7: Has urine leakage affected your feeling frustrated? 
A7: 
Not at all, a little bit, moderately, greatly 
Baseline measurement. No exclusion. 
 
Pelvic Floor Disability Index (PFDI-20) 
While answering these questions, please consider your symptoms over the last 3 months. 
Symptom scale: 0 = not present ,1= not at all ,2 = somewhat, 3 = moderately, 4 = quite a bit 
 
Pelvic Organ prolapse Distress Inventory 6 (POPDI-6)  
Do You… 
1. Usually experience pressure in the lower abdomen? 
2. Usually experience heaviness or dullness in the pelvic area? 
3. Usually have a bulge or something falling out that you can see or feel in your vaginal area? 
4. Ever have to push on the vagina or around the rectum to have or complete a bowel movement? 
5. Usually experience a feeling of incomplete bladder emptying? 
6. Ever have to push up on a bulge in the vaginal area with your fingers to start or 

 
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complete urination? 
 
Colorectal-Anal distress Inventory 8 (CRAD-8) 
Do You… 
7.    Feel you need to strain too hard to have a bowel movement? 
8.    Feel you have not completely emptied your bowels at the end of a bowel movement? 
9.    Usually lose stool beyond your control if your stool is well formed? 
10.  Usually lose stool beyond your control if your stool is loose? 
11.  Usually lose gas from the rectum beyond your control? 
12.  Usually have pain when you pass your stool? 
13.  Experience a strong sense of urgency and have to rush to the bathroom to have abowel 
movement? 
14.  Does part of your bowel ever pass through the rectum and bulge outside during orafter a bowel 
movement? 
 
Urinary distress Inventory 6 (UDI-6) 
Do You… 
15.  Usually experience frequent urination? 
16.  Usually experience urine leakage associated with a feeling of urgency, that is, a strong sensation     
of needing to go to the bathroom? 
17.  Usually experience urine leakage related to coughing, sneezing or laughing? 
18.  Usually experience small amounts of urine leakage (that is, drops)? 
19.  Usually experience difficulty emptying your bladder? 
20.  Usually experience pain or discomfort in the lower abdomen or genital region? 
Baseline measurement. No exclusion. 
 
C. POST-STUDY QUESTIONNAIRES 
Welcome back! 
Thank you very much for participating in our study! We are almost at the end. Please answer the 
following questions honestly and to the best of your knowledge. The full questionnaire will take less 
than 10 minutes of your time. Your answers should refer to the period of time during which you wore 
the Pippa Fitness Pessary. Please respond to all questions honestly and to the best of your knowledge. 
Thank you for your time and effort! 
 
 

 
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PGI-C: Patient Global Impression Scales 
Q: 
Please choose the response below that best describes the overall change in your SUI while 
wearing the device.  
A:  
Very much better, much better, a little better, no change, a little worse, much worse, very much 
worse 
PGI-S: Patient Global Impression Scales 
Check the one number that best describes how your urinary tract condition is while wearing the device.  
□ 
0 – normal 
□ 
1 – mild 
□ 
2 – moderate 
□ 
3 – severe 
QUID Questionnaire 
Please choose the responses below that best describes your SUI while wearing the device.  
Q1: Do you leak urine (even small drops), wet yourself, or wet your pads or undergarments when you 
cough or sneeze?   
A1:  Rarely, once in a while, often, most of the time, all of the time, none of the time 
 
Q2: Do you leak urine (even small drops), wet yourself, or wet your pads or undergarments when you 
bend down or lift something up? 
A2:  Rarely, once in a while, often, most of the time, all of the time, none of the time 
 
Q3: Do you leak urine (even small drops), wet yourself, or wet your pads or undergarments when you 
walk quickly, jog or exercise?  
A3:  Rarely, once in a while, often, most of the time, all of the time, none of the time 
 
Q4: Do you leak urine (even small drops), wet yourself, or wet your pads or undergarments while you 
are undressing in order to use the toilet?  
A4:  Rarely, once in a while, often, most of the time, all of the time, none of the time 
 
Q5: Do you get such a strong and uncomfortable need to urinate that you leak urine (even small 
drops) or wet yourself before reaching the toilet?  
A5:  Rarely, once in a while, often, most of the time, all of the time, none of the time 
 
Q6: Do you have to rush to the bathroom because you get a sudden, strong need to urinate?  
A6:  Rarely, once in a while, often, most of the time, all of the time, none of the time 
 
Each item scores 0 (None of the time), 1 (Rarely), 2 (Once in a while), 3 (Often), 4 (Most of the time) or 5 
(All of the time). Responses to items 1, 2 and 3 are summed for the Stress score; and responses to items 
4, 5, and 6 are summed for the Urge score. 
IIQ-7 Questionnaire 
Q1: Has urine leakage affected your ability to do household chores (cooking, cleaning, laundry)? 
A1: 
Not at all, a little bit, moderately, greatly 
 

 
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Q2: Has urine leakage affected your physical recreation such as walking, swimming, or other exercise? 
A2: 
Not at all, a little bit, moderately, greatly 
 
Q3: Has urine leakage affected your entertainment activities (movies, concerts, etc.)? 
A3: 
Not at all, a little bit, moderately, greatly 
 
Q4: Has urine leakage affected your ability to travel by car or bus more than 30 minutes from home? 
A4: 
Not at all, a little bit, moderately, greatly 
 
Q5: Has urine leakage affected your participation in social activities outside your home? 
A5: 
Not at all, a little bit, moderately, greatly 
 
Q6: Has urine leakage affected your emotional health (nervousness, depression, etc.)? 
A6: 
Not at all, a little bit, moderately, greatly 
 
Q7: Has urine leakage affected your feeling frustrated? 
A7: 
Not at all, a little bit, moderately, greatly 
 
Pelvic Floor Disability Index (PFDI-20) 
While answering these questions, please consider your symptoms while you were wearing the Pippa  
Fitness Pessary. 
Symptom scale: 0 = not present ,1= not at all ,2 = somewhat, 3 = moderately, 4 = quite a bit 
 
Pelvic Organ prolapse Distress Inventory 6 (POPDI-6)  
Do You… 
7. Usually experience pressure in the lower abdomen? 
8. Usually experience heaviness or dullness in the pelvic area? 
9. Usually have a bulge or something falling out that you can see or feel in your vaginal area? 
10. Ever have to push on the vagina or around the rectum to have or complete a bowel movement? 
11. Usually experience a feeling of incomplete bladder emptying? 
12. Ever have to push up on a bulge in the vaginal area with your fingers to start or 
complete urination? 
 
Colorectal-Anal distress Inventory 8 (CRAD-8) 
Do You… 
7.    Feel you need to strain too hard to have a bowel movement? 
8.    Feel you have not completely emptied your bowels at the end of a bowel movement? 
9.    Usually lose stool beyond your control if your stool is well formed? 
10.  Usually lose stool beyond your control if your stool is loose? 
11.  Usually lose gas from the rectum beyond your control? 
12.  Usually have pain when you pass your stool? 
13.  Experience a strong sense of urgency and have to rush to the bathroom to have abowel 
movement? 
14.  Does part of your bowel ever pass through the rectum and bulge outside during orafter a bowel 
movement? 
 

 
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Urinary distress Inventory 6 (UDI-6) 
Do You… 
15.  Usually experience frequent urination? 
16.  Usually experience urine leakage associated with a feeling of urgency, that is, a strong sensation     
of needing to go to the bathroom? 
17.  Usually experience urine leakage related to coughing, sneezing or laughing? 
18.  Usually experience small amounts of urine leakage (that is, drops)? 
19.  Usually experience difficulty emptying your bladder? 
20.  Usually experience pain or discomfort in the lower abdomen or genital region? 
 
 
Likelihood to Recommend 
Q: 
How likely is it that you would recommend the Pippa Fitness Pessary to a friend or colleague? 
NOT AT ALL LIKELY 
 
 
 
 
 
EXTREMELY LIKELY 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
A: 
Scale of 10, where “not at all likely” = 1 and “extremely likely” = 10 
 
User Satisfaction Survey 
Q: 
Overall, how satisfied or dissatisfied are you with the Pippa Fitness Pessary 
A: 
o Very satisfied 
o Somewhat dissatisfied 
o Somewhat satisfied 
o Very dissatisfied 
o Neither satisfied nor dissatisfied 
 
 
 
User Experience Questions 
Q1: 
Choose three words to describe the Pippa Fitness Pessary. 
A1: 
 
 
 
 
 
 
Q2:  Please evaluate the following statement: “The Pippa Fitness Pessary was easy to use.” 
A2: 
o 
Strongly agree 
o 
Disagree 
o 
Agree 
o 
Strongly disagree 
o 
Neither agree nor disagree 
 
Q3:  Please evaluate the following statement: “The Pippa Fitness Pessary improved my confidence in 
social situations.” 
A3: 
o 
Strongly agree 
o 
Disagree 
o 
Agree 
o 
Strongly disagree 
o 
Neither agree nor disagree 
 
 

 
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Q4:  Please evaluate the following statement: “The Pippa Fitness Pessary improved my confidence in 
physically active situations.” 
A4: 
o 
Strongly agree 
o 
Disagree 
o 
Agree 
o 
Strongly disagree 
o 
Neither agree nor disagree 
 
 
Q5:  Please evaluate the following statement: “The Pippa Fitness Pessary was comfortable to wear.” 
A5: 
o 
Strongly agree 
o 
Disagree 
o 
Agree 
o 
Strongly disagree 
o 
Neither agree nor disagree 
 
 
 
Q6:  Given the option, how likely are you to use the Pippa Fitness Pessary again? 
A6: 
o 
Extremely likely 
o 
Not so likely 
o 
Very likely 
o 
Not at all likely 
o 
Somewhat likely 
 
 
Q7: 
Please offer any suggestions or feedback for the makers of the Pippa Fitness Pessary. 
A7: 
 
 
 
 
 
 
Q8: 
Please share any additional comments. 
A8: 
 
 
 
 
 
 
 
 

 
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Observational Study Interest 
Q: 
We plan to conduct a new study of the Pippa Fitness Pessary that simply involves wearing it as one 
wishes for 6 months. Do you agree to be contacted to participate in this study?  
A: 
Yes / no  
 
Exit Interview Questions (to be recorded for automated transcription) 
Q1: 
How would you describe this product and your experience to a friend? 
Q2: 
Please describe any lifestyle changes you made while using the product? 
Q3: 
Is there anything else you think we should know? 
 
 
 

 
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APPENDIX C – PAD WEIGHT TEST PREPARATIONS WORKSHEET 
 
● Before each test session, complete all the preparations described here. 
● Check every box in the right-hand column. 
 
IMPORTANT:   If you are enrolled in the formal study, you will complete a second 1-hour pad weight test 
during treatment. Keep this worksheet. The second test should be as similar as possible to the first test. 
So make sure that you choose a location for the test, and for your 30-minute walk, that you can use 
again in future.  
 
Min. 
 
Test Session Activities 
1st Test 
2nd Test  
(+ device) 
5 
Get ready for the 
call 
• Make sure you have good internet access 
• Have the call-in instructions handy 
• Choose a private time and location. 
• Wear comfortable clothes, suitable for light 
exercise, including a supportive bra (sports 
bra). 
 
 
 
 
 
 
 
 
15 
Drink water and 
rest 
• Have access to a restroom. 
• Have access to drinking water. 
 
 
 
 
30 
Go for a walk and 
climb one flight of 
stairs 
 
• Have a plan for where to walk. 
• 
outdoors if the weather is good 
• 
inside a large building 
• 
on a treadmill 
• 
up and down a hallway 
• Have a plan for where to climb one flight of 
stairs. 
• Have a change of clothes, if needed. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
15 
Perform several 
physical activities 
• Set up your video call for easy visibility. 
• Get a side chair you can move around 
easily. 
 
 
 
 
5 
Prepare return 
shipping of Clinical 
Pak 
• Have a mobile phone nearby. 
• Have ready the address from which you 
would like FedEx to pick up your study 
materials. 
 
 
 
 
 
 
 
 

 
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Instructions for joining the telehealth session: 
 The time and date of your session is indicated on a sticker inside the box lid of the pad weight test 
materials that you received in the mail. 
 The test facilitator will send you a tele-conference invitation and confirmation for each session. 
 Make sure to confirm the invitation.  
 
If you lose connection during the session, please dial back in with the same ID and passcode. 
 
Instructions for return shipping: 
 
Please return ship within 24 hours. You may either schedule a pick up, or drop off the package at a 
FedEx Express location. 
 
Drop off at FedEx location:  
 
You may drop off your Clinical Pak at any FedEx Express Drop Box near you.  
You can look up the nearest drop box here: fedex.com/locate. Or you can call 1.800.463.3339. 
 
Schedule a FedEx pick up: 
 
1. Have the pick-up address and your phone number ready  
2. If needed, have instructions ready for the pick-up driver (example: porch, lobby, doorbell  etc.) 
3. Call FedEx at 1-800-463-3339 
4. FedEx uses automation to schedule the pick up. It can be confusing to answer the questions. 
Here are the answers you need to provide: 
a. Ask for “Express Return” 
b. Answer: There is no stamp on the label 
c. Answer: Provide tracking number 
d. Answer: Provide pick up address 
e. Answer: Provide pick up phone number 
f. 
Answer: Provide earliest/latest pick up time (example: “after 4 pm same day”) 
g. Answer: Provide optional pick up instructions 
 
 
 
 
 
 
 
 
 
 
               Tracking Number 
 
 
 

 
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APPENDIX D – PRE-ENROLLMENT CLINIC VISIT INVITATION 
 
 
To: [Study Candidate] 
 
● You are invited for a clinical assessment based on your recent 1-hour Pad Weight Test.  
● The clinic visit will determine if you meet all of the many requirements for our study. 
● You will be paid $25 at the end of your visit. 
 
Assessment Activities (approximately 40 minutes) 
The visit includes three types of assessments. If you pass each assessment, you will have the opportunity 
to enroll in the full study.  
 
The three assessments are: 
 
1. Clinical Exam (~5 minutes) 
The clinician will conduct a vaginal exam, similar to a yearly gynecological checkup.  
 
2. Cough Stress Test (~10-15 minutes) 
This test involves drinking water and then coughing vigorously, while a clinician monitors for 
visible leakage.  
 
3. Device Fit Assessment (~20 minutes) 
This assessment will determine if the investigational device fits you. The device is a vaginal 
pessary to be worn in the vagina to help control involuntary urine leakage. You will be asked to 
use the device as you would at home, based on package labeling and instructions. Then the 
clinician will check to see if the device fits you. 
 
Enrollment (approximately 10 minutes) 
If you are confirmed eligible for the study and enrolled as a study participant, then you will complete a 
short survey about your current incontinence symptoms. The researcher will also explain the home 
phase of the study and provide all necessary materials. 
 
 

 
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APPENDIX E – STUDY PARTICIPANT GUIDE 
 
Hello! 
Dear Participant, 
 
You have passed the clinical assessment and have been invited to enroll in the full study.  
 
Thank you for taking part in the Clinical Trial of the self-administered Pippa Fitness Pessary (“the 
Pessary”) for adult women with stress urinary incontinence (SUI), hereafter referred to as “the study” or 
“the user experience study.” This study plan has been cleared as safe and ethical by an Institutional 
Review Board (IRB) comprised of medical study experts.  
 
I will be the Study Coordinator and look forward to supporting you with any questions or issues you may 
have. 
[Key Contact Name] 
[Key Contact Job Title] 
[Key Contact Employer Address][ 
Key Contact Email Address] 
[Key Contact Phone Number] 
 
 
 
What are we looking for from you? 
We are asking you to wear the Pippa Fitness Pessary (“the Pessary”) on a particular schedule, and track 
leaking episodes on paper.. Most of all, we ask that you give us your honest feedback on surveys and in 
the exit interview. 
 
What can you expect from us? 
This Study Participant Guide walks you through the study phases and tasks and provides a checklist for 
all the activities. You have also been provided with the Pessary and applicator and Instructions for Use, 
which includes information on routine product care, possible side effects, and medical warnings. 
 
Can I stop using the product if I want to? 
Yes, you can stop using the product at any time without asking for permission. However, you must 
inform the Study Coordinator of any changes or pauses in the study schedule.  
 
What if something goes wrong? 
If you feel you are experiencing a medical emergency, seek medical treatment immediately or call 911. 
Should you experience any pain, discomfort, abnormal bleeding, fever or other side effects – regardless 
of their cause, you must let the Study Coordinator know immediately. 
  
Our primary request during the study, and for any survey you complete, is that you be honest and 
forthcoming. 
 
 

 
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Study Overview & Schedule 
The study takes places at home and includes daily digital reminders from the research team. 
 
Week 1 
Week 2 
Week 3 
Week 4 
7 days of leakage 
tracking without use 
of the Pessary 
14 days of Pessary use during waking hours, 
with ongoing urinary leakage tracking 
1-hour pad 
weight test with 
Pessary use 
Follow-up clinic 
visit and materials 
return  
 
Summary of Activities 
The study consists of multiple activities over 4 weeks of time. 
● Week 1: urinary leakage and symptom tracking without the Pessary 
● Weeks 2 & 3: urinary leakage and symptom tracking with the Pessary 
● Week 4: a 1-hour pad weight test with Pessary use, followed by a final clinic visit 
You will confirm with the Study Coordinator on what day you wish to start the study. You must sign up 
to receive text messages one day prior to your desired start date. During the study, you will follow your 
regular daily routines, including any type of work and leisure activities.  
 
Scheduling and Menstruation 
The Pessary may be worn during menstruation, in combination with menstrual pads. (You may not wear 
tampons or a menstrual cup together with the Pessary. Having multiple devices in the vagina may 
increase the risk of toxic shock syndrome during menses.) However, if you prefer, the study can be 
scheduled to avoid your period, or put on hold during that time if it starts unexpectedly. Although the 
Pessary may impede menstrual flow, it does not stop it or collect it (like a menstrual cup). So, during 
your period, be mindful that removal of the pessary might be messy. 
 
The 1-hour pad weight study must take place between periods, as menstrual flow will prevent an 
accurate assessment of urinary leakage. 
 
Study Communications 
Throughout the study you will receive twice-daily text messages with reminders. You will also be 
contacted by telephone at least twice. At the end of the home use phase, the Study Coordinator will 
reach out to confirm appointments for the 1-Hour Pad Weight Test with Pessary use and the final clinic 
visit.  
 
Study Materials 
The research team will provide you with all materials needed to complete the home study. It is 
imperative that you protect these materials, as they must be returned to the clinic at the follow-up clinic 
visit in exchange for final study compensation. 

 
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Pippa Fitness Pessary Kit 
• Instructions for Use 
• Pessaries (2) 
• Reusable applicator 
• Water-based lubricant 
• Water-based cleanser 
Paperwork 
• This participant guide 
• Paper records to track leakage 
and pessary use 
 
Pad Weight Testing Kit 
• Instructions  
• Incontinence pads (2) 
• Water bottle (if needed) 
• Activity tracker 
• FedEx return mailer 
At Home Study Details 
 
WEEK 1 – Leakage Tracking 
DAYS 
ACTIVITY 
Check 
 
1-7 
 Follow your regular daily routines 
 Track leaking episodes and known causes in the paper record 
 
 
 
During the first seven days of the study, you will not be using the Pessary.  
 
You will record your leakage episodes in the paper record. This part of the study will help us understand 
how much you leak ordinarily. If you usually wear incontinence pads during the day, or for specific 
activities, you should continue to do so. 
 
Leakage information is very, very important for this study. Please create a habit of recording every leak 
during this at-home phase. 
 
 
WEEKS 2 & 3 – Leakage Tracking with Pessary Use 
DAYS 
ACTIVITY 
Check 
 
8-21 
 Wear the Pessary daily (and keep a record of insertion and removal ) 
 Follow your regular daily routines  
 Track leaking episodes and known causes in the paper record 
 Track any other noticeable symptoms 
 
 
 
 
 
 
During the subsequent fourteen days, you will wear the Pippa Fitness Pessary every day during waking 
hours.  
 
You will continue to record your leakage episodes just as you did in the first week of the study. This 
phase of the study will help us understand if the Pessary works as intended for you, by helping to reduce 
or eliminate urine leakage. If you usually wear incontinence pads during the day, or for specific activities, 
you may continue to do so.  
 

 
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You will be expected to report on leakage episodes throughout the day, noting if the leak occurred with 
or without pessary use. You will record pessary insertion and removal times, days of menstruation and 
any side effects or concerning symptoms.  
 
It is essential that you fill out the paper record every day of the study and bring it to the clinic when you 
return! 
 
Preparation for Weeks 2 and 3  
• Carefully read this guide.  
• Determine where you will store the Pessary for air-drying overnight. 
• Re-read the Pessary Instructions for Use carefully. (Make sure, always make sure, that you wash your 
hands properly before inserting or removing the Pessary.) 
 
Daily Study Compliance 
• Wear the Pessary during waking hours. 
• Keep track of leakage episodes and their causes on the paper record. 
• Keep track of Pessary use on the paper record. 
• Disclose any noticeable symptoms of a possible side effect. 
• Care for the Pessary as required by the Instructions for Use.  
• Respond to any additional communications from the research team. 
 
Possible Side Effects or Adverse Events 
During the weeks of Pessary use, there is a possibility you may experience side effects and/or adverse 
events. Potential side effects may include excess vaginal discharge, discomfort, dislodging, spotting or 
pain. Potential adverse events could include vaginal irritation, infection, or erosion and/or Toxic Shock 
Syndrome. 
 
 
WEEK 4 – Final Pad Weight Test & Follow-up Clinic Visit 
DAY 
ACTIVITY 
Check 
 
22-23 
 1-hour pad weight study performed while wearing the Pippa Fitness Pessary  
 Return to clinic for follow-up exam, survey, interview, and materials return 
 
 
 
 
For the final week of the study you will perform a second 1-hour pad weight test with a Pessary, and 
then return to the clinic for the follow-up clinical assessment. The Study Coordinator will contact you to 
confirm both appointments: 
• You will need to use the Pessary one more time for the second 1-Hour Pad Weight Test, and 
• You must bring the 21-Day Leakage Episodes Record and the Pippa Fitness Pessary kit back for the 
follow-up Clinic Visit. 
 
1-Hour Pad Weight Test with Pessary 
When the time comes, follow the provided instructions to prepare by collecting your materials and 
setting up your space. Dial into the telehealth appointment and perform the same set of activities you 

 
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did for the first test, this time with the pessary. Reminder: This test may not be performed during a 
menstrual cycle. At the end of the test, you will return the provided incontinence pads and activity 
monitor via FedEx, just as you did after the pre-enrollment test. 
 
Follow-up Clinic Visit 
Your follow-up clinic visit will be scheduled after the in-home study phase is complete. You must return 
the 21-Day Leakage Episodes Record and the Pippa Fitness Pessary kit to the clinic in order to complete 
the study and receive payment. The clinic visit will include a physical exam, a survey, a brief interview, 
materials return, and confirmation of payment.  
 
Final Note 
Our primary request during the study, and for any survey you complete, is that you be honest and 
forthcoming.  
 

 
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APPENDIX F – 21-DAY LEAKAGE EPISODES RECORD 
 
 

 
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APPENDIX G – DAILY COMMUNICATIONS 
 
Daily communications will be facilitated by a third-party mobile text messaging service called SlickText, 
provided by Slick Innovations, LLC and carefully configured for the study needs by the research team.  
 
Participant-facing communications will include A) instructions to participants sent automatically on a 
daily schedule, and may include B) tailored versions of automated messages that are sent upon possible 
user behaviors like opting out or seeking help with the mobile text messaging service. 
 
A. Scheduled and Automated Instructional Messages 
 
STUDY DAY 
MESSAGING 
PURPOSE 
Communications Preparation 
0 
(text opt-in) 
Hello study participant!  
 
Your phone number is now ready to receive reminder messages from the 
research team at [clinic name]. Messages will be sent daily for three 
weeks, starting tomorrow morning.  
 
If at any time you need to pause or withdraw from the study, you must 
contact [name of Study Coordinator] for assistance. Upon study 
completion, text STOP and your phone number will be deleted from the 
mobile text messaging service.  
 
You can reply HELP for help or STOP to opt out of text messages. Message 
& data rates apply. Terms and privacy policy can be found at 
getapessary.com/communications. 
 
 
 
Opt-in to use text 
message service 
MORNINGS  
Daily Report Summary for "Yesterday" (w/o pessary) 
1 
Good Morning! For the next three weeks you will track any leaking 
episodes and noticeable symptoms in your paper record. SAVE THE PAPER 
RECORD. IT MUST BE RETURNED TO THE CLINIC WHEN YOU RETURN. If 
you have any questions or concerns, please call the Study Coordinator at 
XXX-XXX-XXXX. 
Assign journal use 
2-7 
Good Morning! Please remember to track any leaking episodes in your 
paper record. 
Reminder 
8 
Good morning! Today you will start wearing the Pippa Fitness Pessary. You 
must track pessary use and any leaking episodes in your paper record. Be 
sure to record every pessary insertion and removal. If you have any 
questions or concerns, please call the Study Coordinator at XXX-XXX-XXXX. 
Set up pessary use 
Reminder for 
tracking 
Daily Report Summary for "Yesterday" with Pessary 
9-20 
Good morning! Today you will wear the Pippa Fitness Pessary again and 
track any leaking episodes. If you have any questions or concerns, please 
call the Study Coordinator at XXX-XXX-XXXX. 
Reminder to wear 
Confirm leak 
tracking 
 

 
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STUDY DAY 
MESSAGING 
PURPOSE 
21 
Good morning! Today is the final day for using the Pippa Fitness Pessary.  
 
22 
Good morning!  
If you are not already scheduled for your second 1-hour Pad Weight Test 
and final clinic visit, please contact the Study Coordinator at XXX-XXX-
XXXX. We look forward to seeing you at the clinic soon!  
Confirm Session 
EVENINGS  
Nightly Reminders for Leak Logging 
1-6 
Good evening! Remember to complete your leakage tracking record 
tonight. If you have any questions or concerns, please call the Study 
Coordinator at XXX-XXX-XXXX. 
Tracking reminder 
Catch issues 
7 
Good evening! Week one is almost over. Tomorrow you will start using the 
Pippa Fitness Pessary. If for any reason you cannot start as planned, please 
contact the Study Coordinator at XXX-XXX-XXXX. Over the next two weeks, 
continue to track any leaking episodes or noticeable symptoms while 
wearing the Pippa Fitness Pessary.  
 
Nightly Reminders for Leak Logging and Pessary Use Tracking 
8-13  
&  
15-20 
Good evening! Don’t forget to record your leakage and pessary use 
information. If you have any questions or concerns, please call the Study 
Coordinator at XXX-XXX-XXXX. 
Tracking reminder 
Catch issues 
14 
Good evening! One more week to go. You will continue using the Pippa 
Fitness Pessary next week. Remember to track any leakage episodes and 
record details of pessary use. If you have any questions or concerns, 
please call the Study Coordinator at XXX-XXX-XXXX. 
21 
Congratulations! You have nearly completed the at-home phase of the 
Pippa Fitness Pessary study.  
 
 
B. Standard (Non-Editable) SlickText Service Messages 
 
Reply message for “STOP" 
 
NETWORK MSG: You replied with the word "stop" which blocks all texts 
sent from this number. 
 
Text back "unstop" to receive messages again. 
 

 
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Reply message for “UNSTOP” 
NETWORK MSG: You replied with the word "unstop" and will begin 
receiving messages again from this number. 
 
Reply message for “HELP” 
Pippa Fitness Pessary Study SMS Alerts: Help: getapessary.com or 
[research team email]. 5msg/mth. Reply STOP to cancel. Msg&data rates 
may apply. 
 
Reply message for “CANCEL” 
You are now opted out of Pippa Fitness Pessary Study SMS Alerts. No more 
messages will be sent. Reply HELP for help. Report spam 
to spam@slicktext.com.” (Study team can create a “spam@emailaddress” 
in order to be alerted to this action.) 
 
Rejoining the Service after a 
Pause 
 
You have rejoined [TEXTWORD]! Thanks for coming back! Msg&data rates 
may apply. 
 
Reply STOP to cancel, HELP for help. Msg&data rates may apply. Terms & 
privacy: [link to Terms & Privacy] 
 
 
Terms & Privacy 
To be posted at getapessary.com/communications 
 
MOBILE TEXT MESSAGING TERMS & CONDITIONS 
 
Who operates this mobile text messaging service? 
This mobile text messaging service, known as “SlickText,” is operated by a technology company called Slick 
Innovations, LLC. The service has been carefully configured for the Pippa Fitness Pessary Study by the clinical 
research team. The service will provide automated communications to make study participation easier. You will 
receive no promotional messaging. 
 
What does SlickText do with my information? 
SlickText is a 100% opt-in service. They do not provide lists of phone numbers nor do they access or share their 
users' contact lists. To can access their privacy policy here [hyperlink to 
https://www.slicktext.com/privacypolicy.php]. 
 
What are your mobile terms? 
When you provide us with your mobile phone number, you agree that our research team may send you text 
messages (including SMS and MMS) to that phone number. Our research team may send you up to 50 study-
related messages over the course of the study.  
 
You will receive a confirmation text message, and you may need to reply as instructed to complete registration. 
Message and data rates apply. Reply STOP to cancel, HELP for help. You agree to receive a final text message 
confirming your opt-out. You may opt-out at any time by texting the word STOP to shortcode 31996. For help, 
send a text message with the keyword HELP to shortcode 31996.  
 
Texts may be sent through an automatic telephone dialing system. You agree to notify us of any changes to your 
mobile number. Your carrier may prohibit or restrict certain mobile features and certain mobile features may be 
incompatible with your carrier or mobile device. Contact your carrier with questions regarding these issues. 
 
How do I sign up for these text messages? 
All you have to do is text "[TEXTWORD]" to 31996. When you opt-in to the service, we will send you an SMS 
message to confirm your signup. 
 
If at any time you forget what keywords are supported, just text HELP to 31996. After you send the SMS 
message HELP to us, we will respond with instructions on how to use the service as well as how to unsubscribe. 
 

 
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How do I opt out of these text messages? 
You can cancel the SMS service at any time. Just text STOP to 31996. After you send the SMS message STOP to 
us, we will send you an SMS message to confirm that you have been unsubscribed.   
 
Opting out of text messages will not automatically withdraw you from the study. If you wish to withdraw from 
the study, you must directly contact the Study Coordinator. 
 
Will I be charged for the text messages I receive? 
Our research team will never charge you for the text messages you receive. However standard message and 
data rates may apply for any messages sent to you from us and to us from you.  
 
You will receive up to 50 messages over the course of the study. If you have any questions about your text plan 
or data plan, it is best to contact your wireless provider.  
 
For all questions about the services provided through the number 31996, you can send an email to 
info@slicktext.com. 
 
Supported wireless carriers 
 
United States 
We are able to deliver messages to the following mobile phone carriers: Major carriers: AT&T, Verizon Wireless, 
Sprint, T-Mobile, MetroPCS, U.S. Cellular, Alltel, Boost Mobile, Nextel, and Virgin Mobile. Minor carriers: Alaska 
Communications Systems (ACS), Appalachian Wireless (EKN), Bluegrass Cellular, Cellular One of East Central IL 
(ECIT), Cellular One of Northeast Pennsylvania, Cincinnati Bell Wireless, Cricket, Coral Wireless (Mobi PCS), COX, 
Cross, Element Mobile (Flat Wireless), Epic Touch (Elkhart Telephone), GCI, Golden State, Hawkeye (Chat 
Mobility), Hawkeye (NW Missouri), Illinois Valley Cellular, Inland Cellular, iWireless (Iowa Wireless), Keystone 
Wireless (Immix Wireless/PC Man), Mosaic (Consolidated or CTC Telecom), Nex-Tech Wireless, NTelos, 
Panhandle Communications, Pioneer, Plateau (Texas RSA 3 Ltd), Revol, RINA, Simmetry (TMP Corporation), 
Thumb Cellular, Union Wireless, United Wireless, Viaero Wireless, and West Central (WCC or 5 Star Wireless). 
 
Canada 
Bell (including NorthernTel, Solo Mobile, and Telebec), Fido, MTS, Rogers, SaskTel, Telus (including Koodo 
Mobile and Public Mobile), Videotron, Virgin Mobile, and Wind. 
 
***This service and the carriers are not liable for delayed or undelivered messages*** 
 
MOBILE TEXT MESSAGING PRIVACY POLICY 
 
Our research team is dedicated to protecting your privacy and works hard to ensure our study tools are both 
safe and secure. 
 
Protection of Information 
Any information communicated to our research team for text messaging and or storage will remain in the 
ownership of the user, which will be stored securely in accordance with our security policy and the law. Our 
research team will take the necessary steps to secure your personal information with safeguards appropriate for 
this study, as outlined in the Informed Consent document you signed. 
 
Subscribing and Unsubscribing 
It is policy that, just as a user must opt into a text messaging service, they have the right to opt out of a 
particular text messaging service as well. When a user opts out of a text messaging service, they will no longer 
receive any texts unless they, themselves, re-subscribe. 
 
Opting out of text messages will not automatically withdraw you from the study. If you wish to withdraw from 
the study, you must directly contact the Study Coordinator. 
 
About Policy Changes 

 
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Our research team will notify you of any change to this privacy policy. Your continued use of this service after 
you have been notified of changes to terms and conditions or our privacy policy is taken as acceptance of those 
changes. This privacy policy is subject to and applicable to all privacy laws.  
 
You acknowledge that accepting this policy is a condition of your participation in our study and you agree to be 
bound by all of its terms and conditions.