Early Feasibility Prospective Open-Label Study to Assess the Function of a Novel Pessary for the Non-Surgical Management of Pelvic Organ Prolapse
Phase: NA
Conditions: Pelvic Organ Prolapse, Prolapse
Sponsor: Reia, LLC

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
REVISION HISTORY 
Version # 
Version Date 
Summary of Changes 
Approver 
1 
2/17/2020 
Submission to D-HH IRB for reliance letter 
PH 
2 
5/26/2020 
Include 2.25 and 2.5 in. diameter pessaries 
PH 
3 
9/13/2020 
Include 3 in. diameter pessaries (retracted) 
PH 
4 
11/5/2020 
Include ring pessaries users in inclusion 
criteria, include 3 inch diameter study 
pessaries, number of subject increased to 
15-20 
PH 
 
 
 
Protocol Number: 
CP-001 
NCT Number: 
NCT04275089 
Sponsor: 
Reia, LLC (“Reia”) 
331 River Road 
Lyme, NH  03768 
Medical Monitor: 
Paul Hanissian, MD 
331 River Road 
Lyme, NH  03768 
Principle 
Investigator: 
Kris Strohbehn, MD 
Study Site: 
Department of Obstetrics and Gynecology 
Dartmouth-Hitchcock Medical Center 
One Medical Center Drive 
Lebanon, NH  03756 
Kris.Strohbehn@Hitchcock.org  
Direct phone number for office of the PI: 603 653-9312 
24-hour phone number: 603 650-5000 
Early Feasibility Prospective Open-Label Study to 
Assess the Function of a Novel Pessary for the 
Non-Surgical Management of Pelvic Organ 
Prolapse 

 
 
 
 
 
PROTOCOL TITLE: Early Feasibility Prospective Open Label Study to Assess the 
Function of a Novel Pessary for the Non-Surgical Management of Pelvic Organ Prolapse 
 
 
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Table of Contents 
 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives ................................................................................................................ 4 
3.0 
Background .............................................................................................................. 4 
4.0 
Study Endpoints ....................................................................................................... 5 
5.0 
Study Intervention/Investigational Agent ................................................................ 6 
6.0 
Procedures Involved................................................................................................. 7 
Methods........................................................................................................................... 7 
Study Procedures ............................................................................................................ 7 
Data Collected ................................................................................................................. 8 
Transition from Research Participation ........................................................................ 10 
7.0 
Data and Specimen Banking .................................................................................. 10 
8.0 
Sharing of Results with Subjects ........................................................................... 10 
9.0 
Study Timelines ..................................................................................................... 10 
10.0 Inclusion and Exclusion Criteria ............................................................................ 10 
Sex of Subjects .............................................................................................................. 10 
Age of Subjects ............................................................................................................. 10 
Racial and Ethnic Origin ............................................................................................... 10 
Inclusion Criteria .......................................................................................................... 11 
Exclusion Criteria ......................................................................................................... 11 
Vulnerable Subjects ...................................................................................................... 11 
11.0 Vulnerable Populations .......................................................................................... 11 
12.0 Local Number of Subjects ..................................................................................... 11 
13.0 Recruitment Methods ............................................................................................. 11 
Method of Subject Identification and Recruitment ....................................................... 11 
Payment for Participation ............................................................................................. 12 
Alternatives to Participation ......................................................................................... 12 
14.0 Withdrawal of Subjects .......................................................................................... 12 
15.0 Risks to Subjects .................................................................................................... 12 
16.0 Potential Benefits to Subjects ................................................................................ 12 
17.0 Data Management and Confidentiality .................................................................. 13 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 13 
Data Analysis and Data Monitoring ............................................................................. 13 
Protection Against Risks ............................................................................................... 14 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 15 
20.0 Compensation for Research-Related Injury ........................................................... 15 
21.0 Economic Burden to Subjects ................................................................................ 16 

 
 
 
 
 
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22.0 Consent Process ..................................................................................................... 16 
Process of Consent ........................................................................................................ 16 
Subject Capacity ........................................................................................................... 16 
Subject Comprehension ................................................................................................ 17 
23.0 Process to Document Consent in Writing .............................................................. 17 
24.0 Setting .................................................................................................................... 17 
25.0 Resources Available............................................................................................... 17 
26.0 Multi-Site Research ............................................................................................... 18 
References ......................................................................................................................... 19 
 
 
 

 
 
 
 
 
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1.0 
Study Summary 
 
Table of Study Summary: 
 
Study Title 
Early Feasibility Prospective Open-Label Study to Assess the Function of a 
Novel Pessary for the Non-Surgical Management of Pelvic Organ Prolapse 
Study Design 
Early feasibility study of a medical device 
Primary 
Objective 
• To assess the ability of the study device to be retained during Valsalva 
compared to the ability of the subject’s current pessary to be retained during 
Valsalva (by measuring the distance from each pessary’s leading edge to the 
hymen) 
• To assess the ability of the study device to be retained throughout regular 
activity (by vaginal examination)  
Secondary 
Objective(s) 
• To assess the shape of the study pessary during expulsion if it is not able to be 
retained (by vaginal examination) 
• To assess the orientation of the study pessary stem following regular activity 
(by vaginal examination) 
• To assess the discomfort experienced with removal of the subject’s current 
pessary compared to the discomfort experienced with removal of the study 
pessary (by visual analog scale) 
• To assess the discomfort experienced with insertion of the subject’s current 
pessary compared to the discomfort experienced with insertion of the study 
pessary (by visual analog scale)  
• To globally assess the comfort associated with use of the study pessary (by 
verbal description)  
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Temporary placement and assessment of a novel vaginal pessary 
IND/IDE #  
Device to be considered for an abbreviated IDE (non-significant risk device) 
Study 
Population 
Current users of a ring style or Gellhorn pessary for treatment with Stage II or 
greater pelvic organ prolapse 
Sample Size 
15-20 
Study Duration 
for individual 
participants 
One hour 
Study Specific 
Abbreviations/ 
Definitions  
HRT – Hormone Replacement Therapy 
POP – Pelvic Organ Prolapse 
POP-Q – Pelvic Organ Prolapse Quantification 
UI – Urinary Incontinence 
VAS – Visual Analogue Scale 
FPMRS – Female Pelvic Medicine and Reconstructive Surgery 

 
 
 
 
 
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2.0 
Objectives 
This is an early feasibility, open-label, non-randomized trial to obtain preliminary 
information about the function and effectiveness of a novel vaginal pessary for the use in 
women who suffer from symptoms of pelvic organ prolapse (POP).  Recruited subjects 
will have Stage II POP or greater and will be current users of a legally marketed vaginal 
pessary. In a single visit, data will be collected on the performance and comfort of the 
subject’s current pessary. After fitting and placement of a study pessary, comparative 
data will be collected between subject’s current pessary and the study pessary on ability 
to support prolapse. The study pessary’s function will be assessed under controlled 
circumstances. The subject will have her current pessary replaced at the conclusion of the 
visit. Results will be used to inform future design modifications of the study pessary. 
 
3.0 
Background 
POP is a prevalent condition that can be observed in over 50% of women over the age of 
50.1 POP results from a weakening of the pelvic floor connective tissue and muscles, 
allowing the uterus or vaginal walls to descend.  Typical symptoms, which include bulge 
and pressure, urinary dysfunction, defecatory dysfunction, and sexual dysfunction, can 
result in physical discomfort, emotional distress, and disrupt activities of daily life.  
Using published data on weighted prevalence rates of specific pelvic floor disorders2 in 
conjunction with US census data, it can be estimated that the number of US women with 
symptomatic prolapse in 2016 was 3.6 million.  The lifetime risk for a woman to have 
surgery for pelvic organ prolapse is 12.6%, or 1:8.3 As the specialty of Female Pelvic 
Medicine and Reconstructive Surgery (FPMRS) matures and surgical outcomes are being 
followed with more scrutiny, it is becoming increasingly clear that surgical treatment 
options are less effective than once believed. The 3 most effective and commonly 
performed procedures for apical prolapse have estimated composite recurrence rates by 6 
years of 43%, 49%, and 57%.4  
 
The vaginal pessary is an effective treatment option which is inserted in the vagina and 
acts as a shelf resting upon the pelvic floor muscles to support the descending organs.  
Often, it is as effective to abate the burdens of prolapse as a successful reconstructive 
surgery. 77% of practicing urogynecologists recommend a vaginal pessary as the first 
line treatment option for their patients with POP.5 Based on this number, statistics cited 
above, and financial information from current pessary makers, there are ~2.3 million 
women in the United States who use a pessary for POP. A pessary is not surgically 
implanted and can be removed and reinserted but is only effective while in situ. The root 
cause failure of current pessaries in common use is their rigid and fixed design, which 
makes them difficult or impossible for patients to remove and insert independently. 
Consequently, medical practitioners in the United States see most pessary users 3-4 times 
per year to temporarily remove the pessary, clean it, examine the vagina for epithelial 
erosions, and then reinsert the pessary.6 These steps are needed to avoid preventable 
complications associated with long term pessary use which have been reported as high as 
56%7 and include vaginal erosion, bleeding, increased discharge, as well as discomfort 

 
 
 
 
 
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and dysfunction in voiding and defecation.8 Furthermore, women who experience less 
severe forms of prolapse and who do not need the support of their pessary outside of 
strenuous physical activity often must wear their pessary when not necessary, which 
induces additional lifestyle impacts such as impairing a woman’s ability to engage in 
sexual intercourse.  
 
The two most commonly used pessary types on the market are the ring style and the 
Gellhorn pessary. The Gellhorn pessary is clinically more effective to reduce the life 
impact of prolapse symptoms,9 and once fit has longer continuation rates than the ring 
with support (10.5 years vs. 1.8 years).10 Additionally, the Gellhorn successfully treated 
71% of women at 3 months who failed treatment with the ring with support.11 Yet most 
practitioners, particularly Ob/Gyn physicians who are not additionally specialized in 
FPMRS, preferentially prescribe the ring with support because it is easier and more 
intuitive to use. The Reia Vaginal Pessary (study pessary) has been engineered to 
overcome the liabilities related to difficulty for physicians and patients to remove and re-
insert the pessary. The Reia Vaginal Pessary has a structural form similar to the Gellhorn 
and is hypothesized to be simpler and more intuitive to use than the ring with support. 
 
4.0 
Study Endpoints 
The primary and secondary endpoints of the study are described in the following table: 
Type 
Name  
Time 
Frame  Brief Description  
Primary  
To assess the ability of 
the study device to be 
retained during 
Valsalva compared to 
the ability of the 
subject’s current 
pessary to be retained 
during Valsalva (by 
measuring the distance 
from each pessary’s 
leading edge to the 
hymen) 
During 
treatment 
The subject will be asked to Valsalva with their current 
pessary in place, and the distance from the leading edge 
of the current pessary to the hymen will be measured in 
centimeters. After the current pessary is removed and 
the patient is fit with an appropriate study pessary, the 
subject will be asked to Valsalva again. The distance 
from the leading edge of the study pessary to the hymen 
will be measured in centimeters. In order to assess the 
ability of the study pessary to function and be retained, 
the measurements will be compared.  
Primary 
To assess the ability of 
the study device to be 
retained throughout 
regular activity (by 
vaginal examination) 
During 
treatment 
With the study pessary in place, the subject will be 
asked to ambulate for 10 minutes and attempt to void. 
Following these activities, whether the pessary was 
retained or expelled will be recorded. 
Secondary 
To assess the shape of 
the study pessary 
during expulsion if it is 
not able to be retained 
(by vaginal 
examination) 
During 
treatment 
The subject will be asked to Valsalva. If the study 
device is expelled during Valsalva, whether the study 
device was expelled fully deployed or whether it 
prematurely folded to its collapsed state will be 
recorded. 

 
 
 
 
 
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Secondary 
To assess the 
orientation of the study 
pessary stem following 
regular activity (by 
vaginal examination) 
During 
treatment 
Following ambulation and attempting to void and prior 
to removing the study pessary, it will be recorded if the 
study device’s stem rotated out of its original inserted 
position. 
Secondary 
To assess the 
discomfort experienced 
with removal of the 
subject’s current 
pessary compared to 
the discomfort 
experienced with 
removal of the study 
pessary (by visual 
analog scale) 
During 
treatment 
To indicate discomfort, the subject will be shown and 
asked to mark a visual analogue scale (VAS) after 
removal of her current pessary and before using the 
study pessary. The VAS will be a 10 centimeter linear 
continuum in which 0 represents no pain and 10 
represents worst pain. After use of the study pessary 
and upon removal of the study pessary, the subject will 
be shown and asked to mark another VAS. In order to 
assess the discomfort experienced during removal of the 
study pessary, the distance from 0 to the subject’s mark 
will be measured and compared between the two scales. 
Secondary 
To assess the 
discomfort experienced 
with insertion of the 
subject’s current 
pessary compared to 
the discomfort 
experienced with 
insertion of the study 
pessary (by VAS) 
During 
treatment 
To indicate discomfort, the subject will be shown and 
asked to mark a VAS after insertion of the study 
pessary. The VAS will be a 10 centimeter linear 
continuum in which 0 represents no pain and 10 
represents worst pain. After use of the study pessary 
and upon insertion of the subject’s current pessary, the 
subject will also be shown and asked to mark another 
VAS. In order to assess the discomfort experienced 
during insertion of the study pessary, the distance from 
0 to the subject’s mark will be measured and compared 
between the two scales. 
Secondary 
To globally assess the 
comfort associated with 
use of the study pessary 
(by verbal description) 
Post 
treatment 
Following insertion of the subject's current pessary, and 
after the subject is dressed, she will be asked whether 
the study pessary was more, less, or as comfortable as 
her current pessary when it was in situ. If she responds 
it was more or less comfortable, she will be asked to 
describe why.  
 
Safety endpoints cannot be reasonably assessed in this study because risks to subjects are 
minimal given the short duration of the study intervention (anticipated to be 
approximately 30 minutes) and the nature of the planned intervention. Pain will be 
measured as described in the secondary endpoints above. Unanticipated events will be 
tracked and followed per established FDA guidelines for monitoring investigations of 
medical devices (21 CFR §812.46). 
 
5.0 
Study Intervention/Investigational Agent 
Please see attached document for device description and non-significant risk rationale.  
 

 
 
 
 
 
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6.0 
Procedures Involved 
Methods 
Current users of existing marketed pessaries typically present to their providers every 3-4 
months so that their pessary can be removed and cleaned and their vagina can be 
inspected for erosion caused by their device.  Fifteen subjects will be recruited for this 
study from a panel of established patients who present for this routine care of their ring 
style or Gellhorn pessary to a clinical practice at the Dartmouth-Hitchcock Clinic 
specializing in Female Pelvic Medicine and Reconstructive Surgery (FPMRS). Inclusion 
will be based on pre-defined criteria outlined in “10.0 Inclusion and Exclusion Criteria.” 
There will not be discrimination based on race or ethnicity. It is anticipated that most 
participants will be post-menopausal as this reflects the demographic of women who 
suffer from this disorder. Treatment intervention will be non-blinded to the subject and 
investigator and will occur in a single visit. Each subject will receive the study pessary 
and wear it in a controlled environment for less than 1 hour. Assessment of the study 
pessary’s performance to support the subject’s prolapse will be determined by measuring 
the baseline distance between the leading edge of each subject’s current pessary to the 
hymen and comparing that to the measured distance between the leading edge of the 
study pessary to the hymen, as well as by observing the ability of the study pessary to be 
retained with simulated activities of daily life such as walking and toileting.  Secondary 
outcomes of subject comfort with insertion, use, and removal of the study pessary will be 
measured. 
 
The study pessary is the only device which will be used in this trial, though the subject 
will arrive for her visit and leave with her current pessary. There will be no placebo 
devices placed. The study pessary is not cleared by the FDA, and a rationale is provided 
for a non-significant risk device claim in the attached documents. This trial was devised 
so that it could take place at the time in which subjects present for usual care of their 
current pessary, and the procedures are consistent with the standard of care at Dartmouth-
Hitchcock Medical Center, the site of the study.  
 
Study Procedures 
• Exam – Subject will be asked to disrobe and will be positioned in the lithotomy 
position per routine.  Visual inspection of the vulva will be conducted to note for 
atrophy and determine the absence of open wound or tear near the opening of the 
vagina or perineum [would be done anyway]. 
• Position of the current pessary will be determined in relation to hymen - subject will 
be asked to Valsalva, and the position of the leading edge of the current pessary in 
relation to the hymen will be recorded in centimeters [research purposes]. 
• The current pessary will be removed and the vagina will be inspected for erosion. 
Current pessary size and stem length will be recorded [would be done anyway].  Pain 
with removal will be recorded by VAS, a 10 centimeter linear continuum in which 0 
represents no pain and 10 represents worst pain.  Pelvic floor muscle strength will be 
subjectively recorded by the examiner by instructing the subject to “Kegel” with 

 
 
 
 
 
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examining fingers in the vagina [research purposes].  The current pessary will be 
washed with anti-bacterial soap and tap water [would be done anyway]. 
• The study pessary that maps to the size of the subject’s current pessary should be 
selected at random from the inventory of study pessaries will be removed from its 
sealed bag and the study pessary’s serial number (labeled on the bag) will be 
recorded. The study pessary will be lubricated and placed, and the position of the 
pessary in relation to the hymen will be recorded (in centimeters, with Valsalva).  
Pain with insertion will be recorded by a VAS administered with pessary insertion 
and removal.  If the study pessary is expelled with Valsalva, this will be recorded, and 
a notation will be made if it was expelled in its deployed state or secondary to it 
prematurely collapsing. In the event a 2.25 inch study pessary is expelled, the subject 
will be refit with a 2.5 inch study pessary and the steps in this section will be 
repeated.  Likewise, if a 2.5 inch study pessary is first selected and it is expelled, the 
subject will be refit with a 3 inch study pessary and the steps in this section repeated. 
[research purposes]. 
• The subject will dress, ambulate, and void - the subject will be asked to get dressed, 
walk for 10 minutes, void, and return to the office then disrobe again.  If the study 
pessary is expelled during this activity, this will be recorded [research purposes].  
• The study pessary will be removed.  The orientation of the study pessary inside the 
vagina will be noted prior to removal.  Discomfort with removal will be recorded by 
VAS. The study pessary will be washed with anti-bacterial soap and tap water and 
inserted into a resealable bag along with its original packaging. The used study 
pessary should be returned to Dr. Hanissian’s office which is adjacent to the clinic 
space where the study is being conducted [research purposes].  
• The current pessary will be re-inserted, [would be done anyway] and pain will be 
recorded by VAS [research purposes]. The subject will give a global impression of 
study pessary comfort in comparison to current pessary [research purposes]. 
 
Data Collected 
After the subject provides consent, the subject’s medical record will be abstracted for 
their medical history. The subject may be asked to clarify the medical record.  Data to be 
collected includes: 
Medical History 
• Age 
• BMI (kg/m2) 
o <20 
o 20-30 
o >30 
• Previous gynecologic surgeries 
o Hysterectomy 
o Prior prolapse surgery 
o Prior UI surgery 

 
 
 
 
 
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o Other gynecologic surgery 
 
• Previous non-surgical prolapse treatment 
o Pelvic floor exercises 
o Pessary use 
• Parity 
o No. of births 
o No. of vaginal births 
• Estrogen status 
o Pre-menopausal 
o Post-menopausal 
o HRT 
• Concomitant disorders 
o Urinary Incontinence 
o Fecal Incontinence 
o Other 
• Prolapse stage 
• POP-Q measurements prior to pessary fitting 
 
Outcomes 
• Pessary retention and function 
o Retained, normal position 
o Comes out fully deployed before ambulation 
o Collapses and comes out before ambulation 
o Comes out during ambulation 
o Comes out when on toilet, attempting void 
• Rotation during ambulation 
• Distance from the leading edge of the pessary to hymen with Valsalva 
o Original pessary 
o Study pessary 
• Discomfort with insertion and removal (VAS completed by subject) 
o Original pessary 
o Study pessary 
• Difficulty with insertion and removal (5 point scale completed by provider) 
o Original pessary 
o Study pessary 
• Global impression of comfort while using pessary (3 point scale completed by 
subject) 
• Global impression of ease of use (5 point scale completed by provider) 
 
See attached data collection forms. Forms will be filled out in ink and stored 
according to procedures outlined in “17.0 Data Management and Confidentiality.” 

 
 
 
 
 
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Transition from Research Participation 
At the conclusion of the study, each subject will have her current pessary replaced in her 
vagina, and she will be instructed to present for her next routinely scheduled follow up 
visit per her typical care.  
 
7.0 
Data and Specimen Banking 
N/A 
 
8.0 
Sharing of Results with Subjects 
The performance of the study pessary will be verbally shared with each subject who is 
interested at the time of the visit. 
 
9.0 
Study Timelines 
It is anticipated that each participant will be involved in the study for approximately one 
hour. The study is designed to enroll 15 subjects presenting for routine pessary care to the 
Division of Female Pelvic Medicine and Reconstructive Pelvic Surgery at Dartmouth-
Hitchcock Medical Center. This study site sees an average of 50 patients per month for 
routine pessary care of which 80% are using a ring style or Gellhorn pessary and would 
be eligible to participate. Assuming 1:8 patients who is eligible agrees to participate, it 
should take 3 months to recruit patients and complete this study. 
 
 
10.0 Inclusion and Exclusion Criteria 
Sex of Subjects 
Pelvic organ prolapse (POP) is a disease which only affects females, most typically those 
who are post-menopausal. Males will not be recruited for this study. 
 
Age of Subjects 
Study participants will be at least 18 years old.  Pelvic organ prolapse is primarily a 
disease of post-menopausal women and is therefore not relevant to the population of 
women less than 18 years old.  
 
Racial and Ethnic Origin 
Pelvic organ prolapse (POP) is a disease which only affects females, most typically those 
who are post-menopausal. Males will not be recruited for this study. This is an early 
feasibility study in which 15 subjects will be recruited from a clinical practice at 
Dartmouth-Hitchcock Medical Center, a tertiary care facility in Lebanon, NH. Eligible 
subjects will be screened for participation sequentially as they present for routine pessary 
care without excluding individuals based on race or ethnicity. 2018 US Census estimates 
for nearby Claremont, NH, which has similar demographics to Lebanon, demonstrates a 
population which is 97.6% White alone, 0.9% Black or African American alone, and 

 
 
 
 
 
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0.4% Asian alone. 2.4% are Hispanic or Latino. The population recruited for this study 
would have similar characteristics.  
Inclusion Criteria 
• Women with Stage II pelvic organ prolapse or greater  
• Current ring style or Gellhorn pessary users inclusive of sizes 1.5”-3.5” 
• Capable of giving informed consent  
Exclusion Criteria 
• Pregnancy 
• Deep vaginal erosion noted with removal of current pessary 
• Presence of vesicovaginal fistula 
• Presence of rectovaginal fistula 
• Vaginal, rectal, or bladder tumor 
• Inflammatory Bowel Disease 
• Presence of open wound or tear near vagina or anus by exam prior to removal of 
current pessary 
• Current vaginal or urinary infection requiring treatment 
• Previous pelvic floor surgery in last 12 months 
• Congenital malformation of bladder, rectum, or vagina 
• Significant medical condition interfering with study participation (psychologic, 
neurologic, active drug/alcohol abuse, etc.) 
• Planning pregnancy in next 6 months 
 
Vulnerable Subjects  
Subjects will not be recruited to this study if they are identified as a member of a 
vulnerable population.  
 
11.0 Vulnerable Populations 
N/A 
 
12.0 Local Number of Subjects 
15 subjects will be recruited for this study. Typical early feasibility studies for medical 
devices include 5-15 subjects.  The upper bound was selected due to the variability of the 
presentation of prolapse (apical, anterior, or posterior, as well as degree of severity) to 
evaluate performance of the Reia Vaginal Pessary across a broader range of clinical 
presentations. 
 
13.0 Recruitment Methods  
Method of Subject Identification and Recruitment  
Subjects will be recruited from a panel of established patients in a clinical practice 
specializing in FPMRS at the Dartmouth-Hitchcock Clinic. There will be no 
advertisements.  Screening for potential subjects during a given week of care will be 

 
 
 
 
 
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based on scheduled visit type, duration, and type of pessary currently in use. Prospective 
subjects will have their name, medical record number, and telephone number recorded on 
a handwritten list with pen and paper.  With the list complied, subjects will be contacted 
by telephone, and using the submitted phone script (see attached document), their interest 
in participation will be gauged. The list will be shredded after all potential subjects are 
contacted. If they demonstrate a preliminary interest, they will be scheduled for the 
appropriate amount of time to complete consent in-person and enter the study as they 
present for their pessary care visit. Additionally, the recruiter will offer to mail 
prospective subjects a copy of the consent form to review ahead of their appointment. 
Preferred mailing addresses will be collected over the telephone and handwritten directly 
on the mailing envelope and not copied elsewhere. 
 
Payment for Participation 
Participants will be offered a $100 gift card in compensation for the time due to 
participation that is in excess of the typical time required for routine pessary care. 
 
Alternatives to Participation 
If the patient elects not to participate in the study, they will proceed with their usual 
appointment and care.  
 
14.0 Withdrawal of Subjects 
Reasons for a subject to be withdrawn from the research study include: 
• The subject is found to have a condition which does not allow participation in the 
research, such as a finding upon physical examination that excludes them from the 
study. 
• The subject has a reaction that requires immediate removal of the research pessary. 
 
If a subject is removed, already collected data may not be removed from the study 
database and will be handled with the same protocol as research data. The subject will 
receive the usual ongoing care for their pessary. 
 
15.0 Risks to Subjects 
This study will involve greater than minimal risk. The subject could experience minor 
discomfort with insertion and deployment of the study pessary, while she is being asked 
to Valsalva, or if the study pessary is expelled with Valsalva.  There could be minor 
abrasion of the vaginal epithelium with the study pessary upon insertion or removal or 
disruption of the perineal epithelium. The risk of these events occurring should be lower 
than them occurring during usual care because the study pessary collapses to a smaller 
diameter than current devices. The study pessary could become dislodged during 
ambulation or voiding, which may cause embarrassment.   
 
16.0 Potential Benefits to Subjects 
Subjects will not directly benefit from participation in this study. 

 
 
 
 
 
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17.0 Data Management and Confidentiality 
Each subject who has signed a consent form and entered the study will be assigned a 
random study 3 digit number (001-999).  Data related to the study will be handwritten on 
data collection forms (see attached document).  The case report forms will not contain 
unique identifiers and will be referenced back to subjects only using the assigned study 
numbers. A separate key will be created linking the subjects with their random numbers.  
Once the key is created, it will remain in a locked cabinet which contains other study 
related documents (including, but not limited to, the protocol, instructions for use, all 
versions of the consent form, etc.).  These documents will be maintained by study 
personnel through the trial and for 2 years after termination of the study and will only be 
accessible by study personnel. 
 
Unidentifiable data from the case report forms may be collated in spread sheets for 
purposes of analysis.  Such data will be exclusively stored and processed exclusively on 
password protected and encrypted computers.   
 
Confidentiality protections include Dartmouth-Hitchcock Clinics confidentiality training 
for all employees and annual refresher seminars for all employees. Despite these 
protections, investigators will discuss with the eligible participants the potential for 
inadvertent disclosure of their data and ensure they are fully aware of these minimal, but 
possible risks. Breaches in confidentiality will be reported to Western IRB. 
 
Reia, LLC is partially funded by the NIH. Reia is subject to potential auditing at any time 
by the NIH or the FDA. Reia, LLC may be required to release data from this study to 
these agencies if an audit were to be performed and this information were to be requested. 
The sponsor, monitors, auditors, the IRB, the Food and Drug Administration will be 
granted direct access to subjects' medical records to conduct and oversee the research. 
Excluding this circumstance, Reia, LLC will not intentionally release information to any 
individual, agency, or entity.  
 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
Data Analysis and Data Monitoring 
This is a non-randomized, non-blinded, early feasibility study involving a vaginal 
pessary. Given that this intervention is known to be safe and well-tolerated, there are 15 
subjects with only one visit per subject, and the total time to recruit all subjects is 
anticipated to be 3 months, we do not believe a formal data safety monitoring committee 
is required. However, a data and safety monitoring plan will be in place. The data safety 
monitoring plan will focus on low intensity monitoring by the Data Safety Monitoring 
Team, comprised of the participating clinicians. The Data Safety Monitoring Team will 
meet every other week, or sooner if necessary, to review subject accrual, adherence to 

 
 
 
 
 
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study protocol, and ensure prompt reporting of serious and adverse events to Western 
IRB and the study sponsor (Reia, LLC). 
 
At each contact with the subject, the clinical investigator will seek information on 
adverse events by specific questioning and by examination. Information on all adverse 
events will be recorded for review by the Data Safety Monitoring Team. Moderate 
adverse events will be reviewed by the Data Safety Monitoring Team within one week. 
Serious adverse events, as defined by FDA criteria, will be reviewed by the Data Safety 
Monitoring Team within 24 hours and reported to Western IRB and the study sponsor 
(Reia, LLC). Careful monitoring of the recruitment, enrollment, study procedures, and 
adverse events will help protect the safety of the subjects and quality of the data. 
 
Any unanticipated adverse device effects will be immediately evaluated by the sponsor, 
Reia, LLC.  If it is determined that the adverse device effect presents an unreasonable 
risk to the subjects, the investigation will be terminated within 5 working days of making 
the determination and not more than 15 working days of first receiving notice. 
 
In compliance with 21 CFR §812.46, if the sponsor, Reia, LLC, discovers that the study 
team is not complying with the signed agreement, the study protocol, applicable FDA 
regulations, or any conditions for approval of this IRB application, then Reia, LLC will 
either secure compliance or stop delivery of the device and terminate the investigator’s 
participation.  Additionally, Reia, LLC will require the remaining investigational devices 
be returned.  
 
Protection Against Risks 
Most risks for participating in this study are associated with discomfort in use of the 
study pessary, either with insertion, removal, or unintentional expulsion. Per the above 
protocol, the subject will be awake and unsedated for the complete encounter and will be 
able to communicate any discomfort experienced, and the subject’s level of discomfort 
will be assessed at several points.   
 
It is unlikely that an incidental finding will be discovered since the study population 
presents for similar care every 4 months. In the event there is a finding, the member of 
the clinical research team who has been providing treatment for the subject will follow 
through to provide appropriate care or make appropriate referrals. 
 
Adverse events will be classified as Grade 1 or mild (easily tolerated by the subject no 
intervention necessary), Grade 2 or moderate (causing discomfort or interrupting usual 
activities), or Grade 3 or severe (causing considerable interference with usual activities, 
may be incapacitating, or may require hospitalization). Treatment of any adverse event, if 
indicated, will be coordinated by the member of the clinical study team who provides 
typical care for the study participant. Specific adverse events will be monitored as 
outlined in the data and safety monitoring plan described in the above section. 

 
 
 
 
 
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Additionally, the clinical research team will report any adverse events (regardless of 
whether the event is serious or non-serious) which are unexpected and related to the 
research procedures within 5 working days to the study sponsor (Reia, LLC) and 
Western IRB. Grade 4 (life threating consequences requiring immediate intervention) and 
Grade 5 (death related to adverse event) terminate the study and will be reported to 
Western IRB and the study sponsor within 24 hours. 
 
The subject will have the opportunity to stop the study at any point if desired.  She will 
never leave the facility while using the study pessary and will, therefore, have immediate 
access to care if a problem arises.  The subject will be given a copy of the consent form 
which lists the telephone numbers for the triage nurse of the principle investigator, as 
well as a 24-hour telephone number for the on-call physician if concerns arise after study 
participation. 
 
No publication or public presentation about the research described above will reveal the 
subject's identity. Once data collected for this research study is no longer identifiable, the 
data may be used for other purposes. Protected health information will be handled as 
described in “13.0 Recruitment Methods” and “17.0 Data Management and 
Confidentiality.”  
 
19.0 Provisions to Protect the Privacy Interests of Subjects 
All subjects recruited for this study will have previously received outpatient care for 
management of their pessary in the FPMRS division at the Dartmouth-Hitchcock Clinic.  
Upon arrival for a study visit, the patient will be checked in for care in the standard 
manner, forming a single line 10 feet back from the reception desk. They will then be 
brought to either a patient exam room or a private consultation room to meet with a 
member of the study team who will guide them through the consent process.  Once this 
has been completed, they will be given a chance to void, then brought to an exam room 
by an LNA or RN and be joined by a member of the study team.  Given the sensitive 
nature of conditions treated in the Ob/Gyn department, all care is delivered in areas not 
accessible to the public. The bathrooms and exam rooms are private.  The study team is 
comprised of clinicians who are sub-specialty trained in FPMRS and facile at asking the 
questions and performing the procedures outlined in the study protocol. 
 
20.0 Compensation for Research-Related Injury 
As included in the attached consent form, if the subject develops an illness or sustains an 
injury due to the research study, the study sponsor (Reia, LLC) will pay for the 
reasonable costs of medical treatment.  The sponsor will not pay for: 
• Treatment of illness or injury that results from the negligence of a health care 
provider, or 
• Treatment of a condition the subject had before they were in the study. 
 

 
 
 
 
 
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The sponsor will not offer any other payments for study-related illness or injury such as 
lost wages, expenses other than medical care, or pain and suffering. 
 
 
21.0 Economic Burden to Subjects 
Participation in this study should not lead to additional cost for the subjects.  Laboratory 
testing will not be performed, nor are there reasonably anticipated events which will 
require additional care or follow up.  Since participation will happen at the time of 
routine care, there will not be additional travel expenses incurred.  
 
22.0 Consent Process 
Process of Consent 
Each subject who presents for a study visit will be shown to a private room by a member 
of the clinical research unit or a member of the clinical study team.  The purpose of the 
study will be reviewed, and if the subject continues to be interested in participation, then 
study eligibility will be confirmed, and the informed consent process will begin.  Each 
subject will be given a copy of the consent form.  Based on their preference, the form will 
be read to them aloud or they can read it independently.  Each section will then be 
summarized; questions will be encouraged and answered fully.  The subject will then be 
asked to teach back the information presented in that section to ensure comprehension 
before moving on to the next section. 
 
The consent document will then be signed and dated by the subject providing consent and 
the person obtaining consent.  A copy of the consent document will be scanned into the 
subject’s medical record and a copy will be given to the subject.  The original will be 
kept in the locked cabinet with other research documents.  
 
As part of the process, subjects will be given as much time as they need to decide on 
participation.  If they appear to be feeling pressure or need more time, they will not be 
enrolled in the study.  If at any point the subject indicates she does not want to take part 
in the research, the informed consent process will be stopped. 
 
Subject Capacity 
Potential subjects for recruitment to this study are known to the FPMRS clinical team and 
their baseline capacity is known. The subject will not be entered into the study if there is 
concern regarding capacity to provide consent based on a change in function from 
previous encounters, or any of the following: 
• A diagnosis of dementia or cognitive impairment.  
• History of an evaluation of dementia since the last encounter in the FPMRS clinic. 
• A report, in medical records or from a family member or person well acquainted with 
the subject, that the subject has symptoms of cognitive impairment or dementia.  

 
 
 
 
 
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• An abnormal degree of confusion, forgetfulness, or difficulties in communication that 
is observed in the course of interacting with the subject.  
• Psychotic symptoms, bizarre or abnormal behavior exhibited by the subject.  
 
Subject Comprehension 
As described above, after the subject has read or been read the consent document, each 
section will again be verbally reviewed and summarized.  In this step, comprehension 
will be determined by a “teach back” method.  
 
23.0 Process to Document Consent in Writing 
Consistent with the standard operating procedure: Written Documentation of Consent 
(HRP-091) of the D-HH Human Research Protection Program (local IRB), the informed 
consent process will begin when the subject agrees to take part in the study and end when 
the consent process is documented in writing.  The consent form (see attached) has been 
written in understandable language and has signature blocks for the printed name, 
signature and date for both the subject and the person obtaining consent (the principle 
investigator, co-investigator, research assistant, or coordinator). The subject will receive 
either a photo copied version or a second signed version of the consent form. 
 
24.0 Setting 
The study will take place at Dartmouth-Hitchcock Medical Center in the Faulkner 
Ambulatory Building, Level 5, in the Department of Obstetrics and Gynecology.  
Subjects will be cared for in exam rooms typically used for delivering clinical care of 
patients in the FPMRS division.  
 
25.0 Resources Available 
Fifteen subjects will participate in this study, and participation will be limited to one visit 
on the day of enrollment. The identified study site sees an average of 50 patients per 
month for routine pessary care of which 80% are using a ring style or Gellhorn pessary 
and would be eligible to participate. Assuming 1:8 patients who is eligible agrees to 
participate, it should take 3 months to recruit patients and complete this study. 
 
The Dartmouth-Hitchcock Clinic encompasses Dartmouth-Hitchcock Medical Center, a 
381-bed hospital and the primary teaching hospital associated with the Geisel School of 
Medicine at Dartmouth. Outpatient care for patients seen in the Division of Female Pelvic 
Medicine and Reconstructive Surgery is provided on the 5th floor of the adjoining 
Faulkner Ambulatory Building. The clinic is a shared space with the Department of 
Obstetrics and Gynecology with a dedicated entrance, registration, and scheduling desk. 
Within the shared departmental clinical space, there are 30 exam rooms and 3 consult 
rooms in addition to two shared workrooms for provider documentation. Annually, there 
are over 2000 new patients seen at Dartmouth-Hitchcock with the diagnosis of pelvic 
organ prolapse (POP), and approximately 250 visits for new pessary fittings. The 
Dartmouth-Hitchcock Clinic utilizes an EPIC electronic medical record charting system 

 
 
 
 
 
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and has an electronic data warehouse which is searchable by diagnosis, procedures, and 
visit type. 
 
The members of the study team are a cohesive group of practitioners who work together 
at The Dartmouth-Hitchcock Clinic providing clinical care. The study team will include 
five practitioners who have patients regularly scheduled for care in the study site and who 
will be available to provide medical treatment, should subjects develop an illness or 
injury because of their participation in the research study. 
 
The investigator team and sponsor will meet as a group to review the consent form, 
protocol, instructions for use, data collection form, and phone script prior to commencing 
the study. Each member of the team will have adequate time to review the documentation 
and the opportunity to ask questions to the sponsor and principal investigator. During this 
meeting, the principal investigator will also assign duties and functions to each member 
of the team.  
 
26.0 Multi-Site Research 
N/A 
 
 
 

 
 
 
 
 
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