Assessment of Effectiveness and Safety of a Novel Pessary for the Non-Surgical Treatment of Pelvic Organ Prolapse
Phase: NA
Conditions: Pelvic Organ Prolapse
Sponsor: Reia, LLC

Protocol 
 
Study Title: Assessment of effectiveness and safety of a novel pessary for the non-surgical management 
of pelvic organ prolapse 
 
NCT Number: NCT04508335 
 
Document Date: 5/17/2022 

 
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CONFIDENTIAL 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
REVISION HISTORY  
 
 
 
Protocol Number: 
CP-002-01 
Sponsor: 
Reia, LLC (“Reia”) 
331 River Road 
Lyme, NH  03768 
Medical Monitor: 
Paul Hanissian, MD 
331 River Road 
Lyme, NH  03768 
Principal 
Investigator: 
Kris Strohbehn, MD 
Study Site for 
Principle 
Investigator: 
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 
Revision 
Revision Date 
Summary of Changes/Affected Sections 
01 
3-16-2021 
Initial release of document, submission to IRB 
02 
8-25-2021 
Updated to include recommendations from site initiation visits 
03 
5-17-2022 
Updated to allow Visit 2 to be a phone call & recruitment 
strategies 
Study Title: Assessment of effectiveness and safety 
of a novel pessary for the non-surgical 
management of pelvic organ prolapse 

 
 
 
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Table of Contents 
 
1.0 
Study Summary ........................................................................................................ 4 
2.0 
Objectives ................................................................................................................ 5 
3.0 
Background .............................................................................................................. 5 
4.0 
Study Endpoints ....................................................................................................... 6 
5.0 
Study Intervention/Investigational Agent ................................................................ 8 
6.0 
Procedures Involved................................................................................................. 9 
Methods........................................................................................................................... 9 
Data Collected ............................................................................................................... 11 
Transition from Research Participation ........................................................................ 12 
7.0 
Data and Specimen Banking .................................................................................. 12 
8.0 
Sharing of Results with Subjects ........................................................................... 12 
9.0 
Study Timelines ..................................................................................................... 12 
10.0 Inclusion and Exclusion Criteria ............................................................................ 13 
Sex of Subjects .............................................................................................................. 13 
Age of Subjects ............................................................................................................. 13 
Racial and Ethnic Origin ............................................................................................... 13 
Inclusion Criteria .......................................................................................................... 13 
Exclusion Criteria ......................................................................................................... 13 
Vulnerable Subjects ...................................................................................................... 14 
11.0 Vulnerable Populations .......................................................................................... 14 
12.0 Recruitment Methods ............................................................................................. 14 
Method of Subject Identification and Recruitment ....................................................... 14 
Payment for Participation ............................................................................................. 15 
Alternatives to Participation ......................................................................................... 15 
13.0 Withdrawal of Subjects .......................................................................................... 15 
14.0 Risks to Subjects .................................................................................................... 16 
15.0 Potential Benefits to Subjects ................................................................................ 16 
16.0 Data Management and Confidentiality .................................................................. 17 
17.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 17 
Data Analysis and Data Monitoring ............................................................................. 17 
Protection Against Risks ............................................................................................... 18 
18.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 19 
19.0 Compensation for Research-Related Injury ........................................................... 20 
20.0 Economic Burden to Subjects ................................................................................ 20 
21.0 Consent Process ..................................................................................................... 20 
Process of Consent ........................................................................................................ 20 

 
 
 
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Subject Capacity ........................................................................................................... 21 
Subject Comprehension ................................................................................................ 21 
22.0 Process to Document Consent in Writing .............................................................. 21 
23.0 Multi-Site Research ............................................................................................... 21 
References ......................................................................................................................... 23 
 
 
 

 
 
 
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1.0 
Study Summary 
Study Title 
Assessment of effectiveness and safety of a novel pessary for the non-
surgical management of pelvic organ prolapse 
Study Design 
Prospective open label feasibility study of a medical device 
Primary Objective 
• To assess the effectiveness of the study pessary to support prolapse by 
measuring the change in the score of the Pelvic Floor Distress Inventory-
20 (PFDI-20) 
• To assess the safety of the study pessary  
Additional 
Objective(s) 
• To assess proportion of subjects who are successfully fit and can retain 
the study pessary 
• To assess the subjects’ ability to insert and remove the study pessary 
• To compare subjects’ discomfort experienced with insertion and removal 
of their current pessaries with study pessaries 
• To globally assess satisfaction associated with use of the study pessary  
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Replacement of a subject’s current pessary with a study pessary for use over 
a three-month time interval 
IND/IDE #  
Device to be considered for an abbreviated IDE (non-significant risk device) 
Study Population 
Current users of a Gellhorn or ring style pessary for management of Stage II 
or greater pelvic organ prolapse 
Sample Size 
40, excluding withdrawals 
Study Duration for 
individual 
participants 
4 months 
Study Specific 
Abbreviations/ 
Definitions  
CRAIQ – Colorectal Anal Impact Questionnaire 
EMR – Electronic Medical Record 
FPMRS – Female Pelvic Medicine and Reconstructive Surgery 
FSF – Female Sexual Function 
IIQ – Incontinence Impact Questionnaire 
IUGA – International Urogynecological Association  
PFDI-20 – Pelvic Floor Distress Inventory-20  
PFIQ-7 – Pelvic Floor Impact Questionnaire-7 
PFMT – Pelvic Floor Muscle Training 
PISQ-IR – Pelvic Organ Prolapse/Urinary Incontinence Sexual 
Questionnaire, IUGA-Revised 
POP – Pelvic Organ Prolapse 
POP-Q – Pelvic Organ Prolapse Quantification 
POPIQ – Pelvic Organ Prolapse Impact Questionnaire  
UI – Urinary Incontinence 
VAS – Visual Analogue Scale 

 
 
 
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WCG IRB – Western Copernicus Group IRB 
 
2.0 
Objectives 
The purpose of this study is to obtain preliminary data on the effectiveness, safety, 
function, comfort, and patient satisfaction with a novel vaginal pessary design for the use 
in women who suffer from symptoms of pelvic organ prolapse (POP) and have already 
opted for non-surgical management. Recruited subjects will have Stage II POP or greater 
and will be current users of a Gellhorn or ring style pessary. Following enrollment, each 
subject will enter a 1-month wash out period in which they will continue using their 
current pessary so that baseline subjective and objective data can be collected. They will 
then be fit with a study pessary and enter a 3-month treatment phase. Comparative, 
subjective and objective data will be collected at the conclusion of the study.  
 
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 for POP. A pessary is inserted in the 
vagina and acts as a shelf resting upon the pelvic floor muscles to support the descending 
organs.  A pessary is not surgically implanted and can be removed and reinserted but is 
only effective while in situ. Often, pessaries are as effective as reconstructive surgery in 
improving the symptoms of prolapse. 77% of practicing urogynecologists recommend a 
vaginal pessary as the first line treatment option for their patients with POP.5 It is 
estimated that there are ~2.3 million women in the United States who use a pessary for 
POP, based on financial information from pessary makers and the above epidemiologic 
data on POP. 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 at least 3-4 times per year to temporarily remove the pessary, clean it, examine the 

 
 
 
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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 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 pessaries on the market are the “ring with support” 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 style pessaries because they are easier and more 
intuitive to use. The Reia Vaginal Pessary (study pessary) has been engineered to 
improve the comfort and ability of pessary removal and reinsertion by physicians and 
patients. The Reia Vaginal Pessary has a structural form similar to the Gellhorn, but is 
collapsible, and is hypothesized to be simpler and more comfortable to use than ring style 
pessaries.  This hypothesis is preliminarily supported by data obtained in an early 
feasibility, in-office trial with 15 subjects (NCT04275089).    
 
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 
Pelvic Floor Distress 
Inventory-20 (PFDI-
20)  
Between enrollment and 
the end of washout 
period (before treatment) 
[Week 0-4] and post 
treatment [Week 16]  
The Pelvic Floor Distress Inventory - 
20 (PFDI-20) is a validated 
instrument to assess the presence and 
bother of symptoms that pelvic floor 
disorders have on health-related 
quality of life in women. It is a 20-
item questionnaire and the short 
form of the 46 question PFDI. There 
are three subscales: Urinary Distress 
Inventory 6 (UDI-6), Colorectal-
Anal Distress Inventory 8 (CRADI-
8), and the Pelvic Organ Prolapse 
Distress Inventory 6 (POPDI-6). The 
overall score range is 0-300. The 
higher the score, the greater the 
perceived impact that pelvic floor 
dysfunction has on a patient's life. 
The minimal important change in the 

 
 
 
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PFDI-20 to demonstrate a clinical 
effect in women choosing 
conservative management of their 
prolapse (i.e. a pessary) is between 
13.5 and 18.3 points.  
Primary 
Prevalence and 
severity of adverse 
events that subjects 
experience using the 
study pessary 
compared to those 
experienced with their 
current pessary  
Throughout study [Week 
0-16] Adverse events 
can occur with use of the 
current pessary or during 
the treatment phase with 
the study pessary. They 
can be experienced with 
insertion or removal of 
either the current or 
study pessary, noted on 
physical exam, or 
reported at any time.  
Adverse events experienced with 
insertion or removal of the current or 
study pessary include: pelvic 
cramping or discomfort, perineal 
tear, failure of the study pessary to 
deploy or collapse, or pessary 
expulsion. Adverse events noted on 
physical exam include: vaginal 
irritation, vaginal ecchymosis, 
vaginal abrasions/superficial cuts, 
vaginal erosion, vaginal bleeding, 
vaginal discharge, or urinary 
retention. Adverse events which 
could occur at any time include: 
pelvic cramping or mild discomfort, 
copious vaginal discharge, urinary 
tract infection, substantial 
discomfort, pessary expulsion 
(collapsed or deployed), or adverse 
events unrelated to the pessary or 
study visit. Each event will be 
classified as mild (transient and 
easily tolerated by the subject), 
moderate (causing discomfort or 
interrupting usual activities), or 
severe (causing considerable 
interference with usual activities, 
may be incapacitating, or may 
require hospitalization).  
Secondary 
Pelvic Floor Impact 
Questionnaire (PFIQ-
7)  
Between enrollment and 
the end of washout 
period (before treatment) 
[Week 0-4] and post 
treatment [Week 16] 
Pelvic Floor Impact Questionnaire -7 
is a health-related quality of life 
instrument, designed to assess the 
life impact of pelvic floor symptoms 
in women with pelvic floor 
disorders. The PFIQ-7 has a parallel 
structure to the PFDI with 3 Scales: 
CRAIQ, POPIQ and IIQ. 
Secondary 
Pelvic Organ 
Prolapse/Urinary 
Incontinence Sexual 
Between enrollment and 
the end of washout 
period (before treatment) 
A validated evaluation tool which 
can be used clinically as well as in 
research for assessment of female 

 
 
 
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Questionnaire, IUGA-
Revised (PISQ-IR) 
[Week 0-4] and post 
treatment [Week 16] 
sexual function (FSF) in women 
with female pelvic floor disorders. 
Secondary 
Objective assessment 
of the pessary's ability 
to support the prolapse  
At enrollment [Week 0], 
during treatment [Week 
3-5], and during 
treatment [Week 16] 
POP-Q points Ba and Bp 
(measurements of prolapse) will be 
measured during physical exam, 
with the pessary in situ. 
Secondary 
Global assessment of 
study pessary 
satisfaction compared 
to current pessary  
For current pessary at 
the end of washout 
period [Week 3-5]; For 
study pessary post 
treatment [Week 16]  
Satisfaction will be assessed using a 
Visual Analog Scale (VAS) with a 
10 cm linear continuum 
in which 0 represents no satisfaction 
and 10 represents complete 
satisfaction.  
Secondary 
Pain associated with 
study pessary insertion 
compared to current 
pessary 
During treatment [Week 
3-5], during treatment 
[Week 5-7], and post 
treatment [Week 16] 
Pain will be assessed using a Visual 
Analog Scale (VAS) with a 10cm 
linear continuum in which 0 
represents no pain and 10 represents 
worst pain. 
Secondary 
Pain associated with 
study pessary removal 
compared to current 
pessary 
During treatment [Week 
3-5], during treatment 
[Week 5-7], and post 
treatment [Week 16] 
Pain will be assessed using a Visual 
Analog Scale (VAS) with a 10cm 
linear continuum in which 0 
represents no pain and 10 represents 
worst pain. 
Other 
Proportion of subjects 
successfully fit with 
the study pessary 
Post treatment [Week 
16] 
Proportion of subjects who were 
successfully fit with the study 
pessary. 
Other 
Change in frequency 
of pessary removal for 
self-managers 
Post treatment [Week 
16] 
The monthly frequency of pessary 
self-removal during the washout 
period will be compared against 
monthly frequency of self-removal 
in the treatment phase. 
Other 
Ease of insertion of 
study pessary by 
subject for self-
managers 
Post treatment [Week 
16] 
Ease will be assessed using a Visual 
Analog Scale (VAS) with a 10cm 
linear continuum in which 0 
represents most difficulty and 10 
represents most ease. 
Other 
Ease of removal of 
study pessary by 
subject for self-
managers 
Post treatment [Week 
16] 
Ease will be assessed using a Visual 
Analog Scale (VAS) with a 10cm 
linear continuum in which 0 
represents most difficulty and 10 
represents most ease. 
 
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 
This is a non-randomized prospective trial. Treatment intervention will be non-blinded to 
the subject and the investigator.  Subjects will serve as their own controls and enter the 
treatment phase of the study after a 1-month washout period of using their current 
pessary.  Subjects will be recruited for this study from panels of patients in clinical 
practices 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.”  
 
The primary outcome measure will be the change in the scores of the Pelvic Floor 
Distress Inventory-20 (PFDI-20), administered first during the washout period while still 
using their current pessary and then at the conclusion of the treatment phase with the 
study pessary. The PFDI-20 is a validated health-related quality of life instrument to 
assess the presence and bother of symptoms in women with pelvic floor dysfunction. For 
women with relatively mild pelvic floor symptoms, a minimal important change (MIC) of 
between 13.5 and 18.3 points in the PFDI-20 score can be considered clinically relevant. 
At least fifty subjects will be enrolled, expecting that after drop-out and attrition at least 
40 subjects will have completed the study. This provides power of .80 for a MIC 
equivalence limit of 17 points on the PFDI-20 scale.  
 
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.  
 
The study will take place over 4 visits (Visit 0, Visit 1, Visit 2, and Visit 3).  
 
Visit 0 [research purposes] will involve screening, enrollment, consent, subject 
questionnaires, and chart abstraction for historical data and will take place during a 
regularly scheduled pessary maintenance visit.  The current pessary size and type will be 
recorded, and it will be observed in situ for the presence of rotation and its ability to 
support prolapse by measuring the distance of the most dependent compartment of the 
subject’s prolapse to the hymen (POP-Q points Ba and Bp), as well as the distance from 
the leading edge of the current pessary, if a Gellhorn, to the hymen. After removal of the 
current pessary, a baseline physical exam will be conducted to assess for pre-existing 
vaginal pathology (ecchymoses, abrasions, superficial cuts, erosions, granulation tissue, 
bleeding) or urinary retention associated with current pessary use. Other exam elements 
will include assessment of vulvovaginal atrophy, pelvic muscle strength, perineal 
descent, and POP-Q points GH (with strain) and TVL. After cleaning, the current pessary 
will be replaced, and each subject will begin the washout period where they continue use 
of their current pessary. Either at this first visit or during the washout period, each subject 
will complete the PFDI-20, PFIQ-7, and PISQ-R to establish baseline scores. Self-

 
 
 
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managers will track the frequency of removals. If the current pessary cannot be 
reinserted, they will be treated according to standard of care. 
Visit 1 [research purposes] will aim to be scheduled between 3 and 5 weeks from Visit 0 
(the conclusion of the washout period). Demographic and historical data will be extracted 
from the Electronic Medical Record (EMR) if not completed at Visit 0 and supplemented 
by the subject as needed. Global subject satisfaction of the current pessary will be 
assessed using a Visual Analog Scale (VAS) with a 10 cm linear continuum in which 0 
represents no satisfaction and 10 represents complete satisfaction. As in Visit 0, the 
current pessary will be observed in situ for the presence of rotation and its ability to 
support prolapse by measuring the distance of the most dependent compartment of the 
subject’s prolapse to the hymen (points Ba and Bp), as well as the distance from the 
leading edge of the current pessary to the hymen. The current pessary will be removed, 
washed, placed in a sealed bag, labeled and either stored or given to the subject for them 
to return with at their final visit. The physical exam will be repeated as in Visit 0, and the 
presence of perineal disruption associated current pessary removal will be noted. The 
appropriate study pessary size for the subject based on the provided mapping from the 
subject’s current pessary and practitioner’s expertise will be selected at random from the 
inventory of study pessaries, removed from its sealed bag, and the study pessary’s serial 
number (labeled on the bag) will be recorded. The subject will be fit with the study 
pessary. If a study pessary cannot be fit, and the patient is willing, they can be fit with a 
different sized pessary at Visit 1 or can remain in the study and return for a second 
attempt to be fit with a study pessary at Visit 2. A VAS will be used to assess the 
perceived discomfort with removal of the current pessary and, separately, with insertion 
of the study pessary. For self-managers, ease of current pessary removal and reinsertion 
will be noted using a VAS and teaching will be provided on the proper technique to insert 
and remove the study pessary.  
Visit 2 [research purposes] has the option to be omitted, at the discretion of the 
practitioner and the subject, and will be aimed to be scheduled within 1-3 weeks of Visit 
1. The subject will receive a phone call just prior to this visit. The subject will be asked 
about pessary use and adverse events. If the subject is doing well without any study 
related concerns, the practitioner and subject can decide if this visit can be omitted. The 
purpose of this visit is to minimize unforeseeable risks associated with use of the study 
pessary and/or to refit a subject with a study pessary if the original one was expelled or 
could not be inserted during Visit 1. If conducted in person, physical exam will be 
performed to assess for vaginal pathology (ecchymoses, abrasions, superficial cuts, 
erosions, granulation tissue or bleeding) or urinary retention related to the study pessary, 
and all adverse events will be recorded. The study pessary will be observed in situ for the 
presence of rotation and its ability to support prolapse by measuring the distance of the 
most dependent compartment of the subject’s prolapse to the hymen, as well as the 
distance from the leading edge of the study pessary to the hymen. Those subjects who 

 
 
 
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were not successfully fit with a study pessary in their first visit would be fit with a new 
study pessary. 
 
Visit 3 [research purposes] will occur at the conclusion of the 3-month (from Visit 1) 
treatment phase - a typical length of time between routine visits for patients who choose 
long term pessary management of their prolapse. It can be scheduled in a window 
between 11 and 13 weeks from Visit 1.  When the subject returns for Visit 3, a physical 
exam will be repeated, as in previous visits, for comparative data. The study pessary will 
be observed in situ for the presence of rotation and its ability to support prolapse by 
measuring the distance of the most dependent compartment of the subject’s prolapse to 
the hymen (Points Ba and Bp), as well as the distance from the leading edge of the study 
pessary to the hymen. A VAS will be used to assess discomfort with removal of the study 
pessary, discomfort with reinsertion of their current pessary, and their global satisfaction 
of the study pessary. The subject will have been instructed to return with their current 
pessary which was removed in Visit 1.  If the subject’s current pessary is not brought to 
the visit, they will be given a new pessary of the size and style of their current pessary. 
Each subject will complete the PFDI-20, PFIQ-7, and PISQ-R for a post treatment 
comparison. For self-managers, other data collected will include frequency of removal 
and a VAS for ease of study pessary insertion and removal.  
 
Additional Visits: Subjects will be seen as necessary and adverse events will be managed 
according to standard of care. If the study pessary falls out after Visit 1, the subject may 
be seen at their convenience for reinsertion or resizing. If a study pessary cannot be fit 
and retained, the subject will be withdrawn from the study and their current pessary will 
be placed. If the subject’s current pessary is not brought to the visit, they will be given a 
new pessary of the size and style of their current pessary. 
 
Special Circumstances: If a subject dies between Visit 1 and Visit 3, an attempt will be 
made to contact the coroner to retrieve the study pessary.  If the study pessary cannot be 
retrieved, a copy of the death certificate will be obtained. 
 
The study pessary is the only device that will be used in this trial. 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.  
 
Data Collected 
See attached data collection forms. The data collected will be obtained through chart 
abstraction, verbal history, questionnaire responses, visual analogue scale response, and 
physical exam. 
Data collected on adverse events will be described in “18.0 Provisions to Monitor 
the Data to Ensure the Safety of Subjects.”  

 
 
 
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Forms will be filled out electronically or in ink and stored according to 
procedures outlined in “17.0 Data Management and Confidentiality.” 
Transition from Research Participation 
At the conclusion of the study, each subject will have their current pessary replaced in 
their vagina, and they will be instructed to present for their next routinely scheduled 
follow up visit per their typical care.  If a subject lost their original pessary or if they do 
not bring it to the final visit, they will be supplied with a new pessary identical to their 
original at no additional cost. 
 
7.0 
Data and Specimen Banking 
N/A 
 
8.0 
Sharing of Results with Subjects 
Composite study results will be shared with the subjects upon request following 
publication.   
 
9.0 
Study Timelines 
Participation for each enrolled subject will last 4 months as outlined in the table below. 
 
Visit #  Week Purpose  
Summary of Key Tasks/Measures 
(see “6.0 Procedures Involved” for 
additional details) 
0 
0  
Recruitment, physical exam, 
beginning of washout period  
Consent; 
Assessment of prolapse support with 
current pessary, assessment of adverse 
events with current pessary  
1  
3-5 
weeks 
from 
Visit 0 
Data collection, physical exam, 
removal of current pessary, 
fitting of study pessary  
PFDI-20, PFIQ, and PISQ-R; 
VAS for discomfort with insertion and 
removal of pessaries; 
Re-assessment of prolapse support with 
current pessary, re-assessment of adverse 
events with current pessary  
2 
1-3 
weeks 
from 
Visit 1 
Assessment of adverse events, 
refitting of study pessary if 
necessary 
Physical exam (if in person) and history 

 
 
 
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3 
11-13 
weeks 
from 
Visit 1 
Completion of trial, data 
collection, physical exam, 
removal of study pessary, 
reinsertion of current pessary 
PFDI-20, PFIQ and PISQ-IR; 
VAS for discomfort with insertion and 
removal of pessaries; 
Assessment of prolapse support with 
study pessary, assessment of adverse 
events with study pessary 
 
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 subjects will be at least 18 years old. Pelvic organ prolapse is condition primarily 
developed post-menopause and is therefore not relevant to the female population under 
18 years old.  
 
Racial and Ethnic Origin 
This is a safety and efficacy study in which at least 50 subjects will be recruited. Eligible 
subjects will be screened for participation sequentially as they present for routine pessary 
care at the study sites without excluding individuals based on race or ethnicity. The 
distribution of race and ethnicity for potential subjects will reflect the demographics of 
patients in the practices at the sites.  
 
Inclusion Criteria 
• Females with Stage II pelvic organ prolapse or greater  
• Users of a Gellhorn (inclusive of sizes 2”-3.25”) or ring style pessary (inclusive of 
sizes 2.5-3.5”) for >3 months’ duration 
• Fluency in English or Spanish 
• Capable of giving informed consent  
 
Exclusion Criteria 
• Pregnancy 
• Short vaginal length (total vaginal length < 8 cm), or subjective vaginal narrowing 
• Deep vaginal erosion noted with removal of current pessary 
• Presence of vesicovaginal fistula 
• Presence of rectovaginal fistula 
• Current treatment for vaginal, rectal, or bladder tumor 
• Presence of open wound or tear near vagina or anus by exam prior to removal of 
current pessary 

 
 
 
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• Presence of pelvic, vaginal, or urinary infection requiring treatment 
• Ongoing treatment of recurrent urinary tract or vaginal infections 
• Inflammatory bowel disease 
• Chronic pain syndromes of pelvic or anorectal origin 
• 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 
 
Total study recruitment across all sites will have a requirement to include a minimum of 
12 subjects (approximately 25%) who currently use a Gellhorn pessary and a minimum 
of 12 subjects who currently use a ring style pessary to best characterize the current 
landscape where the Reia Pessary will be used. Current users of Gellhorn pessaries are 
more likely to have advanced baseline prolapse, and current users of ring style pessaries 
are more likely to be self-managers. It is important for both demographics to be 
represented in this study. 
 
Vulnerable Subjects  
The following groups of subjects will not be recruited: pregnant females, prisoners, 
females in mental health facilities, employees of the study site, and students attending 
any of the study institutions. 
 
11.0 Vulnerable Populations 
N/A 
 
12.0 Recruitment Methods  
Method of Subject Identification and Recruitment  
Subjects will be recruited from panels of established patients in the clinical sites, and will 
occur in one of three ways: 
 
1. Subjects can be informed about the study as they present for routine pessary care, 
and if interested, handed a consent form for review, then booked for Visit 0 at the 
time their next routinely scheduled pessary maintenance visit.  Please see attached 
patient flyer document. 
2. If a Partial HIPAA Waiver is granted, subjects can be recruited with a letter, flyer, 
and/or a screening telephone call ahead of a normally scheduled visit. Potential 
subjects will be identified during a given week of care based on scheduled visit 
type, duration, and type of pessary currently in use. Their name, medical record 
number, and telephone number recorded on a handwritten list with pen and paper.  
With the list complied, subjects may be contacted by mail, using the submitted 

 
 
 
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letter and/or flyer, and/or telephone, using the submitted phone script (see 
attached document), and 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 send electronically or mail 
prospective subjects a copy of the consent form to review ahead of their 
appointment. If the latter, preferred mailing addresses will be collected over the 
telephone and handwritten directly on the mailing envelope and not copied 
elsewhere. 
3. Subjects can also be recruited for participation at the time of an already scheduled 
visit if there is latitude in the schedule to extend the visit and complete the 
consent process and other aspects of Visit 0. 
4. Advertisements (pending IRB approval) will be posted on social media, online, 
and/or in print. 
 
Payment for Participation 
Subjects will be offered three separate $100 gift cards in compensation for their time due 
to participation that is in excess of routine pessary care.  Visits 0 and 3 would occur as 
part of routine care.  A $100 gift card will be provided after completing Visits 1 and 2 
(even if conducted as a phone call) for extra time and travel, as well as at Visit 3 upon 
completion of the study. In total, subjects will have received $300 at the completion of 
the study. 
 
Alternatives to Participation 
If the patient elects not to participate in the study, they will proceed with their usual 
appointment and care.  
 
13.0 Withdrawal of Subjects 
Reasons for a subject to be withdrawn from the research study include: 
• The subject is found to have a condition that does not allow participation in the 
research, such as a finding upon physical examination that excludes them from the 
study. 
• The subject no longer tolerates their current pessary during the washout period or 
needs a different size or type of pessary during the washout period. 
• The subject is not able to be fit with a study pessary at the conclusion of Visit 2, or 
the study pessary is repeatedly expelled. 
• The study pessary causes discomfort or adverse reaction for which continued use is 
contraindicated. 
• The subject has a reaction that requires immediate removal of the study pessary. 
• The subject may withdraw themselves at any point for unforeseen circumstances. 

 
 
 
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If a subject is removed from the study, 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. 
 
14.0 Risks to Subjects 
This study will involve greater than minimal risk. The subject could experience: 
 
• Discomfort during insertion, use, or removal of the study pessary. 
• Minor abrasion of the vagina or perineum with insertion or removal of the study 
pessary. 
• Vaginal bleeding caused by the study pessary. 
• Increased vaginal discharge caused by the study pessary. 
• Vaginal epithelial erosion (superficial or deep) from using the study pessary. 
• Difficulty urinating or leakage of urine caused by the study pessary. 
• Difficulty with defecation caused by the study pessary. 
• Embarrassment if the study pessary falls out. 
• Minor discomfort if the study pessary rotates out of position or if it falls out. 
• Inconvenience caused by the inability of the study pessary to support the subject’s 
prolapse. 
 
Each of the risks cited above exist for any patient who chooses a pessary for management 
of their prolapse and are not unique to the study pessary.  Though inconvenient, these are 
not life threatening.   
 
The novelty of our pessary lies in its ability to flex, which we hypothesize will make 
insertion and removal more comfortable for the subject.  Because it does not contain 
buttons, mechanism, or moving parts, it does not have mechanical features subject to 
failure.  The soft and pliable nature of the molded silicone should not be capable of 
pinching the vaginal epithelium when the study pessary is elongated for removal, but this 
metric will be followed. 
 
In common clinical practice, patients often use their pessaries continuously for 3-6 
months without removal or medical evaluation.  Per our protocol, the Reia pessary is 
intended to be used for 3 months continuously, and each subject will be evaluated 1-3 
weeks after the study pessary is initially placed to assess for the presence of adverse 
events.  Each subject will be a current pessary user, and during the course of the trial they 
will be monitored more closely than had they continued to use their existing pessary.  
 
15.0 Potential Benefits to Subjects 
Subjects will not directly benefit from participation in this study. 

 
 
 
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16.0 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 either be recorded 
on data collection forms (see attached document) or collected in REDCap.  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 be kept secure with 
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 spreadsheets for 
purposes of analysis. Such data will be stored and processed exclusively on password 
protected and encrypted computers.   
 
Confidentiality protections include 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 WCG 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, and 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 patient information 
to any individual, agency, or entity.  
 
17.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
Data Analysis and Data Monitoring 
This is a non-randomized, non-blinded, feasibility study involving a vaginal pessary. 
Given that the intervention is known to be safe and well-tolerated and the total exposure 
to our pessary for each subject was chosen to be similar to the typical interval of 
continuous pessary use which is common in clinical practice for current pessary users, we 
don’t 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 one clinician 
from each participating site and a biostatistician. The Data Safety Monitoring Team will 
meet monthly, or sooner if necessary.  Their charge will be to review subject accrual, 

 
 
 
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adherence to study protocol, and monitor adverse events. Additionally, they will ensure 
prompt reporting of serious adverse events to WCG 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 which represent a change in baseline from those experienced in the 
washout period 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 WCG 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 that are possibly, probably, or definitely related 
to the study intervention 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 
The primary somatic risks for participating in this study are associated with either 
discomfort or with pathologic changes to the vagina.  Discomfort can occur with 
insertion, removal, unintentional expulsion or with daily use. Per convention, each 
subject will be awake and unsedated while the study pessary is being fit and will be able 
to communicate any discomfort experienced. A physical exam will be performed at each 
study visit. Pathologic changes to the vagina, which can be noted during these times, 
include vaginal ecchymoses, abrasions, superficial cuts, erosions, granulation tissue, or 
bleeding. Subject reported adverse events include pelvic cramping or mild discomfort, 
copious vaginal discharge, urinary tract infection, urinary retention, substantial 
discomfort, pessary expulsion (deployed or collapsed), pessary failure to deploy or 
collapse, or adverse events unrelated to the pessary or study visit.  
 
Each adverse event 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 

 
 
 
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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. 
Additionally, the clinical research team will report any Grade 1, Grade 2, or Grade 3 
adverse events that are unexpected and possibly, probably, or definitely related to the 
research procedures within 5 working days to the study sponsor (Reia, LLC) and WCG 
IRB. Grade 4 (life threating consequences requiring immediate intervention) and Grade 5 
(death related to adverse event) that are unlikely, possibly, probably, or definitely related 
to the intervention will terminate the study. These adverse events will be reviewed by the 
Data Safety Monitoring Team within 24 hours and reported to WCG IRB and the study 
sponsor (Reia, LLC).  
 
It is unlikely that an incidental finding will be discovered since the study population 
presents for similar care every 3-4 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. 
 
The subject will have the opportunity to stop the study at any point if desired.  The 
subject will be given a copy of the consent form which lists the telephone numbers for the 
nursing staff and lead investigator at each site, as well as a 24-hour telephone number for 
the on-call physician if concerns arise. 
 
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.”  
 
18.0 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 their study site.  Upon arrival for 
a study visit, the subject will be checked in for care in the standard manner per existing 
clinical protocols designed to maintain privacy. 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 study visit. 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. 
 

 
 
 
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19.0 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. 
 
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. 
 
20.0 Economic Burden to Subjects 
Participation in this study should not lead to additional cost for the subjects beyond the 
time and travel associated with the two additional visits related to study participation 
(Visit 1 and Visit 2). Laboratory testing will not be performed nor are there reasonably 
anticipated events which will require additional care or follow up. As stated above, 
subjects will be given three separate $100 gift cards for study participation, one for each 
of the visits which occur in addition to routine care, and one at the conclusion of the 
study.  
 
21.0 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, 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 they do not want to take part in 
the research, the informed consent process will be stopped. 
 

 
 
 
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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.  
• 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.  
 
 
22.0 Process to Document Consent in Writing 
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 a photocopied version. 
 
 
23.0 Multi-Site Research 
There will be at least 50 participants recruited for this study across all sites. All subjects 
will be identified using the methods described in “12.0 Recruitment Methods,” and 
recruited using the same phone script (submitted separately for review), with site specific 
information substituted as indicated.  
 
The investigator teams across all sites 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. The sponsor will additionally visit each site to train the 
practitioners and set up the study materials in the designated locations.  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, and then sign a training log to 
document this process. During this meeting, the Principal Investigator will also assign 

 
 
 
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duties and functions to each member of the team.  Monthly research video 
teleconferences will be held between the Sponsor, the Principal Investigator, and the 
study sites to review progress in executing the study, as well as to communicate 
successes and challenges. Additionally, the sponsor will communicate directly with each 
study site on an ad hoc basis to coordinate changes in the protocol, consent forms, other 
study related documents, or other information necessary for subject safety or study 
execution. 
 

 
 
 
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References 
1. 
Samuelsson EC, Victor FT, Tibblin G, Svärdsudd KF. Signs of genital prolapse in 
a Swedish population of women 20 to 59 years of age and possible related factors. 
Am J Obstet Gynecol. 1999;180(2 Pt 1):299-305. 
http://www.ncbi.nlm.nih.gov/pubmed/9988790. Accessed March 19, 2019. 
2.  
Nygaard I, Barber MD, Burgio KL, et al. Prevalence of symptomatic pelvic floor 
disorders in US women. JAMA - J Am Med Assoc. 2008. 
doi:10.1001/jama.300.11.1311 
3.  
Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of 
stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 
2014. doi:10.1097/AOG.0000000000000286 
4.  
Unger CA, Barber MD, Walters MD, Paraiso MFR, Ridgeway B, Jelovsek JE. 
Long-term effectiveness of uterosacral colpopexy and minimally invasive sacral 
colpopexy for treatment of pelvic organ prolapse. Female Pelvic Med Reconstr 
Surg. 2017. doi:10.1097/SPV.0000000000000313 
5.  
Cundiff GW, Weidner AC, Visco AG, Bump RC, Addison WA. A survey of 
pessary use by members of the American urogynecologic society. Obstet Gynecol. 
2000. 
6.  
Robert M, Schulz JA, Harvey MA, et al. Technical Update on Pessary Use. J 
Obstet Gynaecol Canada. 2013. doi:10.1016/S1701-2163(15)30888-4 
7.  
Sarma S, Ying T, Moore KHK. Long-term vaginal ring pessary use: 
Discontinuation rates and adverse events. BJOG An Int J Obstet Gynaecol. 
2009;116(13):1715-1721. doi:10.1111/j.1471-0528.2009.02380.x 
8.  
Bugge C, Adams EJ, Gopinath D, Reid F. Pessaries (mechanical devices) for 
pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013;(2). 
doi:10.1002/14651858.CD004010.pub3 
9.  
Cundiff GW, Amundsen CL, Bent AE, et al. The PESSRI study: symptom relief 
outcomes of a randomized crossover trial of the ring and Gellhorn pessaries. Am J 
Obstet Gynecol. 2007;196(4):405.e1-405.e8. doi:10.1016/j.ajog.2007.02.018 
10.  
Wolff B, Williams K, Winkler A, Lind L, Shalom D. Pessary types and 
discontinuation rates in patients with advanced pelvic organ prolapse. Int 
Urogynecol J. 2017;28(7):993-997. doi:10.1007/s00192-016-3228-9 
11.  
Deng M, Ding J, Ai F, Zhu L. Successful use of the Gellhorn pessary as a second-
line pessary in women with advanced pelvic organ prolapse. Menopause. 
2017;24(11):1277-1281. doi:10.1097/GME.0000000000000909