guideline no 411 vaginal pessary use

Objective: To review the use, care, andfitting of pessaries.Target population: Women requiring the use of vaginal pessaries forpelvic organ prolapse and/or stress urinary incontinence.. I

It is the Society of Obstetrician and Gynaecologists of Canada (SOGC) policy to review the content 5 years after publication, at which time the document may be revised to re flect new evidence or the document may be archived.

No 411, February 2021 (Replaces No 294, July 2013)

Guideline No 411: Vaginal Pessary Use

This clinical practice guideline was prepared by the authors and

overseen by the SOGC Urogynaecology Committee It was

reviewed by the SOGC Family Practice Advisory Committee and

approved by the SOGC Guideline Management and Oversight

Committee and the SOGC Board of Directors.

This clinical practice guideline supersedes technical update No.

294, published in July 2013.

Authors

Marie-Andr
ee Harvey, MD, MSc, Kingston, ON

Marie-Claude Lemieux, MD, Montr
eal, QC

Magali Robert, MD, MSc, Calgary, AB

Jane A Schulz, MD, Edmonton, AB

SOGC Urogynaecology Committee (2019): Aisling Clancy,

Laura Didomizio, Sin
ead Dufour, Roxana Geoffrion, Dobrochna

Globerman, Maryse Larouche, Marie-Claude Lemieux, Ola

Malabarey, Dante Pascali (co-chair), Marianne Pierce, Jens-Erik

Walter, David Wilkie (co-chair), and Maria Wu

Disclosures: Statements were received from all authors No

relationships or activities that could involve a con flict of interest

were declared All authors have indicated that they meet the journal ’s requirements for authorship.

Keywords: pessaries; pelvic organ prolapse; urinary incontinence; stress; vaginal discharge

Corresponding author: Marie-Andr
ee Harvey, harveym@queensu.ca

RECOMMENDED CHANGES IN PRACTICE

1 All women with pelvic organ prolapse or stress urinary incontinence can be offered a pessary; most women can be successfully fitted with a pessary.

2 While using a pessary, women should be followed with regular, thorough vaginal examinations to look for erosions, performed by a health care provider with specialized training.

3 Although it is recommended that women take care of their own pessary, if a woman is unable to remove and reinsert her pessary, this does not preclude pessary use.

KEY MESSAGES

1 Most women can be successfully fitted with a pessary for pelvic organ prolapse or stress urinary incontinence.

2 Serious complications are rare.

(En fran¸cais : Utilisation des pessaires)

The English document is the original version In the event of any discrepancy between the English and French content, the English version prevails.

J Obstet Gynaecol Can 2021;43(2):255 −266

https://doi.org/10.1016/j.jogc.2020.11.013

© 2020 The Society of Obstetricians and Gynaecologists of Canada/La

Société des obstétriciens et gynécologues du Canada Published by

Elsevier Inc.

This document re flects emerging clinical and scientific advances as of the publication date and is subject to change The information is not meant

to dictate an exclusive course of treatment or procedure Institutions are free to amend the recommendations The SOGC suggests, however, that they adequately document any such amendments.

Informed consent: Everyone has the right and responsibility to make informed decisions about their care together with their health care providers In order to facilitate this, the SOGC recommends that health care providers provide patients with information and support that is evidence-based, culturally appropriate, and personalized.

Language and inclusivity: This document uses gendered language in order to facilitate plain-language writing but is meant to be inclusive of all individuals, including those who do not identify as a woman/female The SOGC recognizes and respects the rights of all people for whom the information in this document may apply, including but not limited to transgender, non-binary, and intersex people The SOGC encourages health care providers to engage in respectful conversation with their patients about their gender identity and preferred gender pronouns and to apply these guidelines in a way that is sensitive to each person ’s needs.

Copyright: The contents of this document, in whole or in part, cannot be reproduced in any form without prior written permission of the publisher

of the Journal of Obstetrics and Gynaecology Canada.

Objective: To review the use, care, and fitting of pessaries.

Target population: Women requiring the use of vaginal pessaries for

pelvic organ prolapse and/or stress urinary incontinence Use may

also be indicated for women with certain pregnancy-related clinical

scenarios, including incarcerated uterus.

Options: Pessaries are an option for women presenting with prolapse

and/or stress urinary incontinence In addition, certain types of

pessaries can be considered for patients with cervical insuf ficiency

or incarcerated uterus.

Outcomes: Most women with prolapse or stress urinary

incontinence can be successfully fitted with a pessary and

experience excellent symptom relief, high satisfaction rates, and

minimal complications.

Bene fits, harms, and costs: Women with pelvic organ prolapse and/

or stress urinary incontinence may choose to use a pessary to

manage their symptoms rather than surgery or while waiting for

surgery Major complications have been seen only when pessaries

are neglected Minor complications such as vaginal discharge,

odour, and erosions can usually be successfully treated.

Evidence: Medline was searched for relevant articles up to December

2018 This is an update of the SOGC technical update published in

2013, which was the first internationally published guidance on

pessary use Subsequently, an Australian guideline on the use of pessaries for the treatment of prolapse was published later in 2013 Validation methods: The authors rated the quality of evidence and strength of recommendations using the approach of the Canadian Task Force on Preventive Health Care (Appendix A).

Intended audience: Gynaecologists, obstetricians, family physicians, physiotherapists, residents, and fellows.

SUMMARY STATEMENTS:

1 Most women can be successfully fitted with a pessary to treat the symptoms of pelvic organ prolapse or stress urinary incontinence (II-2).

2 Satisfaction rates for pessary use are very high (I).

3 Some vaginal pessaries may prevent recurrence of incarcerated uterus (III).

4 The role of pessaries speci fically designed to prevent preterm labour

is not yet elucidated (I).

5 Complications associated with pessary use are usually minor, with vaginal discharge being the most common problem (II-3).

6 Vaginal erosions can be treated with removal of the pessary and optional vaginal estrogen supplementation (II-2).

RECOMMENDATION:

1 Pessaries should be considered in all women presenting with bother-some pelvic organ prolapse and/or stress urinary incontinence (I, A).

This guideline reviews the evidence for the use of

vagi-nal pessaries in pelvic organ prolapse (POP) and

stress urinary incontinence, as well as in certain

preg-nancy-related clinical scenarios, including incarcerated

uterus and risk of premature labour related to cervical

insufficiency In the context of this guideline, the word

pessary is used in its most general definition, as any

device worn inside the vagina to support the uterus

and/or remedy a displacement Many types of vaginal

devices, globally referred to as pessaries, will be discussed

in this guideline

INTRODUCTION

POP occurs in up to 50% of parous women.1 Although

often asymptomatic, POP may present with symptoms of

bulging, pelvic pressure, and occasionally backache It is

often associated with bladder, bowel, and sexual

dysfunc-tion Management options include pelvic floor exercises,2

expectant management, use of mechanical vaginal devices

(pessaries), and surgical correction The focus of this

clini-cal practice guideline is to guide health care providers on

the use of pessaries

A pessary is a device placed into the vagina to either

sup-port the prolapsing vaginal walls or provide urinary

conti-nence Pessaries provide immediate relief of symptoms

and have the distinct advantage of being minimally

inva-sive In the past, pessaries were reserved for older patients

and/or those who were frail However, they are an

excel-lent option for the treatment of POP or stress urinary

incontinence for women of any age, including those who

wish to preserve their child-bearing potential, those who

prefer a non-surgical intervention, and those seeking

symp-tom relief while awaiting surgery Currently, pessaries are

experiencing resurgence in popularity, with increased

avail-ability

SUMMARY STATEMENT 1 AND

RECOMMENDATION 1

Pessaries are made of medical-grade silicone, which has

the advantage of making the devices inert and less likely

to have an odour or cause an allergic reaction.3Ring

pes-saries and incontinence ring pespes-saries also contain surgical

steel to facilitate flexion Surgical steel is contained as well

in rarely used pessaries not discussed in this guideline,

such as the Hodge, Risser, Smith, Gehrund, or Regula

models

Pessaries used for the treatment of POP can generally be classified as either support pessaries or space-occupying pessaries.4Support pessaries sit in the posterior fornix and generally rest above the pubic bone and/or pelvic floor The most common types of support pessary are ring pes-saries (with or without diaphragm, Figure 1A) and the Shaatz pessary (Figure 1B) Space-occupying pessaries include the cube (Figure 1C), Inflatoball (Figure 1D), and donut (Figure 1E) pessaries The cube works by bringing the vaginal walls towards the midline, and the others occupy a larger space than the introitus.4 The space-occupying pessaries are most often used for more severe prolapse The commonly used Gellhorn pessary (Figure 1F) works as a combination of these two meth-ods.4There are many other types of pessaries to address specific defects, but their use is seldom reported in the literature

Pessaries for incontinence are often designed as support pessaries, with extra support provided anteriorly (Figure 2A) to support, elevate, and slightly constrict the urethra.5 Some pessaries are specifically designed to treat stress urinary incontinence: the incontinence ring (Figure 2B), the incontinence dish (Figure 2C), and Ure-sta pessary (Resilia Inc., Shediac, NB) (Figure 2D) If a woman develops stress incontinence after being fitted with a prolapse pessary, switching to an incontinence ring or a pessary with a continence knob may be beneficial.3

INDICATIONS Pessaries can be used for therapeutic or diagnostic pur-poses Therapeutically, pessaries are often used to relieve symptoms of POP6 (for which they are cost-effective7) and stress urinary incontinence Women choosing a pes-sary for the treatment of POP are as likely to be satisfied and have improved pelvicfloor function as those selecting surgery.8

Diagnostically, pessaries can be used to provide preoper-ative evaluation of women with POP by unmasking latent stress incontinence9and information on postoper-ative voiding dysfunction.10,11 Occult urinary inconti-nence could be revealed during the use of a pessary or during the performance of urodynamic testing with and without a pessary, although this method of evaluation may be suboptimal.12 Although urodynamic testing has poor sensitivity, its specificity is high (93%), and the absence of occult incontinence has an excellent nega-tive predicnega-tive value (91%−98%) for postoperanega-tive continence.13,14

Pessaries can also be used to temporarily treat symptoms

while the patient awaits surgery and to help in healing

dependent vaginal ulcers that result from erosions due to a

large prolapse They may also play a role in preventing

POP from progressing

Pelvic Organ Prolapse

Women can be successfullyfitted with a pessary up to 75%

of the time.15,16Symptoms of bulging are relieved in 70%

to 90% of women and symptoms of pressure are relieved

in 29% to 49% of women,15,16thus improving quality of life.17Most women who report successful pessary use at 4 weeks continue to use a pessary at 5 years (Table 1).18

The most common pessary for POP is the ring pessary, followed by the Gellhorn, cube, and donut pessaries.16,19,20 However, a randomized crossover trial found no differen-ces in patient satisfaction or symptom relief between the

Figure 1 Support pessaries: (a) ring pessary with support, (b) Shaatz pessary, (c) cube pessary, (d) In flatoball pessary, (e) donut pessary, (f) Gellhorn pessary

Reproduced with permission from CooperSurgical, Inc., Trumbull, CT

ring and the Gellhorn pessaries.21 Ring pessaries may be

open or covered (also referred to as “with support” or

“with diaphragm”) and are the most widely available and

most commonly used The purpose of a covered ring

pes-sary is to support the cervix and avoid genital

incarcera-tion,22 while perforations allow the escape of vaginal

secretions Ring pessaries, either open or covered, are best

used in POP quantification stage I and II prolapse (mild to

moderate prolapse), although they often work well with a

more advanced degree of prolapse, provided there is an adequate perineal body to ensure the pessary is retained.3 Ring pessaries also have the advantage of ease of insertion and removal

If a ring pessary fails to remain in position or to relieve prolapse, a stiffer support pessary such as a Shaatz or Gell-horn, or a space-occupying pessary such as a cube or donut, may be used Cube pessaries have been successfully used in severe prolapse However, they can be prone to erosions and require frequent removal Patients can learn

to remove a cube pessary themselves

Successful use of a pessary depends on both adequate fit and patient satisfaction The most common reasons women choose to use a pessary are to improve symptoms secondary to POP, such as bulging, and to improve activity and general health.5,23 Other symptoms that can be improved with the use of a pessary include urinary urgency and difficulty with bladder emptying or defecating.16 , 19

Contrary to common belief, sexual activity is not a reason

to avoid pessary use; dissatisfaction with sexual activity does not predict discontinuation of pessary use.19,24 Pessary use may, in fact, enhance sexual activity and satisfaction.25,26

Figure 2 Incontinence pessaries: (a) ring pessary with support and continence knob at 12 o ’clock, (b) incontinence ring, (c) incontinence dish, (d) Uresta kit

Figures 2a −2c reproduced with permission from CooperSurgical Inc., Trumbull, CT; Figure 2 d reproduced with permission from Resilia Inc.

Table 1 Change in symptoms after pessary fitting

% of patients

17a−21 b

a

Fernando et al 16

b

Clemons et al.19

SUMMARY STATEMENT 2

Predictors for unsuccessful fitting include a short vagina

(<6 cm),19 , 27a wide introitus (>4 fingers’ breadth),19 , 27

a ratio of genital hiatus to total vaginal length of >0.8,15

patient discomfort,15younger age (<65 years),15

history of smoking,15lower initial prolapse stage,15and previous

vag-inal surgery.16,19,26,28−30The presence of a rectocele31with

stress urinary incontinence30predicted unsuccessful fit in

some studies but not in others.15We did notfind any

stud-ies that evaluated provider factors associated with

success-ful pessary use Many women may need to try more than

one pessary type tofind the one that works best for them

About one-third (29%32 to 35%33) of women required a

secondfitting using a Gellhorn pessary because the initial

fitting with a ring pessary failed Some women may

subse-quently try a donut or a Shaatz pessary, but this scenario

has not been described in the literature

Factors that predict pessary discontinuation include

poste-rior wall prolapse,16,28,34younger age (<65 years),19urinary

incontinence,19 discomfort,29 and expulsion.17 However,

women successfully fitted with a pessary who had

previ-ously undergone pelvic reconstructive surgery were more

likely to continue pessary use.30

In many centres, a pessary fitting is deemed successful if

the patient is comfortable in clinic, is able to void, and

does not experience uncomfortable descent or expulsion

during a Valsalva manoeuvre, which should be done while

the patient is sitting on a toilet rather than lying on the

examination table After the initialfitting visit, the patient

may require one or more subsequent visits to try other

saries of different sizes or models before an optimal

pes-sary is found and the trial of pespes-sary use is deemed

successful

Urinary Incontinence

Some pessaries have been specifically designed to treat

stress urinary incontinence These include the ring pessary

with support and a continence knob (Figure 2A), the

incontinence ring (Figure 2B), the incontinence dish

(Figure 2C), and over-the-counter pessaries such as Uresta

(Figure 2D) and Impressa (Poise, Kimberly-Clark)

pessaries

The ring and dish pessaries are designed to stabilize the

urethra and increase urethral resistance The rate of initial

successful fitting varies between 60% and 92%,35 , 36

but

continued use drops to 55% by 6 months.37 By 1 year, overall continuation may be as low as 16% However, this finding was from a study of an incontinence ring pessary with diaphragm, in which most women stopped using the device owing to lack of efficacy.38

In a retrospective chart review of 100 women who had a pessary successfully fit-ted, most with an incontinence ring, 59% were continent

or mostly continent at 11 months.39Reasons for discontin-uation included persistent incontinence, pessary falling out,

or pain and bleeding One crossover study (published only

in abstract form) that compared the incontinence ring with

no treatment found that the incontinence ring was more effective for the management of stress urinary inconti-nence, significantly decreasing the number of incontinence episodes and improving quality of life.40Eighty percent of women saw an improvement in continence, and 20% were completely continent However, there is insufficient evi-dence to determine whether pessaries are better than other devices or treatments,41including pelvicfloor exercises.42

In addition to incontinence rings, other commercial vaginal pessaries for bladder neck support are available directly to consumers and allow self-sizing, such as Uresta (Figure 2D) and Impressa (a single-use disposable, similar

to a tampon) pessaries Uresta and Impressa pessaries come in various sizes, and each has a “fitting box” that contains the available sizes to allow patient self-sizing Each size can then be purchased on its own

Sixty-seven percent of patients randomly assigned to Ure-sta for bladder support showed a 50% reduction in urine loss on a pad test using a standardized,fixed bladder vol-ume, compared with 22% of patients assigned to placebo43 (a vaginal silastic ring placed in the cul-de-sac, similar to rings used for estrogen supplementation, but unmedi-cated)

In a prospective before-and-after study of 62 women using Impressa, 85% achieved a≥70% reduction in pad weight, with 92%“feeling that they were continent.” Quality of life (measured on the Incontinence Impact Questionnaire-7 [IIQ-7] and Urogenital Distress Inventory-6 [UDI-6] scales) was statistically significantly improved by the end of

a period of device use Fitting was performed by the patient, who chose the size that best balanced comfort and continence Seventeen percent of the recruited women withdrew, about half owing to lack of interest and the other half owing to adverse effects Although nearly half of women reported discomfort and one-quarter reported spotting, only 7% discontinued the device because of adverse effects.44,45

POP and incontinence can occur during pregnancy It is

estimated that uterine prolapse occurs in 1 out of every

13 000 to 15 000 pregnancies.46,47Prolapse is usually noted

in thefirst trimester (and usually precedes the pregnancy)

but can occur at any time.47,48If prolapse occurs before 12

weeks gestation, it usually resolves by the end of the

sec-ond trimester as the uterus enlarges and ascends into an

intra-abdominal position, whereas, if POP develops during

pregnancy, it is more likely to resolve spontaneously

post-partum.47 Women who develop POP during pregnancy

can be fitted with a pessary, although not always

successfully.3,49,50By 18 weeks, when the uterus lifts out of

the pelvis, symptoms often resolve, and the pessary can be

discontinued Pessaries that have been studied for the

treatment of POP in pregnancy include the donut, Hodge,

ring, and Gellhorn pessaries Fitting issues, particularly

expulsion, appear to be a common concern, suggesting

that the use of a stiffer or space-occupying pessary may be

beneficial.48

The use of an incontinence pessary in

preg-nancy has not yet been studied but is not contraindicated

During pregnancy, women can develop urinary retention

due to an incarcerated uterus.51It has been suggested that

women with a retroverted uterus be examined routinely at

12 to 13 weeks gestation to evaluate whether pessary

place-ment is needed to prevent incarceration This preventative

approach has been used in subsequent pregnancies of

women with a history of incarceration In cases of

incarcer-ation, a pessary may be used to direct the cervix

posteri-orly, which is thought to reduce recurrence of urinary

retention by resolving the acute anterior angulation of the

cervix against the urethra

SUMMARY STATEMENT 3

Pessaries have recently been used in pregnancy for another

indication: preventing preterm labour There are data on

the use of the Arabin pessary (Figure 3), placed around the

cervix, to prevent premature delivery in singleton

pregnan-cies.52Unfortunately, thefindings of these studies remain

contradictory.53−55In twin pregnancies, there is also

con-flicting evidence regarding the benefit of pessaries for the

prevention of preterm birth.56,57 Two meta-analyses, one

in singleton and the other in twin pregnancies, did not

sup-port the use of the Arabin pessary to lower the risk of

pre-term labour and delivery.58,59 Therefore, the use of the

Arabin pessary to prevent preterm labour cannot be

rec-ommended in situations in which alternative established

treatment is available, outside of a clinical trial

SUMMARY STATEMENT 4

GUIDELINES FOR FITTING Successful fitting and continued use of a pessary depend

on adequate patient education (online Appendix, supple-mentary handout 1) The woman or her caregiver must comply with pessary care instructions.60Physicians, as well

as other appropriately trained health care providers (e.g., continence advisors, nurse practitioners, and pelvic health physiotherapists, in some provinces), can fit a pessary in Canada All professionals involved in fitting pessaries should have the skills and knowledge to insert a speculum and inspect thoroughly all parts of the vaginal vault to determine the integrity of the mucosa

Patient history−taking should include inquiring about symptoms of prolapse, bladder and bowel dysfunction, and sexual activity This should be followed by a compre-hensive pelvic examination, which consists of assessing vaginal mucosal health; evaluating the degree and compart-ment of prolapse, including genital hiatus and vaginal length; and measuring pelvicfloor strength It is common practice to begin vaginal estrogen therapy in postmeno-pausal women to improve the health of the vaginal epithe-lium,3,4 but this therapy not essential.61 In fact, no comparative studies have confirmed that vaginal estrogen therapy helps in preventing or managing erosions, although

it is widely believed that this therapy is helpful Similarly, no data were found on the effect of Replens (vaginal moistur-izer), hyaluronic acid, or other non-hormonal vaginal prep-arations on pessary use or related complications

Figure 3 Arabin cervical cerclage pessary

Reproduced with permission from Dr Arabin GmbH & Co KG, Witten, Germany.

For Pelvic Organ Prolapse

Support Pessaries

To determine the approximate size of the pessary, the

exam-iner should assess the width of the vaginal canal by

separat-ing the two examinseparat-ingfingers at the vault in a sagittal plane

and estimating their separation distance A ring pessary is

usually the initial choice forfitting because it is easy to use

and tends to be more comfortable than other types The

pessary is folded, and the leading edge is lubricated It is

inserted by directing it towards the sacrum and allowing it to

unfold above the pelvic floor, with the anterior edge just

behind the symphysis Afinger’s breadth should fit between

the pessary edge and the symphysis anteriorly and between

the side of the pessary and the lateral vaginal wall After

placement, the ring pessary should be rotated a quarter turn

in either direction to prevent the foldable edge from being

placed in front of the introitus, thus reducing the chance of

spontaneous expulsion Once the pessary has been placed,

the patient should walk around in the clinic and perform

activities such as squatting and the Valsalva manoeuvre to

confirm the pessary will remain in place The health care

provider should ensure that patients can void and are given

appropriate educational resources before leaving the clinic

(online Appendix, supplementary handout 1) If obstruction

is clinically suspected, a post-void residual urine test can be

conducted to rule out that possibility Dental floss can be

attached to a pessary to aid in removing the pessary if it is

difficult to reach

Space-Occupying Pessaries

A space-occupying pessary is the type most likely to be

successful if the vaginal introitus exceeds the width of three

or four examining fingers A Shaatz pessary is fitted

simi-larly to a ring, with the convex portion placed anteriorly

Tofit a Gellhorn pessary, the disk should be folded, when

possible, with the stem folded down towards the disk, for

ease of insertion Once the pessary is in the vagina, the

stem should be directed caudally (pointing out), so that a

finger can be passed between the disk and the vaginal

side-wall A cube pessary, owing to its unique square shape,

need not be as large as the width of the vagina (as

mea-sured with the examiningfingers spread apart) but should

be approximately half of that width Inserting a cube

pes-sary simply involves compressing the edge that is

intro-duced into the vaginal opening and pushing it up and back

Donut pessaries must also be compressed for insertion

For Stress Urinary Incontinence

An incontinence ring is fitted by assessing the distance

between the posterior cul-de-sac and the mid-urethra

Because the incontinence ring is moreflexible, it will adapt

to the shape of the vagina The health care provider must ensure that the knob is centred underneath the mid-urethra and that the proximal ring is placed in the posterior cul-de-sac, rather than in front of the cervix in the anterior fornix.62

A ring pessary with an incontinence knob (with or without

a membrane) is placed like a regular ring, but, once the sary has opened, the knob will face the sidewall The pes-sary must thus be rotated a quarter-turn to place the knob under the mid-urethra.62

PESSARY CARE AND FOLLOW-UP After a successfulfitting, the woman should be seen again within 2 to 4 weeks to see whether she is satisfied If possi-ble, further instruction on removing the pessary and pes-sary care should be given.3 The need for instruction is determined by evaluating comfort, pessary retention, con-venience, and relief of symptoms Commonly, another size

or style of pessary may be tried if the patient is dissatisfied Although there are no clear guidelines for pessary care, health care providers should advise women who can per-form self-care to remove the pessary weekly to monthly, according to their preference, and to wash it with mild soapy water or water alone Women unable to perform self-care should initially attend follow-up at 3-month inter-vals Pessary care is typically performed by a health care professional for Gellhorn, cube, and donut pessaries Fol-low-up intervals recommended by the manufacturers are not evidence-based or consistent with common practice and therefore are not considered standard of care.63 Some pessaries may be difficult to remove The Gellhorn pessary can be removed using a ring forceps (clamped on the tip of the stem) or packing self-closing forceps (with one end introduced in the stem’s channel) to apply outward traction, then using one finger to break the suction and fold the round disk along the stem To remove the cube pessary, the seal must be broken by sweeping a finger around the pessary, and, here again, sponge forceps can help with traction A cube pessary requires removal and cleaning more often than every 3 months owing to a greater amount of discharge that can become trapped within the cups (although the cube is available with drain-age holes or holes can be created using a 4-mm punch biopsy) The frequency of required cleaning for a cube pes-sary varies by patient, from as often as every few days to every few weeks

Once removed, the pessary should be washed using mild soapy water or water alone The perforations of the Gellhorn

and Shaatz are best cleaned with a cytobrush or a small cotton

swab The vaginal epithelium should then be inspected for

erosions or ulcerations, with special attention paid to the

pos-terior and lateral fornices of the vagina This is best

accom-plished using a large cotton swab to displace the cervix in the

contralateral direction The size, location, and depth of any

erosions should be noted and documented

If no complications arise, and particularly when the patient

can perform self-care, the interval between visits can be

increased to 6 months or 1 year.36Women can be sexually

active with the ring or Shaatz pessary in place if they

choose A cube, donut, or Gellhorn pessary generally must

be removed before intercourse

SEXUALITY AND PESSARY USE

In a study of new pessary users, sexual function has been

shown to remain unchanged, as assessed using validated

questionnaires.64 Although a ring pessary is said to be

compatible with intercourse, most women choose to

remove it before sex.64

COMPLICATIONS

Complication rates vary, which likely reflects differences in

reporting Hanson et al.26reported a low complication rate of

11% among 1216 women Common complications included

erosions (9%) and vaginal infections (2.5%).26Thesefindings

are in contrast to those of a study by Bai et al.,65who reported

that 73% of women had complications, including bleeding,

erosions, or foul odour Despite this high rate of

complica-tions, over 70% of women reported being satisfied with the

pessary and wanted to continue using it,65 thus suggesting

that these complications are minor Of 187 women offered

pessaries, 151 continued to use one at 1 month, and 130 were

still using one at 5 years.18 Most complications were seen

within 6 months of insertion and included pain (13; 5.3%),

bleeding or excoriations (3; 1.2%), and constipation (3;

1.2%) It was rare for complications to develop after 6

months of use.18

Infection and Discharge

Vaginal discharge is a common experience among pessary

users It can be caused by a physiological response to

fric-tion of the pessary on the vaginal mucosa, by bacterial

vag-inosis, or by yeast infections A study comparing women

using pessaries with women waiting for surgery found that,

although women using a pessary more often have vaginal

discharge, there was no difference in vaginal flora or rate

of bacterial vaginitis.69This contrasts with the findings of

Alnaif and Drutz,70who showed that, in matched women,

pessary users had a higher rate of diagnosed bacterial vagi-nosis than non-users (32% vs 10%) Indications for bacte-rial vaginosis testing and treatment should be the same for pessary users as for non-users

Bacterial vaginosis can cause malodourous vaginal dis-charge, which can be bothersome but is not related to

an ulcer.66,69The use of estrogen cream does not appear

to have a protective effect against bacterial vaginosis.66 However, more frequent pessary removal can reduce the risk of bacterial vaginosis The use of Trimo-San vaginal gel (CooperSurgical Inc., Trumbull, CT) has not been shown to affect discharge.71 Often, simple reassurance that discharge is physiological may be sufficient Other-wise, accepted treatments for bacterial vaginosis are effective.72 Yeast infections can be treated in conven-tional ways Removing the pessary for the duration of treatment is often recommended, although there is no evidence that this makes a difference Gellhorn pessaries are associated with increased vaginal discharge21; thus, changing to another type of pessary may reduce this symptom

SUMMARY STATEMENT 5

Devascularization Local pressure from the pessary can lead to focal devascu-larization This can result in excoriations, erosions, ulcers, and/or granulation tissue Reported rates range from 2%

to 9%.8,10Devascularization may present as vaginal bleed-ing, odour, or increased discharge, which is typically brown A primary indicator of devascularization is the presence of a strong odour upon removal of the pessary When strong odour is detected during routine pessary care, careful examination of the vagina should be per-formed, often facilitated by using large swabs to push the cervix and sidewalls apart

Other causes of vaginal bleeding in pessary users cannot be excluded Endometrial sampling or ulcer biopsy may be indicated if bleeding persists

There is no consensus on optimal care for devasculariza-tion The standard therapy consists of pessary removal for

a period of at least 2 weeks.63,66 For ongoing problems, more frequent visits and a change in pessary type or size may be required There is no consensus about whether changing to a smaller or larger pessary would be most ben-eficial.63

Some physicians apply silver nitrate to treat the erosion; however, no studies have assessed the effective-ness of silver nitrate in the management of erosion If the

pessary is not removed, there is a continuing risk offistula

development despite the management of erosion with

sil-ver nitrate Douching with sucralfate 10% suspension twice

daily has been reported to help with recalcitrant

ulcerations.67

In a study involving 130 women, erosions were seen

exclu-sively in those who were postmenopausal (27% of all

post-menopausal women) at 1-year follow-up of pessary use.68

Vaginal estrogen therapy in postmenopausal women has

not been shown to affect complication rates; however,

there is a trend towards decreased complications with

con-tinued use.66 Although no randomized controlled trials

have been performed to confirm this trend, estrogen

ther-apy is often advised when erosions have been identified

(e.g., one 10 mg estradiol tablet or 0.5−1 g conjugated

equine estrogen cream nightly for 2 weeks then twice per

week, or one estradiol vaginal ring every 3 months).26

However, erosions may also resolve without local estrogen

therapy.66 A consensus study reported that 75% of

care-givers routinely prescribe estrogen therapy with pessary

use.63

Vaginal microflora have been suspected as a possible

etio-logical factor for the development of erosions However, a

study of pessary wearers found that the microflora of

women who developed erosions did not differ from that

of women who did not develop erosions.69

SUMMARY STATEMENT 6

Other Complications

Most complications occur in the first 4 weeks of pessary

use and include expulsion of the pessary (16.3%), pain and

discomfort (5.3%), and constipation (1.2%); these

compli-cations rarely persist, according to a study that evaluated

them over 5 years of use.18

Dislodgment is a common reason for discontinuing the use

of a pessary This is best prevented by avoiding

constipa-tion and straining in general In a large cohort, the

mechan-ical complication rate over 9 years was reported as 5%

Unfortunately, the termmechanical complications was not

fur-ther defined or explored.73

Major Complications

Major complications are uncommon with pessary use

However, erosions can progress to ulcers or fistulae In a

cohort of pessary users from a large Medicare database,

fistulae did not appear until 2 years after placement; by

9 years the reported rate was 3%.73Many case reports of

major complications have been published, including vesi-covaginal fistulae, bowel fistulae, and incarcerated pessa-ries.74 Of those, 91% involved pessaries that had been neglected Vaginal or cervical cancer is rarely associated with a neglected pessary but should be considered in the presence of an ulcer that is not healing.75These risks high-light the importance of continued and diligent pessary care follow-up Overall, complications tend to be minor with the use of a pessary, but diligent follow-up is required to ensure that minor issues do not progress to more serious complications

CONCLUSION Pessaries have high success and low complication rates for the treatment of both POP and stress urinary incontinence When successfully fitted, they are associated with high patient satisfaction Consequently, they should be consid-ered first-line treatment for all women presenting with these indications

GUIDELINE TOOLKIT SOGC members can visit the Guideline Resource Kit web-page on sogc.org tofind complementary tools and resour-ces and to participate in accredited continuing professional development activities

REFERENCES

1 Swift SE The distribution of pelvic organ support in a population of female subjects seen for routine gynecologic health care Am J Obstet Gynecol 2000;183:277 –85.

2 Braekken IH, Majida M, Engh ME, et al Can pelvic floor muscle training reverse pelvic organ prolapse and reduce prolapse symptoms? An assessor-blinded, randomized, controlled trial Am J Obstet Gynecol 2010;203 170 e1−7.

3 Schulz JA, Kwon E, et al Pelvic organ prolapse - pessary treatment In: Baessler K SB, Burgio KL, Moore KH, et al, editors Pelvic floor re-education: principles and practice, London: Springer-Verlag London Limited; 2008 p 271–7.

4 Trowbridge ER, Fenner DE Practicalities and pitfalls of pessaries in older women Clin Obstet Gynecol 2007;50:709 –19.

5 Komesu YM, Ketai LH, Rogers RG, et al Restoration of continence by pessaries: magnetic resonance imaging assessment of mechanism of action.

Am J Obstet Gynecol 2008;198 563 e1 −6.

6 Patel M, Mellen C, O’Sullivan DM, et al Impact of pessary use on prolapse symptoms, quality of life, and body image Am J Obstet Gynecol 2010;202.

499 e1−4.

7 Hullfish KL, Trowbridge ER, Stukenborg GJ Treatment strategies for pelvic organ prolapse: a cost-effectiveness analysis Int Urogynecol J 2011;22:507–15.