PESSARY CARE

1
PESSARY CARE

• Raed Sayed Ahmed

2
BACKGROUND

• Some degree of prolapse seen in up to 50 of
  parous women in a clinic setting although many
  are asymptomatic.
• The aetiology of pelvic organ prolapse is complex
  and multi-factorial.

3
BACKGROUND

• Risk factors include pregnancy, childbirth,
  congenital or acquired connective tissue
  abnormalities, denervation or weakness of the
  pelvic floor, ageing, menopause and factors
  associated with chronically raised
  intra-abdominal pressure .

4
BACKGROUND

• Symptoms, only some of which are directly related
  to the prolapse, include pelvic heaviness,
  dragging sensation in the vagina, bulge/lump or
  protrusion coming down from the vagina, and
  backache.
• Symptoms of bladder, bowel or sexual dysfunction
  are frequently present. These may be directly
  related to the prolapsed organ, eg poor urinary
  stream when a cystocoele is present, or
  obstructed defecation when a rectocoele is
  present.

5
BACKGROUND

• They may also be independent of the prolapse, eg
  symptoms of detrusor overactivity when a
  cystocoele is present.

6
BACKGROUND

• Treatment of prolapse depends on the severity of
  prolapse and its symptoms, and the woman's
  general health.
• Options available for treatment are conservative,
  mechanical and surgical.
• Generally, conservative or mechanical treatment
  is considered for women with a mild degree of
  prolapse, for those who wish to have more
  children, and the frail or those unwilling to
  undergo surgery.

7
BACKGROUND

• An extensive range of mechanical devices have
  been described for the treatment of prolapse.
• Pessaries need to be removed regularly and the
  vaginal mucosa checked for erosions although the
  optimum frequency for this has not been
  established.

8
BACKGROUND

• Some patients will be able to remove and replace
  the pessary themselves, which may lengthen the
  intervals between gynaecological examinations.
• The role of local estrogens in preventing
  complications has not been established.
• Mechanical devices are cheap and complications
  are rare, but their efficacy in the management of
  prolapse is unknown.

9
BACKGROUND

• The aims of mechanical treatment in the
  management of pelvic organ prolapse include
• To prevent the prolapse becoming worse.
• To help decrease the frequency or severity of
  symptoms of prolapse.
• To avert or delay the need for surgery.

10
BACKGROUND

• The era of modern surgery has witnessed a steady
  decline in pessary use as well as a decline in
  instruction in the use of pessaries,such that for
  many physicians, pessaries have become a medical
  curiosity.
• This trend was promoted by much quoted article
  from 1961 that attributed a number of
  complications, including vaginal malignancy,
  vaginal ulceration, fistulas, and pelvic
  cellulitis to the use of pessaries.

11
BACKGROUND

• This has led some authors to describe pessaries
  as obsolete and even dangerous.
• Differences of opinion regarding pessary use are
  even clearer when more specific criteria for
  pessary use are considered.
• Some authors consider vaginal pressure ulcers a
  contraindication to pessaries, while others
  recommend them to permit the healing of vaginal
  pressure ulcers.

12
BACKGROUND

• There are no level I or level II data addressing
  the indications, or appropriate choice of pessary
  for different support defects.
• There is one prospective study addressing the
  effectiveness of pessary use and the impact of
  clinical characteristics including stage of
  prolapse, hormone replacement, and perineal
  support on the success of pessary use.

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Pessary Efficacy in Improving Prolapse Symptoms

• Only a few studies have evaluated the efficacy
  and patient satisfaction of pessaries in
  relieving symptoms of prolapse.
• Clemons et al followed 100 women fitted with
  pessaries for stage II prolapse for changes in
  prolapse and urinary symptoms.
• At 2 months, 92 of women fitted with a pessary
  were satisfied.

14
Pessary Efficacy in Improving Prolapse Symptoms
Contd

• Nearly all prolapse symptoms (bulge, pressure,
  discharge, and splinting) had resolved and
  concurrent urinary symptoms (baseline stress
  incontinence, urge incontinence, and voiding
  difficulty) had improved in approximately half of
  patients.
• However, among women with no urinary symptoms at
  baseline, 21 complained of occult (de novo)
  incontinence with pessary use.

15
Pessary Efficacy in Improving Prolapse Symptoms
Contd

• Many clinicians have noted the decrease in
  prolapse stage after long-term pessary use and
  the successful role of pessaries in preventing
  progression of prolapse.

16
Handa et 2002

• Suggested that there was a therapeutic effect of
  wearing a supportive pessary as evidenced by an
  improvement of stage of pelvic organ prolapse in
  21 of patients followed for 1 year.
• The mechanism of this improvement might be the
  result of improved levator ani function, and that
  pessary support of pelvic organs may allow for
  recovery of passive stretch, thus improving
  levator function and muscular support of pelvic
  organs.

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Factors Effecting Successful Pessary Fitting

• Achieving optimal results and satisfaction with
  pessary use requires accurate identification of
  appropriate patient candidates and proper choice
  of pessary type.
• Successful pessary fitting rates range from 56
  to 74.

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Factors Effecting Successful Pessary Fitting
Contd

• The two studies with the highest rates of success
  used similar protocols.
• Patients were first fitted with ring pessaries
  and, if expelled, a space-filling pessary such as
  the Gellhorn was then attempted.

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Factors Effecting Successful Pessary Fitting
Contd

• Important in the discussion of successful pessary
  fitting is to speculate which patients are likely
  to choose pessary management over surgery or
  expectant management.
• A study evaluating the clinical factors that
  affect a patient's treatment choice for
  symptomatic pelvic organ prolapse found that
  older patients (age 70 12 years) were 10 more
  likely to choose pessary over surgery.

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Factors Effecting Successful Pessary Fitting
Contd

• History of prior pelvic surgery, on the other
  hand, was the strongest predictor of a patient
  choosing surgery as their form of treatment.

21
Factors Effecting Successful Pessary Fitting
Contd

• Clemons et al fitted 100 women with pessaries for
  symptomatic pelvic organ prolapse and found that
  no patient demographic or comorbidity could be
  identified as a risk factor for an unsuccessful
  pessary fitting trial.
• However, this study did find an association with
  shorter vaginal length (lt6 cm) and wider vaginal
  introitus (4 finger breaths) on pelvic
  examination predicted an unsuccessful pessary
  fitting trial.

22
Factors Effecting Successful Pessary Fitting
Contd

• Interestingly, stage III or IV prolapse in each
  compartment (anterior vaginal wall, posterior
  vaginal wall, and vault/uterine prolapse) was not
  a risk factor for an unsuccessful fitting.

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Factors Effecting Successful Pessary Fitting
Contd

• A similar study also evaluated variables, which
  would diminish a patient's ability to retain a
  pessary.
• In this particular study, physical examination
  findings that predicted a patient's inability to
  retain a pessary were absence of sacral reflexes,
  inability to Kegel, higher stage of prolapse, and
  an enlarged genital hiatus (greater than 4 cm).

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Factors Affecting Continued Pessary Use

• Factors that affect a patient's likelihood to
  continue with pessary use have been evaluated by
  several studies.
• Clemons et al found that 72 of women satisfied
  with their pessary after 2 months continued to
  use their pessary after 1 year and 64 continued
  use after 2 years.

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Factors Affecting Continued Pessary Use

• In their study, older age (gt65 years) was the
  strongest predictor of continued pessary use
  after a successful fitting.
• Stage III and IV posterior wall prolapse was
  associated with discontinued use of the pessary.
• This finding is not surprising because
  anecdotally, women with large posterior wall
  defects are less likely to experience relief of
  their prolapse symptoms with pessary use.

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Factors Affecting Continued Pessary Use

• Initial desire for surgical management of
  prolapse symptoms was also found to be associated
  with discontinued use of pessaries.
• Brincat performed a retrospective chart review of
  136 current users versus nonusers (women who
  stopped wearing the pessary during the study
  period) to determine clinical variables
  predicting continued pessary use.

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Factors Affecting Continued Pessary Use

• The authors reported that women with prolapse and
  incontinence or prolapse alone were more likely
  to continue with long-term pessary use than women
  with isolated incontinence.
• Their most significant finding of this study was
  that long-term pessary use was acceptable to
  sexually active women.

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Indications for Pessary use

• Indications for pessary use are
• Primary therapy for prolapse symptoms.
• Diagnosis and preoperative evaluation of patients
  with pelvic prolapse.
• Temporary treatment of prolapse symptoms.
• Urinary incontinence and obstetric indications.

29
Diagnosis and preoperative evaluation of patients
with pelvic prolapse.

• Occult incontinence, urinary retention, and
  pelvic pain are conditions that should be
  evaluated preoperatively to allow for
  comprehensive counseling as to the best surgical
  or nonsurgical form of treatment.

30
Lazarou et al

• Addressed the question of whether preoperative
  reduction of the anterior vaginal wall in
  patients with urinary retention PVR gt100 cc
  with a pessary would predict voiding function
  after reconstructive surgery.
• concluded that pessary reduction of the anterior
  vaginal wall in patients with urinary retention
  has good sensitivity, specificity, and positive
  predictive value for postoperative voiding
  function.

31
Temporary treatment of prolapse symptoms.

• Preoperatively, a pessary can be useful in the
  healing of vulvar erosions secondary to a large
  prolapse.
• Second, mechanical devices can be used as an
  interim measure while a patient prepares for
  surgery and considers nonsurgical options for
  relief of symptoms.
• Younger women will benefit from the symptomatic
  relief of their prolapse symptoms as they wait to
  complete childbearing.

32
Urinary incontinence and obstetric indications.

• Pessaries are an important conservative mode of
  therapy used for urinary incontinence as well as
  the use of pessaries in obstetrics for the
  management of an incarcerated uterus or
  incompetent cervix.
• Pessaries designed to support the urethrovesical
  junction with a knob or prongs may be successful
  alternatives for surgery for the management of
  stress incontinence with a success rate ranging
  from 15 to 59 (Ferrell et al 2002).

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Urinary incontinence and obstetric indications
Contd.

• In obstetrics, pessary use has been reported in
  the first trimester for the treatment of
  incarcerated uterus.
• Rarely pessaries have been used in cases of
  incompetent cervix.

34
Urinary incontinence and obstetric indications
Contd.

• A recent review of the use of pessaries in women
  at risk for preterm delivery reports that they
  might be helpful and seem to be without risks.
• However, the existing data are limited by a lack
  of inclusion criteria and selection bias.
• The review recommends that pessaries be used as
  an adjunct to cerclage and not to replace the use
  of cerclages in the treatment of incompetent
  cervix

35
Health of the Vaginal Epithelium

• Evaluation for vaginal and vulvar atrophy
  secondary to estrogen deficiency should be
  assessed on examination.
• Little to no data is currently available to
  dictate whether vaginal atrophy is indeed a
  contraindication for pessary fitting.
• Wu and colleagues reported on their experience
  and reported that hormone replacement therapy
  (HRT) did not predict successful pessary fitting.

36
Health of the Vaginal Epithelium Contd

• The health of the vaginal epithelium was recorded
  in 75 of these women, and no correlation was
  found between current hormone replacement status
  and vaginal abrasions rates.
• Most experts would advocate local estrogen
  therapy in pessary users provided that there are
  no contraindications to its use.

37
Hendrix et al 2002

• Showed that oral HRT/estrogen replacement therapy
  (ERT) provides no functional improvement of the
  lower urinary tract.
• To definitively answer the question of estrogen
  use and pessaries, we need trials on type, route,
  frequency, and so on.

38
Cundiff et al 2000

• A two-page anonymous survey distributed to the
  members of the American Urogynecologic Society.
• The response rate was 48 (359 of 748).

39
Cundiff et al 2000 contd

• Practice and number of years in practice and
  questions regarding indications for a pessary in
  patients with pelvic organ prolapse.
• The impact of other factors hormonal status,
  sexual activity, prior hysterectomy, and stage
  and site of pelvic organ prolapse.

40
Cundiff et al 2000 contd

• The choice of pessary for specific support
  defects. The long-term management of pessaries.
• 50 of respondents urogynecologists, while a
  third obstetrician-gynecologists, and 10
  gynecologists.

41
Cundiff et al 2000 contd

• Those who described themselves as gynecologists
  tended to have been in practice longer (mean 20
  years).
• Only 4 of respondents described themselves as
  urologists.

42
Cundiff et al 2000 contd

• 98 reported using pessaries in their practice.
  77 used them as a first line of therapy for
  pelvic organ prolapse, while 12 only offered
  pessaries to women who were not surgical
  candidates.
• Gynecologists and urologists were less apt to use
  pessaries as first-line therapy and more apt to
  reserve them for nonsurgical patients than
  obstetrician-gynecologists and urogynecologists.

43
Cundiff et al 2000 contd

• Practitioners with more than 20 years in practice
  were less likely to use a pessary as a first-line
  therapy and more likely to reserve them for women
  who could not undergo surgery.
• Less than half of the respondents considered a
  prior hysterectomy 42, or current sexual
  activity 45 to be contraindications for a
  pessary, while two thirds or 64 considered
  hypoestrogenism to be a contraindication.

44
Cundiff et al 2000 contd

• A variety of pessary removal regimens were
  described with no clear prevailing regimen.
• 53 of physicians reported teaching all their
  patients to change their own pessary,while 45
  reserved this approach for a subset of women
  using support pessaries.

45
Cundiff et al 2000 contd

• 94 recommended concurrent estrogen replacement
  therapy and 61 asked patients to perform pelvic
  muscle exercises while using a pessary.

46
Pessary use by specialty including first-line use
and for patients declining surgery .
47
(No Transcript)
48
Wu et al

• 110 patients with a mean age of 65.
• patients were seen in follow up in 2 weeks.self
  care was encouraged.
• at each visit the pessary was removed,rinsed in
  tap water and dried.the vagina was inspected by
  speculum for evidence of abrasion or erosion.

49
Wu et al contd

• the pessary was replaced if
• too stiff
• encrusted with secretion.
• developed defects.
• been used for 1 year.

50
Wu et al contd

• in the 1st year following insertion following was
  scheduled at 3 month intervals.
• if the patient remaind free of complications,the
  follow up interval was extended to 6 months in
  the 2nd and subsequent year.
• Patients using cube pessaries were managed using
  a different protocol.

51
Wu et al contd

• Current hormone replacement therapy use did not
  predict successful pessary fitting.
• The incidence of abrasions increased sig as the
  mucosa became thinner.

52
Wu et al contd

• There was no correlation between the hormone
  replacement status and the abrasion rate.
• The highest rate of pessary discontinuation was
  in the first year.

53
Wu et al contd

• Minor vaginal abrasions usually were managed with
  vaginal estrogen cream.
• Those patients were reexamined after shorter
  follow-up intervals.
• Vaginal discharge were common and were managed
  successfully in the majority of patients by
  periodic douching and / or the use of Trimo-San.

54
Complications and Contraindications

• Pessary complications are rare occurrences in
  medically compliant patients.
• The most common complications are pessary
  expulsion, urinary incontinence, and rectal pain,
  depending on the type of pessary.

55
Complications and Contraindications

• Vaginal discharge is common.
• A study comparing pessary users with nonusers
  found that the presence of a foreign body
  increased the risk for bacterial vaginosis by
  4-fold.
• If the patient is symptomatic, bacterial
  vaginosis may be treated, but vaginal cultures
  are not recommended.

56
Complications and Contraindications

• Vaginal estrogen is generally recommended to
  patients who are noted to have vaginal atrophy or
  areas ulceration or abrasions from pessary use.
• Typically, if ulceration occurs, the pessary is
  left out and the patient is advised to use
  intravaginal estrogen cream daily (0.5-1.0 g/d)
  for 2 to 3 weeks.

57
Complications and Contraindications

• If the ulcerations have healed, the pessary can
  be replaced, and it is recommended that the
  patient continue to use the vaginal cream 2 to 3
  times per week.
• If ulcerations recur, despite estrogen therapy,
  it may be best to discontinue pessary management
  and consider biopsy of the site.

58
Complications and Contraindications

• More serious complications associated with
  pessary use are generally attributable to a
  neglected device.
• Pessaries may become impacted. This is more
  commonly seen with space-filling pessaries such
  as the Gellhorn and cube pessary.
• These pessaries are more likely to cause vaginal
  erosions.
• Applying estrogen cream to an impacted pessary
  will generally aid in its removal (Poma et al
  1981)

59
Complications and Contraindications

• However, an impacted pessary can require surgical
  removal.
• Other less common serious complications have been
  described in case reports.
• These include incarceration of the cervix, small
  bowel prolapse and incarceration, vesicovaginal
  fistula, and urosepsis.

60
Complications and Contraindications

• what these reports all share in common is that
  the patient had not been examined by a physician
  for several years.
• This highlights the importance of evaluating
  patient compliance in the initial evaluation.

61
Evidence for Pessary Use (Cochrane)

• In 2004, 2 Cochrane Database Systematic Reviews
  were performed on the topics of Mechanical
  Devices for Pelvic Organ Prolapse in Women and
  Conservative Management of Pelvic Organ Prolapse
  in Women.

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Evidence for Pessary Use (Cochrane)

• The review of mechanical devices concluded that
  currently there is no evidence from randomized
  controlled trials (RTC) upon which to base
  treatment of women with pelvic organ prolapse
  through the use of mechanical devices/pessaries.
  
• Likewise, the review of conservative management
  came to a similar conclusion that there was no
  evidence from RTC regarding conservative
  interventions in the management of pelvic organ
  prolapse.

63
Evidence for Pessary Use (Cochrane)

• The conservative management review reported that
  evaluating the effectiveness of pelvic floor
  muscle training (PFMT) in treating pelvic
  prolapse is the most pressing research need, in
  that it is a costly management option.
• A feasibility study is currently underway that
  has an ultimate goal of progressing to a
  multicenter randomized trial (Pelvic Organ
  Prolapse Physiotherapy POPPY).

64
Evidence for Pessary Use (Cochrane)

• Two other randomized studies were identified by
  the Cochrane database that evaluated the
  effectiveness of PFMT in conjunction with surgery
  for symptomatic prolapse.
• One of the studies continues to recruit patients,
  and the other has been completed and awaiting
  publication.

65
Summary

• There is insufficient evidence to allow a
  practitioner to know which patients are likely to
  accept and continue pessary use.
• There is no strong evidence to guide the
  management of a patient with a pessary.

66
Summary

• All patients with symptomatic prolapse should be
  offered conservative management of prolapse using
  pessaries.
• It is difficult to control for various aspects of
  HRT and its role in maintaining healthy vaginal
  epithelium with pessary use.

67
Summary

• Patients at risk for poor follow up should be
  considered poor candidates for pessary management.