2BACKGROUNDSome 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.
3BACKGROUNDRisk 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 .
4BACKGROUNDSymptoms, 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.
5BACKGROUNDThey may also be independent of the prolapse, eg symptoms of detrusor overactivity when a cystocoele is present.
6BACKGROUNDTreatment 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.
7BACKGROUNDAn 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.
8BACKGROUNDSome 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.
9BACKGROUNDThe 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.
10BACKGROUNDThe 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.
11BACKGROUNDThis 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.
12BACKGROUNDThere 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.
13Pessary 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.
14Pessary Efficacy in Improving Prolapse Symptoms Cont’d 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.
15Pessary Efficacy in Improving Prolapse Symptoms Cont’d 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.
16Handa et 2002Suggested 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.
17Factors 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%.
18Factors Effecting Successful Pessary Fitting Cont’d 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.
19Factors Effecting Successful Pessary Fitting Cont’d 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.
20Factors Effecting Successful Pessary Fitting Cont’d History of prior pelvic surgery, on the other hand, was the strongest predictor of a patient choosing surgery as their form of treatment.
21Factors Effecting Successful Pessary Fitting Cont’d 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 (<=6 cm) and wider vaginal introitus (4 finger breaths) on pelvic examination predicted an unsuccessful pessary fitting trial.
22Factors Effecting Successful Pessary Fitting Cont’d 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.
23Factors Effecting Successful Pessary Fitting Cont’d 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).
24Factors 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.
25Factors Affecting Continued Pessary Use In their study, older age (>65 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.
26Factors 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.
27Factors 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.
28Indications 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.
29Diagnosis 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.
30Lazarou et alAddressed the question of whether preoperative reduction of the anterior vaginal wall in patients with urinary retention [PVR] >=100 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.
31Temporary 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.
32Urinary 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).
33Urinary incontinence and obstetric indications Cont’d. 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.
34Urinary incontinence and obstetric indications Cont’d. 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
35Health 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.
36Health of the Vaginal Epithelium Cont’d 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.
37Hendrix et al 2002Showed 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.
38Cundiff et al 2000A two-page anonymous survey distributed to the members of the American Urogynecologic Society.The response rate was 48% (359 of 748).
39Cundiff et al 2000 cont’dPractice 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.
40Cundiff et al 2000 cont’dThe 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.
41Cundiff et al 2000 cont’dThose who described themselves as gynecologists tended to have been in practice longer (mean 20 years).Only 4% of respondents described themselves as urologists.
42Cundiff et al 2000 cont’d98% 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.
43Cundiff et al 2000 cont’dPractitioners 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.
44Cundiff et al 2000 cont’dA 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.
45Cundiff et al 2000 cont’d94 % recommended concurrent estrogen replacement therapy and 61% asked patients to perform pelvic muscle exercises while using a pessary.
46Pessary use by specialty including first-line use and for patients declining surgery .
48Wu 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.
49Wu et al cont’d the pessary was replaced if: too stiff encrusted with secretion.developed defects.been used for 1 year.
50Wu et al cont’din 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.
51Wu et al cont’dCurrent hormone replacement therapy use did not predict successful pessary fitting.The incidence of abrasions increased sig as the mucosa became thinner.
52Wu et al cont’dThere was no correlation between the hormone replacement status and the abrasion rate.The highest rate of pessary discontinuation was in the first year.
53Wu et al cont’dMinor 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.
54Complications 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.
55Complications 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.
56Complications 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 ( g/d) for 2 to 3 weeks.
57Complications 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.
58Complications 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)
59Complications 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.
60Complications 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.
61Evidence 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.”
62Evidence 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.
63Evidence 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]).
64Evidence 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.
65SummaryThere 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.
66SummaryAll 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.
67SummaryPatients at risk for poor follow up should be considered poor candidates for pessary management.