Disclosures - UAB · 2017. 11. 10. · Non‐Surgical Treatment of Pelvic Organ Prolapse – Holly...

Non‐Surgical Treatment of Pelvic Organ Prolapse – Holly E. Richter, PhD, MD, FACOG, FACS

Comprehensive Review Course in Female Pelvic Medicine and Reconstructive Surgery, 2013

Non-Surgical Treatment of Pelvic Organ Prolapse

Disclosures

No relevant disclosures

Learning ObjectivesDiscuss non-surgical options for symptomatic anterior, apical, and posterior prolapse Discuss role of pelvic floor physical therapy in management of prolapse List factors which impact successful pessary fitting for prolapse, including: stage, genital hiatus, uterus, etc Fit and manage prolapse pessaries Discuss the advantages and disadvantages of the following pessary types Ring with and without support– Donut– Gellhorn– Gehrung– Lever– Cube

Discuss the role of estrogen replacement therapy (systemic vs local) in women using pessary for prolapse Explain how recommendations differ based on presence or absence of uterus



Prevalence Rates of Pelvic Floor Disorders in Women from the National Health and Nutrition

Examination Survey (NHANES) 2005-06

Prolapse: Weighted prevalence rate 2.9%, 95% CI2.1-3.7%; with increasing age 4.1%, 95% CI1.1, 7.1%Nygaard et al, 2008

Who are candidates?

Conservative (Conservative (nonnon--surgical) surgical) management of POP management of POP should be offered to should be offered to all patientspatients

--Minimum morbidity and mortalityMinimum morbidity and mortality--Minimally invasiveMinimally invasive--Does not preclude surgeryDoes not preclude surgeryDoes not preclude surgeryDoes not preclude surgery--SSatisfaction highatisfaction high

PATIENT MOTIVATION is key PATIENT MOTIVATION is key to to successsuccess

Hay Smith et al, ICI, 2009Hay Smith et al, ICI, 2009

Conservative Therapy = Less RiskConservative Therapy = Less Risk

The absolute risk of death is low for urogynecologic The absolute risk of death is low for urogynecologic surgerysurgery

Older women = higher risk of mortality/morbidity Older women = higher risk of mortality/morbidity following urogynecologic surgery:following urogynecologic surgery:

--Increasing age increased risk of death (compared to women



Who chooses surgical vs. Non-surgical?Prospective cohort study in women with symptomatic prolapse

– Offered surgical versus pessary treatment

251 women chose surgery, 429 women chose pessary– no difference regarding prolapse stage, leading edge, previous POP surgery and

hysterectomy

Women choosing surgery were: – Younger (58 vs 66)– More bothered with “dragging”, lower abdominal pain, need for vaginal digitationgg g , p , g g

In general, women choosing surgery had more severe symptoms related to bowel emptying, sexual function and quality of life

Overall POP symptom distress was comparable

Treatment approach may not be totally driven by symptoms

Offer to all patients!! Kapoor, 2009

Non-surgical Treatment Options for Symptomatic Vaginal Prolapse

What is the evidence?What is the evidence?

•• Expectant Management/ObservationExpectant Management/Observation•• Expectant Management/ObservationExpectant Management/Observation

•• Pelvic Muscle ExercisesPelvic Muscle Exercises

•• PessaryPessary

Expectant ManagementExpectant Management

Allows patient to monitor symptomsAllows patient to monitor symptomsIdeal for patients with minimal botherIdeal for patients with minimal botherWould not offer: Would not offer: –– Patients with difficulty emptying bowels and Patients with difficulty emptying bowels and

bladderbladder–– Significant vaginal erosionSignificant vaginal erosion–– Inability to reduce prolapseInability to reduce prolapse



Is the prolapse going to get worse?Expectant Management• 64 symptomatic women chose observation (158 selected

treatment)• Majority Stage 2 or 3• Median follow-up 16 months (range 6-91 months)• 78% no change in leading edge, 19% progression, 3%

iregression• On multivariate analysis, no variables associated with

change• 63% continued observation, 38% pessary/surgery

Bottom Line: Natural history of POP = minimal change in women declining intervention

Gilchrist et al, 2012

Pelvic Floor Muscle Exercises

Few studies exist for PFMT/behavioral therapy treatment of pelvic organ prolapseMost are small (until recently), descriptiveSh t t f llShort-term follow-upPatients with mild/moderate prolapse

Pelvic Floor Muscle Training For The Treatment of Pelvic Organ ProlapsePelvic Organ Prolapse Physiotherapy, Pelvic Organ Prolapse Physiotherapy, POPPY TrialPOPPY Trial–– Hagen and colleagues randomized 447 women with Hagen and colleagues randomized 447 women with

newly diagnosed symptomatic prolapse to newly diagnosed symptomatic prolapse to f ff findividualized pelvic floor muscle training or lifestyle individualized pelvic floor muscle training or lifestyle

advice advice –– Stage 1Stage 1--33–– Intervention group Intervention group 5 visits PFMT over 16 weeks5 visits PFMT over 16 weeks–– 11°°outcome outcome --12 month validated questionnaire12 month validated questionnaire

Hagen et al, Lancet 2013



POPPY Trial, POPPY Trial, cont.cont.

–– At 12 months the intervention group At 12 months the intervention group demonstrated fewer prolapse symptoms and demonstrated fewer prolapse symptoms and more likely to report their prolapse as more likely to report their prolapse as ““betterbetter””

–– There were no adverse events related to There were no adverse events related to treatmenttreatment

Hagen et al, Lancet 2013

Bottom Line for PFMT for POPBottom Line for PFMT for POP

May expect subjective and objective

improvements

Most likely best for stage I and II POP

Low risk

Requires motivated patient

Pessary

Pelvic organ prolapse treatments have had a variable course through history……..



History of the PessaryHistory of the Pessary1550 BC Ebers papyrus 1550 BC Ebers papyrus references references ““remedies to allow the remedies to allow the womb of a woman to slip into its womb of a woman to slip into its placeplace””pp–– Honey and petroleum applied to Honey and petroleum applied to

uterusuterus–– FumesFumes

References also seen in Hindu, References also seen in Hindu, Greek, and Roman worksGreek, and Roman works

400 BC 400 BC -- HippocratesHippocratesSuccussion – Suspend a woman upside down and aggressively move her up and down for 3-5 minutes

Shah SM et al, 2006

5 minutes

Gravity and the shaking motion would return the organs to their normal position

Hot oil, astringents, and Hot oil, astringents, and wool plugs were usedwool plugs were used

Leg bindingLeg binding

Fumigation to repel the Fumigation to repel the uterus back into placeuterus back into place

Pomegranates warmed Pomegranates warmed in lukewarm wine were in lukewarm wine were insertedinserted



932 AD Manual reduction of prolapse, 932 AD Manual reduction of prolapse, insertion of a wool pessary and crossing insertion of a wool pessary and crossing of the legsof the legs

1559 AD Replacement for the 1559 AD Replacement for the pomegranate pessarypomegranate pessary–– Sponge wrapped in string, dipped in wax Sponge wrapped in string, dipped in wax

and covered with oil or butterand covered with oil or butter

Various 19thcentury pessariespessaries

Walters MD and Karram MM, 2007

1919thth century: century: ring, Hodge, and Smith pessaries ring, Hodge, and Smith pessaries came into usecame into use

1950s: 1950s: hard rubber hard rubber replaced replaced with polystyrenewith polystyrene

Further refinement has been made to Further refinement has been made to pessariespessaries

Modern day pessariesnon-reactive siliconevarious designs and sizes



Reasons to Consider Pessary Trial

Symptomatic prolapse & patient’s desire for non-surgical interventionMedical contraindications to surgeryDesire to postpone/delay surgical interventionVaginal ulcerations caused by severe POP Younger women with prolapse or incontinence who plan to have children or additional children Diagnostic tool (prediction of surgical outcome)Prevention of increasing prolapse

Atnip et al 2012; Clemons 2012

Do Pessaries Work?

ShortShort--term studies (2term studies (2--6 months): 6 months): –– Satisfaction and continued use 81% (range 63Satisfaction and continued use 81% (range 63--

92%); 59% (4092%); 59% (40--77%) ITT 77%) ITT Cundiff et al, 2007; Wu et al, 1997; Nguyen et al, 2005; Maito et al, 2006; Handa and

Jones, 2002; Clemons, 2004.

MediumMedium--term (1term (1--2 years): 2 years): –– Satisfaction and continued use 62% (53Satisfaction and continued use 62% (53--83%); 83%);

40% (3040% (30--63%) ITT 63%) ITT Powers et al, 2006; Cundiff et al, 2007; Wu et al, 1997; Nguyen et al, 2005; Handa and Jones, 2002; Friedman et al, 2010; Clemons, 2004; Patel et al, 2010.

LongLong--term Outcomesterm Outcomes

Lone and colleagues performed a prospective Lone and colleagues performed a prospective observational study of subjects successfully fit observational study of subjects successfully fit (187/246)(187/246)–– 86.1% successfully utilized the pessary over 5 years86.1% successfully utilized the pessary over 5 years–– Minor complications included:Minor complications included:

P i di f t (6 9%)P i di f t (6 9%)•• Pain or discomfort (6.9%)Pain or discomfort (6.9%)•• Excoriation or bleeding (3.2%)Excoriation or bleeding (3.2%)•• Disimpaction or constipation (2.0%)Disimpaction or constipation (2.0%)11

A retrospective study involving 167 women A retrospective study involving 167 women described a 14% continuation rate over 14 yearsdescribed a 14% continuation rate over 14 years22

1. Lone et al, 2011; 2. Sarma et al, 20091. Lone et al, 2011; 2. Sarma et al, 2009



Patient Selection Considerations

Patient’s motivation

Current sexual function

Type and duration of exercise regimen/ other activity level

Current condition of vaginal walls/cervix

Surgical History

Other considerations

Patient’s cognitive status

Manual dexterityManual dexterity

Support system

Potential ContraindicationsLocal infectionAtrophyExposed vaginal foreign body (mesh)Latex sensitivity (inflatoball)N liNon-complianceMost Important: Patient cannot comply with follow-up (dementia or transportation issues)Persistent vaginal erosionsSexually active women unable to remove/insert pessary

Clemons, 2012



Pessary CharacteristicsPessary CharacteristicsMade of siliconeMade of silicone–– Do not retain odorsDo not retain odors–– NonNon--allergenicallergenic–– DurableDurable

May beMay be autoclavedautoclaved–– May be May be autoclavedautoclaved

22 main typesmain types1.1. SupportSupport

•• Ring (with or without support), lever, Gehrung, Ring (with or without support), lever, Gehrung, incontinence ring or dishincontinence ring or dish

2.2. SpaceSpace--fillingfilling•• Gellhorn, donut, cube, inflatoGellhorn, donut, cube, inflato--ballball

SupportSupport SpaceSpace--fillingfilling

Most Common Types Used for POP

RingRing

GellhornGellhorn

CubeCube

DonutDonut



PracticalPractical

If you only have two pessary types If you only have two pessary types in your office make them a ring in your office make them a ring

with support and a Gellhornwith support and a Gellhornpppp

Which is better: Ring with Which is better: Ring with Support or Gellhorn?Support or Gellhorn?

Randomized crossRandomized cross--over trial with 134 womenover trial with 134 women

Outcomes included satisfaction, quality of life Outcomes included satisfaction, quality of life questionnaires questionnaires

CundiffCundiff, 2007, 2007

Both pessary types were equally effective in Both pessary types were equally effective in relieving symptoms of protrusion and voiding relieving symptoms of protrusion and voiding dysfunctiondysfunction8787% of patients could be fitted% of patients could be fitted45% wore a pessary for 3 months45% wore a pessary for 3 months7% were dissatisfied with both7% were dissatisfied with both–– younger women and those with prior POP surgeryyounger women and those with prior POP surgery

Older and more parous women preferred ring Older and more parous women preferred ring pessariespessariesWomen without prior hysterectomies or prolapse Women without prior hysterectomies or prolapse surgery preferred Gellhorn pessariessurgery preferred Gellhorn pessaries

Cundiff GW et al, 2007.



Real World ExperienceReal World Experience

84% of women are initially fitted with a pessary84% of women are initially fitted with a pessaryTwo to three pessaries usually triedTwo to three pessaries usually triedRing pessary (size 3, 4, and 5) used 70Ring pessary (size 3, 4, and 5) used 70--74%74%Gellhorn and donut used in 26Gellhorn and donut used in 26--29%29%Women with UIWomen with UI–– 7878--80% used incontinence ring or dish pessaries80% used incontinence ring or dish pessaries

–– 1111--20% used ring pessaries20% used ring pessaries

Clemons 2004, Wu 1997, Moore 1999, Robert 2002Clemons 2004, Wu 1997, Moore 1999, Robert 2002

Successful pessary fitting

A retrospective chart review of 1216 patientsA retrospective chart review of 1216 patients–– Patients on local estrogen therapyPatients on local estrogen therapy–– Those fit with:Those fit with:

•• RingRing•• Ring with supportRing with support•• GellhornGellhorn

–– Patients with a previous history of abdominal prolapse Patients with a previous history of abdominal prolapse surgery (compared to vaginal approach)surgery (compared to vaginal approach)

Successful fitting in 2 visitsSuccessful fitting in 2 visitsUsually 2 pessary types attemptedUsually 2 pessary types attempted

Hanson LM et al, 2006.

Unsuccessful fittingUnsuccessful fitting

Prior prolapse surgeryPrior prolapse surgeryPrior hysterectomyPrior hysterectomyShort vaginal length (≤6 cm)Short vaginal length (≤6 cm)Wide vaginal introitus (4 fingerbreadths)Wide vaginal introitus (4 fingerbreadths)Concurrent POP and UIConcurrent POP and UIYounger ageYounger ageObesityObesity



Who continues pessary use at 1 year?

Prospective evaluation of 59 women who Prospective evaluation of 59 women who were satisfied with their pessary 2 months were satisfied with their pessary 2 months postpost--fittingfitting–– 73% continued pessary use73% continued pessary useyy–– Factors associated with continued pessary use:Factors associated with continued pessary use:

•• Older age (65 years old was cutOlder age (65 years old was cut--off)off)•• Poor surgical riskPoor surgical risk

–– Factors associated with surgery:Factors associated with surgery:•• Sexual activitySexual activity•• Stress incontinenceStress incontinence•• Stage IIIStage III--IV posterior wall prolapseIV posterior wall prolapse

Clemons JL et al, 2004.

Anything to help improve pessary continuation?*

Identifying patientIdentifying patient--selected goals may helpselected goals may help–– Prospective study of 80 womenProspective study of 80 women–– Asked to identify up to 5 goals at fitting Asked to identify up to 5 goals at fitting

(bladder/urinary, activity, social relationships, (bladder/urinary, activity, social relationships, etc.)etc.)

–– Followed for 1 yearFollowed for 1 year–– Those who met goals were more likely to Those who met goals were more likely to

continue usecontinue use

Komesu YM et al, 2008.

Fitting a pessary

Start with support type (Start with support type (vsvs spacespace--filling)filling)

--More easily removed and insertedMore easily removed and inserted

--May allow intercourse while in placeMay allow intercourse while in place

--Often more comfortable Often more comfortable

Clemons, 2012Clemons, 2012



Ring with and without support

Pros• Able to fold (easiest to insert/remove)• Prolapse and UI• Intercourse possible while in place• Drainage holes (with support)

Cons• May not be effective for higher stage prolapse

with enlarged genital hiatus

Gellhorn

Pros• Base provides good support to apex

(convex surface)• Often used if ring does not stay in place

due to introital laxitydue to introital laxity• Drainage holes

Cons• More difficult to insert/remove • Remove for sexual activity

DonutDonut Pros

• More difficult to insert and remove• Good for massive vault/uterovaginal

prolapse/large posterior defects Cons

G it l hi t t b f ffi i t i t• Genital hiatus must be of sufficient size to admit, yet smaller than pessary

• Increased vaginal discharge



Gehrung• Rarely used - difficult to place• Tends to rotate out of proper position• Can be manually molded to fit type and size of prolapse (convexity

toward bulge)

Lever (Smith, Hodge and Risser)• Originally designed for uterine retroversion (used for uterine

l / t l )prolapse/cystocele)• Difficult placement • Can leave in for sexual intercourse • Rarely used

Cube (6 concave sides)• Suction - difficult removal• Highly effective for many types of prolapse• Cannot be left in place long periods: erosions/discharge

•

Role of ERT (systemic vs local) in Women Using Pessary for Prolapse, cont.

NAMS published a position statement – intravaginal estrogen more effective than systemic for

urogenital atrophy– progestogen generally not indicated when low-dose

intra-vaginal estrogen is administered locally for atrophy (individualize) NAMS M 2010 d 2007atrophy (individualize), NAMS, Menopause, 2010 and 2007

Cochrane review – estrogen creams, tablets, and vaginal rings were all

equally effective at management of atrophy, Suckling et al, Cochrane Database Syst Rev, 2006

Recommendation to use estrogen cream up to 3X per week with continued pessary use, Arias et al, 2008; Sarma et al, 2009

Common ProblemsCommon Problems

Erosion Erosion –– If an erosion does not heal consider a If an erosion does not heal consider a

biopsybiopsyMost common side effects of pessary Most common side effects of pessary use are:use are:–– Vaginal dischargeVaginal discharge–– OdorOdor



ComplicationsVaginitisVaginitis

–– Bacterial vaginosisBacterial vaginosis

De novo incontinenceDe novo incontinenceDe novo incontinenceDe novo incontinence

BleedingBleeding

Ulceration of vaginaUlceration of vagina

Embedded/Incarcerated cervix or uterusEmbedded/Incarcerated cervix or uterus

Severe ComplicationsVisceral obstructionVisceral obstructionVesicovaginal and rectovaginal fistulaVesicovaginal and rectovaginal fistulaFecal impactionFecal impactionH d h i d iH d h i d iHydronephrosis and urosepsisHydronephrosis and urosepsisCancerCancer–– 2.6% of cervical cancers and 30% of vaginal cancers 2.6% of cervical cancers and 30% of vaginal cancers

in a series of 2500 patients treated in France since in a series of 2500 patients treated in France since 1971 1971

–– 93/96 tumors occurred at the site of contact93/96 tumors occurred at the site of contact–– Mean time from insertion to diagnosis was 18 yearsMean time from insertion to diagnosis was 18 years

Schnaub et al, 1991.

Severe Complications

PubMed search: 39 cases of major PubMed search: 39 cases of major complications related to pessary use were complications related to pessary use were identifiedidentified–– VVF n=8VVF n=8–– Urologic complications n=5Urologic complications n=5–– RVF n=4RVF n=4–– Bowel complications n=3Bowel complications n=3–– Impacted pessaries n=19Impacted pessaries n=19

Almost always related to a neglected pessary Almost always related to a neglected pessary (91%)(91%)

Arias, 2008.



Bottom-Line Complications

Severe complications are rareSevere complications are rareAlmost all are preventable with close Almost all are preventable with close vigilancevigilanceggDiscuss importance of followDiscuss importance of follow--up with the up with the patient and familypatient and familyTreat erosions earlyTreat erosions early

Conclusions

Offer to all patients with POP

Data regarding long-term satisfaction and ti d lcontinued use, unclear

Should be a part of the full spectrum of treatment options for patients with POP

ReferencesCulligan P. Nonsurgical management of pelvic organ prolapse. Obstet Gynecol 2012;119:852-860

Hagen S, Starck D, Glazener C, et al. Individualised pelvic floor muscle training in women with pelvic organ prolapse (POPPY): a multicentre randomized controlled trial. Lancet 2014;383:796-806

Clemons JL. Vaginal pessary treatment of prolapse and incontinence http://www uptodate com/contents/vaginal pessaryincontinence. http://www.uptodate.com/contents/vaginal-pessary-treatment-of-prolapse-and-incontinence. Retrieved 2/24/14.

Atnip S, O’Dell K. Vaginal support pessaries: Indications for use and fitting strategies. Urol Nursing 2012;32:114-125

Hagen S, Stark D. Conservative prevention and management of pelvic organ prolapse in women. Cochrane Review, 2011, Issue 12

Atnip SD. Pessary use and management for pelvic organ prolapse. Obstet Gynecol Clin N Am 2009;36:541-563



ReferencesCundiff GW, Amundsen CL, Bent AE, Coates KW, Schaffer JI, Strohbehn K, Handa VL. The PESSRI study; symptom relief outcomes of a randomized crossover trial of the ring and Gellhorn pessaries. Am J Obstet Gynecol 2007;196:405.e1-8Adams EJ, Thomson AJM, Maher C, Hagen S. Mechanical devices for pelvic organ prolapse in women. Cochrane Review, 2009, Issue 1Oliver R Thakar R Sultan AH The history and usage of the vaginalOliver R, Thakar R, Sultan AH. The history and usage of the vaginal pessary; a review. Eur J Obstet Gynecol Reprod Biol 2011;156:125-130Lamers BHC, Broekman BMW, Milani AL. Pessary treatment for pelvic organ prolapse and health-related quality of life; a review. Int Urogynecol J 2011;22:637-644Arias BE, Ridgeway B, Barber MD. Complications of neglected vaginal pessaries; case presentation and literature review. Int Urogynecol J 2008;19:1173-1178

Disclosures - UAB · 2017. 11. 10. · Non‐Surgical Treatment of Pelvic Organ Prolapse – Holly...

Documents

Transcript of Disclosures - UAB · 2017. 11. 10. · Non‐Surgical Treatment of Pelvic Organ Prolapse – Holly...