Fibroid Treatment Dilemmas - UCSF · PDF fileObjectives Help women with symptomatic fibroids choose between different treatment options Know the evidence to support the use of Mirena®

Fibroid Treatment DilemmasFibroid Treatment Dilemmas

Alison F. Jacoby, MDAlison F. Jacoby, MDDirector, Comprehensive Fibroid CenterDirector, Comprehensive Fibroid CenterUniversity of California, San FranciscoUniversity of California, San Francisco

ObjectivesObjectives

Help women with symptomatic fibroids choose Help women with symptomatic fibroids choose between different treatment options between different treatment options

Know the evidence to support the use of MirenaKnow the evidence to support the use of Mirena®® IUD, IUD, endometrial ablation, UAE and myomectomyendometrial ablation, UAE and myomectomy

Review current literature about fibroid impact on Review current literature about fibroid impact on fertility and pregnancy outcomesfertility and pregnancy outcomes

Case 1Case 1

AF is a 44 yr old G0 who presents with a 9 month history of AF is a 44 yr old G0 who presents with a 9 month history of heavy periods lasting 10heavy periods lasting 10--12 days/month. She smokes 1 12 days/month. She smokes 1 pack/day. Her hematocrit is 32%. A pelvic US shows a pack/day. Her hematocrit is 32%. A pelvic US shows a 12 x 6 x 6 cm uterus w/ several 312 x 6 x 6 cm uterus w/ several 3--4 cm intramural 4 cm intramural fibroids. At least one has a submucosal component. A fibroids. At least one has a submucosal component. A saline sonohysterogram shows a 3 cm fibroid extending saline sonohysterogram shows a 3 cm fibroid extending 30% into the cavity. She wants to avoid major surgery.30% into the cavity. She wants to avoid major surgery.

What are her treatment options?What are her treatment options?

Case 1 Case 1 Submucous fibroid and menorrhagiaSubmucous fibroid and menorrhagia

Potential treatment options:Potential treatment options:

Birt

h contro

l pills

Mire

na® IU

D

Endometr

ial ab

lation

Hys

terosc

opic

myo... U

AE

19%

31%

10%

21%19%

1.1.

Birth control pillsBirth control pills2.2.

MirenaMirena®®

IUDIUD3.3.

Endometrial ablation Endometrial ablation

4.4.

Hysteroscopic myomectomyHysteroscopic myomectomy5.5.

UAEUAE

What is the evidence to support What is the evidence to support these treatments?...these treatments?...

Submucous Fibroid Submucous Fibroid ClassificationClassification

Type 0 fibroid

MirenaMirena®®

in Contraception Trialsin Contraception Trials

Less bleedingLess bleedingLess anemiaLess anemiaLess dysmenorrheaLess dysmenorrheaFewer incident fibroidsFewer incident fibroids

Sivin 1994, Hidalgo 2002

http://images.google.com/imgres?imgurl=http://www.cmdrc.com/Data/Images/Mirena2.jpg&imgrefurl=http://www.cmdrc.com/ContraceptiveOptions/&h=279&w=239&sz=55&hl=en&start=3&um=1&usg=__risRhZHTjvmC-8KYgHjjx9tHWKA=&tbnid=A5wI2FEZs0DoHM:&tbnh=114&tbnw=98&prev=/images?q=mirena&um=1&hl=en&sa=N

MirenaMirena®®

IUD for FibroidsIUD for Fibroids

2 prospective, before2 prospective, before--andand--after studies after studies n=69 and n=32n=69 and n=32

Sono confirmed fibroidsSono confirmed fibroidsUterine size Uterine size ≤≤12 wk size12 wk sizeNormal cavityNormal cavity

MirenaMirena®®


Grigoreva V, Fertil Steril 2003;79:1194Grigoreva V, Fertil Steril 2003;79:1194Bleeding results:Bleeding results:

Mean baseline PBAC scoreMean baseline PBAC score-- 9797Mean 12 month PBAC scoreMean 12 month PBAC score-- 1616Amenorrhea rateAmenorrhea rate-- 40% 40%

Mercorio, Contraception 2003;67:277Mercorio, Contraception 2003;67:27760% completed 12 months60% completed 12 months

Mean baseline PBAC scoreMean baseline PBAC score-- 310310Decreased bleedingDecreased bleeding74% still had PBAC score > 10074% still had PBAC score > 100

40% withdrew by 6 months40% withdrew by 6 months4 IUD expulsions (12%)4 IUD expulsions (12%)7 persistent menorrhagia , requested surgery (22%)7 persistent menorrhagia , requested surgery (22%)2 lost to follow2 lost to follow--upup

MirenaMirena®®


Decreases bleeding in women with fibroidsDecreases bleeding in women with fibroids≤≤ 12 week size uterus12 week size uterusNo submucous componentNo submucous component

Level of evidence Level of evidence IIII--3 3 Strength of recommendationStrength of recommendation BB

••

Moderate effectModerate effect••

Less effective as bleeding becomes heavierLess effective as bleeding becomes heavier

Endometrial Ablation in the Endometrial Ablation in the Presence of FibroidsPresence of Fibroids

Microsulis

Hydrothermablator

Thermachoice Novasure

FDA FDA ApprovalApproval

PublishedPublishedEvidenceEvidence

FibroidFibroidTypeType

Diameter Diameter (cm)(cm)

ThermaChoiceThermaChoiceTMTM

(thermal balloon)(thermal balloon)NoNo YesYes

(Level I)(Level I)IIII < 3< 3

Hydro ThermAblatorHydro ThermAblatorTMTM

(circulating hot fluid)(circulating hot fluid)NoNo YesYes

(Level II(Level II--3)3)I, III, II ≤≤

44

Her OptionHer OptionTMTM

(cryotherapy)(cryotherapy)NoNo NoNo NANA NANA

NovasureNovasureTMTM

(radiofrequency energy)(radiofrequency energy)NoNo YesYes

(Level II(Level II--2)2)I, III, II ≤≤

33

Microsulis Endometrial Microsulis Endometrial AblationAblationTMTM

(microwave)(microwave)YesYes YesYes

(Level I)(Level I)I, III, II ≤≤

33

Endometrial Ablation in the Presence of Submucous Fibroids

ACOG Practice Bulletin, 81, May 2007

Thermal Balloon Ablation and FibroidsThermal Balloon Ablation and Fibroids

RCTRCT of 96 Turkish women with fibroids and of 96 Turkish women with fibroids and menorrhagiamenorrhagia

Age Age ≥≥ 4040Uterine size Uterine size ≤≤ 12 wk with IM/SS myoma < 5 cm or SM 12 wk with IM/SS myoma < 5 cm or SM type II fibroid < 3 cmtype II fibroid < 3 cmPBAC score PBAC score ≥≥ 15015045 underwent thermal balloon ablation under local45 underwent thermal balloon ablation under local48 underwent rollerball ablation under general48 underwent rollerball ablation under general

Soysal ME Gynecol Obstet Invest 2001;51:128


PBACPBACInitialInitial

PBACPBAC12 m12 m P valueP value HgbHgb

InitialInitialHgbHgb12 m12 m P valueP value

ThermalThermalBalloonBalloonAblationAblation

384384 4141 <0.0001<0.0001 10.010.0 12.812.8 <0.0001<0.0001

RollerRoller--ballballAblationAblation 385385 4040 <0.0001<0.0001 9.89.8 12.912.9 <0.0001<0.0001



Amenorrhea ratesAmenorrhea rates-- 11% TBA, 19% RBA11% TBA, 19% RBAHysterectomy ratesHysterectomy rates-- 9% in each group9% in each groupThermal balloon ablation groupThermal balloon ablation group

Fewer complicationsFewer complicationsShorter operative time Shorter operative time Performed comfortably under local anesthesiaPerformed comfortably under local anesthesia


FDA Pivotal Trial data, Filing date 7/14/03

MicrosulisTMTM

Endometrial Ablation and Fibroids

FDA Pivotal Trial: RCTFDA Pivotal Trial: RCT71 subjects with menorrhagia71 subjects with menorrhagiaRandomized to MicrosulisRandomized to MicrosulisTMTM or rollerball ablationor rollerball ablationSize: Size: ≤ 3 cmLocation: Submucous, type I and IILocation: Submucous, type I and II

Amenorrhea Rates Amenorrhea Rates (%)(%)

Clinical Success (%)Clinical Success (%)(PBAC score (PBAC score ≤≤

75)75)

Microsulis Endometrial Microsulis Endometrial AblationAblation

(microwave)(microwave)6161 6868

Rollerball AblationRollerball Ablation 3939 7777

MicrosulisTMTM

Endometrial Ablation and Fibroids

FDA Pivotal Trial data, Filing date 7/14/03Fibroid Inclusion Criteria:

≤

3 cm

Type I and II SM fibroids

Comparable results to subjects without fibroids

Endometrial ablation in the presence of Endometrial ablation in the presence of submucous fibroidssubmucous fibroids

Decreases bleeding in women with fibroidsDecreases bleeding in women with fibroids≤≤ 12 week size uterus12 week size uterusType I and II submucous fibroidsType I and II submucous fibroidsSize Size ≤≤ 3 cm3 cm

Level of evidence: Level of evidence: II-- Thermachoice, MicrosulisThermachoice, Microsulis

IIII--33--

Novasure and Thermablator Novasure and Thermablator

Strength of recommendation:Strength of recommendation: AA••

Moderate effectModerate effect••

Comparable to rollerball ablationComparable to rollerball ablation

Hysteroscopic MyomectomyHysteroscopic Myomectomy


Predictors for resolution of menorrhagia:Predictors for resolution of menorrhagia:Complete surgical resectionComplete surgical resection

Type 0 > Type I > Type IIType 0 > Type I > Type IIFibroid sizeFibroid size

Uterine sizeUterine sizeNumber of fibroidsNumber of fibroids

Emanuel MH et al Obstet Gynecol 1999;93:743-8


Decreases bleeding in women with fibroidsDecreases bleeding in women with fibroidsEffectiveness decreases over timeEffectiveness decreases over timeMost efficacious for type 0 and type I submucous Most efficacious for type 0 and type I submucous fibroidsfibroids

Level of evidence: Level of evidence: IIII--22

Strength of recommendation:Strength of recommendation: BB••

Accepted method for management of AUB caused by Accepted method for management of AUB caused by SM fibroidsSM fibroids

Uterine Artery Embolization Uterine Artery Embolization

Pre-UAE Post-UAE

89 88 88 8690 90

83

0

10

20

30

40

50

60

70

80

90

100

%

Ravina Worthington Goodwin Hutchins Pelage Spies Pron

Reduction in Menorrhagia after UAE

9491

68

91

84

0

10

20

30

40

50

60

70

80

90

100

%

Worthington Goodwin Hutchinson Spies Pron

Reduction in Bulk Symptoms

31

4643

48

52

3835

0

10

20

30

40

50

60

%

Ravina Worthington Goodwin Hutchins Pelage Spies Pron

Fibroid Size Reduction after UAE

Long term outcomes after UAELong term outcomes after UAE

182 of 200 pts (91%) completed 5 yr follow182 of 200 pts (91%) completed 5 yr follow--up:up:Sustained symptom controlSustained symptom control-- 73%73%Failure or recurrenceFailure or recurrence-- 25%25%

Major interventionsMajor interventions-- 20%20%25 hysterectomies25 hysterectomies8 myomectomies8 myomectomies3 repeat UAE3 repeat UAE’’ss

Spies J et al Obstet Gynecol 2005;106:933Spies J et al Obstet Gynecol 2005;106:933--99

Predictors of successPredictors of successThe Fibroid Registry:The Fibroid Registry:

In multivariate analyses, predictors of In multivariate analyses, predictors of improvementimprovement in in symptom and QoL scores included: symptom and QoL scores included:

Heavy bleeding as a presenting symptom Heavy bleeding as a presenting symptom √√Submucous location Submucous location √√Older ageOlder ageLower BMILower BMILow initial symptom scoreLow initial symptom score

Spies J et al Obstet Gynecol 2008;111:22Spies J et al Obstet Gynecol 2008;111:22--3333

Predictors of failurePredictors of failureIncreased fibroid sizeIncreased fibroid size1, 2, 31, 2, 3

Multiple fibroidsMultiple fibroids2, 42, 4

AdenomyosisAdenomyosis22

Hypovascularity of fibroidHypovascularity of fibroid44

Location in LUS or cervixLocation in LUS or cervix11

Less volume reduction after 1 yrLess volume reduction after 1 yr33

11Spies J et al Obstet Gynecol 2008;111:22Spies J et al Obstet Gynecol 2008;111:22--333322Marret H et al BJOG 2005;112:461Marret H et al BJOG 2005;112:461--46546533Spies J et al Obstet Gynecol 2005;106:933Spies J et al Obstet Gynecol 2005;106:933--9944Isonishi S et al Am J Obstet Gynecol 2008;198:270Isonishi S et al Am J Obstet Gynecol 2008;198:270

Uterine Artery EmbolizationUterine Artery Embolization

Outcomes:Outcomes:Decreases bleeding, dysmenorrhea and urinary symptomsDecreases bleeding, dysmenorrhea and urinary symptomsRCTRCT’’s of UAE + hysterectomy and UAE + myomectomy:s of UAE + hysterectomy and UAE + myomectomy:

Shorter hospital stays, faster return to activities following UAShorter hospital stays, faster return to activities following UAEE

Level of evidence: Level of evidence: II


““Based on longBased on long--

and shortand short--term outcomes, UAE is a safe and term outcomes, UAE is a safe and effective option for appropriately selected women who wish to effective option for appropriately selected women who wish to retain their uteri.retain their uteri.””

ACOG Practice Bulletin 96, 2008ACOG Practice Bulletin 96, 2008

Case 1: Case 1: Submucous fibroid and Submucous fibroid and menorrhagiamenorrhagia

Potential treatment options:Potential treatment options:Birth control pills Birth control pills Smoker age Smoker age ≥≥

35 yrs35 yrs

Mirena IUD Mirena IUD No data for submucosal fibroidsNo data for submucosal fibroidsEndometrial ablationEndometrial ablationHysteroscopic myomectomy Hysteroscopic myomectomy Better for type 0 and I fibroidsBetter for type 0 and I fibroidsUAEUAE

√√

√√

Case 2Case 2A 39 yr old G1P1 with known fibroids for several A 39 yr old G1P1 with known fibroids for several

years, now has worsening urinary frequency, years, now has worsening urinary frequency, pelvic pressure and discomfort lying prone. On pelvic pressure and discomfort lying prone. On exam, the fundus is palpable at the umbilicus. A exam, the fundus is palpable at the umbilicus. A pelvic US shows 3 fibroids: 10 cm SS fundal, 6 pelvic US shows 3 fibroids: 10 cm SS fundal, 6 cm IM posterior and 4 cm IM anterior. She cm IM posterior and 4 cm IM anterior. She desires future childbearing.desires future childbearing.

What treatments would you recommend?What treatments would you recommend?

Case 2: Case 2: Large uterus w/ bulk symptomsLarge uterus w/ bulk symptoms

Potential treatment options:Potential treatment options:

GnRH ag

onist x

6 m...

Myo

mectom

y

UAE

Hys

terec

tomy

Fibroid

s too la

rge f

or...

24%

61%

0%11%

5%

1.1.

GnRH agonist x 6 GnRH agonist x 6 monthsmonths

2.2.

MyomectomyMyomectomy3.3.

UAEUAE

4.4.

HysterectomyHysterectomy1.1.

Fibroids too large for Fibroids too large for other optionsother options

MyomectomyMyomectomy

How well does How well does myomectomymyomectomy work?work?

Resolution of symptoms: Resolution of symptoms: MenorrhagiaMenorrhagia: 81% : 81% Bulk symptoms: 70Bulk symptoms: 70--80%80%

Predictors for recurrence: Predictors for recurrence: Number of fibroids Number of fibroids Uterine sizeUterine sizeParity after Parity after myomectomymyomectomyUse of Use of GnRHGnRH agonistagonistRoute of Route of myomectomymyomectomy

How well does How well does myomectomymyomectomy

work?work?

Recurrence of fibroids after Recurrence of fibroids after myomectomymyomectomy

Review of 41 studies, published from 1924Review of 41 studies, published from 1924--19981998Poor methodologyPoor methodology

Various techniques to assess recurrenceVarious techniques to assess recurrenceUS at regular intervals, Clinical exam w/ oriented US at regular intervals, Clinical exam w/ oriented US, recurrence of symptoms, etcUS, recurrence of symptoms, etc

Sample bias due to cases lost to followSample bias due to cases lost to follow--upupFailure to define followFailure to define follow--up periodup period

Fauconnier

A Human Repro Update 2000; 6(6): 595-602


work?work?

Recurrence of fibroids after Recurrence of fibroids after myomectomymyomectomy

Cumulative risk of Cumulative risk of clinically significantclinically significantrecurrence:recurrence:

~10% at 5 yrs~10% at 5 yrs

Cumulative risk of Cumulative risk of US detectedUS detected recurrence:recurrence:51% at 5 yrs 51% at 5 yrs Represents the prevalence rate of fibroids after Represents the prevalence rate of fibroids after myomectomymyomectomySignificance is questionable since many will Significance is questionable since many will remain asymptomaticremain asymptomatic

Fauconnier

A Human Repro Update 2000; 6(6): 595-602


work?work?

Recurrence of fibroids after Recurrence of fibroids after abdominal abdominal myomectomymyomectomy

SingleSingleFibroidFibroid

MultipleMultipleFibroidsFibroids

RecurrenceRecurrenceRate (%)Rate (%)

2727 5959

ReRe--operationoperationRate (%)Rate (%)

1111 2626

•125 myomectomy

cases from 1944-1962

•Follow-up > 5 yrs

•Cited in ACOG Practice Bulletin, August, 2008

Is abdominal Is abdominal myomectomymyomectomy

more more risky than hysterectomy?risky than hysterectomy?

3 studies show similar rates of complications3 studies show similar rates of complications

1 study shows 1 study shows myomectomymyomectomy less morbidless morbidLess blood loss, fever and fewer bladder, bowel, Less blood loss, fever and fewer bladder, bowel, ureteralureteral injuries compared to hysterectomyinjuries compared to hysterectomy

Iverson RE et al Iverson RE et al ObstetObstet

GynecolGynecol

1996;88:4151996;88:415--99

Abdominal Abdominal MyomectomyMyomectomy

Outcomes:Outcomes:Decreases bleeding and bulk symptomsDecreases bleeding and bulk symptomsHigh rates of recurrence and reHigh rates of recurrence and re--operationoperation

Level of evidence: Level of evidence: IIII--22


““Safe and effective alternative to hysterectomy for treatment of Safe and effective alternative to hysterectomy for treatment of women with symptomatic women with symptomatic leiomyomasleiomyomas..””

ACOG Practice Bulletin ACOG Practice Bulletin 96, 200896, 2008

Is UAE a good option?Is UAE a good option?

Reserve for women who have completed Reserve for women who have completed childbearingchildbearing““There is insufficient evidence in the current literature to There is insufficient evidence in the current literature to

ensure safety in women desiring to retain fertility. ensure safety in women desiring to retain fertility. Therefore, the procedure should be considered Therefore, the procedure should be considered investigational or relatively contraindicated in women investigational or relatively contraindicated in women wishing to retain fertility.wishing to retain fertility.””

ACOG Committee Opinion, Number 293, February 2004ACOG Committee Opinion, Number 293, February 2004

UAE vs. UAE vs. MyomectomyMyomectomy

Mara et al Mara et al CardiovascCardiovasc

InterventIntervent

RadiolRadiol

2008;31:732008;31:73--8585

UAEUAE MyomectomyMyomectomy

Pregnancy rate Pregnancy rate (%)(%) 5050 7878Miscarriage rate Miscarriage rate (%)(%) 6464 2323Delivery rate Delivery rate (%)(%) 1919 4848

Case 2: Case 2: Large uterus w/ bulk symptomsLarge uterus w/ bulk symptoms

Potential treatment options:Potential treatment options:GnRH agonist x 6 monthsGnRH agonist x 6 monthsTemporary solution onlyTemporary solution onlyMyomectomyMyomectomyUAEUAEAvoid if future childbearing desiredAvoid if future childbearing desiredHysterectomyHysterectomyRefer if not comfortable performing Refer if not comfortable performing myomectomy for large fibroidsmyomectomy for large fibroids

√√

Case 3Case 3

MJ is a 38 y.o woman recently diagnosed with an MJ is a 38 y.o woman recently diagnosed with an 8 cm posterior intramural fibroid. The 8 cm posterior intramural fibroid. The endometrial stripe appears displaced anteriorly. endometrial stripe appears displaced anteriorly. She has no fibroid symptoms. She hasnShe has no fibroid symptoms. She hasn’’t tried t tried to become pregnant, but wants to know how the to become pregnant, but wants to know how the fibroid will impact her fertility and pregnancy fibroid will impact her fertility and pregnancy outcomes.outcomes.

How would you advise her?How would you advise her?

Asx IM fibroid and pregnancyAsx IM fibroid and pregnancy Counseling options:Counseling options:

A.A.

Attempt pregnancy without preAttempt pregnancy without pre--treatmenttreatmentB.B.

Prophylactic myomectomyProphylactic myomectomy

C.C.

Perform saline sono or diagnostic Perform saline sono or diagnostic hysteroscopy to better evaluate the cavityhysteroscopy to better evaluate the cavity

The BIG Questions:The BIG Questions:

Do uterine fibroids decrease fertility?Do uterine fibroids decrease fertility?Does removal enhance fertility?Does removal enhance fertility?

Impact of Fibroids on FertilityImpact of Fibroids on Fertility

What does the literature tell us for women What does the literature tell us for women who havenwho haven’’t yet tried to conceive?t yet tried to conceive?

No StudiesNo Studies

What data is available?What data is available?Studies of women with infertilityStudies of women with infertility

Fibroids and InfertilityFibroids and Infertility

Updated systematic reviewUpdated systematic review23 studies included in data analysis23 studies included in data analysis

1 RCT, 9 prospective, 13 retrospective1 RCT, 9 prospective, 13 retrospective15 had age matched controls15 had age matched controls7 examined effect of myomectomy7 examined effect of myomectomyFibroid size ranged from 1Fibroid size ranged from 1-- 10 cm10 cmFibroid number ranged from 1Fibroid number ranged from 1--88

Pritts E, Parker W, Olive D. Fertil Steril 2009;91:1215-23


Conclusions:Conclusions:Subserosal fibroids do not affect fertility and Subserosal fibroids do not affect fertility and removal does not show benefitremoval does not show benefitSubmucosal fibroids lower fertility rates and Submucosal fibroids lower fertility rates and removal increases conception and live birth removal increases conception and live birth ratesrates

Results from 2001 and 2009 systematic Results from 2001 and 2009 systematic reviews are in agreementreviews are in agreement



However, in contrast to the 2001 systematic However, in contrast to the 2001 systematic review, the 2009 review shows that:review, the 2009 review shows that:

Intramural fibroids appear to decease fertility Intramural fibroids appear to decease fertility andand there is no clear evidence that there is no clear evidence that myomectomy is beneficialmyomectomy is beneficial

CaveatsCaveatsData is still sparse and methodological issues limit Data is still sparse and methodological issues limit confidence in conclusionsconfidence in conclusions


Fibroids and Pregnancy OutcomesFibroids and Pregnancy Outcomes

Qidwai I, Caughey AB, Jacoby AF. Obstet Gynecol 2006;107:376Qidwai I, Caughey AB, Jacoby AF. Obstet Gynecol 2006;107:376--8282Retrospective cohort studyRetrospective cohort studySubjects: 401 women with fibroids detected on routine Subjects: 401 women with fibroids detected on routine 22ndnd trimester ultrasounds from 1994trimester ultrasounds from 1994--2003 who 2003 who subsequently delivered at UCSFsubsequently delivered at UCSFControls: 25,000 women delivering at UCSF during Controls: 25,000 women delivering at UCSF during same time periodsame time period


Presence of fibroids associated with:Presence of fibroids associated with:Preterm delivery Preterm delivery Placenta previa Placenta previa Breech presentationBreech presentationCesarean delivery Cesarean delivery PostPost--partum hemorrhagepartum hemorrhage

Qidwai I, Caughey AB, Jacoby AF. Obstet Gynecol 2006;107:376Qidwai I, Caughey AB, Jacoby AF. Obstet Gynecol 2006;107:376--8282

(AOR 1.45, 95%CI 1.08(AOR 1.45, 95%CI 1.08--1.96)1.96)(AOR 1.86, 95% CI 1.02(AOR 1.86, 95% CI 1.02--3.39)3.39)(AOR 1.64, 95% CI 1.11(AOR 1.64, 95% CI 1.11--2.40)2.40)(AOR 1.57, 95% CI 1.16(AOR 1.57, 95% CI 1.16--2.13)2.13)(AOR 2.57, 95% CI 1.54(AOR 2.57, 95% CI 1.54--4.27)4.27)


Presence of fibroids Presence of fibroids notnot associated with:associated with:PPROM PPROM Placental abruptionPlacental abruptionOperative vaginal deliveryOperative vaginal deliveryChorioamnionitis Chorioamnionitis Endometritis Endometritis

Qidwai I, Caughey AB, Jacoby AF. Obstet Gynecol 2006;107:376Qidwai I, Caughey AB, Jacoby AF. Obstet Gynecol 2006;107:376--8282

Cesarean Section RatesCesarean Section Rates

0

10

20

30

40

50

60

FibroidControl

* * * *

*

p < 0.05

%

Breech RatesBreech Rates

0

10

20

30

40

50

FibroidControl

* * *

*

p < 0.05

%

Asx IM fibroid and pregnancyAsx IM fibroid and pregnancy

Counseling options:Counseling options:Attempt pregnancy without preAttempt pregnancy without pre--treatmenttreatmentDiscuss increased risk for infertility, SAB and Discuss increased risk for infertility, SAB and

adverse pregnancy outcomesadverse pregnancy outcomesProphylactic myomectomyProphylactic myomectomy““Proxy literatureProxy literature””

does not supportdoes not support

Perform saline sono or diagnostic Perform saline sono or diagnostic hysteroscopy to better evaluate the cavityhysteroscopy to better evaluate the cavityIf a submucosal component is identified, may justify If a submucosal component is identified, may justify

myomectomymyomectomy

√√

√√

ConclusionsConclusions

ConclusionsConclusionsEvidence supports use of MirenaEvidence supports use of Mirena®® IUD, endometrial ablation and IUD, endometrial ablation and UAE in addition to traditional hysterectomy and myomectomyUAE in addition to traditional hysterectomy and myomectomy

Use GnRH agonists to facilitate a surgical procedure, not as a sUse GnRH agonists to facilitate a surgical procedure, not as a stand tand alone treatmentalone treatment

Subserosal fibroids have no effect on fertility and should only Subserosal fibroids have no effect on fertility and should only be be removed for symptomsremoved for symptoms

Submucosal fibroids affect pregnancy rates and benefit shown forSubmucosal fibroids affect pregnancy rates and benefit shown forremovalremoval

Intramural fibroids may diminish pregnancy rates and myomectomy Intramural fibroids may diminish pregnancy rates and myomectomy may not reverse this effect but more research needed may not reverse this effect but more research needed

Thank youThank you


and Fibroidsand Fibroids

Prospective, singleProspective, single--arm study of 65 Canadian arm study of 65 Canadian women with fibroids and menorrhagiawomen with fibroids and menorrhagia

PrePre-- and postand post--menopausal women enrolledmenopausal women enrolledType I and II submucous fibroids, Type I and II submucous fibroids, ≤≤ 3 cm3 cm

Menstrual questionnaire at screening and 12 moMenstrual questionnaire at screening and 12 moSuccess defined as return to normal bleedingSuccess defined as return to normal bleeding

Sabbah R, J Minimally Invas Gynecol 2006;13(5):467



Success rateSuccess rate-- 95%95%Amenorrhea rateAmenorrhea rate-- 69%69%Satisfaction rateSatisfaction rate-- 95%95%Decrease in premenstrual sx and dysmenorrheaDecrease in premenstrual sx and dysmenorrhea

Sabbah R, J Minimally Invas Gynecol 2006;13(5):467

HydrothermablatorHydrothermablatorTMTM


Retrospective, observational study Retrospective, observational study 22 US women22 US womenAge 34Age 34--60 yrs60 yrsPresence of submucous fibroid Presence of submucous fibroid ≤≤ 4 cm4 cmPretreatment with lupron, danazol or Pretreatment with lupron, danazol or norethindronenorethindroneOffice procedure with local anesthesiaOffice procedure with local anesthesia12 m follow12 m follow--upup

Glasser MH J Am Assoc Gynecol Laparosc 2003;10:521

HydrothermablatorHydrothermablatorTMTM


Success rateSuccess rate--91%91%Amenorrhea rateAmenorrhea rate-- 55%55%Failure rateFailure rate-- 9%9%

No objective documentation of No objective documentation of menorrhagiamenorrhagiaObservational study with small numbersObservational study with small numbers

Glasser MH J Am Assoc Gynecol Laparosc 2003;10:521

FibroidsFibroids MyomectomyMyomectomy

FibroidsFibroids HysterectomyHysterectomy

Reproductive Age

Post-Reproductive

Jane is a 47 yearJane is a 47 year--old woman with a old woman with a history of fibroids. Last year, you history of fibroids. Last year, you documented a 12 week size uterus. This documented a 12 week size uterus. This year, ityear, it’’s 20 week size. A pelvic US shows s 20 week size. A pelvic US shows multiple fibroids, the largest of which is a multiple fibroids, the largest of which is a 10 cm. On an US 3 yrs ago, it measured 10 cm. On an US 3 yrs ago, it measured 5 cm. Although she has no symptoms, the 5 cm. Although she has no symptoms, the rapid growth is worrisome for rapid growth is worrisome for leiomyosarcoma. leiomyosarcoma.

What would you do next?What would you do next?

Case 3Case 3

What is the incidence of What is the incidence of sarcoma?sarcoma?

Retrospective study of 1332 women Retrospective study of 1332 women Hysterectomy or myomectomy for fibroidsHysterectomy or myomectomy for fibroids1 leiomyomsarcoma (0.08%)1 leiomyomsarcoma (0.08%)2 endometrial stromal sarcomas (0.15%)2 endometrial stromal sarcomas (0.15%)

Incidence 0.23%Incidence 0.23%Actual incidence much lowerActual incidence much lower

~20% of women w/ fibroids undergo surgery~20% of women w/ fibroids undergo surgery

Parker et al, Obstet Gyn 1994;83:414Parker et al, Obstet Gyn 1994;83:414--88

Case 3Case 3 What would you do next?What would you do next?

Order a pelvic MRI to rule out sarcomaOrder a pelvic MRI to rule out sarcomaBiopsy the large massBiopsy the large massSchedule an abdominal myomectomy and Schedule an abdominal myomectomy and consent for hysterectomy tooconsent for hysterectomy tooSchedule a hysterectomy with Gyn Onc Schedule a hysterectomy with Gyn Onc backback--upupCounsel about fibroids and follow for Counsel about fibroids and follow for symptom developmentsymptom development

What is the incidence of What is the incidence of sarcoma?sarcoma?

During study period, 9 women had preDuring study period, 9 women had pre--op op diagnosis of sarcomadiagnosis of sarcoma

Age: 64Age: 64--86 yrs86 yrsPresentation: vaginal bleeding, pelvic painPresentation: vaginal bleeding, pelvic pain1 endometrial stromal sarcoma1 endometrial stromal sarcoma8 mixed mesodermal tumors8 mixed mesodermal tumors


Does Does ““rapid growthrapid growth””

predict predict sarcoma?sarcoma?

Rapid growth defined as Rapid growth defined as ≥≥

6 wk increase in 6 wk increase in uterine size within 1 yruterine size within 1 yr

0/198 had sarcoma0/198 had sarcoma0/17 post0/17 post--menopausal women had sarcomamenopausal women had sarcoma

10/17 were on HRT10/17 were on HRT


Abdominal Myomectomy:Abdominal Myomectomy: Safety and feasible with large Safety and feasible with large

fibroidsfibroidsRetrospective chart review by 1 gynecologistRetrospective chart review by 1 gynecologist

N=91 women N=91 women Uterine size Uterine size ≥≥ 16 wk (range 1616 wk (range 16--36 wk, mean 21 wks)36 wk, mean 21 wks)Pfannestiel incisionsPfannestiel incisions

ResultsResults# fibroids removed: 1# fibroids removed: 1--25, mean 725, mean 7Fibroid weight: 100 to 2500 gm, mean 668 gmFibroid weight: 100 to 2500 gm, mean 668 gmOR time: 120OR time: 120--390 min, mean 236 min390 min, mean 236 minEBL: 50EBL: 50--3000 cc, mean 800 cc3000 cc, mean 800 ccLOS: 1LOS: 1--5 days, mean 1.8 days5 days, mean 1.8 daysNone converted to hysterectomyNone converted to hysterectomyNo sarcomasNo sarcomas

West S et al Fertil Steril 2006;85 (1): 36

DisclosuresDisclosures

No financial associations to discloseNo financial associations to discloseAlert: Off label use for devices will be Alert: Off label use for devices will be discusseddiscussed

Documents

Fibroid Treatment Dilemmas - UCSF · PDF fileObjectives Help women with symptomatic fibroids choose between different treatment options Know the evidence to support the use of Mirena®