The Ontario Uterine Fibroid Em

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The Ontario Uterine Fibroid Embolization Trial. Part 1. Baseline patient characteristics, fibroid burden, and impact on life Gaylene Pron, Ph.D., a,b Marsha Cohen, M.D., b Jennifer Soucie, M.Sc., a Greg Garvin, M.D., c Leslie Vanderburgh, M.D., d and Stuart Bell, M.D. e for the Ontario Uterine Fibroid Embolization Collaborative Group University of Toronto, Toronto; Sunnybrook and Women’s College Health Sciences Center, Toronto; St. Joseph’s Health Care, London; and William Osler Health Center, Brampton, Ontario, Canada Objective: To determine baseline characteristics of women undergoing uterine artery embolization (UAE) for symptomatic fibroids. Design: Multicenter, prospective, single-arm clinical treatment trial. Setting: Eight Ontario university and community hospitals. Patient(s): Five hundred fifty-five women undergoing UAE for fibroids. Intervention(s): Baseline questionnaires completed before UAE. Main Outcome Measure(s): Questionnaires were analyzed for demographic, medical, and gynecologic histories. Fibroid symptoms, impact of symptoms, previous consultations, and treatments were also analyzed. Result(s): The Ontario cohort (66% white, 23% black, 11% other races) had an average age of 43. Thirty-one percent were under age 40. Most women were university educated (68%) and working outside the home (85%). Women reported heavy menstrual bleeding (80%), urinary urgency/frequency (73%), pain during intercourse (41%), and work absences (40%). They experienced fibroid-related symptoms for an average of 5 years and consulted with on average of three gynecologists before UAE. High fibroid life-impact scores were reported by 58%. Black women were significantly younger (40.7 vs. 44.0 years), more likely to experience symptoms longer (7 vs. 5 years), and more likely to undergo myomectomy before UAE (24% vs. 9%) than white women. Conclusion(s): Our study illustrates that large numbers of women with highly symptomatic fibroid disease are averse to surgery despite their burden of suffering and are actively seeking alternatives to hysterectomy. (Fertil Steril 2003;79:112–9. ©2003 by American Society for Reproductive Medicine.) Key Words: Uterine artery embolization, leiomyoma, uterine fibroids, burden of disease, menorrhagia, clinical study Uterine fibroids occur in 20%–50% of adult females, and when they are large enough they may produce disabling pelvic pain, menorrha- gia, and urinary frequency (1, 2). These symp- toms can have a tremendous impact on wom- en’s health and well-being. To date, most therapy for fibroids has been surgical, either myomectomy or hysterectomy. Of the over 50,000 hysterectomies performed annually in Canada and the over 600,000 hysterectomies performed annually in the United States, ap- proximately 30% are performed for fibroids (3, 4). Surgical interventions require general anes- thesia, lengthy hospital stays, and long recov- ery periods, presenting hardships for women working at home and in the workforce (5, 6). Furthermore, hysterectomy does not allow women to preserve their fertility. In general, women would prefer to have a benign uterine disease such as fibroids treated as conservatively as possible. Uterine artery embolization (UAE) is a promising nonsurgi- cal, minimally invasive therapy being offered to women for treatment of their fibroids. There have been a number of published clinical series involving the use of UAE therapy for fibroids Received April 19, 2002; revised and accepted September 16, 2002. The Ontario Uterine Fibroid Embolization Trial was funded in part by the Boston Scientific Corporation. Reprint requests: Gaylene Pron, Ph.D., Department of Public Health Sciences, Faculty of Medicine, University of Toronto, 100 College St., Room 513, Banting Building, Toronto, Ontario M5G 1L5, Canada (FAX: 416-971-2240; E-mail: [email protected]). a Department of Public Health Sciences, University of Toronto. b Center for Research in Women’s Health, Sunnybrook and Women’s College Health Sciences Center. c Department of Radiology, St. Joseph’s Health Care. d Department of Radiology, William Osler Health Center. e Department of Medical Imaging, Sunnybrook and Women’s College Health Sciences Center. FERTILITY AND STERILITY VOL. 79, NO. 1, JANUARY 2003 Copyright ©2003 American Society for Reproductive Medicine Published by Elsevier Science Inc. Printed on acid-free paper in U.S.A. 0015-0282/03/$30.00 PII S0015-0282(02)04539-9 112

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Pron, Gaylene, Marsha Cohen, Jennifer Soucie, Greg Garvin, Leslie Vanderburgh, Stuart Bell, and Ontario Uterine Fibroid Embolization Collaborative Group. "The Ontario Uterine Fibroid Embolization Trial. Part 1. Baseline Patient Characteristics, Fibroid Burden, and Impact on Life." Fertility and sterility 79, no. 1 (2003): 112-119.

Transcript of The Ontario Uterine Fibroid Em

The Ontario Uterine Fibroid EmbolizationTrial. Part 1. Baseline patientcharacteristics, broid burden, and impacton lifeGaylene Pron, Ph.D.,a,bMarsha Cohen, M.D.,bJennifer Soucie, M.Sc.,aGreg Garvin, M.D.,cLeslie Vanderburgh, M.D.,dand Stuart Bell, M.D.efor the OntarioUterine Fibroid Embolization Collaborative GroupUniversity of Toronto, Toronto; Sunnybrook and Womens College Health Sciences Center, Toronto; St.Josephs Health Care, London; and William Osler Health Center, Brampton, Ontario, CanadaObjective: To determine baseline characteristics of women undergoing uterine artery embolization (UAE) forsymptomatic broids.Design: Multicenter, prospective, single-arm clinical treatment trial.Setting: Eight Ontario university and community hospitals.Patient(s): Five hundred fty-ve women undergoing UAE for broids.Intervention(s): Baseline questionnaires completed before UAE.MainOutcomeMeasure(s): Questionnaires wereanalyzedfor demographic, medical, andgynecologichistories. Fibroid symptoms, impact of symptoms, previous consultations, and treatments were also analyzed.Result(s): The Ontario cohort (66% white, 23% black, 11% other races) had an average age of 43. Thirty-onepercent wereunderage40. Most womenwereuniversityeducated(68%)andworkingoutsidethehome(85%). Womenreportedheavymenstrual bleeding(80%), urinaryurgency/frequency(73%), painduringintercourse (41%), and work absences (40%). They experienced broid-related symptoms for an average of5 years and consulted with on average of three gynecologists before UAE. High broid life-impact scores werereported by 58%. Black women were signicantly younger (40.7 vs. 44.0 years), more likely to experiencesymptoms longer (7 vs. 5 years), and more likely to undergo myomectomy before UAE (24% vs. 9%) thanwhite women.Conclusion(s): Our study illustrates that large numbers of women with highly symptomatic broid disease areaverse to surgery despite their burden of suffering and are actively seeking alternatives to hysterectomy. (FertilSteril 2003;79:1129. 2003 by American Society for Reproductive Medicine.)KeyWords: Uterinearteryembolization, leiomyoma, uterinebroids, burdenof disease, menorrhagia,clinical studyUterine broids occur in 20%50% of adultfemales, and when they are large enough theymay produce disabling pelvic pain, menorrha-gia, and urinary frequency (1, 2). These symp-toms can have a tremendous impact on wom-ens health and well-being. To date, mosttherapyfor broidshasbeensurgical, eithermyomectomy or hysterectomy. Of the over50,000hysterectomiesperformedannuallyinCanadaandtheover 600,000hysterectomiesperformedannuallyintheUnitedStates, ap-proximately 30% are performed for broids (3,4). Surgical interventions require general anes-thesia, lengthy hospital stays, and long recov-eryperiods, presentinghardshipsfor womenworking at home and in the workforce (5, 6).Furthermore, hysterectomy does not allowwomen to preserve their fertility.Ingeneral, womenwouldprefertohaveabenign uterine disease such as broids treatedas conservativelyas possible. Uterine arteryembolization(UAE)isapromisingnonsurgi-cal, minimallyinvasivetherapybeingofferedto women for treatment of their broids. Therehave been a number of published clinical seriesinvolving the use of UAE therapy for broidsReceived April 19, 2002;revised and acceptedSeptember 16, 2002.The Ontario Uterine FibroidEmbolization Trial wasfunded in part by theBoston ScienticCorporation.Reprint requests: GaylenePron, Ph.D., Department ofPublic Health Sciences,Faculty of Medicine,University of Toronto, 100College St., Room 513,Banting Building, Toronto,Ontario M5G 1L5, Canada(FAX: 416-971-2240;E-mail: [email protected]).aDepartment of PublicHealth Sciences, Universityof Toronto.bCenter for Research inWomens Health,Sunnybrook and WomensCollege Health SciencesCenter.cDepartment of Radiology,St. Josephs Health Care.dDepartment of Radiology,William Osler HealthCenter.eDepartment of MedicalImaging, Sunnybrook andWomens College HealthSciences Center.FERTILITY AND STERILITYVOL. 79, NO. 1, JANUARY 2003Copyright 2003 American Society for Reproductive MedicinePublished by Elsevier Science Inc.Printed on acid-free paper in U.S.A.0015-0282/03/$30.00PII S0015-0282(02)04539-9112(715).Mostcentersreportsignicantdecreasesinbroidsize and improvements in symptoms after embolization ther-apy. The trials, however, have generally involved smallseriesofpatients. Atthestartofthisstudy, therewerenoprospectivereports describingthecharacteristics of largenumbers of women undergoing embolization therapy or theburden of their broid disease.The Ontario Uterine Fibroid Embolization (UFE) Trial isaprospectivemulticenterclinicalstudywithobjectivesin-volving safety, technical success, efcacy, and durability ofembolization therapy. The purpose of this report is to doc-ument thecharacteristicsofwomenundergoingemboliza-tiontherapyinthetrialaswellastheirbroidsymptoms,burden, and impact on their lives. Fibroids occur much morecommonly in black women (1618), and as many as 75% oftheirhysterectomieshavebeenreportedtobeforbroids(19). Secondaryobjectiveswerethereforetodetermineifblack women undergoing UAE differed from white womenwith respect to their demographics, broids, symptoms, andbroid impacts. Although UAE was initially being evaluatedas an alternative to hysterectomy, many women undergoingUAE were younger women interested in preserving fertility.Thus, anotherobjectiveofthisreport wastodetermineifyoung women undergoing UAE differed from older womenwith respect to their broids, symptoms, and impacts on theirlives. This report is based on the baseline questionnaires andultrasound exams completed for the 555 women who under-went UAE at eight Ontario hospitals.MATERIALSANDMETHODSStudy Design and Participating CentersThe Ontario UFETrial is a multicenter clinical trialinvolving the prospective follow-up of consecutive womenundergoing embolization treatment for symptomatic uterinebroids. Treatment was provided by 11 interventional radi-ologistspracticingat eight Ontariohospitals. InstitutionalReviewBoardapproval wasobtainedfor thestudyat allinstitutes.Patient EligibilityWomen were eligible for the study if they had symptom-atic uterine broid(s) documented by pelvic ultrasound. Pre-vioussurgicalormedicaltherapyforuterinebroidswerenot prerequisites, but symptoms had to be severe enough towarrant considerationofhysterectomy. Eligibilitywasnotrestricted by age, broid size, or location. Although womendesiringchildrenwerenot excludedfromthestudy, theywerefurtherinformedoftheuncertaineffectsofUAEonconception or carrying to full term. Patients were ineligiblefor the studyif theyhadanactive pelvic inammatorydisease, undiagnosedpelvicmass, endometrial carcinoma,pregnancy, or renal insufciency.Baseline QuestionnaireBefore UAE, patients completed a six-page baselinequestionnaireincludinginformationondemographics andmedical and gynecologic history. Body mass index (wt kg/ht2m) was grouped according to categories used by StatisticsCanada in the National Population Health Survey (20): un-derweight (18.5); acceptable weight (18.624.9); over-weight (25.029.9); obese (30.0).Thenatureofbroidsymptoms,durationofsymptoms,and previous broid treatment(s) were also determined.Symptom information included presence, extent, and impactanddurationofpelvicpain, bleeding, andmass-orbulk-related effects (such as urinary urgency/frequency). Specicquestionsaboutmenstruationincludedaveragedurationofmenstruation and sanitary napkin use on heaviest menstrualday. Patient perceptionof excessive bleedingwas deter-mined by asking the patient whether she felt her menstrualbleeding was unusually heavy because of her broids. Theywere also asked if they were anemic or low on blood orusedironsupplementsorinjections. Menorrhagiawasde-ned as menstruation longer than 7 days or sanitary napkinuse exceeding 12 for a 24-hour period. Postmenopausalstatus was dened as an absence of menstrual cycles for overa year.Occurrence of pelvic pain was determined by askingwomen whether they ever had pain or pelvic cramping whichtheybelievedtoberelatedtotheir broid. Questions onpelvic pain also included duration, timing, relief with med-ication, andinterferenceinusualactivities. Fibroid-relatedsymptoms were grouped for statistical purposes according tosymptomcategories developed for hysterectomy profes-sional practice guidelines (21). Symptom categories includedgroup 1, pelvic pain only; group 2, pelvic pain with bleeding;group 3, bleeding only; group 4, bulk-related effects withoutpain or bleeding. Women were asked to rate the degree ofoverall impact or interference of broids on their lives usinga 10-point visual numerical rating scale. A life-impact scoreof 1 represented little or minimal interference and 10 repre-sented total or complete interference with their daily or usualactivities.Uterineandbroidsizewasbasedonultrasoundmea-surements includingmaximumdiameters inthree planes(longitudinal [D1], anterior-posterior [D2], andtransverse[D3]). Measurementsweretakenonlyofthedominant orlargest broid. Uterine and broid volumes were calculatedusing the formula (V 0.5233 D1 D2 D3) for anellipsoid shape (22). The number (14, 5) and location ofbroids were also recorded.AnalysisData forms were monitored for completeness and subse-quently entered into a centralized database system. Overalltrends inageandrace(blackvs. white) wereexamined.Differences betweenyounger andolder womenwereas-FERTILITY&STERILITY 113sessed comparing two age groups, those40 years of ageand those 40 years of age. Mean differences between racialandage groups for uterine volume, broidvolume, andlengthoftimewithsymptomswerecomparedbytheStu-dents t-test. Therelationshipof self-reportedlife-impactscorestosymptomgroupswasdeterminedbycomparingdifferences in median life-impact scores. Differences in life-impact scores between two groups were tested by the Wil-coxon rank sum test and between more than two groups bytheKruskal-Wallistest. Differencesinsymptomgroupingbetween racial groups and age groups were tested by Pear-sons 2test. P .05 was considered statistically signicantin two-sided tests. All analyses were performed with SPSS,version 10.1 (SPSS Inc., Chicago, IL).RESULTSPatient CharacteristicsBaseline questionnaires were completed by 97% (539 of555)oftheparticipants(Table1). Themajority(66%)ofwomen were white; 23% were black and 11% were of otherraces, mostly Asian. The women undergoing UAE were onaverage 43.0 years of age (SD 6.04; range, 1859 years).Thirty-one percent (167 of 539) were young women underT A B L E 1Patientdemographicsbyrace.AllN (%)RacePWhiteN (%)BlackN (%)EducationHigh school or less 171 (32) 113 (33) 42 (35)College/university 358 (68) 234 (67) 77 (65) .59aEmployment statusUnemployed 64 (12) 39 (11) 17 (14)Employed 380 (72) 242 (70) 93 (76)Self-employed 81 (15) 60 (17) 12 (10)Retired 5 (1) 5 (1) 0 (0) .11aMarital statusSingle 145 (27) 76 (22) 52 (42)Married/partner 303 (56) 220 (63) 46 (37)Divorced/separated 82 (15) 49 (14) 24 (20)Widowed 9 (2) 7 (2) 1 (1) .01aFamily intentionsNo children 268 (50) 170 (49) 65 (53)Decided not to have 95 (18) 74 (21) 12 (10)Would like to have 127 (24) 69 (20) 42 (34)Unable to have 35 (7) 22 (6) 8 (7)Children 269 (50) 180 (51) 58 (47)Decided no more 196 (36) 138 (39) 33 (27)Would like more 37 (7) 19 (5) 15 (12)Unable to have more 30 (6) 21 (6) 6 (5) .42aGeneral healthExcellent 89 (17) 59 (17) 21 (18)Very good 215 (40) 149 (42) 48 (40)Good 196 (37) 122 (35) 44 (37)Not very good 35 (7) 21 (6) 7 (6) .88bBody mass indexUnderweight 6 (1) 2 (1) 2 (2)Acceptable weight 241 (47) 164 (49) 45 (39)Overweight 179 (35) 112 (33) 47 (41)Obese 87 (17) 59 (18) 20 (18) .30bMenopausal statusPremenopausal 431 (80) 271 (77) 103 (85)Perimenopausal 92 (17) 68 (19) 17 (14)Postmenopausal 14 (3) 13 (4) 1 (1) .06aaPearson 2.bWilcoxon rank sum.Pron. Women undergoing broid embolization. Fertil Steril 2003.114 Pron et al. Women undergoing broid embolization Vol. 79, No. 1, January 2003age40. Blackwomenwereonaverage3.3yearsyoungerthan white women (40.7 vs. 44.0 years; P.01).Most women (68%) were highly educated, either univer-sity graduates or postgraduates, and 79% of them had accessto the Internet. Women undergoing UAE were mostly work-ing outside the home (85%) and 15% were self-employed.Womenweremorelikelytobemarriedorwitharegularpartner (56%) than to be single, divorced, or separated(44%). Half (268 of 537) of women in this trial did not haveany children. Fertility was still an issue for many; 31% (164of 537) expressed a desire for children.Only 17% of women described their general health, com-paredwithother womenof their age, asbeingexcellent.Self-reported general health status varied by age group butnot byrace. Youngwomenweremorelikelythanolderwomen (10% vs. 5%; P .04) to self-report their health tobe not very good. Among women in the trial, 35% wereoverweight and 17% were obese. Nineteen percent (102 of539) reported other major health problems such as hyperten-sion, thyroiddisease, asthma, diabetes, andarthritis. Fivepercent (28 of 539) also reported that they were consideredat increasedsurgical riskbecauseof amedical condition,suchasanemia, highbloodpressure, cardiomyopathy, orcoagulopathy.Most women were premenopausal (80%) (Table 1); 17%describedthemselvesasperimenopausal and3%aspost-menopausal. Other gynecological problems were reported by125 women (23%), and 101 of them had undergone previoustreatment. Among their conditions were endometriosis, cer-vical dysplasia, and ovarian cysts.Fibroid Uterine CharacteristicsThe majority of women (70%) had multiple broids (Ta-ble 2). Many of these broids were very large; pre-emboli-zation average broid volume was 293 cm3(95% condenceinterval [CI], 259327 cm3). Fibroid lengths were on aver-age 8 cm (range 124 cm). Pre-embolization average uterinevolume was 680 cm3(95% CI, 626734 cm3), and averageuterine length was 14 cm (range, 530 cm). Black womenwere signicantly (P.01) more likely than white women tohave multiple broids. Fibroid volume or uterine volume didnot differ by race or age group (Tables 2 and 3).Fibroid-Related SymptomsSymptoms reportedbythewomentendedtooccur incombination (Table 2). Most (80%) women reported heavymenstrual bleeding, many of whom reported being anemic ortaking iron supplements. Thirty-one percent (168 of 539) ofthe women reported lengthy, i.e., longer than 7 days, men-strual periods. Of the405women(75%) reportingpelvicpain, especiallyduringmenstruation, 195(48%) of themreported that they had experienced the pain for over 2 years.Eighty-six of the women were not able to relieve their painwith medication.Overall symptom groups differed by race (P .02) andby age group (P.01) (Tables 2 and 3). Black women weremorelikely(73%vs. 60%; P.01) toreport painandbleedingthanwhitewomen. Thebleedingonlysymptomgroup was more common in older women (19% vs. 10%; P .01).Duration of Fibroid SymptomsThe mean duration of reported broid-related symptomswas5years; 42%reportedlonger than5yearsand18%reported longer than 10 years (Table 2). Duration of symp-toms varied by race, with black women reporting a signi-cantly longer duration of symptoms than white women (7 vs.5 years; P.01).Duringthisperiod, womenhadextensiveconsultationswith physicians, on average three gynecologists and as manyas 10 physicians, about their uterine broids and treatment.Eighteenpercentofthewomenhadself-referredforUAEtreatment. Forty percent of the women reported having un-dergoneprevioustreatmentsfortheirbroids. Includedinself-help remedies were herbal treatment (8%), vitamin sup-plements (8%), anddietarychanges (5%). Theyalsore-portedundergoingtraditional therapies suchas hormonaltherapies (12%), endometrial ablation(3%), dilationandcurettage (10%), or myomectomy(14%). Prior myomec-tomywas foundtovarysignicantlybyrace(Table2).Black women were signicantly more likely than whitewomen (24%vs. 9%; P.01) to undergo myomectomybefore UAE.Fibroid Symptom Impact on LifeFor most women (88%), their broid size and/or locationwere bothersome. For women whose uterus was enlarged bybroid(s), the appearance of being pregnant was embarrass-ing. Because of the large size and abdominal location of thebroids, they often pressed on surrounding organs, causingincreased urinary frequency or urgency (73%) and low backpain. For some women, they also caused pain during inter-course(41%) andlimitedtheir abilitytoexercise(45%).Manywomen(40%)alsoreportedhavingtotaketimeoffwork in the previous year for broid-related reasonsoftenseveral days a month, particularly around their menstruation.Excessive bleeding or menorrhagia interfered with theirsleep, and many women reported being housebound or hav-ingtobeclosetoawashroomduringtheir menstruation.Almost all women reported that these symptoms had a heavyimpactontheirlives;overhalf(58%)reportedlife-impactscoresof7.0orgreater. Life-impact scoreswerestronglyrelated to symptom group (P.001; Fig. 1) and were highestfor symptom groups of bleeding (median 7.0) and bleed-ing with pain (median 7.0).DISCUSSIONTheOntarioUFETrial represents thelargest reportedpatient group undergoing embolization therapy for broidsFERTILITY&STERILITY 115todate. Our studyndsthat, despiteexperiencingseveresymptoms that have a heavy impact on their lives, womenwithuterinebroidscontinuedtoseekalternativestohys-terectomyfortheirbroidsoverextendedperiodsoftime.Theyhadsufferedwithbroid-relatedproblems suchasheavy menstrual bleeding and pain for many years, some forlonger than 10 years. As a consequence, most women in ourstudy also had large and multiple broids that often lled theentireuterus. Uterinegestational size, becauseofbroids,wascommonlyestimatedtobe4monthsor greater. Thewomenhadmultipleconsultationswithphysicians, under-went extensive imaging follow-up, and had been repeatedlyadvised to have hysterectomy.There may be several reasons for some womens reluc-tance to undergo hysterectomy. Many may have been largelydelaying treatment decisions in the hopes of either a naturalregression of their broids or the emergence of new nonsur-gical treatment options like UAE. For some it may have beenabout treatment choice and being unwilling to undergo therisks of major surgery. As many women in the Ontario UAETrial were young women under 40 years of age, fertility orat least uterine preservation was likely an important issue.Women in this cohort were also highly educated: 68% ofthemhaduniversityor college educationcomparedwithapproximately38%of other Canadianwomen(23). Ourndings are consistent withreports inthe literature thatsuggest that women with less education are at greater risk ofhaving a hysterectomy (2426). In a study by Harlow andBarbieri (25), only one in ve highly educated women com-T A B L E 2Fibroiduterinecharacteristics,symptoms,andimpactsbyrace.All N (%)RaceP(t-test) White N (%) Black N (%)No. of broids1 150 (30) 110 (35) 13 (12)24 220 (44) 143 (45) 56 (50)5 125 (26) 62 (20) 43 (38) .01aFibroid volume (cm3)0100 174 (35) 106 (32) 47 (41)101200 114 (23) 69 (21) 32 (28)201400 91 (18) 70 (21) 12 (11)401 121 (24) 83 (25) 23 (20)Mean (95% CI) 293 (259327) 307 (264349) 275 (200350) .46bUterine volume (cm3)0250 106 (22) 71 (22) 24 (21)251500 131 (27) 82 (26) 33 (29)5011,000 149 (31) 101 (32) 28 (25)1,001 102 (21) 62 (20) 28 (25)Mean (95% CI) 680 (626734) 656 (596716) 765 (614916) .19cSymptom groupPelvic pain only 68 (13) 46 (13) 16 (13)Pain with bleeding 337 (63) 211 (60) 90 (73)Bleeding only 89 (17) 60 (17) 12 (10)Bulk/mass effects 45 (8) 35 (10) 5 (4) .02dSymptom duration1 year 20 (4) 14 (4) 2 (2)14 years 278 (54) 188 (56) 52 (43)59 years 122 (24) 83 (25) 29 (24)10 years 94 (18) 49 (15) 37 (31)Mean (95% CI) 5 (4.85.7) 5 (4.25.3) 7 (6.28.5) .01cPrior myomectomy 73 (14) 33 (9) 30 (24) .01dFibroid impact score13 90 (17) 54 (16) 21 (18)46 135 (26) 91 (26) 30 (25)710 304 (58) 201 (58) 69 (58)Median score 7 7 7 .54aaEqual variances assumed.bEqual variances not assumed.cPearson 2.dWilcoxon rank sum.Pron. Women undergoing broid embolization. Fertil Steril 2003.116 Pron et al. Women undergoing broid embolization Vol. 79, No. 1, January 2003pared with four out of ve less educated women (high schoolor less) initially accepted hysterectomy as the treatmentchoice. However, not only were women in our study gener-ally highly educated, most of them had access to the Internet.The use of additional sources of health information like theInternet mayreect thedesireofthesewomentobecomemore informedandparticipate more activelyindecisionmakingregardingtheir care. Their activeparticipationisfurther evidencedbythe highself-referral rate for UAEtreatment.Wealsonotedthat theOntariocohort, inadditiontoexperiencinglong-termsymptomsassociatedwiththeir-broids, was also relatively unhealthy. Unhealthy bodyweight categories were more common in this cohort than inother Ontario women: overweight (35% vs. 24%) and obese(17% vs. 11%) (20). The overall self-reported general healthwas alsosignicantlylower comparedwiththat of otherCanadians: only 57% of UAE women reported their health tobeverygoodorexcellentcomparedwith67%oftheCanadian population (27). The high rate of overweight andobese womenundergoingUAEmayalsoreect referralpatterns of gynecologists, who may be more likely to referthese patients because of potential increased risk of infectionand postoperative complications. Heavy menstrual bleedingand pelvic pain were the most common symptoms reportedby women undergoing UAE. Very few women reported onlybulk-related affects. The high prevalence of bleeding isconsistent with that reported in other clinical series involvingUAE.It has been reported that broids occur more commonly inblack women and that they can occur earlier, are larger, andresult insymptomsforalongertimebeforehysterectomy(28). Wefoundsimilarresultsinourstudy. Blackwomenundergoing UAEdiffered fromwhite women in severalrespects. In general they were younger and had experiencedsymptoms longer. Black women were also more likely thanwhitewomentoreportpainandbleeding. Theywerealsomuch more likely to have undergone surgery (myomectomy)for their symptoms. Althoughwedidnot ndbroidoruterinesizetobelargerinblackwomen, theyweremorelikely than white women to have multiple broids, suggest-ing a greater genetic predisposition for broids.Younger women (both black and white) were also morelikely to report pain and bleeding symptoms. Their reportingof more symptoms was consistent with their tendency to alsoreport poorer general health than older women in the trial.Older women, in comparison, were more likely than youngerwomen to report only bleeding symptoms. This is to somedegree consistent with the general principle that menorrhagiaitself increases with age (29).At the time when this research was initiated, there was nodisease-specic health-related quality-of-life assessment in-strument for broids. Until recently, there were alsonoreports on the impact of broids and symptoms on thequality of life of women undergoing UFE. Spies et al. (30)recently developed a formal health-related quality-of-lifequestionnaire that includedgeneric components fromtheMedical Outcomes Study (SF-36 scales) and additionalquestions onactivity, sexual functioning, self-image, andhealth distress. The instrument, however, was developed onasmallgroupofpatientsfromoneinstitution, andfurthertesting on other patient groups has not been reported.Inour study, wedevelopedasimplenumerical ratingscale to summarize the overall impact of broids and symp-toms on womens lives. Most women in the Ontario cohortwere highly symptomatic so the rating scale was not testedonawiderspectrumoflesssymptomaticwomen. ImpactT A B L E 3Fibroiduterinecharacteristics,symptoms,andimpactsbypatientage.Age groupP(t-test) 40 N (%) 40 N (%)No. of broids1 56 (36) 92 (27)24 62 (40) 160 (47)5 38 (24) 87 (26) .13aFibroid volume (cm3)0100 54 (34) 120 (35)101200 39 (24) 75 (22)201400 26 (16) 65 (19)401 42 (26) 79 (23)Mean (95% CI) 325 (249401) 278 (244312) .27bUterine volume (cm3)0250 39 (26) 67 (20)251500 39 (26) 92 (27)5011,000 45 (30) 104 (31)1,001 29 (19) 73 (22)Mean (95% CI) 666 (559772) 687 (624749) .73cSymptom groupPelvic pain only 23 (14) 45 (12)Pain with bleeding 119 (71) 218 (59)Bleeding only 17 (10) 72 (19)Bulk/mass effects 8 (5) 37 (10) .01aSymptom duration1 year 10 (6) 10 (3)14 years 88 (55) 190 (54)59 years 40 (25) 82 (23)10 years 23 (14) 71 (20)Mean (95% CI) 5 (4.05.3) 6 (5.06.1) .04bPrior myomectomy 23 (14) 50 (13) .92aFibroid impact score13 26 (16) 64 (17)46 40 (25) 95 (26)710 97 (60) 207 (57)Median score 7 7 .20daPearson 2.bEqual variances not assumed.cEqual variances assumed.dWilcoxon rank sum.Pron. Women undergoing broid embolization. Fertil Steril 2003.FERTILITY&STERILITY 117scores were not found to vary by race, patient age, or uterinesize. Theywere, however, foundtobestronglyassociatedwith symptoms, particularly heavy menstrual bleeding.This result was consistent with quality-of-life scores re-ported for patients undergoing UFE in the study of Spies etal. (30), in which scores were higher for bleeding than forpain or bulk-related symptoms. Rowe et al. (31) have alsoshown that symptoms of bleeding and pain can have asignicant functional impact on women and can even repre-sent a greater health burden than other major chronic healthconditions. In that study, women undergoing hysterectomyfor benign uterine conditions and having symptoms of painand/or bleeding scored signicantly higher on SF-36 indicesof emotional well-being than women with hypertension,diabetes, heart disease, chronic lung problems, and arthritis.Inconclusion, ourstudyillustratesthatwomenseekingminimallyinvasivetreatment alternativestohysterectomyhave large broid uteri and experience long-term and severesymptoms of bleeding and pain. The women in the trial werehighlyeducated, hadaccesstotheInternet, andhadcon-sultedwithmanyphysicians beforeUAEtherapy. Blackwomen in general were younger, experienced symptomslonger, weremorelikelytoreport painandbleeding, andwere more likely to have undergone myomectomy thanwhitewomen.Almostallwomenratedthesesymptomstohave a heavy impact on their lives. Symptoms, particularlyheavy menstrual bleeding, rather than broid or uterine size,were responsible for the high life-impact scores in this co-hort. Our study illustrates that large numbers of women withhighlysymptomaticbroiddiseaseareaversetosurgerydespitetheir burdenof sufferingandareactivelyseekingalternatives to hysterectomy.Acknowledgments: The trial represents the collaborative efforts of membersof theOntarioUFECollaborativeGroupandconsists of thefollowingF I G U R E 1Fibroid life-impact rating by symptom group.Pron. Women undergoing broid embolization. Fertil Steril 2003.118 Pron et al. Women undergoing broid embolization Vol. 79, No. 1, January 2003individuals and institutions: Dr. Gaylene Pron, University of Toronto,Toronto, Ontario, Department of Public Health Sciences; Dr. Andrew Com-mon and Dr. Jane Wall, St. Michaels Hospital, Toronto, Ontario, Depart-ment of Medical Imaging; Dr. AnthonyCecutti, Dr. JerzyCupryn, Dr.AdelmoMartoglio, Dr. Paul McCleary, Dr. Eva Mocarski, Dr. DonnaSteele, and Dr. Karen Tessler, St. Michaels Hospital, Department ofObstetrics and Gynecology; Dr. John Bennett, Dr. Roman Kozak, and Dr.GregGarvin, St. JosephsHealthCare, London, Ontario, Department ofRadiology; Dr. GeorgeVilos, St. Josephs HealthCare, Department ofObstetrics andGynecology; Dr. Stuart Bell, SunnybrookandWomensCollege Health Sciences Center, Toronto, Ontario, Department of MedicalImaging; Dr. Jennifer Blake, Dr. Deborah Butler, Dr. Rose Kung, and Dr.Michael Shier, Sunnybrook and Womens College Health Sciences Center,Department of Obstetrics and Gynecology; Dr. Marsha Cohen, SunnybrookandWomens College HealthSciences Center, Center for ResearchinWomensHealth;Dr. MurrayAsch, MountSinaiHospital, Toronto, On-tario, DepartmentofMedicalImaging;Dr. PeterHawrylyshyn, Dr. NickLeyland, andDr. Michael Sved, Mount Sinai Hospital, Department ofObstetricsandGynecology;Dr. TerryColgan, MountSinaiHospitalPa-thologyandLaboratoryMedicine; Dr. KennethSnidermanandDr. JohnKachura, Toronto General Hospital, Toronto, Ontario, Department of Med-ical Imaging; Dr. Martin Simons, Toronto Western Hospital, Toronto,Ontario, Department of Medical Imaging; Dr. Leslie Vanderburgh, WilliamOsler HealthCenter, Brampton, Ontario, Department of Radiology; Dr.CuongTran, McMaster UniversityMedical Center, Hamilton, Ontario,Department of Medical Imaging.References1. 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