Can the PFDI or PFIQ be used to predict outcome in pelvic reconstructive surgery? 夽

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ORIGINAL ARTICLE

Can the PFDI or PFIQ be used to predict outcome in pelvic reconstructive surgery? ^夽

Le PFDI ou PFIQ permet-il de prédire les résultats en chirurgie reconstructive pelvienne ?

V. Letouzey

^a^,∗

, G. Mercier

^b

, S. Adjoussou

^a

, E. Bohoussou

^a

, P. Mares

^a

, R. de Tayrac

^a

aGynecologyandobstetricsdepartment,Caremeauuniversityhospital,placePrR.-Debré, 30900Nimes,France

bMedicalinformaticsdivision,ArnauddeVilleneuveuniversityhospital,34000Montpellier, France

Received13January2013;accepted9April2013

KEYWORDS Genitalprolapse;

PFDI;

PFIQ;

Predictingoutcome;

Vaginalsurgery

Summary

Objective.—TodetermineasyndromescorethresholdonPFDIorPFIQpredictiveofasigniﬁcant improvementinpost-operativefunctionalresults.

Design.—Aretrospectivecasereview(CanadianTaskForceClassiﬁcationII-2).

Setting.—Universityandresearchhospital.

Population.—Womendiagnosedwithpelvicorganprolapseandrepairedwithsyntheticvaginal mesh.

Methods.—Qualityoflifewasarbitrarilyconsideredtohaveimprovedsigniﬁcantlyifthescore decreasesbymorethan50%betweenpre-operativelyand36monthspost-operatively.Weinves- tigatedthepre-operativecut-offscorepredictiveofnoqualityoflifeimprovementatM36from aprospectivetrialforsurgicalpelvicorganprolapsetreatment.

Results.—Themostaccuratepre-operativecut-offscorepredictingafailuretoimprovequality oflifeat36monthspost-operativelywas62/300(PFDIScore).Thiscut-offvaluehadapositive predictivevalueof83.6%andspeciﬁcityof62.1%.Nosigniﬁcantthresholdwasobtainedfrom thePFIQscore.

Conclusion.—The intensityofsymptomsbeforesurgerymay interfereasapredictivefactor foroutcome.

Abbreviations: AUC,Areaunderthecurve;M0,pre-operativeevaluation;M36,36monthspost-operatively;PFDI,PelvicFloorDisorder Inventory;PFIQ,PelvicFloorImpactQuestionnaire;POP,PelvicOrganProlapse;POP-Q,InternationalPelvicOrganProlapsestagingsystem;

QOL,Qualityoflife;ROC,Receiveroperatingcharacteristic.

夽 Levelofevidence:4.

∗Correspondingauthor.

E-mailaddress:Vincent.go@wanadoo.fr(V.Letouzey).

http://dx.doi.org/10.1016/j.purol.2013.04.010

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MOTSCLÉS

Prolapsusdesorganes pelviens;

PFDI; PFIQ; Prédictiondes résultats; Chirurgievaginale

Résumé

Objectif.—Déterminerunseuil surlescoredes questionnairesdesymptômes PFDIouPFIQ prédictifd’uneaméliorationsigniﬁcativedesrésultatsfonctionnelspostopératoires.

Type.—Étuderétrospective(II-2).

Population.—Lesfemmesdiagnostiquéesavecprolapsusdesorganespelviensettraitéesavec prothèsessynthétiqueparvoievaginale.

Méthodes.—La qualitédevieétait arbitrairementconsidéréecommeaméliorée silescore diminuedeplusde50%entrelapériodepréopératoireet36moispostopératoire.Nousavons recherchéleseuilpréopératoireprédictifdelanon-améliorationdelaqualitédevieàM36,à partird’uneétudeprospectivesurlapriseenchargeduprolapsus.

Résultats.—Leseuilpréopératoireprédisantundéfautd’améliorationpostopératoireétaitde 62/300(PFDIScore).Cettevaleurseuilavaitunevaleurprédictivepositive de83,6%etune spéciﬁcitéde62,1%.Aucunseuilsigniﬁcatifn’aétéobtenuduPFIQ.

Conclusion.—L’intensitédessymptômesavantl’interventionchirurgicalepourraitinterférer danslesuccèsdelachirurgiecommeunfacteurprédictif.

Introduction

Pelvicorganprolapseisseeninupto43to76%ofwomenpre- sentingforroutinegynecological care,and3to6%involve descent beyond the hymen [1,2]. In the Women’s Health Initiative,41% ofwomen age50to79yearsshowedsome degreeofpelvicorganprolapse(POP),includingcystocele in34%,rectocelein19%,anduterineprolapsein14%[3].In amulticentrestudyof1006womenage18to83yearspre- senting for a routine gynecological examination, 24% had normalsupport and38% hadstage I,35% stageII, and2%

stageIIIpelvicorganprolapse[4].

POP is a common disorder with prevalence, all stages combined,of30%.Aftermenopause,eventhoughincidence isstable,arelationshipisseenbetweentheseverityofthe prolapseandpatientage[4].

POPisnotresponsibleforanyseveremorbidityormortal- ity,butitmayhaveamarkedfunctionalimpactonqualityof life,self-esteemandsexuality[5—7].Asaresult,POPmust oftenbesurgicallyrepaired.Previousstudieshavedemon- stratedthefeasibilityofsurgicaltreatment,bylaparoscopy or vaginal route, and also its efﬁcacy on both anatomic andfunctionalsymptoms[8,9].Moreover,an improvement in qualityof life(QOL)has been reportedonthe basisof validatedquestionnaires[10,11].

However,althoughthequestionnairescoreimprovedsub- stantially in some women after surgery, others reported only a slight improvement. It would therefore be use- ful to be able to distinguish between these subgroups of women pre-operatively in orderto select the bestcandi- dates for surgery. This functional surgery can also cause complications,andthisisevenmorebothersomeifpatients arenotnecessarilyimproved.

Asaprognosticfactor,Gutmanetal.foundthatvaginal descensusdistal tothehymenaccurately predictsbulging symptoms; however, they were unable to predict other pelvicﬂoorsymptoms[12].This signtherefore appearsto havelimitations.Othermarkerspotentiallyidentifyinggood candidatesforsurgerythereforeneededtobetested.

No mechanism has yet been developed that correlates anatomical abnormalities with the impact of genital prolapse on quality of life. And, in order to identify good

candidatesforgenitalprolapsesurgery,itis clearthatwe needcriteriathatareabletopredictpost-surgicalchanges inqualityoflife.

The aimof thispreliminary study wastouse validated questionnaires, before and after surgery for genital prolapse,toassesssymptoms(PFDI)andqualityoflife(PFIQ) inan attemptto highlight a thresholdabove which there is a likelihood of improving post-surgical quality of life [5,13,14].

Population and methods

Aprospectivestudywasconductedin230womendiagnosed withpelvic organprolapse inthe gynecologydepartments of13publicandprivatehospitalsinFrance[15].Theywere aged18or moreandunderwentPOPrepair. Allgavetheir informedconsenttotakepartinthestudy.

Thepre-operativeevaluation(M0)includedmedicalhis- toryandaurogynaecologicalexamination.Alldepartments used a standardized case report form. Physical evalua- tionswereperformed usingtheInternationalPelvic Organ Prolapsestagingsystem(POP-Q),assessinganteriorandpos- teriorvaginalwallprolapse,anduterineorvaultprolapseon maximumValsalvaeffortintheseatedsemi-lithotomyposi- tion.Quality of life wasassessed using translatedFrench versions of the Pelvic FloorDisorder Inventory (PFDI) and PelvicFloorImpactQuestionnaire(PFIQ)[5].PFDIandPFIQ areself-administered questionnairesand were completed by patients without the presence of medical staff. They coverurinary,colo-recto-analandpelvic/vaginalsymptoms relatedtopelvicﬂoordisorders.Apsychometricevaluation showeda goodcorrelation between PFDI/PFIQscores and physicalsymptoms.

Eachpatientrecruitedpresented withat leastasymp- tomatic vaginal wall prolapse staged 2 to 4 by the International Pelvic Organ Prolapse stagingsystem (Ba or Bp≥—1)andadecreasedqualityoflife.Nothresholdinthe QualityofLifeQuestionnairewasusedasanindicationfor surgery.

In order to avoid bias due to the surgical procedure, cystocele repair was performed using the same vaginal

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synthetic mesh procedure. All patients were operated on by the vaginal route using a prosthetic mesh (Ugytex^TM, Sofradim, Trévoux, France). This is a low-weight, poly- propylene monoﬁlament mesh offering appropriate tissue in growth [16].Posteriorly, the mesh was implanted with twoarms suturedtothe sacrospinousligaments,asprevi- ouslydescribedbytheauthors[17].Concomitantprocedures suchasvaginalhysterectomywereperformedinaccordance witheachsurgeon’spreferredtechnique.Whenthepatient sufferedfromassociatedpre-operativestressurinaryincon- tinence,amid-urethralslingwasputinplaceafteranterior vaginalskinclosure,byaseparateincision.

Patientswere instructed torest for 2 weeksafter the surgery,theywereallowedtoreturntoworkafter4weeks, andtotake partin sportor havesexual intercourseafter 6 weeks. Follow-up visits were scheduled for 6 weeks, 6 months, and 1, 2 and 3 years (M36). A urogynecolog- ical examination was performed at each visit using the POP-Qsystem. Post-operative functionalresults for symp- tomsandqualityoflifewereevaluatedusingthePFDIand PFIQ.

Themainendpointforeachfollow-upstepwasimprove- ment in quality of life at M36 deﬁned as a decrease of more than 50% in the score at M36 compared with the baseline score. On this basis, patients were consid- eredas‘‘improved’’ (decrease≥50%) or‘‘non-improved’’

(decrease<50%orincrease). Noinstitutionalreview board or ethics committee has been solicited, because this speciﬁcretrospectivestatisticalanalysishasconcernedval- idatedquestionnaire scoreona non-randomized patient’s cohort.

The sample size was calculated in order to achieve a precisionof0.1forasensitivityof80%.Assuminga95%conﬁ- dencelevelanda67%prevalenceofnon-improvedpatients, atotalsamplesizeof93wasneeded.

The epidemiological and clinical characteristics of the

‘‘improved’’and‘‘non-improved’’patientswerecompared usingtheChi²testorFisher’sexacttestforcategoricalvaria- bles,andStudent’sttestortheWilcoxonrank-sumtestfor continuousvariables.

Logistic regression was used to determine the baseline PFDI cut-off that predicted an improvement at M36.

A receiver operatingcharacteristic (ROC) curve was con- structed by plotting sensitivity against 1—the speciﬁcity of each possible cut-off. The area under the ROC curve (AUC)wascalculatedalongwithits95%conﬁdenceinterval.

The AUC is equal to the probability that the classi- ﬁer will rank a randomly chosen positive patient higher

than a randomly chosen negative one. The cut-off was determinedtooptimizebothsensitivityandspecificity.Sta- tistical measures of the performanceof the cut-off point (sensitivity, specificity, positive predictive value and negative predictive value) were calculated along with their 95% confidence intervals. Model performance was quan- tified by the AUC (the closer to 1, the better). The goodness-of-fit ofthemodelwasevaluatedusingtheHos- mer and Lemeshow (lack of fit if P<0.05). No validation was used due to the small sample size. Spearman correlation coefficients were tested for correlation between Quality of Life Scores (M0, M36, delta) and symptoms.

Statistical signiﬁcance was set at 5% and all statistical testsperformedusingSASsoftware9.1(SASInstitute,Cary, NC).

Results

Baseline characteristics

Two hundred and thirty consecutive patients with symp- tomatic anterior or posterior vaginal wall prolapse were recruited in a prospective multicenter study involving 13 Frenchgynecologicalorurologicaldepartments(fouruniver- sity,threepublicandsixprivatehospitals)and18surgeons experienced in vaginal prolapse repair. One hundred and twenty-four were following up at 36 months. Question- nairesof 114womenwereanalyzed.PFDIandPFIQscores were established at M0and M36for 109 and 67 patients, respectively. Medianbaselinepre-operativePFDIandPFIQ scorescorrespondedto75(range:0—229.6)and41(range:

2.7—297.2),respectively(Fig.S1).Thebaselinecharacteris- ticsofthe‘‘PFDI’’populationcorrespondedtomeanparity of2.8 (SD=1.6),age64years(SD=11.6) andabodymass indexof 25 (SD=3.7).Other baselineepidemiological and clinical characteristics arepresented in Tables S1, S2and Table1.

Comparison between ‘‘improved’’ and

‘‘non-improved’’ patients

At M36,67 patients completedthe PFIQ, giving a median score of 17.6 (range: 0—223.8). This PFIQ indicated that 53 (79.1%; 95CI 68—87) had experienced an improvement in qualityof life.No differencewasfound between improved and non-improved patients for median baseline PFIQ score which was 38.8 (range: 3.1—297.2) and Table1 MeanscoresforQualityofLifemeasurements.

Symptoms PFDI(n=109) Qualityoflife PFIQ(n=67)

Scales Pre-op Post-op P Scales Pre-op Post-op P

MeanUDI 86.7 26.6 <0.0001 MeanUIQ 85.0 31.2 <0.0001

MeanCRADI 73.8 26.8 <0.0001 MeanCRAIQ 37.5 13.4 <0.0001

MeanPOPDI 107.6 23.9 <0.0001 MeanPOPIQ 55.8 8.3 <0.0001

UDI:Urinary DistressInventory; UIQ:Urinary ImpactQuestionnaire; CRADI:Colo-Recto-Anal DistressInventory; CRAIQ:Colo-Recto- Anal Impact Questionnaire; POPDI: Pelvic Organ Prolapse Distress inventory; POPIQ: Pelvic Organ Prolapse Impact Questionnaire;

M0: pre-operative evaluation; M36: 36 months post-operatively; PFDI: Pelvic Floor Disorder Inventory; PFIQ: Pelvic Floor Impact Questionnaire.

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Table2 Sensitivityandspeciﬁcityofthebestbaseline PFDIcut-off(i.e.62)predictinganimprovementatM36.

% 95%CI

Sensitivity 70.0 (58.7—79.7)

Speciﬁcity 62.1 (42.3—79.3)

PPV 83.6 (72.5—91.5)

NPV 42.9 (27.7—59.0)

Accuracy 67.9 (58.3—76.5)

PFDI:PelvicFloor DisorderInventory;PPV:Positivepredictive value;NPV:NegativePredictivevalue.

56.8 (range: 2.7—124.2), respectively (P=0.52, Wilcoxon rank-sumtest).Thus,baselinePFIQwasnotconsideredas a potentialpredictor of an improvement at M36,and the analysiswashalted(Fig.S2.a).

AtM36,109patientscompletedthePFDI,givingamedian scoreof9.6(range:0—193.8).ThisPFDIindicatedthat 80 (73.4%, 95CI 64—81) had experienced an improvement in qualityoflife.ThemedianbaselinePFIQscorewassignif- icantlyhigherin improvedthan innon-improved patients:

81.1(range: 4—229.6)and55.4 (range:0—179.7),respectively(P=0.02,Wilcoxonrank-sumtest) (Fig.S2.b).Based onthemaximizationofthesumoftheestimated sensitiv- ityandspeciﬁcity,thebestbaselinePFDIcut-offpredictive ofanimprovementatM36was62.Thisresultedinsensitiv- ity of0.7 (95CI: 0.59—0.80) andspeciﬁcity of 0.62 (95CI:

0.42—0.79) (Table 2). Overall performance was deemed acceptable: AUC=0.64 (95CI:0.53—0.76;P=0.02) (Fig.1) and the ﬁt of the model was good:P=0.49 (Hosmer and Lemeshowtest).

In other words, 83.6% (72.5%—91.5%) of patients with a baseline PFDI score of more than 62 were improved at M36 while 42.9% (27.7%—59.0%) of patients with a baseline PFDI score of less than 62 were not improved;

and 70% (58.7%—79.7%) of patients improved at M36 had

Figure1. ThebestbaselinePFDIcut-offpredictinganimprove- mentatM36wasa scoreof62.Overall modelperformance was deemedacceptable:AUC=0.64(95CI:0.53to0.76;P=0.02)aswas itsgoodnessofﬁt:P=0.49(HosmerandLemeshowtest).

a baseline PFDI score of more than 62 while 62.1%

(42.3%—79.3%) of patients not improved at M36 had a baselinePFDIscoreoflessthan62.Thepredictionwasright for67.9%(58.3%—76.5%)ofthe109patients.

Discussion

This study showed that pre-operative assessment of the PFDIscorecouldpredicttheimprovementexperiencedafter vaginalsurgeryforgenitalprolapserepairusingpolypropyl- enemesh.

LikeRedwineandWright[18]forendometriosissurgery, wefound thatwomen withhigherpre-operative symptom scores showed a greater improvement in post-operative symptom scores. But vaginal prolapse literature did not includeanypre-operativesymptomassessmentthatisable topredictthepost-operativeimprovementinsymptoms.

One of the major challenges for physicians treating womenwith pelvicorgan prolapsewas toselect the best candidatesforsyntheticmeshrepair.Currentguidelinespro- pose using surgical treatment for advanced prolapse and a non-surgical approach for early stages. These criteria werequestionable sinceno studies have shown anystrict relationship between prolapse stage and improvement in symptomsandqualityoflife.Infact,thiswasaprocedure thatexposedwomentoasmallbutrealriskofpotentially severecomplicationssuchasmesherosionanddenovodys- pareunia,withnoguaranteeofanimprovementinsymptoms andQOL.

Thedefinitionofclinicalimprovement,i.e.a50%reduc- tion,shouldbeestablishedbothbyastatisticallysignificant differencebetweenpre-operativeandpost-operativeques- tionnairesandbytheclinicalcourse.A50%improvementin symptomswaslikelytoconstituteasignificantimprovement andisroutinely usedin theliterature[19]. Wearbitrarily definedsignificantimprovementinqualityoflife.Itleaded todifferent requirements of symptom relief for improve- mentbasedonbaselinescoressuchthatthosewithlargest symptomburden(highestscores)atbaselinearerequiredto havethegreaterimprovementintermsofabsolutechange in score than those with lower symptom burden (lower scores) to be called ‘‘improved’’. However, with a low pre-operative score it would be difficult to improve but itwasalways true when you have nocomplaint.Further- more,we did notuse any subjective questionnaire to fix ourimprovementdefinition.Barberetal.estimatethemin- imumimportantdifference(MID)for subscalesofthePFDI [20].They useanchor-anddistribution-based approaches.

Anchors included a subjective and non-referenced global indexofchange.

Inthis preliminarystudy,eventhough all patientspre- sented advancedprolapse, very substantialdifferences in symptomsandtheirimpactonqualityoflifewereobserved.

Forinstance,thescores obtainedinthePFDI20question- nairerangedfrom0to224onascale of0—300.Similarly, thePFIQ7questionnaireshowedthatpre-operativevalues rangedfrom5to297,showingthatsomepatientsreported no impairment of quality of life associated with genital prolapse.However,it isinterestingtonotethat theques- tionnaireshadtheadvantageofgivingawidedistributionof pre-operativevalues.

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Thechoiceofthisthresholdgavethefollowingdiagnos- tic values: 83.6% of patients with a PFDI score of more than 62 at M0 were ‘‘improved’’ at M36, and 62.1% of patientswhowere notimproved at M36hadscoreof less than62atM0.Patientswithascoreofmorethan62(PFDI- M0)were signiﬁcantlymore likelyto beimproved at M36 (83.6%versus57.1%,P=002).Ifthemistakeismadeofnot operating,POP willdeteriorateandtheprocedurewillbe requiredlater.Itnowremainstodeﬁnetherevaluationdate (1year).Regardingpatients witha PFDIscoreof lessthan 62atM0,medical(hormonalornon-hormonaltreatments) shouldbe preferred, pending an increase in the score to the surgery-triggering threshold (Table 2). QOL question- naireandthresholdmaynotbeafactorindicatingsurgical procedurebyitself.

Weusedalogisticregressiontodetermine thebaseline PFDIcut-offpredictive of animprovement. This approach isparticularlyrelevantwhen theobjectiveistomaximize theaccuracyoftheprediction,i.e.tomaximizebothsensi- tivityandspeciﬁcity[19,21].Theoverall performanceand goodness-of-ﬁt of the regression model were acceptable.

Inaddition, the database was multicenterand therefore included the diversity of patient recruitment by differ- entoperators(gynecologists,urologists,private,publicand universityinstitutions). Wedidnotperformanycrossvali- dationoftherule.However,aprospectivevalidationstudy isongoing,which istherecommendedmethodtovalidate predictionrules[22].

Althoughquestionnairescoveredabroadfieldandvali- dateevidencerelatedtothevaginalprolapse,itshouldbe notedthatapatientwithveryspecific POP-relatedsymp- toms might see little improvement in her questionnaire scoreaftersurgery. This wasespecially thecase withthe short-form questionnaires that are always preferred. The factthatnostatisticallysignificantimprovementwasfound betweenM0 andM36for the PFIQ questionnaire probably underlinesthelimitsofthisquestionnaire,orsimplythesize ofthesample.

Finally, the results of this study were established at the3-yearfollow-uppoint,whichisvalidforassessingthe impactof surgery. However,this lead toa lost of follow- up rate to almost 50% (109/230). This could be likely to biasthe results but no difference, except history of prolapse, was detected between the two groups of patients (TableS3).Repeatsurgeryandanatomicalresultswerenot different for the patients answering the questionnaire or not.

Certain limitations to this study should be underlined.

Firstly, our results only concerned women with advanced stage POP where there is a greater risk of complications after surgical repair. Moreover, our study only concerned womenundergoingvaginalrepair,andthereforemaynotbe relevantto(oftenyounger)womenundergoinglaparoscopy.

The impactofPOPcannot befullyassessedwithout an evaluationof the patient’s sexuality. This itemwas espe- ciallyimportantgiventhatprostheticsurgeryisassociated with almost 10% of de novo dyspareunia. However, this questionnaire could be validated only for sexually active patients.

InordertoevaluatethesurgicalrouteusedforPOPsurgi- calrepairusingmesh,thepre-operativesymptomsthreshold shouldalsobeevaluatedafterlaparoscopytreatment[23].

Ourcohortstudiedmaybeconsideredastoosmall,and aswesoughttoobtaintheadvantagesofthequestionnaire forpatientselection,wearecurrentlyconductingastudyin alargerpopulation.Thiswaswhyaprospectivevalidation studywithhigherpopulationisongoing.

Basedontheresultsofthisstudy,webelievethatQOL andsymptomsquestionnairesshouldbeextensivelyusedas methodstoevaluatePOPbeforeanytreatment,andensure long-term follow-up in effortsto identify changesin cer- tainquality of lifeparameters. Goalsfactor as resolution ofurinarysymptoms,abilitytoperformdailyactivities,and sexualfunctiongoals wereatleastasimportantasresolu- tionofprolapsesymptomsandmaybethereasonforseeking care [24].This waswhy, insteadof usinga simpler set of questionnaires,wehaveplannedtouseanelectronicform ofthe questionnaires,for instanceonatabletPC[25],to helppractitionersusingourmodel.

ResearchintopredictivefactorswasnecessaryifQOLina functionaldiseasesuchaspelvicorganprolapse,withsurgi- calrepair,hastobeimproved.ImpactonQOLbeforesurgery wouldseemtoholdsomepromise.Acut-offpre-operative score,ifvalidatedonPFDI(>62),shouldimprovePOPtreat- ment,andaprospectivemulticentreevaluationwasongoing tovalidthiscut-off.Thisvalidatedquestionnaire,whichwas availableinseverallanguages,providedasimpletoolthat canbeusedtoselectandinformwomenwhomightbeneﬁt fromvaginalrepairforPOP.

Disclosure of interest

NoconﬂictofinterestforanyauthorsexceptPrR.deTwho isconsultantforBostonSci.

Acknowledgments

Weacknowledgetheotherinvestigatorsforcollectingdata ondifferentcenters:J.-L.Béniﬂa,F.Demaria^†,J.Blanchot, P.-L.Broux,M.Cosson,J.-P.Lucot,P.Delporte,H.Fernan- dez, C. Frayret,F.Hacquin, K.-M.Maaliki, L. Marpeau,F.

Sergent,G.Devoldere,J.Renaudie,P.Villard,O.Guilbaud andG.Eglin.

Fundingstatement:this study wasnot support by any grantorindustry.

Appendix A. Supplementary material

Supplementary materials (Tables S1—S3, Fig. S1 and S2 and French version of the text)associated with thisarti- cle can be found at http://www.sciencedirect.com, at doi:10.1016/j.purol.2013.04.010.

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