Genital prolapse repair with Avaulta Plus ® mesh:

Disponibleenlignesur

www.sciencedirect.com

ORIGINAL ARTICLE

Genital prolapse repair with Avaulta Plus ^® mesh:

Functional results and quality of life ^夽

Cure de prolapsus par voie basse avec prothèse Avaulta Plus ® : résultats fonctionnels et qualité de vie

A. Thomin

, C. Touboul

, D. Hequet , S. Zilberman , M. Ballester , E. Daraï

Departmentofobstetricsandgynecology,universitéPierreetMarieCurieParisVI,hôpital TenonParis,4,ruedeChine,75020Paris,France

KEYWORDS Genitalprolapse;

Cystocelerepair;

Vaginalroute;

Qualityoflife;

Vaginalmesh exposure

Summary

Purpose.—Evaluateanatomicandfunctionaloutcomesofgenitalprolapse repairbyvaginal routeusingamixedpolypropyleneandporcineskinmesh.

Patientsandmethods.—ProspectivepilotstudyfromJanuary2009toJanuary2011inthegyne- cologicdepartmentofatertiary universityhospital.Twentypatients withstageII-IIIgenital prolapseunderwentanteriorwallprolapserepairwithanteriorAvaultaPlus^®mesh.Functional resultswereevaluatedusingthePelvicFloorDistressInventory-shortform(PFDI-20),thePelvic FloorImpactQuestionnaire-7(PFIQ-7)andthePelvicOrganProlapse/UrinaryIncontinenceSex- ualquestionnaires(PISQ-12).

Results.—No per-operative complications occurred. One postoperative hematoma (5%) occurredrequiringasecondsurgery.Atameanfollow-upof19.7months,threepatientshad vaginalmeshexposure(15%) requiringasecond surgeryfortwo ofthem.Ofthe20women, 17(85%)hadoptimalanatomicresultsandthree(15%)hadresidualgenitalprolapse(Ba=—2 intwocasesandBp=—2intheone).Norecurrencewasobservedduringthestudyperiod.A significantimprovementinthePFDI-20(P<0.001)andPFIQ-7scores(P<0.001)wasobserved butnoimprovementinthePISQ-12score.

Conclusion.—Inthisseries,wereportedthatgenitalprolapserepairusingAvaultaPlus^®mesh resultedinahighsuccessrateandimprovedqualityoflifebutwithanimportantprevalence ofvaginalmeshexposure.

©2013ElsevierMassonSAS.Allrightsreserved.

夽 Levelofevidence:4.

∗Correspondingauthor.

E-mailaddresses:[email protected],[email protected](A.Thomin),[email protected](E.Daraï).

1Theseauthorscontributedequallytothiswork.

1166-7087/$—seefrontmatter©2013ElsevierMassonSAS.Allrightsreserved.

http://dx.doi.org/10.1016/j.purol.2013.01.016

GenitalprolapserepairwithAvaultaPlus mesh 271

MOTSCLÉS Prolapsusgénital; Curedecystocèle; Chirurgievaginale; Qualitédevie; Exposition

prothétiquevaginale

Résumé

But.—Évaluer lesrésultatsanatomiques etfonctionnelsdelacuredeprolapsusgénitalpar voievaginaleavecmiseenplaced’uneprothèsemixtedepolypropylèneetdedermeporcin (AvaultaPlus^®).

Patientsetméthodes.—Étudepiloteprospectivedejanvier2009àjanvier2011dansleservice degynécologieobstétriqued’uncentrehospitalieruniversitaire.Vingtpatientesontétéopérées d’unecuredeprolapsusgénitalavecposedeprothèseantérieureAvaultaPlus^® pourunstade IIouIII.Lesrésultatsfonctionnelsontétéévaluésàpartirdetroisquestionnaires:PelvicFloor DistressInventory-shortform(PFDI-20),PelvicFloorImpactQuestionnaire-7(PFIQ-7)etPelvic OrganProlapse/UrinaryIncontinenceSexualquestionnaires(PISQ-12).

Résultats.—Lamoyennedesuivi(écarttype)aétéde19,7(7,5)mois.Aucunecomplication peropératoiren’aétéobservée.Un hématomepostopératoire(5%) anécessitéuneseconde intervention chirurgicale. Troispatientes ont présentéune exposition prothétique vaginale (15%)avecunereprisechirurgicalepourdeuxd’entreelles.Parmiles20patientes,17(85%) onteudesrésultatsanatomiquesoptimauxettrois(15%)présentaientunprolapsusgénitalmo dérépersistant(Ba=—2dansdeuxcasetBp=—2dansuncas).Aucunerécidiven’aétéobservée aucoursdeladuréedesuivi.UneaméliorationsignificativedesscoresPFDI-20(p<0,001)et PFIQ-7(p<0,001)aétéobservée,maisaucuneaméliorationduscorePISQ-12.

Conclusion.—Danscettesérie,ilaétéobservéquelacuredeprolapsusgénitalparprothèse AvaultaPlus^®permettaitd’obteniruntauxderéussiteélevéavecuneaméliorationsignificative delaqualitédevie,maisavecuneprévalenceimportanted’expositionprothétiquevaginale.

©2013ElsevierMassonSAS.Tousdroitsréservés.

Introduction

Pelvic organprolapse is a majorpublichealth issue in an aging population: the prevalence varies between 2.9 and 97.7%according tostudies.Itvaries respectivelybetween 2.9and11.4%withdetectionbyquestionnaireorbetween 31.8 and97.7% practicing clinical examination andclassi- ficationofBadenWalkerorPOP-Qclassification[1,2].The lifetimeriskofthesewomenundergoingpelvicorganpro- lapsesurgeryisestimatedbetween11.8and19.6%[3].

Pelvic reconstructive surgery can be performed by laparotomy, laparoscopy or the vaginal approachdepend- ingonthepatient’scomorbidities,thesurgeon’schoiceand thepatient’spreference.Inarecentmeta-analysisinclud- ing40trials,abdominalsacralcolpopexywasdemonstrated tobe moreeffective than vaginalsacrospinous colpopexy witha lowerrate of recurrent vault prolapse [4].On the otherhand,vaginalsacrospinouscolpopexywasquickerand cheapertoperformandassociatedwithanearlierreturnto dailyactivities [4].To reduce therisk of recurrenceafter vaginalsurgery,syntheticmeshesusingpolypropylenehave beendeveloped[5]andtheirefficacyconfirmedcompared to standard anterior repair [4]. However, the use of syn- theticmeshesisassociatedwithariskof 11.9%ofvaginal meshexposure[6]thusquestioningthelegitimacyofitsuse.

Conversely,theuseofporcineskinimplantiswelltolerated withalowrateofexposure(0.9%),butitisassociatedwitha highrecurrencerate[7].Toreducetherateofvaginalmesh exposurewhileimprovinglong-termresults,amixedmesh composedofbothporcineskinandpolypropylene(Avaulta Plus^®,Bard,France)hasbeen developed. Avaultaplus^® is afour arm syntheticmesh inserted throughtheobturator foramen used for the surgical cystocele repair by vaginal approach.However,fewdataregardingtheuseofAvaulta Plus^® isavailable[8].

Therefore,theaimofthisstudywastoevaluateper-and postoperativecomplications,anatomicandfunctionalout- comesandqualityoflifeinpatientsaftergradeII-IIIgenital prolapserepairusingtheAvaultaPlus^®mesh.

Patients and methods

FromJanuary2009toJanuary2011,99patientswithstage II-IIIgenitalprolapse were referredto theDepartment of Gynaecology of Tenon Hospital for pelvic reconstructive surgery.Amongthem,68patientsunderwentalaparoscopic sacrocolpopexy,11underwentnativetissuerepairbyvagi- nalrouteand20patientsunderwentanteriorwallprolapse repair using anterior Avaulta Plus^® (Bard, France) by the transobturator route. Patients eligible for vaginal sacro- colpopexy had a contraindication to laparoscopy due to multiplelaparotomies or comorbidities.These 20patients composedthestudypopulation.EthicsCommitteeapproval was obtained for this prospective study by the Collège NationaldesGynécologuesetObstétriciensFranc¸ais(CNGOF CEROG-2010-011).

Allwomenunderwentpelvicexaminationtogradegen- ital prolapse using the International Continence Society terminologyforfemalePelvicOrganProlapse-Quantitation (POP-Q)scale. The maximalextent of prolapse was mea- sured during a Valsalva manoeuvre or coughing and was confirmedbythepatientasbeingthemostsevereprotru- sion.

Surgery

AvaultaPlus^® is a monofilament, four arm polypropylene mesh coated in the central part with a porous, cellular crosslinkedcollagenbarrier,usedforanteriorwallprolapse.

The polypropylene mesh is made of small fibers, which provide a thin cross section of the mesh without loss of strengthandmayalsocontributetodecreasing thesizeof encapsulation.Thecentralpartofthepolypropylenemesh, butnottheouterlimit,iscoveredwithalayerofporcine collagen.

Surgery was performed under general or spinal anes- thesia.Prophylacticanticoagulanttherapy(low-molecular- weightheparin)wasgiventheeveningbeforetheoperation, and prophylactic antibiotic therapy (cefazolin, 2g intra- venously)at the beginningof theoperation. The patients wereplacedinthedorsal lithotomyposition.Genitalpro- lapserepairwasprecededbyroutinevaginalhysterectomy byperformingatransversalcolpotomy2cmfromtheuter- inecervixaccordingtothemodifiedHeaneytechnique[9].

Ifthelatterhadalreadybeenperformed,atransversalinci- sion wasmade at the apex of the vagina. Cystocele was dissectedcentrallyandlaterallywhile keepingthe Halban pubocervicalfascialyingonthevaginalwall.Afteraccessing theparavesicalspace,fingerpalpationidentifiedtheArcus TendinousFasciaPelvis(ATFP),whichextendsfromthepos- terioraspectofthepubicarchtotheischialspine.Fourskin incisions were made onthe genitocrural crease to insert cannula-equipped guides. The mesh was placed with the porcineskinfacingthevaginalskinbetweenthebladderand theanteriorvaginalwallandsecuredbilaterallybyfourarms across the obturator foramen according to the technique previouslydescribed [10]. Traction onthe lateralarms of themeshallowedfor‘‘tensionfree’’adjustmentunderthe bladder. No colpectomy was performed. Colporraphy was achievedbyanon-lockingcontinuousabsorbablesuture.A Foleycatheterwasleftinplacefor24h.Theoperatingtime andintra-andpostoperativecomplicationswererecorded.

Anatomic and functional results analysis

All patients were evaluated by clinical examination at 1 and 6 months postoperatively and then every year using theInternationalContinenceSocietyterminologyoffemale pelvic organ prolapse. They completed three question- naires. The Pelvic Floor Distress Inventory- short form (PFDI-20) [11] is composed of the Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), the Colorectal Anal Dis- tress Inventory-8 (CRADI-8), and the Urogenital Distress Inventory-6(UDI-6).ThePOPDI-6,CRADI-8,andUDI-6ques- tionnairesare scored from0 to100, with 0indicating no discomfortand100,majordiscomfort.Therefore,thePFDI- 20isscoredfrom0to300.TheyalsocompletedthePelvic FloorImpactQuestionnaire-7(PFIQ-7)foreachpelviccom- partment Urinary Impact Questionnaire-7 (UIQ-7), Pelvic Organ Prolapse Impact Questionnaire- 7 (POPIQ-7), and Colo-Rectal-Anal Impact Questionnaire-7 (CRAIQ-7), with a score from 0 to 300 (0 indicating no discomfort and 300,majordiscomfort).Finally,theycompletedthePelvic OrganProlapse/UrinaryIncontinenceSexualQuestionnaire- 12 (PISQ-12),scored from 0 to48, with 0 indicating high satisfactionand48,majordiscomfort[12].

Statistical analysis

Parametriccontinuous variableswere comparedwithStu- dent’s t-test. The scores were categorized according to

quartiles, and the probability of improvement was eval- uated for the quartiles. Potential predictive factors of improvementwereevaluated.Pvalue<0.05wasconsidered statisticallysignificant.Alltestsweretwo-sided.Statistical analyseswereperformedusingRsoftware.

QualitativevariableswerecomparedusingFisher’sexact test or the Chi² test, and quantitative variables by the Wilcoxonrank-sumtest.UDIandUIQscoreswerecompared using the Wilcoxon signed-rank paired test. Multivariate analysiswasperformed usingthe generalizedlinear logis- ticmodel. Avalue ofP<0.05 wasconsideredtodenote a significantdifference.

Results

Epidemiological and surgical characteristics

This retrospective cohort study is about all women with stageIIIorIIgenitalprolapsewhounderwentpelvicrecons- tructivesurgery andplacementof avaginal meshAvaulta plus^®.

Epidemiological characteristics of the 20 patients are shown in Table 1. In mean, women had 75 years old. All the women were menopausal. Mean bodymass index BMI (kg/m²) was26.Four women hada BMIabove30. Eleven patients(55%) hadsignificantmedicalcomorbiditiesand7 (35%)hadahistoryofabdominalsurgeryincludingfour(20%) hysterectomies:oneforcervicalepidermoidcarcinoma,two for myoma andonefor genitalprolapse. This lastpatient underwent5yearsagosurgicalprolapserepairincludinghys- terectomy associated with porcine skin implant cystocele repairandsacrospinousfixation.

Amongthe20 patients,three(15%)hada stageIIgen- ital prolapse and17 (85%) patients hada stageIII genital prolapse. Anterior wall prolapse (Ba)of grade 2or 3was

Table1 Epidemiological characteristics of the 20 patientsundergoingagenitalprolapserepairbyvaginal routeusingAvaultaPlus^® mesh.

Characteristic Value

Age(y)Mean±SD 74.8±6.7

Weight(kg)Mean±SD 65.4±11.3

Bodymassindex(kg/m²)Mean±SD 25.9±3.9

Parity(n)Mean±SD 3.1±2.7

Patientswithdiabetes,n(%) 3(15) Patientswithhighbloodpressure,n(%) 11(55) Priorhysterectomy,n(%) 4(20) Priorsurgeryforgynaecologicalcancer,

n(%)

1(5) Priorsurgeryforgenitalprolapse,n(%) 1(5) Priorabdominalsurgery,n(%) 7(35) Genitalprolapsestage,n(%)

StageII 3(15)

StageIII 17(85)

Urinaryincontinence,n(%) 9(45)

Stressincontinence 9(45)

Urgency 6(30)

n:number;Y:years;SD:standarddeviation.

GenitalprolapserepairwithAvaultaPlus mesh 273

Table2 Pre-andpostoperativesymptomsreportedby the20patientsundergoinggenitalprolapserepairbythe vaginalrouteusingAvaultaPlus^®mesh.

Symptoms Patientswith

symptoms preoperatively (%)

Patientswith symptoms postoperatively

Generalsymptoms

Pelvicheaviness 9(45) 2 (10)

Pelvicpain 0 1(5)

Vaginaldiscomfort 19(95) 1(5) Digestivesymptoms

Constipation 20(100) 1(5) Painfulbowel

movements

0 1(5)

Urinarysymptoms

Urinaryfrequency 7(35) 1(5)

Nocturia 1(5) 1(5)

Urgency 4(20) 4(20)

observed in threeand 17 patients, respectively. Posterior wallprolapse(Bp)ofgrade2,or3-4wasobservedinthree andsixpatients,respectively.Superiorvaginalprolapse(C) ofgrade 2,or 3wasobservedin fourandseven patients, respectively,andposteriorfornixprolapse(D)ofgrade2,or 3wasobservedinoneandtwopatients,respectively.

Preoperativestressurinaryincontinencewaspresentin nine (45%) patients, associated with urgency in six (30%) patients. Placement of Avaulta Plus^® mesh was feasible inall thepatients.Genitalprolapse repairwasassociated with hysterectomy in 13 patients (65%), with transobtu- rator midurethral tape in nine patients (45%), and with sacrospinousfixationin sixpatients(30%). Twosenior sur- geonsperformedthesurgeryofthestudygroup.

No per-operative complications were observed. One immediate postoperative complication occurred in a 75- year-oldpatientconsistingofaretroperitonealhaematoma a few hours after surgery that included, in addition to mesh placement, a hysterectomy, a sacrospinous fixation andstressurinaryincontinencetreatmentusingatransob- turatormidurethral tape.She required alaparotomy with packingand bloodtransfusion.The origin ofbleedingwas related tothe hysterectomy but not to mesh placement.

Themedianhospitalstaywas4days(range2—15).

Functional and anatomical results

The mean follow-up was 19.7±7.5 months. A significant improvementingeneraldigestiveandurinarysymptomswas observed aftergenitalprolapse repair usingAvaultaPlus^® mesh (Table 2). At the first postoperative visit, 17 (85%) patientshadoptimalanatomicalresultsandthree(15%)sub- optimal anatomicalresults withresidualgenitalprolapse:

twocasesofBa=—2andonecaseofBp=—2.Norecurrence of genitalprolapsewasobserved duringthestudy period.

Four patients (20%) had postoperative complications.

Three patients had a mesh exposure. One occurred in the patient experiencing a retroperitoneal haematoma diagnosed8monthsaftersurgeryforaprolapseofthethree

compartmentsbut didnotrequire additionalsurgery. The twoothersmeshexposuresoccurredina78-and61-year-old patientswithonlyanteriorwallprolapserepairwithouthys- terectomy,andrequiredapartialmeshresectionat18and 6weeks,respectively.Overall,asecondsurgicalprocedure wasperformed in threepatients. The fourthcomplication occurredina80-year-oldpatientwhohaditerativeurinary infectionwithdenovostressurinaryincontinence:thecys- toscopywasnormal,shedidn’trequiredadditionalsurgery.

Changes in quality of life after genital prolapse repair

ChangesinPFDI-20,PFIQ-7andPISQ-12scoresaregivenin Table3.AnimprovementinPFDI-20(89.2vs30.5,P<0.001) was observed, also in subgroups POPDI-6 (43.1 vs 9.7, P<0.001),UID-6(34.4vs13.7,P<0.02)andCRADI-8(11.6 vs7.1,ns).

An improvement in PFIQ-7 (63.5 vs 8.7, P<0.001) was observed,alsoinsubgroupsPOPIQ-7(30.9vs2.1,P<0.001), UIQ-7(20.9vs6.9,ns)andCRAIQ-7(11.9vs0,P<0.01).

Only woman with de novo urinary symptoms had a decreasingqualityoflife.

Nochanges in thePISQ-12 score wasnotedin the two patientswhoweresexuallyactive.

Discussion

Thecurrentstudydemonstratesthatgenitalprolapserepair using the Avaulta Plus^® mesh, a mixed polypropylene and porcine skin mesh, was associated with a significant improvement in symptoms and quality of life with good anatomicalresults.However,despitethe useof aporcine skincomponent,meshexposureremainsarisk.

Twoendpointsarecrucialtoevaluatethesafetyandthe efficacyofgenitalprolapserepairusingamesh;therateof complications,particularlyofmeshexposure,andtherate ofsecond surgeryfor recurrence.Arecent reviewin gen- italprolapserepairproceduresincludingeightrandomized trialscomparingstandard anteriorrepairtopolypropylene mesh augmentation and three randomized trials compar- ingstandard anteriorrepairtoporcineskinaugmentation, showedthat the rate of mesh exposure was11.9% in the polypropylene group and 0.9% in the porcine skin group underliningtheprotectiveroleofbiologicalmesh[4,13].In thepresentstudy,threeofthe20patients(15%)hadmesh exposuredespitetheuseofamixedmesh.Atoneyearof follow-up,Cervignietal.[14]observedthedevelopmentof vaginalmeshexposurein21patients(21.6%).Moreover,two ofourthreepatientsexperiencingmeshexposurerequired asecondsurgery.Theseresultsareinagreementwiththose ofrandomizedtrialsusingarmedtransobturatorpolypropyl- enemeshbythevaginalroutewithanincidenceofsecond surgicalproceduresformeshexposurevaryingbetween3%

and16% [4,15]. No study hascompared the risk between polypropylenemeshaloneandmixedmeshusingpolypropyl- eneandporcineskin.Ourresultssuggestthattheaddition ofporcineskin doesnotseem toimpacttherate ofmesh exposure.Theseresultsareinkeepingwiththosepublished byAchtarietal.[16]comparingpolypropylenemeshtopol- ypropylene+polyglactinewitharate of meshexposure of

Table3 Pre-andpostoperativePFDI-20,PFIQ-7andPISQ-12scoresofthe20patientsundergoinggenitalprolapserepair bythevaginalrouteusingAvaultaPlus^®mesh.

Questionnaire Preoperativescore Postoperativescores P(Wilcoxontest)

(mean±SD) (mean±SD)

PFDI-20 89.2±50.0 30.5±32.6 <0.001

POPDI-6 43.1±24.2 9.7±11.1 <0.001

UDI-6 34.4±30.2 13.7±16.6 <0.02

CRADI-8 11.6±12.7 7.1±10.2 NS

PFIQ-7 63.5±59.2 8.7±20.9 <0.001

POPIQ-7 30.9±32.1 2.1±9.0 <0.001

UIQ-7 20.9±22.8 6.9±15.2 NS

CRAIQ-7 11.9±26.4 0 <0.01

PISQ-12 32(27—37) 33(29—37) NS

PFDI-20:Pelvic Floor DistressInventory- shortform; POPDI-6:Pelvic OrganProlapse DistressInventory-6; CRADI-8: ColorectalAnal Distress Inventory-8; UDI-6: Urogenital Distress Inventory-6; PFIQ-7: Pelvic Floor Impact Questionnaire-7; UIQ-7: Urinary Impact Questionnaire-7;POPIQ-7:PelvicOrganProlapseImpactQuestionnaire-7;CRAIQ-7:Colo-Rectal-AnalImpactQuestionnaire-7;PISQ-12:

PelvicOrganProlapse/UrinaryIncontinenceSexualQuestionnaire-12.

7.2%and 6.9%, respectively. Our high rateof mesh expo- sureraises theissue ofthe determinantfactors.Although obesitywasacriteriontooptforthevaginalrouteforgen- italrepair inourstudy,Aracoetal. [17]have shownthat obesepatientswithaBMIgreaterthan30hadanoddsratio of10.1formeshexposurebuttheauthorsdidnotreported theconfidenceintervals.Moreover,inthepresentstudy,13 ofthe20patientsunderwenthysterectomyassociatedwith genitalprolapserepair.Noconsensusexistsabout therole of concomitant hysterectomy and genital prolapse repair on the risk of mesh exposure [16,18]. The only random- izedtrial, which involved only 15patients, didnot finda negativeeffectonmeshexposureinpatientswhohadunder- goneconcomitanthysterectomyandgenitalprolapserepair by the vaginal route [19]. Moreover, because of the risk ofcomplications andthe lack ofdata,the Foodand Drug Administration(FDA) sentletters outtoall manufacturers ofthe vaginalmeshproductincludingAvaultaPlus^®,issu- ingarequirementthatmanufacturersconductpost-market studiesintheunitedstates.

Inthecurrentstudy,optimalandsuboptimalanatomical resultswereobservedin 85%and15%of patients,respec- tively.Noneofthepatientswithsuboptimalresultsneeded furthersurgerylinkedtoresidualdiscomfort.Moreover,no recurrencewas observed during the study periodbut the meanfollow-up wasonly of 19.7 months.A recentmeta- analysis has demonstrated that standard anterior vaginal repairisassociatedwithmorerecurrencesthanwhensup- plementedwithresorbablemesh(RR1.39, 95%CI1.02 to 1.90)orporcineskinmesh(RR2.72,95%CI1.20to6.14)[4].

Moreover,standardanteriorrepairwasassociatedwithmore recurrencesonexaminationthanwhenusingpolypropylene mesh(RR2.14,95%CI1.23to3.74),armedtransobturator mesh(RR3.55,95%CI2.29to5.51)[20,21]orcommercial kits[15].However,dataonmorbidityandlong-termanatom- ical,functionalandquality-of-lifecriteriawerelacking.Ina reviewincludingeightrandomizedtrialscomparingstandard anteriorvaginalrepairtotheuseofpolypropylenemeshby thetransobturatorroutewithfourarms,therateofsecond

surgeryfor recurrencewassignificantlylowerinthe mesh group(4.2%vs7.8%, P<0.01)confirming theeffectiveness ofthistechnique[15,21,22].

Despitethesmallsamplesize,thecurrentstudydemon- strates the positive impact of genital prolapse cure by vaginalrouteonsymptomsandqualityoflifeevaluatedby validatedquestionnaires.Exceptforurgency,allsymptoms reported by the patients preoperatively were improved.

These results are in agreement with those of a previous study showing that most preoperative urinary symptoms decreased after genital prolapse surgery with equivalent proportionsof denovo symptomsbetweenpatientsin the laparoscopicandvaginalroutegroups[23].Usingmultivari- ateanalysis,theseauthorsfoundthatonlytheimprovement intheimpactofurinarysymptomsondailylivingwasinde- pendently associated to thevaginal route (OR=5.45 [95%

confidence interval 2.20—13.44], P=0.01). In addition to improvement in the symptoms, all parametersof PFDI-20 and PFIQ-7 quality-of-life questionnaires were improved.

TheseresultsareinagreementwiththoseofusingAvaulta^® mesh without the porcine skin component [8]. Little is known about the risk of dyspareunia and change in sexu- alityafterrepairofgenitalprolapsebythevaginalroute.In aprospectiveseriesusingthePISQ-12questionnaire,Sentil- hesetal.[24]reportedanimprovementinsexualqualityof lifein60%ofwomenwhile40%wereworse.Similarly,ina multicentrestudyusingapolypropylnemeshbythetransob- turatorroute,Altmanetal.[12]foundasignificantdecrease inthePISQ-12score.Thishighriskofalteredsexualquality oflifesuggeststhattheuseofmeshbyvaginalrouteshould berestrictedtosexuallyunactivepatients.

Thelimitationsofthispilotstudyshouldbehighlighted.

First,thelownumberofpatientsmaybeapotentialsource of bias. Second, our population was mainly composed of elderlypatientswithpriormorbidityheighteningtheriskof meshexposure.However,nodataareavailabletosupport theimpactofdiabetes,immunosuppresortreatmentorthe absenceofpreoperativehormonaltreatmentontheriskof meshexposure[18].Finally,thelowexperienceofsurgeons

GenitalprolapserepairwithAvaultaPlus mesh 275 withAvaulta Plus^® mesh could alsobe a potentialsource

of bias. However,our teams had considerable experience ingenitalprolapsecurebythevaginaltransobturatorroute [23].

Conclusion

Despitethelimitsofthepresentpilotstudy,ourresultssug- gestthattheuseofAvaultaPlus^®meshoffersahighsuccess rate with a significant improvement in quality-of-life but withanimportantprevalenceofvaginalmeshexposure.Fur- therstudiesarerequiredtoevaluatethebenefitofadding aporcinecomponenttoclassicpolypropylenemeshin the cureofgenitalprolapsebythevaginalroute.

Disclosure of interest

Theauthorsdeclarethattheyhavenoconflictsofinterest concerningthisarticle.

Appendix A. Supplementary data

Supplementary data associated with this article can be found, in the online version, at doi:10.1016/j.purol.

2013.01.016.

References

[1]LousquyR,CostaP,DelmasV,etal.Updateontheepidemiology ofgenitalprolapse.ProgUrol2009;19:907—15.

[2] RivauxG, FattonB,Letouzey V,etal.Utero-vaginalsuspen- sionusingabilateralvaginalanteriorsacrospinousfixationwith mesh.Preliminaryresults.ProgUrol2012;22:1077—83.

[3]Smith FJ, Holman CD, Moorin RE, et al. Lifetime risk of undergoingsurgeryforpelvicorganprolapse.ObstetGynecol 2010;116:1096—100.

[4]MaherC,FeinerB,BaesslerK,etal.Surgicalmanagementof pelvicorganprolapseinwomen.CochraneDatabaseSystRev 2010, http://dx.doi.org/10.1002/14651858 [CD004014.pub4:

CD004014].

[5]DelmasV,HaabF,CostaP.Themeshesinthecureofcystocele byvaginalway.ProgUrol2009;19:1025—30.

[6]Migliari RDAM, Madeddu G, Verdacchi T. Tension-free vagi- nalmeshrepair for anteriorvaginalwall prolapse.EurUrol 2000;38:151—5.

[7]MeschiaM,PifarottiP,BernasconiF,etal.Porcineskincollagen implantstopreventanteriorvaginalwallprolapserecurrence:

amulticenter,randomizedstudy.JUrol2007;177:192—5.

[8]CulliganPJ,LittmanPM,SalamonCG,et al.Evaluationofa transvaginalmeshdeliverysystemforthecorrectionofpelvic organprolapse:subjectiveandobjectivefindingsatleast1year aftersurgery.AmJObstetGynecol2010;203:506[e501—506].

[9]KalogirouD,AntoniouG,ZiorisC,etal.Vaginalhysterectomy:

techniqueandresultsinthelasttwentyyears.JGynecolSurg 1995;11:201—7.

[10]DebodinanceP,BerrocalJ,ClaveH,etal.Changingattitudes onthesurgicaltreatmentofurogenitalprolapse:birthofthe tension-freevaginalmesh.JGynecolObstetBiolReprod(Paris) 2004;33:577—88.

[11]Barber MD, Kuchibhatla MN, Pieper CF,et al. Psychometric evaluationof2comprehensivecondition-specificqualityoflife instrumentsforwomenwithpelvicfloordisorders.AmJObstet Gynecol2001;185:1388—95.

[12]AltmanD,ElmerC,KiilholmaP,etal.Sexualdysfunctionafter trocar-guided transvaginalmesh repair of pelvicorgan pro- lapse.ObstetGynecol2009;113:127—33.

[13]Deffieux X, Savary D, Letouzey V, et al. Prevention of the complicationsrelatedtotheuseofprostheticmeshesinpro- lapse surgery: guidelines for clinical practice — literature review.JGynecolObstetBiolReprod(Paris)2012;40:827—50.

[14]CervigniM,NataleF,LaPennaC,etal.Collagen-coatedpoly- propylenemeshinvaginalprolapsesurgery:anobservational study.EurJObstetGynecolReprodBiol2011;156:223—7.

[15]AltmanD,VayrynenT,EnghME,etal.Anteriorcolporrhaphy versustransvaginalmeshforpelvic-organ prolapse.NEnglJ Med2011;364:1826—36.

[16]AchtariC,HiscockR,O’ReillyBA,etal.Riskfactorsformesh erosionaftertransvaginalsurgeryusingpolypropylene(Atrium) orcompositepolypropylene/polyglactin910(VyproII)mesh.

IntUrogynecolJPelvicFloorDysfunct2005;16:389—94.

[17]AracoF,GravanteG,SorgeR,etal.TheinfluenceofBMI,smok- ing,and ageonvaginalerosionsaftersyntheticmeshrepair of pelvicorganprolapses. Amulticenter study.Acta Obstet GynecolScand2009;88:772—80.

[18]GuillibertF,Chene G,Fanget C,etal.Risk factorsofmesh exposureaftertransvaginalrepairofgenitalprolapse.Gynecol ObstetFertil2009;37:470—5.

[19]CarramaoS,AugeAP,PacettaAM,etal.Arandomizedcom- parisonoftwovaginalproceduresforthetreatmentofuterine prolapseusing polypropylenemesh: hysteropexyversushys- terectomy.RevColBrasCir2009;36:65—72.

[20]NieminenK,HiltunenR,HeiskanenE,etal.Symptomresolu- tionandsexualfunctionafteranteriorvaginalwallrepairwith orwithoutpolypropylenemesh.IntUrogynecolJPelvicFloor Dysfunct2008;19:1611—6.

[21]SivasliogluAA,UnlubilginE,DolenI.Arandomizedcomparison ofpolypropylenemeshsurgerywithsite-specificsurgeryinthe treatmentofcystocoele.IntUrogynecolJPelvicFloorDysfunct 2008;19:467—71.

[22]Maher CF,QatawnehAM,Dwyer PL,etal. Abdominal sacral colpopexyorvaginalsacrospinouscolpopexyforvaginalvault prolapse:aprospectiverandomizedstudy.AmJObstetGynecol 2004;190:20—6.

[23]RamanahR, BallesterM,Chereau E,etal. Effectsofpelvic organ prolapse repair on urinary symptoms: A comparative studybetween thelaparoscopicand vaginalapproach.Neu- rourolUrodyn2012,http://dx.doi.org/10.1002/nau.21117.

[24]Sentilhes L, Berthier A, Sergent F, et al. Sexual function in women before and after transvaginal mesh repair for pelvicorganprolapse.IntUrogynecolJPelvicFloorDysfunct 2008;19:763—72.