Long-term experience with a novel uterine-sparing transvaginal mesh procedure for uterovaginal prolapse

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Full

length

article

Long-term

experience

with

a

novel

uterine-sparing

transvaginal

mesh

procedure

for

uterovaginal

prolapse

Giulio

Nicita

*

,

Donata

Villari,

Vincenzo

Li

Marzi,

Martina

Milanesi,

Omar

Saleh,

Tommaso

Jaeger,

Alberto

Martini

DepartmentofUrology,UniversityofFlorence,CareggiHospital,Florence,Italy

ARTICLE INFO

Articlehistory:

Received26February2017

Receivedinrevisedform3November2017

Accepted8January2018

Keywords: Mesh

Pelvicorganprolapse

Qualityoflife

Transvaginalsurgery

Uterussparingsurgery

ABSTRACT

Objectives:Toevaluateoutcomesandqualityoflifeinpatientsoperatedtransvaginallywithanoriginal mesh shapeforuterus-sparingprolapsesurgeryandtodemonstratethesafetyandefﬁcacyofthe technique.

Studydesign: Weprospectivelyevaluated66postmenopausalpatients(POP-QStageIII:32,IV:34) operatedbetweenMay2008andDecember2013.Weusedwideweavepolypropylenemonoﬁlament meshthatfunctionsasahammockanchoredposteriorlytosacrospinousligaments,itsanteriorwings exitthepelvisthroughtheobturatorymembrane.

Follow-upwasscheduledat3-,12-monthsandinMay2016.Prolapse-QualityofLifeQuestionnaire (P-QoL)wasadministeredpreoperatively,at12monthsandinMay2016.ThechisquareandWilcoxontest wereusedforstatisticalanalysis.

Results:Meanfollow-upwas5.6(SD:1.6,Range:1.1–8.1)years.Theoverallsuccessrate(POP-Q2)was 92.5%at12months and84.4%atMay 2016,thesedata remainedstableovertime(p>0.05).Early complicationsoccurredin2(3%)patients,latein5(7.8%)ofwhichmeshextrusionin4(6.3%).Datafrom P-QoLshowedsigniﬁcantimprovementbetweenpreoperativeandpostoperativedata(P<0.01forall domains)andtheyremainedstablewithtime(p>0.05).De-novodyspareuniawas17.6%at12months and10.3%atMay2016.

Conclusions:Thelowrateandgradeofcomplicationsdemonstratesthesafetyoftheprocedure,which offersstableanatomicalcorrectionwithsigniﬁcantimprovementinQoL.

Introduction

Patients diagnosed withhigh-grade uterine prolapse, either III–IV according to the Pelvic Organ Prolapse Staging System (POP-Q),oftenrequiresurgicaltreatmenttocorrecttheir anatomo-functionaldefect.Therearemanysurgicaloptions,suchasvaginal hysterectomy combined with native tissue repair including uterosacralorsacrospinousligamentsuspension.Anotheroption istousesyntheticmaterialsin therepairorapicalsuspension. Furtherstill,uterus-sparingsurgerymaybeperformed,againwith variouscombinationsandoptionsforrepairandsuspensionusing nativetissueand/orsyntheticmaterials[1].RecentlytheU.S.Food andDrugAdministration(FDA)increaseddatarequirementsfor theuseofsurgicalmeshesforpelvicorganprolapse(POP)repair throughthevagina,andsuchmesheswerere-categorizedasclass

IIIinsteadofclassIIwhichmadethemhigh-riskdevices[2].The FDApolicydecisionaffectedtrans-vaginalproceduresemploying synthetic meshes,even outside theUSA. Yet,is it realistic that manystudiesdescribingtheanatomicalrationalefortheuseofa meshinPOPandthethousandsofpatientswhohavesuccessfully undergonethistreatmenthaveallbeenanerror?

Our two decades’ experiencewith mesh surgery prompts a critiqueoftheFDAreclassiﬁcation.WebegantorepairPOPwith meshinthe1990s[3],andhavepersistedtothepresentbecause ourresultshavebeenconsistentlymorethansatisfactory.Infact, wereportonlyamodestrateofminorcomplications.

Inourcenterweadopttwooriginalvaginaltechniques,onefor singleprolapse oftheanterior segment(cystocele)[3], andthe otherforprolapseofthemiddlesegment(cystoceleanduterusor vaginalvault)[4].Foreachdefectweusesoft,macroporous,wide weavepolypropylenemonofilamentmesh(type1accordingtothe Amidclassification[5])fromthecommercialmarket.Specifically, from2006weselectedGynemesh(Ethicon)andusedituntil2013 thoughin2012ithadgoneoffthemarket.NowweuseRestorelle1

* Correspondingauthorat:ClinicaUrologicaII,AziendaOspedalieraCareggi,

UniversitàdiFirenze,VialeSanLuca,50134,Firenze,Italy.

E-mailaddress:gnicita@uniﬁ.it(G.Nicita).

https://doi.org/10.1016/j.ejogrb.2018.01.003

ContentslistsavailableatScienceDirect

European

Journal

of

Obstetrics

&

Gynecology

and

Reproductive

Biology

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FlatMeshwhichwecutintotwodifferentshapesparticulartothe twotypesofprolapse.Thenoveltiesofourprocedurearetheshape ofthemeshandthemethodofanchoringittotheuterus.

Theaimsofthecurrentstudyweretoevaluateoutcomesand patientsatisfactionincasesofuterineprolapse(POP-QstageIII/IV) treatedwithvaginalmesh,whilepreservingtheuterus.

The primary objective of the study was to assess the effectivenessofanatomicalcorrection,safetyandcomplications. The secondary objective was to evaluate the resolution of symptomsandtheeffectonqualityoflife(QoL).

Studydesign

WeperformedaprospectiveobservationalstudybetweenMay 2008andDecember 2013.Inaverage,atourcenter20 patients receive procedure for anterior prolapse yearly, while 10–12 patientsreceiveoperationforPOPyearly;2–3patientsarereferred tothegynecologydepartmenteitherforpatient’spreferenceorfor underlyinggynecologicalpathologiessuchasuterineﬁbromatosis.

We enrolled 66 patients with high grade anterior and apical descensus,i.e.pointAa,BaandpointCatstage>2accordingtothe POP-Q. Absolute exclusion criteria were: hypersensitivity to synthetic materials, previous hysterectomy or POP surgery, postmenopausal bleeding, abnormal cervical smears, uterine disease,anadnexalmasses,orBMI>30kg/m2.

For eachpatient theutilityofa mesh implantwas carefully evaluated. Informed consent, clarifying the novelty of the technique, the possibility of failure, and correlative risks was obtainedfromallparticipants.

ThecharacteristicsofthemeshareshowninFig.1.Themesh corrects the weakened fascial support that led to the POP by recreatingthetwolevelsofsupportforthebladderandtheuterus theorizedbyDeLancey[6].The dimensionsconform toaverage pelvicdiameters.

Preoperative patient assessment consisted of history, pelvic examination using POP-Q, supine stress test with prolapse reduced,todetectoccultstressincontinencethatwasmeasured using the Ingelman-Sundberg scale [7]. Urodynamic evaluation

Fig.1.TheRationalefortheShapeoftheMesh.

Theestimatedareaofthecentralbodyofthemesh(excludedwings)is4500mm2

itissmallerthantheareaofProlift(6770mm2

excludingthewings).Thesizefacilitates

drawingthemeshtautlywithoutcreases,whichreducestheriskofextrusions.Theshape:thecystoceleliesintheanteriorportionofthemesh(A).Theneckoftheuterusis

placedinbackofthecentralaperture(B)whereitisencircledandsustained,likethecardinalligaments,bythetwoposteriorhalves,astheyarepassedthroughatunnel

createdoneithersideofthecervix.Thesehalves,joinedunderthecervixwithtwostitches,makeasurfacethatsupportstheenterocele(C).Thestitchesareplaced

immediatelyunderthecervixbutnotsostrictastocreatetissuelesions.Thediameteroftheholeinthemeshissmallerthanthatofcervixtoavoidthattheuterusslide

throughit.Themeshfastening:twofrontwingsexitthepelvispassingthroughtheipsilateralobturatoryforamen(theysubstitutethesupportofthepubo-urethraland

urethropelvicligaments).Tworearwingsareﬁxedtotheipsilateralsacro-spinousligamentwithasinglestitch(theysubstitutethesupportofthesacro-uterineligaments).

Finally,themesh,taughtbetweentheanchoringpointsformsanewstableﬂoorfortheorganslyingaboveit.Inorthostatismthemeshinthepelvisissimilartoahammock

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includeduroflowmetry,post-voidresidualvolume,filling cystom-etryandpressure/flowstudywithandwithoutprolapsereduction using a pessary,following theInternationaI ContinenceSociety (ICS)standard[8].AllpatientswereaskedtocompiletheItalian versionoftheProlapse-QualityofLifeQuestionnaire(P-QoL)[9]. Allpatientswerepost-menopausal.Baselinepatients’ charac-teristics, LUTSand pre-operative urodynamic dataare listedin

Table1.

Surgicaltechnique

Allpatients,aftergeneralanaesthesia,wereplacedinthedorsal lithotomypositionanda16Fbladdercatheterwasintroduced.A Scottretractorwaspositionedandamidlinelongitudinalanterior colpotomywas madefrom thebladderneck tothecervix.The pubo-cervicalfascia,thatliesoverthecystocelewasexposedupto itsinsertionontheischio-pubicbranchatboththerightandthe leftsides.Eachfrontwingoftheprosthesis,connectedtoan inside-out transobturator handle, was passed through the obturator membrane and theskin, and it was pulled out until themesh reachedthe bladder. A midline posterior colpotomywas made fromthefornixtotheendoftheenterocele,andbyusinga Kelly-typecurvedforceps,Fig.2,apassagebetweentheposteriorand anteriorvaginalsegmentswaspiercedascloseaspossibletothe apexofthecervix.Eachhalfofthemeshwaspassedthroughthe ipsilateralpassageuntilthecervixwasplacedatthecenterofthe apertureinthemesh,tofastenittotheprosthesis.Twosutures joined themedial edges of thehalves of the mesh tocreate a supportplanefortheenterocele.Therearwingswereﬁxedtothe ipsilateralsacrospinousligamentswithastitchusingtheCapio1 instrumentandtheuteruswaspushedupintoitscorrectposition. Eventuallythecolpotomiesweresutured.Figs.3and4showthe locationof the meshin thepelvis.Patients withstressurinary incontinence(SUI)receivedasingleincisiontransvaginalsling.All procedureswereperformedbyanexpertsurgeon(G.N.).

Postoperativefollow-upanddataanalysis

Post-operativeassessmentwas plannedat1 (functionaldata not considered for the study purposes), 3 and 12 months. All patientswereofferedavisitfreeofchargeinMay2016.Eachtime thevisitincludedapelvicexamination.P-QoLquestionnaireswere distributed at 12 months and in May 2016. Postoperative urodynamicanalysiswasperformedonlywhenneeded.

WedeﬁnedobjectiveanatomicalcureatPOP-Qstagelessthan 2,satisfactorycureatPOP-Qstageequalto2,whileunsuccessful repairwasPOP-Qstagesof3or4.

Weused theClavien-Dindograde for surgicalcomplications andtheIUGA/ICSclassiﬁcationformesh-relatedones[10,11].

Forstatisticalanalysis,thechi-squaretestwasusedtocompare datafromPOP-Qatdifferenttimes,theWilcoxontestwasusedfor comparing the differences in P-QoL. Results were considered statisticallysigniﬁcantwhenp<0.05.

Methods, deﬁnitions and units conform to the standards recommendedbytheICS[12].

Noﬁnancialassistancewasreceivedfromanycompanyinthe designorexecutionofthisstudy.

Results

Allpatientswerealiveat3and12monthsfollow-up.InMay 2016,64(97%)patientswereexamined,2(3%)werelostat follow-up. The meanfollow-up time was 5.6 (SD: 1.6, Range: 1.1–8.1) years. 21 (32%) patients with stress incontinence received contemporary SUI surgery using a single incision transvaginal sling.Meanoperatingtimewas8220min.Bladdercatheterwas removedonthethirdpostoperativeday.Medianhospitalstaywas 3(Range3–5)days.The30-dayClaviencomplicationratewas3%, dueinbothcasestogradeIIIAcomplications:apelvichematoma inonepatientandurinaryretentionrequiringoneweekof self-catheterization in another who underwent concomitant SUI surgery.Latecomplicationsoccurredinatotalof5(7.8%)patients; speciﬁcally:1(1.5%)gradeIIdenovourgeincontinence(without urodynamic detrusoroveractivity) treated withantimuscarinics and,4(6.3%)gradeIIIAsmallvaginalmeshextrusion(IUGA/ICS classiﬁcation1,T3,S1,ainallcases)treatedwithvaginalremovalof theexposed portionof themesh asan outpatientthat didnot require even local anaesthesia. No patient referred de novo subjectivecomplaintsrelatedtobowelfunction.

Concerningtheprimaryobjective,theoverallsuccessrate (POP-Q2) was 92.5% at 12 months and 84.4% at May 2016. We registered3(4,5%)stageIVcasesat3months.Weconsideredthese cases as failures, not complications. In our experiences early recurrenceoftheprolapseisprobablyduetoatechnicalmistake, looseningofthestitches,breakageofthemeshoroftheanchorage structure. At12 monthsafter surgery42 (63.6%) patientswere cured:(9(13.6%)stage0,33(50%)stageI)and19(28.9%)presented satisfactoryprolapsecure.5(7.6%)wereconsideredunsuccessful (2 (3%)stage IIIand 3(4.5%) stageIV). Thesevalues tendedto remainstableovertime,Table2,infactnostatisticaldifference was observed comparingpostoperative data between3 and 12 months(p>0.05)norbetween12monthsanddatacollectedin May 2016 (p>0.05). In May 2016, 10 (15.6%) patients of 64 compliant with follow-up, presented unsuccessful repair (2 of themunderwenthysterectomyinanotherhospitalwhile5stage III, 3 stage IV did not receive other procedures), rendering an overallsuccessrateof84.4%.

Regarding the secondary objective, a statistical difference emerged between data frompreoperativeP-QoL questionnaires and from postoperative questioning (p<0.01 for all domains). However,acomparisonoffollow-updataforpatientsinMay2016 with their12 months postoperativedata showed no statistical difference(p>0.05foralldomains),Fig.5.Nopatientsdeveloped denovoSUI.Concerningthepersonalrelationshipsdomainofthe P-QoLquestionnaire,32 patientsweresexuallyinactive,not for reasonsattributabletoPOP(eitherforage,lackingofpartner,ecc.). Amongtheremaining34patients,at12months11(32.4%)referred dyspareunia, 5 of them reportedsuchsymptom already before surgery;thusthede-novodyspareuniaratewas17.6%(6patients) at 12months.AtMay2016,7(20.6%) outof 29sexuallyactive patients complained of dyspareunia, 4 of them were already affectedbeforesurgery.Thede-novodyspareuniarateatMay2016 was10.3%.Atexamination,thepatientswithde-novodyspareunia presentedvaginaldrynessand/orvaginalrigidity.

Table1

Baselinepatients’characteristics,lowerurinarytractsymptoms(LUTS)and

pre-operativeurodynamicdata.

Meanage(SD,Range),years 69.7(7.7,50–87)

MeanBMI(SD),kg/m2 _24.9_(5.2)

Medianparity(IQR),n 2(1–2)

FillingphaseLUTS,n(%) 28(42.4)

VoidingphaseLUTS,n(%) 15(22.7)

MeanVoidedvolume(SD),ml 348.75(98.41)

MeanMaximalcapacity(SD),ml 375.74(75.48)

MeanQmax(SD),ml/min 18.07(7.12)

MeanQaverage(SD),ml/min 11.4(4.94)

MeanPVR(SD),ml 44.81(69.07)

MeanMUCP(SD),cmH2O 54.26(20.12)

SD:standarddeviation;IQR:interquartilerange;PVR:post-voidresidual;MUCP:

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Discussion

Surgeryaimedatpelvicﬂoorreconstructionallowsfordifferent approaches: vaginal, open abdominal, laparoscopic or robotic. Operativetimeisgenerallyshorterwhenthevaginalapproachis adopted,asarehospitalstayandrecoverytime[13,14]. Biocom-patible or synthetic materials can be employed in pelvic ﬂoor reconstructivesurgery,thedebateaboutthebestoptionisongoing [15,16]. Syntheticmeshes havebeen highly criticized in recent

years, but the use of mesh in pelvic floor surgery is the reconstructive technique that best corresponds to anatomy becausetheshape ofthemeshcorrectlyreproducesthehuman pelvicfloor.Moreoverliteraturehasunderlinedtheuterussparing technique as a viable option for the surgical management of uterine prolapse, because it is best at retaining the original anatomyandstaticsofthepelvicfloor[17].

Theresultsofourstudycon_ﬁrmtheeffectivenessofour uterus-sparingtechniquefor thecorrectionofhigh-gradeanteriorand

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apicaldefectsintermsofanatomicalcorrection.Ourrateofsuccess is comparable to data reported in the literature for different procedures[1,18,19].Thelengthofourfollow-upperiodsuggests

that results are stable over time. We have also observed a signiﬁcantimprovementinprolapsesymptomsandqualityoflife. Ourpositiveresultsareduetothelogicofthemesh,itsshape,and

Fig.3.Meshinthepelvis.Upperview.

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alsoitscorrect implementation.The pubo-cervical fascia, inter-posedbetweenmeshandbladderactsasabufferavoidingdirect contactbetweenbladderand mesh.Weprefertointerposethe fasciabetweenthemeshandthebladdertoaddprotectiontothis organ.Therarevesicalerosionsaremuchmoreseriousthanthose ofthevagina,whichareeasilyrepaired.

Moreover when thepubocervical fascia is isolated fromthe bladderandleftattachedtothevaginalwall,theweaksite(where erosionsoftenoccurred),isexactlywherethewallsandfasciaare cutand then sutured. Theprocedure counteractsthe causes of prolapsebyrecreatinganewpelvicﬂoorsupport,andimpliesno organ removal. The mesh, ultimately lies on a plane withthe posteriorparthigherthantheanteriorone,thusitreestablishes theanatomicalﬂoorofthelevatoranimuscle,itisplaced tension-freeinthepelvis,avoidingwrinklesthataretheprimarycauseof vaginalerosions.Therectum,locatedbetweentheposteriormesh wings,maintainsitsanatomicalpositionandisundernopressure fromthemesh.

Surgical correction of uterovaginal prolapse traditionally involveshysterectomyeveniftheuterusisbelievedtobepassive in thedisease. Removal of the uterus disruptsthe equilibrium betweenthe interactions of the pelvic organs regarding organ descent[20].Additionally,hysterectomycuresthemain“prolapse symptom”,butit islessefﬁcientintreatingthecause,which is weakenedsupportfrommusculofascialstructures[21].Thevoid createdbyhysterectomycancauseaweakenedareathroughwhich vaginalsegmentsmayprolapse[22].

Overthepastfewdecades,uterus-sparingsurgery,whichwe wereamong theﬁrst topractice[3], hasbecomemore popular worldwideandthereisgrowingconsensusthattheuteruscanbe preservedinpelvicreconstructivesurgeryinappropriatepatients

[23,24].Infact,whenhysterectomyisassociatedwithPOPsurgery, operationtimegrows,bloodlossisgreater,andtherearegenerally morecomplications,aboveallwhenameshisinsertedbyavaginal approach[24].Moreover,thereisdebateaboutwhether anatomi-cal modiﬁcationsinduced byhysterectomy implicatesexuality [25].

TheuseofmeshesintreatingPOPwaspromptedbytheirusein incontinence surgery: the ease of implementationand positive resultsobtainedsuggestedthatmeshesmightyieldsimilarresults inPOPsurgery.Manyproductsappearedonthemarketwithout appropriateclinicaltrialsduetotheirsimpleproduction technol-ogyandhighprofitmargins[26].Furthermore,surgeonswithlittle experienceinthisfieldwereattractedbytheapparentsimplicityof useofferedbycommercialkits,someofthemweredifficulttouse duetodimensionsandanchoringtechnique.Allthesefactorsare responsible for a great amount of complications in patients receiving trans-vaginal procedures, leading to lawsuits failed againstsurgeonsandindustries.ThesecircumstancesledtheFDA torequire strictpre-clinical validation of meshes, and to a re-classification of these devices. Now they must meet stricter standardsofefficacyfor resolvingtheanatomical problemthey intend tocorrect before they reach the market. In addition, a focusedtrainingwhich,however,hasnotyetbeenstandardized, should be required. Indeed surgical experience is of pivotal importance[1,27].Kellyetal.foundtheriskofcomplicationstobe lowerforsurgeonsperforming14ormoreproceduresperyear [27].WeagreewiththeFDArestrictionsontheuseofmeshesfor POP,butwetakeissueontheirdesignationashighriskdevices[2]. A specific risk resulting from the use of mesh in pelvic floor reconstructionsurgery ismesh exposure[26].The modernsoft polypropylenelargeweavemeshesreducedthis riskasourlow

Table2

DatafromPOP-Qatdifferentfollow-uptimes.

Preoperative,n=66 3monthspostoperative,n=66 12monthspostoperative,n=66 May2016a

,n=64b Stage0,n(%) – 10(15.1) 9(13.6) 7(11.3) StageI,n(%) – 32(48.5) 33(50) 31(50) StageII,n(%) – 19(28.9) 19(28.9) 16(25.8) StageIII,n(%) 32(48.5) 2(3) 2(3) 5(8.1) StageIV,n(%) 34(51.5) 3(4.5) 3(4.5) 3(4.8) a

2patientswerelostatMay2016follow-up:onewhohadStageIVPOPQat12monthsandanotherwhohadStageIIat12months.

b

2patientsunderwenthysterectomyinanotherhospital,after2and4yearsofsurgeryrespectivelyandhavebeenconsideredasunsuccesfulrepair.

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rateandgradeofminorvaginalerosionsdemonstrate.Otherrisks suchasdyspareuniaand pelvicﬂoorpain mayalso resultfrom biocompatible materials [28]. Dyspareunia in post-menopausal womenisnotuncommonevenwithoutPOP,itsentityisusually difﬁculttoevaluate.Therateofde-novodyspareuniaamongour sexuallyactivepatientswas10.3%,whichiscomparabletovalues reportedbyotherauthors[15,29], noneofourpatientsreferred pelvicpainattributabletosacrospinousligamentsstitches.

Despite criticism of synthetic materials, recent Cochrane reviews,albeitwithmetanalysesbiases,affirmedthattheuseof vaginal meshes lowers the risk of prolapse symptoms and of recurrentanteriorvaginal prolapsewhen compared to biocom-patibletissueandfascialrepair[26,30].Ourresultsareinkeeping withthosefindings,confirmingstablesuccessrateoverthe long-term.

The limits of this study are: its monocentric prospective observationalstructurewithalimitednumberofpatientsandits lackofacomparisonwithothertechniques,suchashysterectomy andfascialrepair.Uterussparingsurgerydoesraisequestionsof mostsuitableapproach, whethervaginal,abdominal,or laparo-scopic.

Inconclusion,ourtechniqueisfeasibleforaurogynecologistof averageexperiencetrainedbytakingahandinafewprocedures. Thelowrateofcomplicationsdemonstratesthesafetybothofthe material and the procedure, which offersa stable and notable anatomicalcorrectionofprolapsewithimprovementsinpatient QoL.Thisﬁndingwarrantsprospectiveevaluationinclinicaltrials. Moreexperienceisneededtodeterminewhichapproachisbestfor prolapsesurgery.

Financialdisclaimer/conﬂictofinterest None.

Aknowledgement

ToProf.GailSolbergforlinguisticrevisions,withthanks. References

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