Long-term outcomes of I-Stop TOMS TM male sling implantation for post-prostatectomy incontinence management

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ORIGINAL ARTICLE

Long-term outcomes of I-Stop TOMS ^TM male sling implantation for post-prostatectomy incontinence management

Résultats à long terme de la bandelette I-Stop TOMS pour le traitement de l’incontinence urinaire après prostatectomie radicale

B. Malval , J.-D. Rebibo , M. Baron , F.-X. Nouhaud , C. Pﬁster , J.-N. Cornu

^∗

, P. Grise

DepartmentofUrology,Charles-NicolleUniversityHospital,UniversityofRouen,1,ruede Germont,76031Rouencedex,France

Received22June2017;accepted14September2017 Availableonline31October2017

KEYWORDS Stressurinary incontinence;

Prostatectomy;

I-StopTOMS;

Male;

Sling

Summary

Objectives.—Toreportlong-termoutcomesafterI-StopTOMS^TM implantationforPPI.

Patientsandmethods.—Aretrospectiveevaluationwasconductedinthreetertiaryreference centers.All consecutive patients implantedwith anI-Stop TOMS^TM sling between 2007and 2012for mildto moderatePPI(24-hour Pad test<400g)without historyofpelvicradiation therapywereincluded.Evaluationhadbeenconductedpreoperatively,atoneandsixmonths postoperativeandyearlythereafter.Themainoutcomecriterionwasthenumberofpadsper day.SecondarycriteriawereInternationalConsultationonIncontinenceQuestionnaire(ICIQ), SF-36questionnaire,andcomplications.

Results.—Ahundredpatientswereevaluatedwithamedianfollow-upof58months[19—78].

Padusewassignificantlyreducedandqualityoflifeimprovedatlastfollow-up(P<0.0001).The percentageofpatientsdryandsociallycontinent(0or1pad)were40%and77%at1year,then droppedto15%and22%,respectivelyafter5years.Twelvepatientsweretreatedbyartificial urinarysphincterimplantation,fivebyProACT^TMballoonsandonebyare-doI-StopTOMS^TM.No severecomplicationswererecordedatlastfollow-up.

∗Correspondingauthor.

E-mailaddress:Jean-nicolas.cornu@chu-rouen.fr(J.-N.Cornu).

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Conclusions.—I-StopTOMS^TMimplantationisasafeandeffectiveoptionintheshort-termfor mildtomoderatePPImanagement.However,asigniﬁcanttrendtorecurrenceofleakagehas beenestablishedafterlong-termfollow-up.Ifconﬁrmedbyfurtherstudies,theseresultsmay substantiallyimpactpatientinformationbeforemaleslingimplantation.

Levelofevidence.— 4.

MOTSCLÉS

Incontinenceurinaire d’effort;

Prostatectomie; I-StopTOMS; Homme; Bandelette

Résumé

But.—Rapporterlesrésultatsàlongterme del’implantationd’unebandeletteI-Stop TOMS pourletraitementdel’incontinenceurinairepost-prostatectomie.

Méthodes.—Uneétuderétrospectiveaétémenéedanstroiscentresderéférence. Tousles patientsconsécutifstraitésavecunebandeletteI-StopTOMSentre2007et2012pouruneincon- tinenceurinairepost-prostatectomielégèreàmodéréesansantécédentd’irradiationpelvienne ontétéinclus.L’évaluationaétéréaliséeenpréopératoire,puisà1mois,3mois,6moiset annuellement ensuite. Le critère principal étudiéétait le nombre de protectionspar jour.

Lescritèressecondairesd’évaluationétaientlesquestionnairesInternationalConsultationon IncontinenceQuestionnaire(ICIQ)etSF-36ainsiquelescomplications.

Résultats.—Centpatientsontétéévaluésavecunsuivimédiande58mois[19—78].Leport deprotectionsétait signiﬁcativement réduitet la qualitédevieaméliorée audernier suivi (p<0,0001).Lepourcentagedepatientssecsousocialementcontinents(0ou1protectionpar jour)étaitde40%et77 %à1an,puisachutéàrespectivement15 %et22%après5ans.

Douzepatientsontététraitésparsphincterartiﬁciel,5parballonnetsetunparuneseconde bandeletteI-Stop.Aucunecomplicationsévèren’aéténotéeaucoursdusuivi.

Conclusions.—LabandeletteI-StopTOMS^TMestundispositifsûretefficaceàcourttermepour lesincontinencespost-prostatectomielégèresàmodérée.Cependant,unenettetendanceàla récidivedessymptômesaétéconstatéeaucoursdusuivi.Sicesdonnéessontconfirméespar d’autres,ellespourraientinfluencerl’informationdupatientenpréopératoire.

Niveaudepreuve.— 4.

Introduction

Prostatecancerisahighlyprevalentdiseaseinthewestern world[1]andradicalprostatectomyisconsideredasatreat- ment of choicefor localized disease [2].Persistent stress urinaryincontinenceafterradicalprostatectomy(so-called post-prostatectomyincontinence[PPI][3])cansigniﬁcantly impactqualityoflifeandrequiresspeciﬁcsurgicalmanage- mentinaround4%ofcases[4].

Aside artificial urinary sphincter (AUS) implantation, minimallyinvasiveoptionshavebeenproposedforPPIman- agementinthelast10years,includingperi-urethralballoons andavarietyofnewgenerationmaleslings[5].Maleslings havebecomerapidlypopularandfixedtransobturatormale slingarenowrecognizedasavaluablealternativeformild tomoderatePPImanagementinthemostrecentguidelines [6].TheI-StopTOMS^TM(CLMedical,France)isafixedtran- sobturator polypropylene tape, placed by perineal route, whichprovidesalargesupporttotheurethra[7].Multiple studieshaveestablishedthesafetyandshort-termefficacy ofthissurgicalapproach[8—10],butlong-termstudiesare lacking.

Ourgoalwastoreporttheefﬁcacyandsafetyoutcome afterI-StopTOMS^TM implantationformildtomoderatePPI managementafterlong-termfollow-up.

Patients and methods Study design

A retrospective study was conducted in three university hospitals. All consecutive patients implanted with an I- Stop TOMS^TM sling for PPI between June 2007 and May 2012 were included. Every patient had a preoperative workup including clinical examination, 24-hour pad test to assess incontinence severity, urodynamics study (UDS) to rule out severe detrusor dysfunction (overactivity or impairedcontractility), and urethrocystoscopytoruleout urethral stenosis or anastomosis stricture. All three centers had applied the same criteria for I-Stop TOMS^TM implantation during the study period: mild to moderate PPI (24hour Pad test<400g and pad use<6pads/day), persisting after at least at least 12months after radical

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prostatectomy,withundetectablePSA.Patientswithprevi- ouspelvicradiationtherapy,neurologicaldisease,urethral stenosis,severedetrusordysfunctionatUDS,chronicreten- tionwere excluded fromthe analysis. In lieu of a formal ethicscommittee,theprinciplesoftheHelsinkiDeclaration werefollowed.

Intervention

All patients were implanted with an I-Stop TOMS^TM sling undergeneralanaesthesiaaspreviouslydescribed,bythree surgeonshavingappropriateexpertiseofmaleincontinence therapy[7].Aurineculturewasrequiredbeforeinterven- tion, and patient received antibiotics in case of positive results. No systematic administration of antibiotics was scheduled postoperatively. Urinary catheter was removed after48handpatientsweredischargedaftertwovoidsand acceptable post-void residual volume (<100mL). Patients werescheduled for postoperative visits at 1, 3, 6months andyearlythereafter.

Data collection

Patientcharacteristics, perioperative dataand immediate follow-upwererecorded ina commondatabasegathering allcasesfromthethreecenters.Atbaseline,thefollowing parameterswere prospectivelyrecorded:age, uroﬂowme- try, pad usage, validated quality of life questionnaires (International Consultation of Incontinence Questionnaire [ICIQ][11],SF-36qualityoflifequestionnaire),and24hpad test.Short-termpostoperativedata(date ofintervention, immediatecomplications)werecollectedineachcenterson ayearlybasis.In2015,allchartsandfollow-updatawere reviewedandatelephoneinterviewbyanon-surgeonthird personwasproposedtoallpatientstoevaluatetreatment efﬁcacyandcomplications.Datacollectedatthisstagewere padusage,ICIQandSF-36validatedquestionnaires,asatis- factionquestionnaireandaperinealpainscale.

Efficacyof thetreatment wasthe mainoutcome criterion.Success wasdefined by no pad usage. Patient were statedasimprovedifpadusagewasreducedby50%ormore, andfailurewasdefinedbylessthan50%ofimprovementon padusage,worseningofthesymptoms(includingincreased paduse),orsalvagesurgerybyasecondlinesurgicalproce- dure(AUS,peri-urethralballoons,orre-dosling).

Statistical analysis

Descriptiveanalysiswasconductedfor everypatientchar- acteristicandoutcomeparameter.Forpadusageanalysis, usedasthemainoutcome,ayear-by-yeardescriptionofsta- tus(cured,improveorfailed)wasprovided.Anypatientwith furtheranti-incontinencesurgeryorfailurewasconsidered asfailed for the rest of subsequent follow-up, regardless heansweredornottothephoneinterview.Patientslostto follow-upwhowerenotre-operatedorpreviouslyclassiﬁed asfailurewereputoutfromthemainanalysis,andincluded asfailures in asecondary analysistoavoid attritionbias.

PaduseevolutionwithtimewasstudiedbyStudenttestfor theﬁrst4yearsandwithaWilcoxontestfortheﬁfthyear becauseof asmaller group.The assessment of predictive

Table1 Preoperativepatientcharacteristics.

Age(years)^a 68[54—82]

Uroﬂowmetry(Qmax,mL/s)^a 20,95[5—50]

Paduse/day^a 2[1—6]

24hrsPadtest(g) 185[50—400]

SF-36score^b 286±150[50—500]

ICIQscore^b 13±3[8—19]

ICIQ:InternationalConsultationofIncontinenceQuestionnaire;

Qmax:maximumﬂowrateaturoﬂowmetry.

a Medianvaluesandextremesboundariesinbrackets.

b Meanmeans±SD[range].

factorswasdonethroughunivariateanalysis(Studenttest).

DatawereanalyzedwithSAS9.2(Cary,NC,USA).

Results

Patient characteristics

One hundred consecutive patients were included with a medianfollow-upof58months[19—78].Preoperativechar- acteristics aredisplayed in Table 1.All patients hadmild to moderate incontinence. At one year of follow-up, 95 patientswereanalyzed(5operatedpatientswereexcluded duetoradiotherapy,secondaryonsetofaneurologicaldis- ease). At 2years of follow-up, 22 patients were lost to follow-upand17patientsunderwentanadditionalsurgical proceduredue toshort-termfailure.AsdetailedinFig.1, 26patients werelosttofollow-upandthus 41,32 and21 patientshadcompleteevaluationafter3,4and5years.

Efﬁcacy

Pad usagewas signiﬁcantly decreased at each time point comparedtobaseline(P<0.001)(Fig.2).Intheshort-term, 38%ofpatientsweredryand77%ofpatientsused0or1pad.

Afteramedium-tolong-termfollow-up,theresultsdropped progressivelywith a rateof patient dry of about 40% ini- tiallyto23%and15%afterfourandﬁveyears,respectively.

Threepatientshadshort-termworseningoftheirsymptoms.

Thefailureratewas34%at oneyear,and18requiredfur- thersurgicaltreatmentoftheirincontinence(12hadanAUS placement,5patientsweretreatedbyproACT^TMballoons and one by a second I-Stop TOMS^TM sling). None of these patientsunderwentslingremovalduringsecondarysurgery.

Nopreoperativefactorwasfoundtobesigniﬁcantlyassoci- atedwithfailure.

ICIQandSF-36questionnaires(Table2)haveshownasim- ilarevolutionwithgoodshort-termoutcomesandworsening secondarilyafter3years.Symptomswerehoweverimproved at eachtimepointcomparedtobaseline.Thesatisfaction ratewasexcellentwithverysatisﬁedpatientsregardingthe surgery.Itwasworseforthepatientswhowerenotimproved butstillgoodregardingthesurgeryitself.

Complications

Aftershort-termfollow-up,onepatientcomplainedofocca- sional perinealpain symptoms, persisting after twoyears

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Figure1. Patientﬂowchart.

Table2 EvolutionoftheSF-36andICIQquestionnaireovertime(presentedinmean±SD[range]).

Preoperative 1year 2years 3years 4years 5years

SF-36questionnaire 286±150 [50—500]

302±139 [50—500]

294±133 [50—500]

281±130 [50—500]

256±149 [50—500]

194±136 [50—500]

ICI-Qquestionnaire 13±3 [8—19]

7±5 [0—20]

6±5 [0—19]

8±5 [0—21]

8±5 [0—19]

9±6 [0——9]

Numberofpatients 100 95 51 43 32 21

(2/10onapainscale,andnoneedforfurthertreatment).

Noerosion,urinaryretention,infectionorchronicperineal painwasrecordedduringfollow-up.

Discussion

Male slings are now considered as a ﬁrst line option for PPI management, especially for mild to moderate symptoms [6]. A number of slings have been marketed during thepast 10years,withvariousdesigns,materials andsur- gical approaches, making ‘‘male slings’’ a heterogeneous

group[5,12,13].Furthermore,theuseofeachslingissup- portedbythesameamountofevidence,accordingtorecent literature reviews [5,12,13]. Fixed male slings placed by transobturatorroute,suchasAdvance^TM(AMS,Minnetonka, Minnesota, USA) and I-Stop TOMS^TM have shown promis- ing short-term efﬁcacy results with an excellent safety proﬁle[3,6—10,14—16],but long-termresults arelacking.

Adjustablemaleslingshaveshownalsogoodefﬁcacyinthe shortterm,butahighrateofcomplications[6],and4-arm deviceshavebeenratherdisappointingaccordingtorecent reports[17].Lastbutnotleast,nowell-designedcompara- tivestudyhasbeenpublishedtodate.

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1 year 2 years 3 years 4 years 5 years Pad use (median [range]) 1 [0-4]* 0 [0-4]* 0 [0-6]* 1 [0-2]* 1 [0-3]*

Cured 40% 37% 33% 23% 15%

Improved 26% 17% 12% 12% 7%

Failed 34% 46% 55% 65% 78%

Lost to follow-up/

unknown status or censored

0 25 29 35 40

* All significant compared to pre-op values (p<0.001) 0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

Cured

Improved

Failed

Figure2. Efﬁcacydataovertime.Thebarsshowthepercentagesofpatientscured,improvedoffailedduringfollow-up(yearsoffollow- upareplottedonthex-axis).Forcompleteaccuracy,thenumberofpatientsnotconsideredforanalysisisdetailedunderthedisplay.The completesampleat1yearwas95patients.

Numerouscasesseriesaboutﬁxedmaleslingshavebeen publishedfocusingonpatientselectiontotrytodepictthe bestcandidatesformaleslingimplantation.Predictivefac- tors of failure proposed in the literature include severe incontinence, previous surgery for urethral stricture, his- toryofradiationtherapy,andlowresidualsphincterfunction [18—23].Exclusionofthesepatientshasthusledtoconsider ratherfavorableproﬁles for malesling implantation. This canexplainedthegoodshort-termresults obtainedinour cohort,with40%patientsdryand77%ofthemwearing0or onepad.Thesedataareclosetothosereportedinthevast majorityoftheliteratureaboutAdvance^TM[3,14,15,18—24]

andI-Stop^TM[8—10].

Themainassetofourreportislong-termdatathathave never been reported before. While showing a very good safety profile in the long term, the efficacy of the sling seemstosignificantlydecreasewithtime.Symptomsrecur- rencehasbeenshowntooccurasearlyasaftertwoyears, thenslightly butcontinuouslywithtime.In ordertocom- pensate for theloss of follow-up,considering all patients censoredordroppedoutasfailureswouldleadtoadryrate ofless than10% afterfive years.Conversely,if everylost tofollow-up was treated by last observation carried for- wardmethod, the dry rate would drop anywayto 32% at 4yearsand26%at5years,andimprovementratewouldbe 20% and18%, respectively. Despiteno previous study had gonebeyondfurther3yearsoffollow-upforanentiregroup

ofpatients,previousreportshavepostulatedalossofefﬁ- cacyovertimeandtheneedforlong-termstudies[15,24].

Recurrence of incontinence after sling placement for PPI managementis thus anewlyestablished issue,withthree majorimplicationsdiscussedhereunder:pathophysiologyof symptomsrecurrence,managementoffailures,andpatient information.

Possibleexplanationsforsymptomsrecurrencearemulti- ple.First,patientaginginthelongtermcanunmaskfurther decrease of sphincter function,as slingsproperly provide urethralsupportandmildcompression,butrequireagood sphincterresidualfunctioncontrarilytoAUS.Inafewcases, additionalphysiotherapy hasbeen proposed for long-term recurrence of symptoms, and has led to a mild improvement.AsHiltonstatedaboutlong-termfollow-upstudiesin functional urology [25], results are submitted tothe bias of ageandother deﬁciencies.This conceptincludesover- activebladderandpossiblyurgeincontinence,whichcould impacttheresults.Sinceourevaluationwasmainlydrivenby paduseandsatisfactionquestionnaires,we mayhavedis- regardedalternative causesof recurrenceor failuressuch asdetrusor overactivityor detrusordysfunction.The sec- ondreasonthatcouldexplainincontinencerecurrenceisthe looseningoftheslingattachmentovertimeoramigration oftheslingposteriorlyanddownfromtheurethra.Unfortu- nately,noimagingdatawereavailableforourpatientswith secondaryfailure.

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Giventherateofmaleslingimplanted,ifourresultsare conﬁrmed, many patients will have to be offered a new additional treatment for PPI recurrence after malesling.

These challenging cases are to be treated in a tertiary referencecenterformaleincontinence,asclinicaldecision- makingmightbedifﬁcult.Technically,alloptionshavebeen reportedinthe literatureabout secondline therapy after aﬁxedmaleslingandincludeasecondsling, AUSimplan- tation,orperi-urethralballoons.Thechoicebetweenthese optionsincludesleakageintensity,patientpreference,and clinicalbackground.Whilstalloptionshavebeentestedin our groups, no conclusions can be made due to the low numbers.Thebiggestseriestodatehavereported30%suc- cessratewithare-dosling[26],and50%improvementwith secondary implantation of ACTballoons [27]. The success ratesafterAUSimplantationareclosetothoseobtainedin comparablevirgincases[28].

Lastly,ifourfindingsareconfirmedbyothergroupswork- ingonmaleslings,patientinformationmaychangebefore initialimplantationofafixedmaleslingforPPI.Indeed,the patients shouldbewarned that the resultsare notstable overtimeespeciallyinthelongterm,andthatanadditional surgery may be required a few years later. However, the safetyprofileoftheslinginourstudyremainedexcellent.

Althoughourstudyprovidedkeyinformationinthefield, it has some limitations that have to be considered, and shouldleadtocarefulinterpretation.Beyonditsretrospec- tivedesign andthelimitednumberof patientincluded, a limit of our study is the pad use as a main criterion, as padusemightnotperfectlyreflectincontinencesymptoms andseverity[29,30].Althoughpadusereflectsthepatient’s condition, the 24-hour pad test wasnot done for all the patientsduringthefollow-upandreliableresultscouldnot beshown.However,mostoftheliteratureisbasedonpad use,asamaincriterion,whichallowscomparisonwithtime in the same patient, is easy to measure and remains an acceptablemarkerofthepatient’sdiscomfort.

Anothersigniﬁcantlimitationofthestudyis thelossof patientsateachtimepoint.Thiscouldbiastheresultswhen leadingcomparativetestingduringfollow-up.However,we considered that a fair report of patient numbers, as an annualreportofthedevicefunctionisparticularlyinterest- ingandmoreusefulthanamedianfollow-uptoappreciate theriskofdeteriorationovertime.

Furthermore, the ﬁrst casesincluded in this study are partofthelearningcurveofthesurgeonswhoparticipated.

As toourknowledge noreliabledataregarding malesling learning curve areavailable, the impacton ourresults is difﬁcult to quantify. Finally, as previously discussed, our patient selection was limited to good candidates, which makestheresultsrelevantonlyforthisgroupofpatients.

Conclusion

I-StopTOMS^TMimplantationformildtomoderatePPIman- agementisasafeprocedurewithgoodshort-termefficacyin carefullyselectedpatients.However,long-termresultshave shownadecreaseinefficacyduringfollow-up,infavourof recurrenceofincontinenceinthelongterm.Ifconfirmedby

furtherstudies,theseresultsmayhaveseveralimplications forpatientinformationandclinicaldecision-making.

Acknowledgements

None.

Disclosure of interest

JNCisconsultant/advisor/investigator forAstellas, Boston Scientiﬁc, Allergan, Coloplast, SAP, Medtronic, Recordati, PierreFabreMedicaments,GSK.

PGisconsultantforAstellas.

BM,JDR,MB,FXNandCPdeclarethattheyhavenocom- petinginterest.

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