The two-year outcome of the I-Stop TOMS TM transobturator sling in the treatment of

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ORIGINAL ARTICLE

The two-year outcome of the I-Stop TOMS ^TM transobturator sling in the treatment of

male stress urinary incontinence in a single centre and prediction of outcome

Traitement de l’incontinence urinaire masculine par bandelette transobturatrice I-StopTOMS

^TM

, évaluation monocentrique avec deux ans de suivi

J. Drai

^a

, R. Caremel

^a

, J. Riou

^b

, P. Grise

^a^,∗

aUrologyDepartment,RouenUniversityHospitalCharles-Nicolle,1,ruedeGermont,76031 Rouencedex,France

bBiostaticsUnit,UniversityHospitalBicêtreUniversityHospital,78,rueduGénéral-Leclerc, 94275Le-Kremlin-Bicêtre,France

Received22April2013;accepted21August2013

KEYWORDS Maleurinary incontinence;

Malesling;

Transobturatorsling;

Prostatectomy

Summary

Purpose.—The aimofthisstudy wastopresenttheresultsofthe2yearoutcome ofI-Stop TOMS^TM transobturator slingfor post-prostatectomy (UIPP) minortomoderate maleurinary incontinencetreatment.

Materialsandmethods.—Aprospective,singlecenterstudy,including26patientswithminor tomoderateIUPPandoperatedonusingasuburethralsling(MS)TOMS^TM (fourarms)wasper- formed.UIPPassessmentwasmadepreoperativelyand1yearpostoperatively,usingvalidated questionnaires(SF36andICIQ),numberofpadsdaily,andthe24hoursPad-test(LPT).Telephone follow-upevaluationwasperformedin21patientsovera2yearsperiodfollowingsurgery.

Results.—Radicalprostatectomywasperformed48.4monthsearlierandaveragepatientage was67.3years.Preoperatively,themeannumberofpadsuseddailywas2.3withanaverage weightlossof207.1gramsatLPT.At1year,ICIQandSF36scoressigniﬁcantlyimproved.Weight lossintheLPTaswellasthenumberofpadssigniﬁcantlydecreased(P<0.05).At1year,13 patientswerecured,12wereimproved,onereachedimprovementcriteria,and96.2%usinga paddailymaximum.Withmorethana2yearfollow-up,10/21patientsweredry,nineimproved andtwofailed,and90.5%using0to1padperday.

∗Correspondingauthor.

E-mailaddress:[email protected](P.Grise).

http://dx.doi.org/10.1016/j.purol.2013.08.308

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Conclusions.—The transobturator TOMS^TM malesling is asimple and well-toleratedproce- durepermittingasigniﬁcantimprovementofUIPP, with50%ofpatients achievingcomplete continenceat1yearpostoperatively,thesegoodresultscontinuedbeyond2years.

Levelofevidence.—4.

MOTSCLÉS

Incontinenceurinaire masculine;

Bandelettehomme; Bandelette

transobturatrice; Prostatectomy

Résumé

But.—Le but était de rapporter avec deux ans de suivi les résultats du traitement de l’incontinenceurinairemasculinemineureàmodérée(IUPP)parbandelettetransobturatrice I-StopTOMS^TM.

Matériel.—L’étudeprospectivemonocentriqueaportésur26patientsayantuneIUPPetopérés debandelettetransobturatriceI-StopTOMS^TM quatrebras,ayantauminimumunanderecul.

L’analyseaportésurlacontinence,lenombredegarnitures,lepoidsdesfuites/jour,lesques- tionnairesSF36etICIQ.Pour21patientsayantunreculminimumdedeuxans,l’analysedes mêmesparamètresaétéréaliséeparévaluationtéléphonique.

Résultats.—Ledélaientrelaprostatectomieetlaposedebandeletteétaitde48,4mois,l’âge moyendespatientsde67,3ans.Lenombremoyendegarnituresétaitde2,3etlepad-testde 24h.de207g.Àunan,lesscoresSF36etICIQétaientsigniﬁcativementaméliorés,demême lepad-testetlenombredegarnitures,13/26patientsétaientguéris,12étaientaméliorés,et 96%despatients avaient0à1garniture parjour.Àdeux ans,10/21patientsétaientguéris, neufaméliorés,deuxenéchec,et90,5%despatientsavaient0à1garnitureparjour.

Conclusion.—LabandelettetransobturatriceI-StopTOMS^TM estuneprocéduresimplequiper- metsuneaméliorationsigniﬁcativedeIUPPmineureàmodérée,avec50%depatientsayantune continencecomplèteàunetdeuxans,etpour90%despatientsuneaméliorationsigniﬁcative avec0à1garnitureparjour.

Niveaudepreuve.—4.

Introduction

The incidenceof urinary incontinencepost-prostatectomy (UIPP)varies from10to87% [1,2].It affectsthepatient’s qualityoflife(QOL)evenwhenonlyonepadisusedperday [3].

Severe incontinenceis treated by implanting an artiﬁ- cialsphincter(AS),whichtodayremainsthegoldstandard, but slightor moderate incontinencemay betreated with periurethralinjections,periurethraladjustablecontinence therapy (ACT) balloons or suburethral male slings (MS)in order toimprove the continence witha minimal invasive surgery. Theaim ofthis studywastoevaluatethe results oftheTOMS^TMbulbar-transobturatorsuburethralmalesling withfour armstotreat slight tomoderate UIPP at 1year then 2yearsfollow-up and tosearchpredictive factorsof success.

Material and methods Structure of the study

Aprospectivesinglecentrestudyinaseriesof26patients operated onby the same surgeon wasreported. Patients gavetheirinformedwrittenconsenttobeincludedin the study,whichwasapprovedbythelocalEthicsCommittee.

Inclusioncriteriawere:slighttomoderateUIPP;urinary physiotherapyfailure;prostatectomymorethan1yearpre- viously.Exclusioncriteriawere:signofrecurrenceonPSA,

radiotherapy,neurologicaldisease,urethraloranastomotic stenosisconﬁrmedby urethrocystoscopyorurethrography, detrusoroveractivity withleak from bladder contraction, chronicurinaryretentionorcurrenturinaryinfection.

Slightincontinencewasdeﬁnedasonetotwopadsper day,moderateincontinenceasthreetofourpads,severeas equalormorethanﬁvepads.

Data collection

Thedatacollectedwere:patient’sage;RP-MStime(delay inmonthsbetweenradicalprostatectomyandMS);UD(uro- dynamicsrecordingbladdercompliance,maximumbladder capacity, maximum urethral closure pressure, and detru- soractivity);uroflowmetry(recordingmaximumflowrate, urine volume and post-urination volume obtained from a bladder scan); ICIQ questionnaire score: based on three questionsconcerningtheleakageandQualityoflifeaffected by leakage, the total value varying from 0 (no incontinence) to 21 (major incontinence); SF36 questionnaire Score:specificscoreonurinaryincontinenceandQOL.The total value obtained varied from 0 (major incontinence) to500(noincontinence);numberofpadsperday;24hour LongPad-Test(LPT)accordingtoICSrecommendations[4];

occurrenceof early postoperativecomplications; Indexof satisfactionbased ontwo questions,each hadfour items i.e.very satisfied,satisfied,dissatisfiedand verydissatis- fied.Thetwoquestionswere‘‘Whatdoyoufeelaboutthe surgeryperformed?’’and‘‘Whatisyouropinionaboutyour

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condition after the operation compared to your previous condition?’’;AVisual Analogicpainscale (VAS)range0 to 10.

The timetable for data collection wasbefore surgery;

during hospital stay; at 30, 90, 180 and 360days after surgery.Atelephoneinterviewwasaddedmorethan2years postoperativelyusingthesameevaluationbasedontheICIQ questionnaireplusaspeciﬁcquestionnairei.e.:doyousuf- ferfromurineleakage: yesor no?Howmanypads doyou useperdayonaverage?

Surgical technique

ThetechniquewaspreviouslydescribedbyGriseetal.[5].

Theshapeofthetapeisarectanglewithfourarmsextension (twooneachside).Itsstructure ismadeofpolypropylene monoﬁlamentsorganizedintoamacroporousmesh.

Patientclassiﬁcationresults:

• groupA:patientcured:ifthefollowingfourcriteriawere numberofpads0or1;LPT0g;SF36score500;ICIQscore

• 0;groupB:patientimproved:ifthefollowingfourcriteria

werereachedi.e.numberofpadsreducedbymorethan 50%,orequalto0or1;LPTreducedbymorethan50%;

improvedSF36orICIQscore;

• group C: patient failure. It could be either a patient slightlybetter(numberofpadsreducedbylessthan50%, orequaltoor 2or more;LPTreducedbylessthan50%;

SF36scoreimproved; ICIQscoreimproved)or a patient completefailure.

Statistical analysis

The preoperative and one-yearpostoperative characteristics were compared using the Wilcoxon, or the Friedman test,non-parametricRanktestonrelatedseries.Thepre- operative characteristics of cured andnon-cured patients were compared with the Mann-Whitney non-parametric Ranktest.Analysesandgraphicalrepresentations(boxplot andstripchart)wereperformedusingR-2.14.0softwarefor Windows.

Results

Descriptive analysis of the preoperative population

Radicalprostatectomywasperformed48.4months(12—156) earlierandaveragepatientagewas67.3years(54—80).Pre- operatively, themean numberof pads useddaily was2.3 (1—4)withanaverage weightlossof 207.1g(24—1100)at LPT.

Characteristics of the hospital stay

In 24 of the 26 patients (92.3%): no postoperative complicationswerereported.Onepatientpresentedwitha smallhaematomanearthesiteoftheincision,whileanother patient experienced pain conducting to 24hours-delayed dischargefromhospital.Postoperativepainwasevaluated at2[range0—7]onaVAS.Theindexofsatisfactionwasvery

satisfiedorsatisfiedfor25patients(96.1%)butonepatient wasdissatisfiedduetothepersistenceofincontinence.

Results of male slings 1 year after surgery

AsregardstheICIQscore,14patients(54%[CI95:33%—73%]) had an ICIQ score evaluated at 0 1year after surgery, whereas the 12 others all had an improved score (46%

[CI95:27%—67%]).ThemedianICIQscorechangedfrom14.5 [11—18]preoperativelyto0[0—12]1yearaftersurgery.The differencewasstatisticallysigniﬁcant(P<0.001).

SF36 scores showed that 13 patients (50% [CI95:

30%—70%])obtainedthemaximum scoreof500,while the 13 others (50% [IC95: 30%—70%]) had an improved score.

BetweenD0andD360,therewasasigniﬁcantimprovement in the median SF36score, which changed from83 [range 0—167] preoperatively to425 [range83—500] 1year after theoperation(P<0.001).

As regards results of the LPT, 15 patients (58% [CI95:

37%—77%])obtainedanilﬁnalweight,whilethe11others (42%[CI95:23%—63%])allhadalowerurinarylossweight.

The median LPT changed from207g [24—1100]preopera- tivelyto22.5g[0—200]1yearaftersurgery.Thedifference wasstatisticallysigniﬁcant(P<0.001).

Numberofpads(Fig.1):allpatientsreducedtheirnum- ber of pads, with 15 patients (58% [IC95: 37%—77%]) no longer usingany pads, 10 patients (39% [IC95: 20%—59%]) onlyusingone,andonepatient(4%[IC95:0%—20%])using threepadsperday.Themediannumberofpadsusedvaried from2[1—4]to0[0—3]1yearaftersurgery.

Results of male slings 2 years after surgery

Twenty-one patients wereevaluated at morethan 2years post-surgery,withamedianperiod35months(24—48).Con- cerningdailynumberofpadsused(Fig.1):12patientsused respectively0 pads(57%[IC95:34%—78%]),seven patients usedonepadperday(33%[CI95:15%—57%]),onetwopads (5%[CI95:0%—24%]),onethreepads (5%[IC95:0%—24%]).

Dailyuseofpadscomparedwiththenumberusedpriorto surgery decreased signiﬁcantly (2 [range1—4]; P<0.001), buttherewasnodifferencewhencomparedto1year.

ConcerningICIQscore:10patients(48%[IC95:26%—70%]) hadascore0,11patients(52%[IC95:30%—74%])hadabet- terscorethanbeforesurgeryandﬁvepatientsamongthese (24%[IC95:8%—47%])hadaworsescorethanatthe1year evaluation.

The median ICIQ score was 2 [0—15], signiﬁcantly lowerthanthepreoperativescore(whichwas14[11—18];

P<0.001). There was no signiﬁcant difference from the scoreobtainedat1year.

Group results at 1 and 2 years after surgery

At 1year: 13 patients were cured (group A) (50% [IC95%:

29.9—70.1]), 12 patients were improved (group B) (46.2%

[IC95%:26.6—66.6]),onepatientwasslightlybetterbutcon- sidered as failure(group C) (3.8% [IC95%:0—19.6]) and 0 patientshadcompletefailure(0%[IC95%:0—13.2]).

At2year:10patients(47.6%[CI95:25.7%—70.2%])were cured(noleakage,0padsandICIQscoreof0),ninepatients (42.8%[CI95:21.8%—66.0%])wereimproved(leakagewith

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Figure1. Resultsoncontinenceaccordingtopadperdayduringthefollow-upperiod.

theuseofasinglepadperdayandanimprovedICIQscore), twopatients(9.5%[CI95:1.2%—30.3%])experiencedtreat- ment failure(leakagewiththe useof twoor morepads).

TheresultsaresummarizedonFig.2.

Figure2. Resultsoncontinenceaccordingto%ofthetotalnum- berofpatientsandtoclassiﬁcationincompletelydry(A),improved (B),failure(C).

Predictive factors of success

Inordertoidentifyfactorspredictiveofsuccess,twogroups wereconsidered: acompletelydrygroup(groupA),anda nodrygroup(groupBandC).Allthepreoperativedatawere successivelytested,inordertosearchforasigniﬁcantdif- ferencebetweenthesuccess groupandthefailuregroup, deﬁnedasP<0.05.(Mann-Whitney-Ranktest).Theonlypre- dictiveofsuccessfactorwasalowLPT,withamedianof50 gminthecompletelydrygroupascomparedto200ginthe non-drygroup(P=0.024).

Discussion

Ourserieshasshown that half of the patientswithslight ormoderatepost-prostatectomyincontinencemaybecured andthatmorethan90%had0to1padperday,thesegood resultsweresimilarat1and2years.

A comparison of our continence results with those described inthe literature is difficult due tothe variable definitionofsuccess, which hasnotbeen standardized.If success is defined by the wearing of a maximum daily 0 to 1 pad, our series showed a 96.2% success rate 1year aftersurgeryanda90.5%successrateafter2years(median elapsed time of 35 months). In comparison, the artificial sphincter series [6,7] ranged from 75 to90%, those with balloons[8]rangedfrom52to81%,thosewithotherslings varied widely from 40% to 96% [9]. The good results in our series are probably explained by our patient selec- tionexcluding severe incontinenceand radiatedpatients.

Infact,only onepredictive factorofsuccessin themulti- variateanalysiswasa50gLPTscoreinthecompletelydry group versus 200g in the non-dry group which underlines the importance to select patients based on LPT in order to propose a MS versus an artiﬁcial sphincter. A correla- tionof success (verymuch or muchimproved) or failure, basedonLPTandPatientGlobalImpressionofImprovement questionnaire,wasalsoreportedbyFisheretal.[10]with respectively22.5gversus350g.

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In contrast toour study most authorsreported results withonlyone-yearfollow-up. Ourresults,over 2yearsfor 21patients,were:18wearingthesamenumberofpads,two deterioratedandoneimproved.Thisstabilityofresultsover timecouldbeduetoatoughtransobturatorattachmentof theslingandalargesurfaceoverthebulbarurethra.Con- cerningmoderatedeteriorationintwopatients,onecould assumea possible loosing of the attachmentor slidingof thesling toa posterior locationbetweenthe urethraand therectum.Asregardstheimproved patient,thismaybe explainedbya retractionfromﬁbrosis aroundthesling or alateimprovementof thesphincter.Nevertheless, along follow-upover5or10yearswouldbenecessaryforabetter evaluation.

Wemustalsounderlinethesinglecentresingle-surgeon natureofourstudywithasurgeonabovethelearningcurve andexperiencedwiththepreviousTOMS^TMwithtwoarms.

Theresultsafter1yearinaserieswith2-armTOMS^TMshowed only30%drypatients,30%improvedpatientsand40%failure [11].Therefore,theMSwasmodiﬁedfromtwotofourarms.

This was reported on a TOMS^TM multicenter series [5] on 104patientsat 1year follow-upi.e; 59.4%ofpatients dry and20.3%improved.Ourresultsareinaccordancewiththis series.

Acomparativestudy[9]oftwoMStechniques,between bone anchor MS and transobturator TOMS MS, showed a signiﬁcant decrease in pad usage in the TOMS group and a better improvement on PGI, although this was a retro- spective study it conﬁrms the favorable outcome of the transobturatorsling.

There is no strict consensus concerning the choice betweenvarioustechniques,evenifminimalinvasivetech- niquesarepreferred for minor incontinenceandartiﬁcial sphincterforsevereincontinenceandradiatedpatients.In moderateincontinence,thephysicianandthepatientmay discussbetweenthetwotechniques.Afterimplantationof anAS, thepatientsatisfactionvaries between85and95%

[6,7],howeverthissurgeryisinvasive,witharevisionrateof 40to64%at10years[12].Inarecentstudyaskingpatients whatwouldbetheirchoicebetweenaMSandanartiﬁcial sphincter,alargemajorityoptedfortheMS[13].

The TOMS^TM male sling could be compared favourably toothermini-invasivetechniquesinregardstosafety.The non-invasive natureof the transobturator route has been establishedonlargeseriesinwomenanddemonstratedinan anatomicalstudyonmen[14].ThePro-ACT^®balloonsproce- duremayreach66%continencerateinnonradiatedpatients [8]butnumerouscomplicationswerereportedi.e.bladder orurethralperforations,ruptureoftheballoon,urinereten- tion,urethralorbladdererosion.Thebulbarandanchored InVance^® MSproducedgoodresults concerningcontinence ratebuthasbeendiscontinuedduetoinfection(2to10%), acuteurine retention (3to4%), perinealpain(4 to22%), and an explantation rate of approximately10% [15]. The bulbo-membranoustransobturator MSAdvance^® wasorigi- nallyproposedinordertoimprovetolerance,howeversome complications have stillbeen reportedi.e. urinary retention up to 20% but only few patients with perineal pain [16—18].SimilarlytotheTOMS^TMlocationonbulbarurethra, the series involving the bulbar-transobturator Gynemesh PS^® tape showed minor complications such as retention, superﬁcialinfectionorchronicpain[19].Inordertomake

postoperativeadjustmentsofthetension,adjustableMShas beenused[20]howevertheamountofinsertedbiomaterial is possiblya factor toexplainthe infection complications leadingtoslingexplantation.

Inthe final analysis,the positive results ofTOMS^TM MS needtobeconfirmedbyalonger-termstudy.Nevertheless, the study does confirm the good results and good toler- ance in selected patients with noradiation and minoror moderate incontinence. Comparative studiesbetween the varioustechniquesavailable,basedoncomparablecohorts andidenticalassessmentcriteriaarewarranted.

Conclusion

In the reported series of TOMS^TM transobturator MS, 50%

of patients obtained a full continence and 90% used no more thanone padper dayat 1yearafter surgery. These good resultswere maintainedat 2years.This biomaterial is an attractive option for minor and moderate post- prostatectomyincontinence.

Disclosure of interest

Philippe Grise was a invited speaker for Medtronic^®, Astellas^®,CLmedical^®,andisaconsultantforAstellas^®and Coloplast^®.Noconﬂictofinterestfortheotherauthors.

Acknowledgements

TheauthorsaregratefultoRichardMedeiros,MedicalEditor

—MedicalEditingInternational,foreditingthemanuscript.

Appendix A. Supplementary data

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

2013.08.308.

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