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ORIGINAL ARTICLE
Sequential treatment with ProACT TM device implantation after male sling failure for
male urinary incontinence
Implantation de ballons ProACT
TMen seconde ligne de traitement de
l’incontinence urinaire masculine après échec de bandelettes sous-urétrales
M.G. Baron
a,∗, C. Delcourt
a, F.-X. Nouhaud
a, A. Gillibert
b, C. Pfister
a, P. Grise
a, J.-N. Cornu
aaUrologydepartment,Charles-NicolleHospital,RouenuniversityHospital,1,ruede Germont,76000Rouen,France
bStatisticdepartment,Charles-NicolleHospital,76000Rouen,France
Received16April2017;accepted4August2017 Availableonline25August2017
KEYWORDS Continencedevice;
I-STOPTOMS;
Maleurinary incontinence;
ProACTTM; Radical prostatectomy
Summary
Objectives.—Thereisnostrongevidenceforsecondlinetherapyaftermaleslingfailurefor post-prostatectomy urinaryincontinence (PPUI). Wereport theoutcomesafter periurethral balloons implantationfor persistence or recurrence ofmild PPI symptomsafter male sling implantation.
Methods.—Allpatients implantedofaProACTTM device(Uromedica, Inc.,MN,USA) follow- ingI-STOPtransobturatormalesling(TOMS)failure, inatertiaryreference centerbetween 2009and2016,wereincluded.Patientswereevaluatedby24-hourpad-testbeforeandafter implantation,andaftereachballoonrepressurizingprocedure.PGI-IandLikertscalepatient satisfactionwere estimatedduringatelephoneinterviewconductedin2016. Objectiveand subjectivecureofurinaryincontinenceweredefinedbya24-hourpad-test<8gandtheuseof zerooronepadperday,respectively.
∗Correspondingauthor.
E-mailaddress:maximilienbaron@hotmail.com(M.G.Baron).
http://dx.doi.org/10.1016/j.purol.2017.08.001
1166-7087/©2017ElsevierMassonSAS.Allrightsreserved.
ProACT deviceimplantationaftermaleslingfailure 1099 Results.—Fourteenpatientswereincluded.Medianfollow-upwas34months[4—89].Objective andsubjectivecurewere29%(n=4)and57%(n=8),respectively.Medianpad-testdecreased from95g[IQR:130]to34g[IQR:83](P=0.022).ProACTTMsignificantlydecreasedmedianpad- testbyafactor2.73[1.19—6.29].Eighty-eightpercentpatientswerefeeling alittlebetter, muchbetterorverymuchbetterand77%weresatisfiedorverysatisfiedattheendoffollow- up.Reoperationratewas28%(n=4):3balloonswerechangedforcaudallymigration(n=2)or deflation(n=1)and1hadaurinarysphincterimplantedforsevereUI.
Conclusions.—ProACTTMisasafeandefficienttreatmentthatcanbeusedinsecondlinetherapy afterTOMSfailureforPPUI.
Levelofevidence.— 4.
©2017ElsevierMassonSAS.Allrightsreserved.
MOTSCLÉS BandelettesI-STOP TOMS;
Incontinenceurinaire del’homme; BallonsProACTTM; Prostatectomie radicale
Résumé
Introduction.—L’inefficacité d’une bandelette sous-urétrale TOMS dans le traitement de l’incontinenceurinairelégèreàmodéréeamèneàrechercherdesalternativesthérapeutiques desecondeintention.IlexistetrèspeudedonnéessurlaposedeballonsACTaprèsbandelette sous-urétrale.
Méthodes.—ÉtuderétrospectivemonocentriquedespatientsayanteuuneposedeballonsACT aprèséchecdebandelettesous-urétraletypeTOMSentre2009et2016.Lecritèredejugement principalétaitunpad-testde24hpostopératoireinférieurà8g.Lescritèressecondairesétaient leportdegarnituresetlesquestionnairestéléphoniquesPGI-Ietéchelle desatisfactionde Likertévaluéslorsdurecueildesdonnées.
Résultats.—Quatorzepatientsontétéinclusavecunsuivimédiande34mois[4—89].Letaux desuccèsétaitde29%(n=4)et57%(n=8)despatientsportaient0ou1garnitureparjour.
Lepad-testmédiandiminuade95g[EI:130]à34g[EI:83](p=0,022),soitunebaissed’un facteurde2,73[1,19—6,29].Quatre-vingt-huitpourcentdespatientsseconsidéraientunpeu mieux,mieuxoubeaucoupmieuxet77%étaientsatisfaitsoutrèssatisfaitsdelachirurgie.
Quatrepatientsontétéréopérés(28%):3pourmigrationoudéflationd’unballon(n=2)et 1pourimplantiond’unsphincterartificiel.
Conclusion.—LesballonsACTpermettentuneaméliorationsignificativedelacontinenceaprès échec de bandelette sous-urétrale et peuvent être proposés chez des patients fragiles en secondeintention.
Niveaudepreuve.— 4.
©2017ElsevierMassonSAS.Tousdroitsr´eserv´es.
Introduction
Stress urinary incontinence (SUI) is one of the major complicationsafterradicalprostatectomy.Itsprevalenceis hardtodefinepreciselybutseemstorangefrom4%to31%
atoneyearpost-prostatectomyowingtonopaddefinition [1]. Although artificialurinary sphincter (AUS)is the gold standardformoderatetoseveremaleSUI,thereisnostrict recommendation for treating mild to moderate SUI. Male fixedoradjustableslingmightbeproposedtothepatients alongwithbulkingagent[2].I-STOPTOMShasshowngood improvementfor mild tomoderate incontinencewith87%
ofpatientsreportedimprovement[3].However,thereisno strongrecommendationforsecondline therapyaftermale slingfailure,whichcanoccurin13%ofcases[3].Periurethral bulkingofferstemporaryreliefofcontinencesymptomsand regenerativetherapiesneedfurtherinvestigationandlong- term studies in men [4]. ProACTTM device is an efficient
technique,whichshowedgoodresultsinfirstline therapy afterradicalprostatectomy[5].Onlyonestudyhasreported efficacyofProACTTMdeviceaftermaleslingfailure[6].Our aimwastoreportuseofProACTTMdeviceafterI-STOPTOMS failureforpost-radicalprostatectomyurinaryincontinence (PRPUI).
Methods
Study population
It is a retrospective study of all patients, with post- prostatectomyorpost-ablathermurinaryincontinence,who choosetobeimplantedwithaProACTTMdevice(Uromedica, Inc.,MN,USA)afterI-STOPTOMSfailureinatertiaryrefe- rencecenterbetweenMay2009andFebruary2016.I-STOP TOMSfailurewasdefinedaspersistenceofleakmorethan
8gper24hormorethanonepadperdayanddesireofthe patientstohaveanothertreatment.Allpatientsgavewrit- teninformedconsenttoparticipateinthestudy.Giventhe retrospectivenatureofthestudyandtheabsenceofexper- imentalarm, thework wasconductedin accordancewith theprovisionsoftheDeclarationofHelsinki.
Intervention technique
Thedeviceimplantationwasperformedundergeneralanes- thesiainoutpatientprocedurewithslightdifferencesfrom previously described technique [6]. Patients were oper- ated in dorsal lithotomy position and the bladder was filled with 200mL of contrast solution (Omnipaque 350).
A rigid cystoscopy was done to check bladder neck posi- tion on concomitant fluoroscopy. Two cutaneous incisions weremadebilaterally,mediallytotheischiaticrami.TheU- channeledsheathwasintroducedthroughtheincisionand directedtoward the bladder neck under fluoroscopic and fibroscopiccontrol.Balloonwasplacedjustbelowtheblad- derneck,laterallyclosetotheurethralwall.Thetrocarwas thenremovedandtheballoonwasinsertedinthesheathto theareabelowthebladderneckandimmediatelylaterally tothe urethra.Thisstepwascontrolledbyfluoroscopyas aradiopaquemarkerwasat the topof theballoon. Once theballoonplacedingoodposition,theU-shapesheathwas withdrawnandtheballoonrefilledwith0.5mLofcontrast (omnipaque350,73%)andsterilewater(27%).Thesamepro- cedurewasdoneintheotherside,symmetrically.Finally,a bluntdissectionwasperformedtowardthescrotumtoplace theballoonportsundertheskin.Nourinarycatheterwasput attheendoftheprocedure.Thepresenceofmaleslingdid notaffectsurgicaltechnique.Allpatientsweredischarged atday1andwereseen at1monthtoinflateballoonwith 1mLofcontrastsolution.Ifneeded,complementaryfilling oftheballoonwasdone1mLby1mL,onetimepermonths untilfullcontinencewasachievedoruntilthelimitof8mL.
This fillingwasmade througha percutaneous injectionin eachscrotalport.
Preoperative evaluation
Allpatientswereclinicallyevaluatedpriortosurgerywith physicalexamination,padcountanda24hpad-test.
Postoperative evaluation
Patientswereseen at every inflationwitha pad-test and every 6 months afterward. Patient Global Impression of Improvement(PGI-I)andafive-pointLikert scale satisfac- tion(0unsatisfied, 1 norunsatisfied, norsatisfied,2 mild satisfaction, 3 satisfied, 4 very satisfied)evaluation were madebytelephonicquestionnairewhencollectingthedata.
Objectivesuccesswasdefinedasapad-testlessthan8gper dayandsubjectivesuccess,whenpatientneededlessthan onepadperdayoruseonlyonepadforsecurity.
Statistical analysis
A student test for paired data with logarithmic transfor- mation wasconducted tocompare pre and postoperative values.
Table1 Baselinepatientscharacteristics.
n 14
Medianage(years) 69[60—79]
Pathology 13prostatectomy
1ablatherm Previousurethralsurgery 1
Radiotherapy 1
Mediantimebetweensurgeryand TOMS(months)
21[5—44]
Medianpad-testbeforeTOMS(g) 175[40—380]
MedianpadperdaybeforeTOMS 2[1—3]
MediantimebetweenTOMSand ProACTimplantation
14.2[3—65]
Medianpad-testbeforeProACT(g) 95[15—330]
MedianpadperdaybeforeProACT 1[0—3]
Results
Baseline characteristics
Fourteenpatientswereincludedinthestudy.Baselinechar- acteristics are listed in Table 1. No patients had severe incontinence. Onepatient (7%) had twointernal urethro- tomyandoneurethralstenosisexcisionbyperinealsurgery before TOMSTM implantation for stenosis of the uretro- vesical anastomosisandone patient(7%)had past history ofradiotherapyafterprostatectomy.
Postoperative evaluation
Allpatientswereseenatonemonthtoinject1mLineach balloon. Atthe endof follow-up,mean volumeofadjust- ment was 4mL [2—7.5].Median follow-up was34 months [4—89]withamedianpad-testof34g[4—300]evaluatedat lastfollow-up.
Objectivecurewas29%(n=4)andsubjective curewas 57% (n=8) after ProACTTM device implantation. Objec- tive curewas achievedwithina mean timeof 12 months [0.9—23.3] and a mean volume of adjustment of 3.1mL [2—4.5].Medianpad-testdecreasedfrom175g[interquar- tilerange(IQR):180]to95gafterI-STOPTOMSimplantation [IQR:130]and34g[IQR:83]afterProACTdeviceimplanta- tion(cf.Fig.1).ProACTTMdeviceimplantationsignificantly decreasedmedianpad-testfromI-STOPTOMSimplantation byafactor2.73[1.19—6.29],P=0.022.Thedifferencewas alsosignificantcomparetopost-prostatectomymedianpad- test,P=0.0017.
Threepatients(21%[CI95:5%—51%])worsentheirconti- nenceafterProACTdeviceimplantation.Allthosepatients had an initial 24h pad-test above 250g.Results of Likert scaleandPGI-IquestionnairesaredescribedinFigs.2and3.
Ofninepatientswhoanswered,8(88%)werefeelingalit- tlebetter,muchbetteror verymuchbetterattheend of follow-upand7(77%)weresatisfiedorverysatisfiedabout thesurgery.Onepatient(12%),notsatisfiedwiththesurgery, waswaitingforAUSdeviceimplantation.Ofthefivepatients whodidnotanswer,twowereobjectivelycontinentatlost to follow-up while one had had an AUS implanted after- ward.The tworemaininghadapad-test of70gand300g respectivelyatlosttofollow-up.
ProACT deviceimplantationaftermaleslingfailure 1101
Figure1. Twenty-four-hourmedianpad-testevolutionaftereach procedure.
Figure2. PostoperativePGI-Iquestionnaire.
Figure3. PostoperativesatisfactionLikertscale.
Reoperation rate was 28% (n=4),supplementary Table 1.Twopatients hadmigrationoftheballooncaudally and one had his left balloon spontaneously deflated. Among them, onehadpast history ofradiotherapy.All threehad theirballoonchangedandrefilled.The fourthpatienthad
apostoperativepad-test at 260gandwasimplanted with an AUS device. He achieved continence with a median follow-up after implantation of 13 months. The patient who had previous radiotherapy failed to achieve conti- nenceandwasproposedforAUSdeviceimplantationatlast follow-up.
Discussion
ProACTTMdevicecan beproposedaftermaleslingimplan- tation with satisfaction rate as high as 77% and a 54%
rateofsubjective,afteramedianfollow-upof34months.
Aftermaleslingfailure,ProACTTMdeviceimplantationmight decrease 24h pad-test by a factor 2.73. We present the largestseriestodateofProACTTMdeviceimplantationafter failureofmaleslingI-STOPTOMS.
Anotherstudyhas shown66% ofsuccess withProACTTM device aftermale sling implantation (2 Invance,9 I-STOP TOMS,9Advance). Thisdifferencemaybecaused bydef- initionoffull continence,which ismorerestrictive inour study(pad-test<8g/24hversusoneornopaduse)[6].
HowProACTTMcanimprovecontinenceandhowitsasso- ciationwithI-STOPTOMScouldenhancecontinence isnot fullyunderstood, even ifan increase in urethralpressure seemsa possibleexplanation.MRIimagingstudiesshowed thatimportance of PPI(post-prostatectomy incontinence) was correlated with the periurethral fibrosis [7] and the membranousurethrallength(whichisthedistancebetween bladder neck and the penile bulb). Other urodynamic studies after radical prostatectomy (RRP) demonstrated that urinary incontinence after RRP was associated with adecrease in maximum urethral closure pressure(MCUP) andfunctional profile length (FPL) and that low preoper- ative value of MCUP and FPL were associated with and increasedrisk of postoperative incontinence [8]. In a lit- eraturereview,DubbelmanandBosch[8]showasignificant decreaseofthe functionalurethrallength afterRRP from 5.0cm (range 4.3—6.1cm) at baseline to 2.6cm (range 1.6—3.1cm)postoperatively(range2—10monthsafterRRP).
Inthisarticle,theyalsofoundamediandecreaseofMCUP from73cmH2O(49—95cmH2O)to56cmH2O(30—83cmH2O) postoperatively. In another study, 6months after radical prostatectomy,they observed that patients who regained continencehadasignificantlyhighermedian MUCPbefore and after operation as compared to incontinent patients [9]. Reuvers et al. in 2016 showed a significant eleva- tionofMCUPandFPLinpatientssuccessfullytreatedwith ProACTTM device [10]. Patients who were fully continent hadahighergainofMUCPcomparetootherpatientsfrom 58cmH2O preoperatively (47—71) to 79cmH2O (56—136).
MeanFPL was2.9cm(2.4—5.2)preoperatively and4.3cm (3.2—5.5)postoperatively.However,thechangesinFPLwere not significantly different between successful and unsuc- cessful groups but this could be due to the insufficient amountof patientsinunsuccessful group(n=4).This sug- gests that ProACTTM device could obtain continence by increasingstaticurethralpressure.
TheI-STOPTOMSseemstoactinasimilarway.Rehderand Gozzi[11]showedinfivepatientsthattransobturatorsling modified significantly MCUP from 13cmH2O to 86cmH2O postoperativelyandthatFPLincreasedfrom3mmto17mm.
Thereisnostudythatevaluatesurethralpressureprofile inpatientsimplantedwithbothI-STOPTOMSandProACTTM device.However,thedevicesareplacedinadifferentposi- tion around the urethra. By increasing urethral pressure attwodifferentlocations,thisassociation mayleadtoan increaseinFPLthatcouldleadtocontinence.Furthermore, the position of the device is not the same, the transob- turator sling producing a sub-urethral compression while balloonsareplacedlaterallytotheurethra.Althoughthis ideaisattractive,itcannotfullyexplaincontinenceinthese patients because some successfully treated patients with ProACTTMdevicedidnothavesignificantmodificationatthe dynamicurethralpressureprofile[10].
Another explanation of success is the compression of theurethra toward thepubic bone asshown incadaveric patients[11].However,thiswasnotshownafterprostatec- tomywherefibrotictissuemayhamperthisphenomenon.
Some authors [6] have suggested that the association of ProACTTM device after male sling could be an alter- native for severe incontinence in patients not eligible to AUS with three out of four patients being fully conti- nent at the end of follow-up in their study. In our study of fourteen patients with severe incontinence, threehad their continence worsenafter ProACTTM device implanta- tion.Those patientshadinitial pad-testsuperiorto250g.
Continence after prostatectomy is the result of a frag- ileequilibrium,which implieslevatorani muscle,intrinsic sphincterandfibroticconnectivetissue.Weshouldbeaware thatcontinencesurgerymightalteroneoftheseelements andhampers continenceasshown for twopatients inour study. Indications must be put precociously and patients warnedofapotentialworseningofcontinence andunpre- dictableoutcomes.
Furthermore,reoperation(28%)rateofProACTTMdevice implantationaftermaletransobturatorslingmatches with thoseoftheliteratureofProACTTMfirstlinetherapy[12,13].
There does not seem to be an increasing morbidity in this second line therapy nor than technical difficulties in theProACTTMdevice implantation.Furthermore,ProACTTM deviceafterI-STOPTOMSdoesnotseemtohamperanother continence surgery, suchasSAU asshown in one patient.
Other studies [14] have shown same results in patients treatedbySAUinfirstlinetherapyoraftermaleslingfailure.
We are aware of the limitations of our study. It is a monocentric,retrospectivecohortwithnourodynamicdata.
Populationisheterogeneous, whichmight haveinfluenced theoutcomeandPGI-Iisanon-specificquestionnairethat mightnotreflecttheimprovementofthegiventreatment.
Furthermore,wedidnotseekforurgeurinaryincontinence afterProACTTMdeviceimplantationwhichmightberespon- sibleofpersistentleakage.However,thisstudyshowsthata combinedtherapyispossibleandthatfailureofI-STOPTOMS couldbemanagedwithProACTTMdeviceimplantation.
ProACTTM is a safe treatment that can be used as an alternative to AUS device implantation, in second line therapy after transobturator male sling for post- prostatectomy incontinence with high satisfaction rate for selected patients. Patients who had severe inconti- nence(especiallypad-test>250g)mustbeinformedbefore ProACTTM device implantation of a possible worsening on continence.
Author’s contribution
Allauthorscontributetothisarticlebydraftingandrevising thearticlecriticallyforimportantintellectualcontent.
PrJean-NicolasCornudidfinalapprovaloftheversionto bepublished.
Disclosure of interest
Theauthorsdeclarethattheyhavenocompetinginterest.
Appendix A. Supplementary data
Supplementary data associated with this article can be found, in the online version, at http://dx.doi.org/
10.1016/j.purol.2017.08.001.
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