Treatment of benign prostate hyperplasia using the Rezum ® water vapor therapy system: Results at one year

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ORIGINAL ARTICLE

Treatment of benign prostate hyperplasia using the Rezum ^® water vapor therapy system: Results at one year

Traitement de l’hyperplasie bénigne de prostate par thermothérapie à la vapeur d’eau (système Rezum ® ) : résultats à 1 an

C. Alegorides

^a^,∗

, M. Fourmarier

^a

, C. Eghazarian

^a

, S. Lebdai

^b

, A. Chevrot

^c

, S. Droupy

^c

aServiced’urologie,centrehospitalierduPaysd’Aix,avenuedesTamaris,13616 Aix-en-Provence,France

bServiced’urologie,CHUd’Angers,49933Angers,France

cServiced’urologie,CHUdeNîmes,34029Nîmes,France

Received13March2020;accepted12May2020 Availableonline18August2020

KEYWORDS Prostate;

Benignprostate hyperplasia;

Rezum^®;

Lowerurinarytract symptoms;

Thermotherapy

Summary

Purpose.—Toreporttheresultsofconvectiveradiofrequency(RF)watervaporthermaltherapy inmenwithlowerurinarytractsymptoms(LUTS)associatedwithbenignprostatichyperplasia (BPH)withone-yearfollow-upevaluation.

Materialandmethod.—Thestudywasconductedin2Frenchhospitals,formenwithmoderate tosevereLUTSsecondarytoBPH,asanalternativetoclassicalsurgerytreatment.Thepre-and postoperativeevaluationofurinarysymptomatologywasbasedontheInternationalProstate SymptomScore(IPSS)questionnaire,measuresofpeakurinaryﬂowrate(Qmax)andpost-void residualvolume (PVR).Erectile andejaculatory functions wereevaluated viatheIIEF5 and MSHQ-ejdquestionnaires.Ratesofretreatmentandcomplicationswerealsoreported.

Results.—Sixty-twooutpatientsincluding8withurinaryretentionweretreated.Themedian preoperativeprostatevolume was47(27—200)mL.At6monthspostoperative,theIPSShad decreasedsigniﬁcantlyby13.9points(68.1%,P<0.001)and,atoneyear,by12points(61.5%, P<0.001).Thequalityoflife(QoL)scoreatoneyearhaddecreasedby3.2points(P<0.001)and theQmaxhadimprovedby6mL/s(P<0.001).Allpatientswithurinaryretentionwereweaned frombladdercatheterization.Noserioussideeffects(>ClavienII)wereobserved.Nocasesof denovoerectiledysfunctionandananejaculationrateof10.8% wasreported. Thesurgical retreatmentrateatoneyearwas2.1%.

∗Correspondingauthor.

E-mailaddress:camille.alegorides@gmail.com(C.Alegorides).

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Conclusion.—Theshort-termresultsareencouraging,withsigniﬁcantefﬁcacyonurinarysymp- tomsandrespectofsexualfunction.Nevertheless,itwillbenecessarytopursuethefollow-up ofthiscohorttoevaluatethemid-termandlong-termevolution.

Levelofevidence.—3.

MOTSCLÉS Prostate;

Hyperplasiebénigne deprostate; Rezum^® ;

Symptômesdubas appareilurinaire; Thermothérapie

Résumé

Objectif.—Rapporterlesrésultatsdutraitementdel’hyperplasiebénignedeprostate(HBP) parlesystèmeRezum^®aprèsunandesuivi.

Matérieletméthode.—L’intervention a été proposée dans 2 centres franc¸ais aux patients ayantuneHBPsymptomatiqueoucompliquée,enalternativeàuntraitementchirurgicalablatif classique.L’évaluationpré-etpostopératoiredelasymptomatologieurinaireaétébaséesurle questionnaireIPSS,lamesuredudébiturinairemaximal(Qmax)etdurésidupost-mictionnel (RPM).L’évaluationdesfonctionsérectilesetéjaculatoireontétébaséessurlesquestionnaires IIEF5etMSHQ-ejd.Lestauxderetraitementetlescomplicationsontétérapportés.

Résultats.—Soixante-deuxpatientsambulatoiresontététraités.Levolumeprostatiquemédian préopératoireétaitde47(27—200)mL.À6moispostopératoire,lescoreIPSSétaitsigniﬁca- tivementdiminuéde13,9points(68,1%,p<0,001)etàunande12points(61,5%,p<0,001).

Àunan,lescoredeQualitédevieaétédiminuéde3,2points(p<0,001)etleQmaxaété amélioréde6mL/s(p<0,001).Touslespatientsenrétentionurinaireontétésevrésdeleur sondevésicale.Aucuneffetindésirablegrave(>ClavienII)n’aétéobservé.Aucunedysfonction érectiledenovoet10,8%d’anéjaculationrétrogradeontétérapportés.Letauxderetraitement chirurgicalàunanaétéde2,1%.

Conclusion.—Lesrésultatsàcourttermesontencourageants,avecuneefficacitésignificative surlessymptômesurinairesetunrespectdelafonctionsexuelle.Néanmoins,lapoursuitedu suividecettecohorteestnécessaireafind’évaluerl’évolutionàmoyenetlongterme.

Niveaudepreuve.— 3.

Introduction

InFrance,medicaltreatmentiswidelyprescribedasaﬁrst lineof treatmentforlowerurinarytractsymptoms(LUTS) relatedtoBPH. However,itsefﬁcacy is limitedover time andsideeffectsarethecauseoftreatmentinterruptionin over15%ofcases[1,2].Theproposedalternativeissurgery toreduceobstructivenatureofprostate[3].

The development in endoscopic techniques has led to a reductionin perioperativemorbidity and hospitalstays.

The efﬁcacy ofthesetechniques onurinary symptomatology has been demonstrated at the expense, however, of adverseeffectsonsexualfunctioningand,particularly,ejaculation[4].Topreserveejaculationandmaintainthequality oflife,especiallyinyoungpatientswhodonotwishtotake dailymedication treatment over a longperiod, theselast fewyearshaveseenthedevelopmentofminimallyinvasive surgicaltechniques(MISTs).Theirevaluationisessentialfor themtobepositionedonthemarketamongthetherapeutic arsenalofurologistscannowpropose.

TheRezum^®system(Bostonscientiﬁc),useswatervapor energytodestroytheadenomatoustissueintheprostate.

Itisanendoscopictreatmentduringwhichthermalenergy obtainedbyradiofrequencyisdeliveredbyconvectiontothe

targetedareas,usingwatervaporasavector.Theefﬁcacyof thisablativetherapyhasbeenvalidatedbyhistologicalstud- iesandmagneticresonanceimaging[5].Nothermaleffect exceedsthetreatmentzonesotheintegrityoftheadjacent structuresisnotcompromised[6].

This system allows the surgeonto visualizeand target the obstructed zones.It is adaptable to all morphologies ofprostate,especiallywhenthereisamedianlobe,which maysometimeslimittheaccessforotherminimallyinvasive techniquesandmedicaltreatment[7].

The treatmentcan beperformedin theofﬁceor asan outpatientprocedure,underlocalanesthesia(LA)orgeneral anesthesia(GA)[8].

ItbringssigniﬁcantfastreliefforBPH-relatedLUTSand an improvementin the qualityof life of patientswith no detrimentaleffectontheirsexlives[9].The efﬁcacyand safetyofthisMISTisbackedupbydatafromseveralstud- ies,whichcontributedtoestablishing criteriafor useand obtainingEuropeanconformancein2013andFDAclearance in2015[10—12].Rezum^® therapyiscurrentlybeingevalu- atedinFrance.

The purpose of this work is to report the results of Rezum^®watervaportherapyonBPH-LUTSandsexualfunc- tionatoneyearoffollow-up.

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Material and methods

The study protocol was validated by the local ethical committee underInstitutional Review Board(IRB)number 19.10.09.

PatientswithinvalidatingLUTSduetoBPHandtreated viatheRezum^®systemwereincludedfromtwocenters(Aix RegionalHospitalandNîmes UniversityHospital) withret- rospective data collection from October 2017 to January 2020.

Inclusion criteria

Rezum^® therapy wasofferedtopatientswithmoderateto severe BPH-relatedLUTS which wasclinically resistant to optimalmedicaltreatment(ineffective,poorlytoleratedor refusedbythepatient)whodidnotwishtoundergoclas- sicalsurgery.Therewerenorestrictionsregardingprostate volumeorconformationinthesepatients.

Preoperative characteristics of patients

The initial evaluation consisted of IPSS questionnaire, clinical examination, PSA-test, diagnostic cystoscopy (if required),aurinarytractultrasoundwithaprostatevolume evaluation, uroﬂowmetry and post-void residual volume (PVR)measurement.Unrodynamictestingwasperformedas required.

Thepresenceofamedianlobewasdeﬁnedbyaprostate protrusionindexofover5mmonprostateultrasoundandan endoscopicappearanceevokingthis.

UrinarysymptomatologywasevaluatedviatheIPSSques- tionnaire. The sexualfunction of sexually active patients wasevaluatedviatheIIEF-5andMSHQ-ejdquestionnaires.

Patients were evaluated preoperatively then at 1month, 3months and/or 6months and 1year. At each consultation,uroﬂowmetrywithPMRmeasurementwasperformed whenever possible. The duration of urinary catheterization, duration of hospitalization, complication rate and re-interventionratewerealsoreported.

Surgical intervention

All the interventions were performed at the outpatients departmentwiththeRezum^®system(Bostonscientiﬁc).

Atthepatient’srequest,theinterventionwaseitherdone underGAorunderhypnosiswithslightsedationifrequired.

Hypnosis was performed by an anesthetist or anesthetics nursetrainedinmedicalhypnotherapy.

Thepatientswerecatheterizedthroughouttheinterven- tionfordurationof3days.

OuroperatoryprotocolisdescribedintheAppendix.

Statistical analysis

The statistical analysis was made after data anonymiza- tion. Preoperatively-measured variables were compared withthosecollectedduringfollow-upusingtheStudentt- test,consideringthatthiswasadependentmatchedsample sinceeachpatientwashisowncontrol.Whendistributionof thevariableunderstudyfollowedalawthatwasnotnormal, theWilcoxon-signedranktest wasused.Athresholdvalue

Table1 Subjectdemographics.

62patients Mean±SD Median(min—max)

Age 64.3±11.9 64(30—90)

Prostatevolume(mL) 54.3±28.4 47(27—200) Priorsurgery 6(9.6%)

Anticoagulation 6(9.6%) Activesexuality 54(87%) Medianlobe 29(46.7%)

PSA(ng/mL) 2.9±2.7 1.7(0.6—9.3) Qmax(mL/s) 11.0±3.4 11(5—18) PVR(mL) 78.9±88.9 52(0—500) IPSSscore 19.9±6.3 21(2—34) MSHQ-ejdscore 8.6±4.9 10(1—15) MSHQBother 2.0±1.7 2(0—5) IIEF5score 19.4±5.5 21(3—25) LUTSseverity

Moderate 19(30.6%)

Severe 35(56.5%)

Retention 8(12.9%)

ofP<0.01wasconsideredassigniﬁcant,tolimitbiasdueto analysisrepetition.

Results

Atotalof65patientsweretreatedwiththeRezum^®system by 3urologistsin2 Frenchhospitals.The practitioners all hadassistanceduringtheirlearningcurve(ﬁrstthreecases) andtheselearningcurvepatientswereallincluded.Three patients were lost from follow-up (4.6%). Among the 62 patientswhocompletedfollow-up,8hadurinaryretention treatedbyindwellingorintermittentcatheterization.

PreoperativedataonpatientsarereportedinTable1.

The 8 patients who had urinary retention were ana- lyzed separately from the 54 non-catheterized patients as, for these patients, we had no reference values for theurodynamic scoresandparametersdue tothembeing catheterized.

Perioperative data

All the treatments were performed without any intraop- erativecomplications. Fiftypatientswereoperated under GA (80.7%) and 12 (19.3%)under hypnosis. Among the 12 patientsoperated underhypnosis,2patientshadhypnosis alone,7hadslightsedationand/orsupplementaryantalgic and3changedovertogeneralanesthesiaforcomfortrea- sons.

Themediandurationoftreatmentwas6minutes(3—19) withamediannumberof5punctures(2—11)pertreatment.

Allpatientsapartfromthreeweredischargedfromhos- pitalonthesameday(4.8%).Amongthesethreepatients, one patienthada hemorrhoidal painand 2patients were retainedforsocialraisons.Themeandurationoftheirhos- pitalizationwas3.6days.

Regardingablation of the urinarycatheteronday four afterprocedure,11% (6/54)ofpatientswhohadnotbeen catheterizedpreoperativelyand50%(4/8)ofpreoperatively

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catheterizedpatientsdidnotresumespontaneousmictions.

Inthesepatients,thetotalmeandurationsofcatheteriza- tionwere10daysand22.5days,respectively.

Postoperative side effects and their frequency are reported in Table 2. No serious adverse events occurred (>ClavienII).

Fourteenpatients(22.5%;14/62)reportednosideeffects attheone-monthfollow-upconsultation(M1).Tenpatients (16%; 10/62) consulted in an emergency before the M1 consultation(3withacuteurinaryretention;6withprostati- tisincluding3casescomplicatedbyacuteurinaryretention and1patientwithhematuriaandclotting).

We reported one case of mixed postoperative urinary incontinencethat regressedat 3monthsafter pelvic-ﬂoor reeducationinapatientaged84yearsoldwithaprevious historyoftransurethralprostateresection.

Between 3months and 6months, two patients sponta- neouslyevacuateda‘‘bladderstone’’afteraseriousepisode ofdysuria.These‘‘bladderstones’’resultedfromcalciﬁca- tionofnecroticdebrisinthebladder.

Functional urinary results

Patients with spontaneous mictions (Table 3)

Fifty-fourpatients wereevaluatedat least oneyear later for41ofthem.

Onaverage,theIPSSdecreasedsigniﬁcantlyby9.7points (48.5%), 11.6 points (59.5%), 13.9 points (68.1%) and 12 points(61.5%) respectivelyat 1, 3,6 and12months com- paredwiththematchedreferenceIPSS(P<0.001).

At oneyear, theQmax hadincreasedby an averageof 6mL/s(58.8%,P<0.001).

Atoneyearoffollow-up,2patientshadresumedalpha- blockerstreatmentandonepatientwasre-operateddueto thepersistenceofLUTSwithanobstructiverightlobeseen on the endoscopy. This patient underwent Holmium laser enucleationoftheprostatewithoutanytechnicaldifﬁculties imputabletohispreviousRezum^® treatment.

Theresultswerealsosigniﬁcantinpatientswithamedian lobe (48.1%;26/54) withahigher meandecrease inIPSS:

−15.4(±7.7)pointsat6months(P<0.001)and−13.3points (±6.5) at 12months (P<0.001), i.e. a mean decrease of 70.9%and66.1%, respectively.The Qmaxhad signiﬁcantly increasedby6.1mL/s(P<0.001).

Patients with chronic urinary retention

The 8 patients with chronic urinary retention, mean age 74.6years(±15.4)withameanprostatevolumeof71.8mL (±38),were all de-catheterized within a median timeof 2weeks(3—40days)aftertheintervention.

Nopatientswerere-catheterizedwithameanfollow-up of15months(3—21)andfollow-up ofat least1year for 6 patients.

Atoneyear,themeanPMRwas90mLandthemeanIPSS was5.8(±2.0).Halfthe patientscontinuedwithmedical treatment (dual therapy). None of them required second surgicaltreatment.

Fourpatients(including2withretention)hadaprostate volume>120cm³. The mean number of punctures was 9 perpatientandthe meandurationofcatheterizationwas 3weeks.Thetreatmentwasineffectiveforonepatient(PV

200mL)and3patients(75%)hadtocontinuewithmedical treatment.

Sexuality

Theratesofsexuallyactivepatientswereidenticalpreop- eratively(90.7%;49/54)andatoneyear(90.2%;37/41).

The IIEF-5 score (19.4±5.5) was not modiﬁed postop- eratively andremained stablethroughout theduration of follow-up(Table3).

At1year,theMSHQscorehadincreasedbyanaverageof 2points(P=0.056).

Outof37patientswhoweresexuallyactiveatoneyear,4 patients(10.8%)reportedadecreaseinejaculatoryvolume and4patients(10.8%)reportedanejaculation.

Amedianlobehadbeentreatedin5ofthese8patients (62.5%).

Discussion

ThiswasthefirststudyreportingaFrenchexperimentusing theRezum^® system totreat BPH.Severalprevious studies hadalreadydemonstratedtheefficacyandsafetyoftreating BPHwithconvectivewatervaporthermotherapybutthese were prospective North American studies with restrictive inclusioncriteria[10—12].Ourstudy seemstoconfirmthe reproducibilityoftheseobservationsonaFrenchpopulation incurrentpractice.

Theresultsofourstudyclearlyindicateareliefinurinary symptomatology,withasigniﬁcantimprovementintheIPSS andQOLwhosevalueshaddecreasedbyover60%onaverage atoneyear.Theurodynamicparametershadalsoimproved withanotablemeangainof6mL/sontheQmax.

Attheendofthestudy,78.8%ofpatientshadanimprove- ment in their IPSS of at least 8 points, indicating a good response[13],68%ofpatientshadaQmaxofover15mL/s and95% ofnon-catheterized patients and 50%of patients catheterized preoperatively were weaned from all treatment.Onlyonepatientrequiredanewintervention.

Theseresultsatthebeginningoftheexperimentconﬁrm thedatafromthepilotstudybyDixonetal.[10].

McVaryetal.andRoehrbornetal.recentlyreportedthe resultsofaprospectiverandomizedcontrolledtrial(RCT), comparingtheRezum^®systemon136patientswithasimu- latedinterventionfocusingon61patientswithacrossover at 3-month anda 4-year follow-up. At 3months,the IPSS haddecreased by 10points (±7.1) for the Rezum^® group (n=136)and3.9points(±6.7)forthecontrolgroup(n=61) (P=0.0004),respectively.Inthisstudy,theyreportedamean improvementof51to52.2%ontheIPSSand2to2.2points onQoLaswellasanimprovementinQmaxof5.5to5.9mL/s at1year[11,12].

Whereas ourresults showan improvementidentical to themeanQmax, a greaterimprovement maybe notedin theIPSS and QoL for our sample. This difference maybe explainedbythefollowingpoints:Thepatientsweincluded weremostlypatientswhohadalreadybeeninformedabout theRezum^®systemandhadrequestedthistreatment,which mayhavestrengthenedtheplaceboeffectduetoarecruit- ment bias. Furthermore, in our population, there was a greaterprevalenceofmedianlobe:48.1%against31%inthe

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Table2 Postoperativecomplications.

Adjudicatedadverse event

No.events No.Subjects(%) Clavien—Dindoclassiﬁcation

GradeI GradeII GradeIIIa GradeIIIb GradeIV GradeV

Overactivebladder 14 14 22% 6 8 0 0 0 0

Grosshematuria 11 11 17.7% 11 0 0 0 0 0

Painfulurination 8 8 12.9% 8 0 0 0 0 0

Urinarytractinfection 7 7 11.2% 0 7 0 0 0 0

Urinaryretention 7 6 9.6% 7 0 0 0 0 0

Severedysuria 5 5 8% 3 2 0 0 0 0

Hemospermia 2 2 3.2% 2 0 0 0 0 0

Hemorrhoidscrisis 2 2 3.2% 2 0 0 0 0 0

Bladderstone 2 2 3.2% 0 2 0 0 0 0

Clottinghematuria 1 1 1.6% 0 1 0 0 0 0

Painfulejaculation 1 1 1.6% 1 0 0 0 0 0

Pelvicpain 1 1 1.6% 1 0 0 0 0 0

Urinaryurgency incontinence

1 1 1.6% 0 1 0 0 0 0

Chronicpelvicpain syndrome

1 1 1.6% 0 1 0 0 0 0

Total 63 41 22 0 0 0 0

RCT.Now, it is exactlythesepatients witha medianlobe whoseemtobenefitmostfromthistreatment,bothinour studyandintheliterature[12,14].Also,inourstudyallthe medianlobesidentifiedweresystematicallytreated,which hadnotbeenthecaseinthefirststagesoftheRCTstudy.

ThissigniﬁcantimprovementinLUTSbecameclearright fromtheﬁrstmonth.McVaryetal.showedthattheseresults persistedforupto4yearsaftertheinterventionwitha46.7%

improvementinIPSS,43%inQoLand50%inQmax.

The rate of retreatment is a relevant indicator of the efﬁcacyofsurgicaltreatment.Ourstudyreﬂectsasurgical retreatment rate of 2.1% at 1year. This rate is compara- ble with those in the literature: 2% at 1year for Darson et al. and 3.7% at 2years for Roehrborn et al. [12,14].

IntheRCT, 4.4%ofpatientsweresurgically retreatedand 5.2%resumedmedicaltreatmentwithalpha-blockersafter 4yearsoffollow-up[11].

The 8 patients with complete urine retention were treated with success and were de-catheterized. At the end of follow-up, no patients had been re-catheterized, althoughonepatientintwohadkeptonwithhisdualther- apytreatment.

McVaryet al.usedRezum^® totreat 38patients witha medianageof75.5yearswithBPHcomplicatedbycomplete urineretentionandindwellingcatheterization.Thesewere mostlypatientswithseverecomorbiditieswhowereineli- gibleforclassicalsurgery.Twenty-six(70.3%)ofthemcould bede-catheterized,withinamediantimeof26daysafter surgeryand69%ofthemwereabletointerrupttheirmedi- caltreatment.Therewerenopredictivefactorsofsuccess identiﬁed.Outofthe20patientswithamedianfollow-up of475days(140—804days)onlyonewasre-catheterizedat 2years[15].

TreatmentwithRezum^® couldbeconsideredasathera- peuticoptionforpatientswithBPHcomplicatedbyurinary

retention with indwelling catheterization and, more particularly,for patientswhoaretoofragiletohave classical ablation surgery.Apparently, forthisindication, theduration of postoperative bladder catheterization need to be prolongedby atleast 14days.Longer-termstudieswillbe required todetermine thedurationof efﬁcacyof Rezum^® therapyforthisindication.

Treatmentoflargeprostatevolumes(>120cm³)withthe Rezum^® system turned out to be more complex and less effective, but few patients were included at the start of ourexperiment.The ‘‘REZUMXL’’study[16]willevaluate theresults ofthe approachforthis particularcategory of patients.

Rezum^®therapyisfast,withamediandurationof6minin ourstudy.Itcanbeperformedunderlocalanesthesia(xylo- cainegelandclassicalormodifiedprostateblock)oreven underoral medicationalone[8].Atthestartofourexper- imentwefavoredgeneralanesthesiaandthenweevolved towardssimple,conscioussedationandthenfinallytowards hypnosisaloneforthosepatients whoweremotivated.All ourtreatmentswereperformedintheoperatingroomatthe outpatients’surgerydepartmentandnotintheoffice,for comfortandsafetyreasons.

Our postoperative complications are the same as those related to any endoscopic intervention. Most were resolvedspontaneouslywithintheﬁrst3weeks.Noserious complications(>ClavienII)werenoted.However,theinci- denceofthesecomplicationswashigherinourstudythan in the literature [17] with, notably, twice as much bladder hyperactivity and macroscopic hematuria, and three times more urinary infections and cases of acute urinary retention.Thismaybeexplainedbytheabsenceofpatient selection.Weincludedpatientswithariskofcomplications and previous histories of urological treatment (3 cases of transurethral resection of the prostate, 1 patient who

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Table3 Pairedoutcomesmeasuresafterwatervaporthermaltherapyfrombaselinethrough12months.

Outcomemeasure Baseline 1Mos 3Mos 6Mos 12Mos

No.patients 54 54 54 53 41

IPSS

No.(pairedvalues) 54 50 42 41 41

Mean±SDbaseline 20.0±6.3 20.0±5.8 19.5±5.6 20.4±5.9 19.5±6.1

Mean±SDfollow-up 10.3±5.7 7.9±5.0 6.5±4.2 7.5±4.7

Change±SD −9.7±8.4 −11.6±8.7 −13.9±7.9 −12±8.7

%Change −48.5% −59.5% −68.1% −61.5%

P-value <0.001 <0.001 <0.001 <0.001

QOLIpss

Mean±SDbaseline 4.5±1.0 4.6±0.9 4.5±0.9 4.6±0.9 4.4±1

Mean±SDfollow-up 2.1±1.6 1.5±1.6 1.1±1.4 1.2±1.6

Change±SD −2.5±1.7 −3.0±1.8 −3.5±1.6 −3.2±1.7

%Change −54% −66% −76% −72%

P-value <0.001 <0.001 <0.001 <0.001

Qmax

Mean±SDbaseline 11.0±3.4 10.9±3.4 10.7±3.4 10.7±3.4 10.2±3.7

Mean±SDfollow-up 13.2±5.1 14.5±4.8 16.4±5.1 16.2±5.3

Change±SD 2.4±4.9 3.7±5.4 5.7±5.3 6±4.8

%Change +23.8% +31.8% +53.2% +58.8%

P-value 0.006 <0.001 <0.001 <0.001

RPM

Mean±SDbaseline 78.9±90 78.8±95.7 75.8±92.2 74.6±93.4 73.3±100

Mean±SDfollow-up 24.2±23.7 25.0±35.5 24.8±25.6 16.9±22.5

Change±SD 54.6±92.5 −50.8±82.2 −49.8±76.4 −56.4±89.8

%Change −69% −67% −67% −76%

P-value 0.002 <0.001 0.002 0.002

IIEF-5

Mean±SDbaseline 19.4±5.5 19.3±5.8 19.3±5.8 20.5±5.4 19±6

Mean±SDfollow-up 19.6±5.1 19.8±5.1 20.8±5.2 19.4±5.6

Change±SD 0.3±2.5 0.5±2.6 0.3±3.5 0.4±3.8

%Change +1.5% +2.6% +1.5% +2.1%

P-value 0.5 0.22 0.7 0.54

MSHQ-ejd

Mean±SDbaseline 8.6±5 7.5±5.9 8.3±5.1 9±5 7.9±5.1

Mean±SDfollow-up 5.7±6.9 9.5±5 11.9±2.9 10±3.5

Change±SD −1.8±4.5 1.25±3 2.9±3.7 2.1±4

%Change −24% +15% +30% 26.6%

P-value 0.4 0.21 0.037 0.056

MSHQ-ejdBother

Mean±SDbaseline 2.0±1.7 1.5±1.4 1.9±1.6 2±1.8 2.2±1.7

Mean±SDfollow-up 1.75±1.8 1.2±1.1 0.7±0.9 0.9±1.1

Change±SD −0.25±1 −0.7±1.1 −1.3±1.3 −1.3±1.7

%Change −16.6% −36.8% −65% −57.5%

P-value 0.5 0.1 0.03 0.008

had undergone vapo-enucleation and 1 patient who had undergone transurethral incisionof the bladder neck and prostate),anticoagulanttreatments,largeprostatevolumes or an indwelling catheter. This absence of selection was intentional sothat we could make an evaluation asclose aspossibletothepopulationencounteredindailypractice.

Ourstudynoted4casesofdenovoanejaculation(10.8%

ofsexually active patients at1year) andone decreasein ejaculatory volume noticed by 4 other patients (10.8%).

Ourrateofdenovoanejaculation ishigherthantherates reportedin the literature. The RCT study found nocases of denovo anejaculation but there wasa 2.9% incidence

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of decreased ejaculatory volume at 3-month reduced to 1.5%by3months[17].Intheircrossover study,Roehrborn et al. identiﬁed no decrease in ejaculate in control arm (n=61) and a 1.9% incidence of decreased ejaculatory after the crossover (n=53) [12]. However, our rates are still clearly lower than those reported for the classical medical and surgical treatment of BPH (41.8—76.3%) [18].

Erectile function was not impacted by Rezum^® treatment.The IIEF-5scorewaspreserved postoperativelyand remained stableover time. No cases of de novo erectile dysfunctionwerereported,a conﬁrmedadvantage ofthis approach[5,8,10—12,17].

In the RCT study, the IIEF5 and MSHQ-ejd scores of patientstreated withRezum^® differedneitherfromthose ofthecontrol groupat 3monthsnorfromtheirreference valueatoneyearoffollow-up[19].

This is a preliminary studywhich evaluates the results oftheRezum^®systeminareal-lifesituation.Nevertheless, this study has several limits relatedto a restricted number of patients, a recruitment bias because the patients included mostly wanted this treatment, heterogeneity of the sample and retrospective data collection. Long-term follow-upofourcohortandlarger-scaleprospectivestudies willbenecessarytoconﬁrm theseﬁrstresults.A medico- economic evaluation will also have to be performed to positionthistreatmentwithinthetherapeuticstrategyfor BPH.

Conclusion

Theshort-termresultsofRezum^® treatmentareencourag- ing, with a signiﬁcant efﬁcacy on urinary symptoms, the possibilityoftreatingchronicurinaryretention,respectof the erectile function and conservation of ejaculation as beforein90%ofcases.

Appendix A. Supplementary data

Supplementary data (Appendix) associated with this article can be found, in the online version, at https://doi.org/10.1016/j.purol.2020.05.004.

Disclosure of interest

Theauthorsdeclarethattheyhavenocompetinginterest.

References

[1]Lukacs B, Cornu JN, Aout M, Tessier N, Hodée C, Haab F, et al.Managementof lowerurinarytract symptomsrelated tobenignprostatichyperplasiainreal-lifepracticeinFrance:

a comprehensive population study. Eur Urol 2013;64(3):

493—501.

[2]Roehrborn CG, Siami P, Barkin J, Damião R, Major-Walker K, Nandy I,et al. Theeffects of combination therapy with dutasterideandtamsulosinonclinicaloutcomesinmenwith symptomaticbenignprostatichyperplasia:4-yearresultsfrom theCombATstudy.EurUrol2010;57(1):123—31.

[3]Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Mader- sbacher S, Mamoulakis C, et al. EAU guidelines on the assessment of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol 2015;67(6):1099—109.

[4]Robert G,de laTailleA, DescazeaudA. Traitementschirur- gicaux de l’obstruction prostatique bénigne : standards et innovations.ProgUrol2018;28(15):856—67.

[5]DixonCM,CedanoER,MynderseLA,LarsonTR.Transurethral convective water vapor as a treatment for lower urinary tract symptomatology due to benign prostatic hyperplasia usingtheRezum^®system:evaluationofacuteablativecapa- bilities in the human prostate. Res Reports Urol 2015;7:

13—8.

[6]Mynderse LA, Hanson D, Robb RA, Pacik D, Vit V,Varga G, et al. Rezum system water vapor treatment for lower uri- narytractsymptoms/benignprostatichyperplasia:validation of convectivethermal energy transferand characterization withmagnetic resonanceimagingand3-dimensionalrender- ings.Urology2015;86(1):122—7.

[7]LebdaiS,AmmiM,BigotP,CornuJN,MathieuR,Descazeaud A,etal.Impactenpratiquecliniquedel’indicedeprotrusion prostatiqueintravésicale:unerevuedelalittératureduCTMH del’AFU.ProgUrol2014;24(5):313—8.

[8]Cantrill CH, Zorn Kevin C, Elterman DS, Gonzalez RR. The Rezum system —a minimally invasive water vapor thermal therapyforobstructivebenignprostatichypeplasia.CanJUrol 2019;26(3):9787—93.

[9]McVary KT, Rogers T, Mahon J, Gupta NK. Is sexual function better preserved after water vapor thermal therapy or medical therapy for lower urinary tract symptoms due to benign prostatic hyperplasia? J Sex Med 2018;15(12):

1728—38.

[10]DixonC,CedanoER,PacikD,VitV,VargaG,WagrellL,etal.

EfﬁcacyandsafetyofRezumsystemwatervaportreatment forlowerurinarytractsymptomssecondarytobenignprostatic hyperplasia.Urology2015;86(5):1042—7.

[11]McVaryKT,RogersT,RoehrbornCG.Rezumwatervaporther- maltherapyforlowerurinarytractsymptomsassociatedwith benignprostatichyperplasia:4-yearresultsfromrandomized controlledstudy.Urology2019;126:171—9.

[12]RoehrbornCG,GangeSN,GittelmanMC,GoldbergKA, Patel K, Shore ND, et al. Convective thermal therapy: durable 2-year results of randomized controlled and prospective crossoverstudiesfortreatmentoflowerurinarytractsymp- tomsduetobenignprostatichyperplasia.JUrol2017;197(6):

1507—16.

[13]BarryMJ,WillifordWO,ChangY,MachiM,JonesKM,Walker- CorkeryE,etal.Benignprostatichyperplasiaspeciﬁchealth statusmeasuresinclinicalresearch:howmuchchangeinthe AmericanUrologicalAssociationSymptomIndexandthebenign prostatichyperplasiaimpactindexisperceptibletopatients?

JUrol1995;154(5):1770—4.

[14]Darson MF, Alexander EE, Schiffman ZJ, Lewitton M, Light RA, Sutton MA, et al. Procedural techniques and multicenter postmarket experience using minimally invasive convectiveradiofrequencythermal therapywithRezum system for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. Res Reports Urol 2017;9:

159—68.

[15]McVaryKT,HollandB,BeahrsJR.Watervaporthermaltherapy toalleviatecatheter-dependenturinaryretentionsecondary tobenignprostatichyperplasia.ProstateCancerProstaticDis 2019[ISS1476-5608(online)].

[16]HenryWooM.Minimallyinvasiveprostaticvaporablationfor thetreatmentofBPHinlargeprostates(Rez¯umXL).Noresults posted.ClinicalTrials.gov.

(8)

[17] McVary KT, Gange SN, Gittelman MC, Goldberg KA, Patel K, Shore ND, et al. Minimally invasive prostate convective water vapor energy ablation: a multicenter, randomized, controlled study for the treatment of lower urinary tract symptomssecondaryto benignprostatichyperplasia.JUrol 2016;195(5):1529—38.

[18] MarraG,SturchP,OderdaM,TabatabaeiS,MuirG,Gontero P.Systematicreviewoflowerurinarytractsymptoms/benign

prostatic hyperplasia surgical treatments on men’ s ejaculatory function: time for a bespoke approach? Int J Urol 2016;23:22—35.

[19]McVary KT, GangeSN, GittelmanMC,GoldbergKA, Patel K, ShoreND,etal.Erectileandejaculatoryfunctionpreserved withconvectivewater vaporenergy treatmentofloweruri- narytractsymptomssecondarytobenignprostatichyperplasia:

randomizedcontrolledstudy.JSexMed2016;13(6):924—33.