Title:TransUrethralNeedleAblation(TUNA)-February2002

Agency:MedicalServicesAdvisoryCommittee(MSAC)

CommonwealthDepartmentofHealthandAgeing GPOBox9848CanberraACT2601Australia.

Reference:MSACApplication1014. AssessmentreportISBN0642821000

Aim

Toassessthesafety,effectivenessandcost-effectivenessofTransUrethralNeedleAblation(TUNA)forthe

treatmentofbenignprostatichyperplasia(BPH)andunderwhatcircumstancessuchservicesshouldbe supportedwithpublicfunding.

Conclusionsandresults

Safety

TUNAappearstobearelativelysafeprocedure.RandomisedtrialevidencesuggeststhatTUNAhas

fewerpost-operativecomplications,suchasbleeding,thandoesTURP.Non-randomiseddatasuggests thatapartfromurinaryretention,whichappearsmorecommonwiththeTUNAprocedure,theearly adverseeventrateforTUNAandTURPissimilar.ItisalsolikelythatTUNAresultsinfewer complicationsrelatingtosexualfunctionthandoesTURP.HoweverasTUNAhasalsoevolvedover time,itispossiblethatthenewerTUNAproceduresmayresultinfewercomplicationsthanolder procedures,althoughatthisstagethisremainsunclear.TUNAmayalsobeofvalueinpatientswitha highanaestheticriskasitcanbeperformedasanoutpatientorin-clinicprocedure,againfurther evidenceofthisisneeded.

Effectiveness

Thebodyofevidenceonwhichthisreviewisbasedisrelativelysmall.Overall,TUNAappearstobea relativelyeffectiveprocedurefortheshort-termmanagementofsymptomsassociatedwithbenign prostatichyperplasia.However,datasuggestthatthedurationofmaximumbenefitforTUNAis betweenapproximatelythreeand12months,dependingupontheparametermeasured.Thisdurationof benefitisshorterthanthatseenforpatientstreatedwithTURP(longerthanthreeyears),withmore TUNApatientsthanTURPpatientsexperiencingareturnofBPHsymptomsandmorerequiring retreatmentinthelongerterm.

Costeffectiveness

Adecisionanalyticmodelwasdesigned,basedonasetofplausibleassumptions,toassessthe comparativecost-effectivenessoftwotreatmentstrategies:1)TURP;or2)TUNA,asinitialtreatment forsymptomaticBPH.ThebasecaseanalysisindicatedthattreatingpatientsinitiallywithTURPwas bothmoreeffectiveandlesscostlythantreatinginitiallywithTUNA.Overarangeofsensitivity analyses,thisconclusionvariedfromTURPbeingacost-effectiveinitialtreatmenttoTUNAbeinga cost-effectiveinitialtreatmentforpatientswithBPH.Theanalysiswasparticularlysensitivetothe annualfailurerateofbothprocedures,andsubsequently,tothedurationoffollow-up.Theconclusion regardingoptimalinitialtreatmentchangedovertheplausiblerangesevaluated.Additionalclinicaldata isrequiredtostrengthenourcertaintyconcerningparticularvariablesbeforedefinitiveconclusionscan bedrawnregardingtherelativecost-effectivenessofTUNAandTURPinthissetting.

Recommendation

MSACrecommendedthatinterimfundingforaperiodofthreeyearsbesupported,andthatthisfunding

berestrictedtothetreatmentofparticularpatientsgroupsaswellastheacquisitionofdataonthetype ofpatientstreatedandsafetydatatomonitortheuseofTUNAundertheseinterimarrangements.

Method

TheNHMRCClinicalTrialsCentreattheUniversityofSydneyconductedasystematicreviewofthe

literatureontheroleofTUNA.ThefollowingsourcesweresearchedfromcommencementtoJune2001: Medline,PreMedline,NLMHealthServicesResearchDatabases,BiologicalAbstracts,BestEvidence, AustralianMedicalIndex,CurrentContents,EMBASE,theCochraneLibrary,ISTAHC,andtheNHS Databases,DARE,EEDandHTA.Internetandhealthtechnologyassessmentagencysourcesweresearched; studieswerealsoidentifiedfromMSACapplicationsandmembersoftheSupportingCommittee.

PreparedbyKirstenHoward(epidemiologist)andSallyWortley(researchassistant),NHMRCCTC, Australia.