Emptying cystometry: A feasibility and validation pilot study on female patients

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ORIGINAL ARTICLE

Emptying cystometry: A feasibility and validation pilot study on female patients

Cystomanométrie de vidange : une étude pilote de faisabilité et de validation dans une population féminine

C. Chesnel

^a^,^b^,∗

, A. Charlanes

^a^,^b

, A. Declemy

^a^,^b

, F. Le Breton

^a^,^b

, J. Kerdraon

^a^,^c

, S. Sheikh Ismael

^a^,^b

, G. Amarenco

^a^,^b

aGREENGRC-01UPMC(GroupofclinicalResearchinNeuro-urology),SorbonneUniversity, Paris,France

bDepartmentofNeuro-urology,TenonHospital,AP—HP,4,ruedelaChine,75020Paris, France

cDepartmentofPhysicalMedicineandRehabilitation,KerpapePloemeurHospital,Ploemeur, France

Received27December2017;accepted13June2018 Availableonline14July2018

KEYWORDS Urodynamics;

Urinarybladder;

Overactive;

Botulinumtoxins;

Cholinergic antagonists

Summary

Introduction.—To assess the feasibility and the accuracy ofemptying cystometry in order tosimplifythe manometric follow-upof overactivedetrusorinneurological patients under anticholinergicorbotulinumtoxininjections.

Material.—Femalepatientswithastabledetrusorunderwentbothaconventionalcystometry andsequentialmeasurementsofbladderpressureduringemptying(emptyingcystometry).At theendofthestandardcystometry,aCH12urinary catheterwasintroducedinthebladder andwasconnectedtoathree-waystopcock.Thesecondwayofthestopcockpermittedthe emptying.Thethirdwayofthestopcockwasconnectedtoaverticalgraduatedtubetomeasure thebladderpressureeach50mLduringthebladderemptying.

∗Correspondingauthor.DepartmentofNeuro-urology,TenonHospital,AP—HP,4,ruedelaChine,75020Paris,France.

E-mailaddresses:[email protected](C.Chesnel),[email protected](A.Charlanes),[email protected](A.Declemy), [email protected](F.LeBreton), [email protected] (J. Kerdraon),[email protected] (S.Sheikh Ismael), [email protected](G.Amarenco).

https://doi.org/10.1016/j.purol.2018.06.008

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Results.—Elevenfemalepatientswereincluded(meanage:59.4years).Ninepatients(82%) hadneurogenicbladder.Meancystometriccapacitywas439mL(SD:35mL).Duringtheemp- tyingcystometry,8to10measuresweretaken(mean:9.4).Themeandetrusorpressurewas 1.7cmH2O(SD2.1)fortheﬁllingcystometryand2.3cmH2O(SD:2.7)fortheemptyingcystome- try.Theagreementbetweenthedetrusorpressurebetweenthetwocystometrieswasgoodwith intra-classcorrelationcoefﬁcientat0.66[0.48—0.77]—andthecorrelationwashigh(r=0.7;

P<0.000001).

Conclusion.—Inasmall,selectedsampleofpatients,emptyingcystometry providessimilar results of detrusor pressure to ﬁlling cystometry. This technique could constitute a home monitoringofbladderpressuresinaselectedpopulationofpatientswithintermittentcatheter- izationinwhomamanometricfollow-upofdetrusoroveractivityisrequired.

Levelofevidence.—4.

MOTSCLÉS Urodynamique; Hyperactivité détrusorienne; Toxinebotulinique; Anticholinergiques

Résumé

Introduction.—L’objectifdecetteétudeestd’évaluerlafaisabilitéetlavaliditéd’unecystom- anométriedevidangeaﬁndesimpliﬁerlesuivimanométriquedespatientsneurologiquesavec undétrusorhyperactifettraitésparanticholinergiquesouinjectionsdetoxinebotulinique.

Matériel.—Les patientes ayant un détrusor stable ont bénéﬁcié d’une cystomanométrie conventionnelleet demesuresséquentielles dela pressionvésicaleaucours dela vidange (cystomanométriedevidange).Àlaﬁndelacystomanométriestandard,unesondeurinairede CH12connectéeàunrobinetàtroisvoies,étaitintroduitedanslavessie.Ladeuxièmevoiedu robinetétaitconnectéeàuntubegraduéverticalmesurantlapressionvésicaletousles50mL vidangés.

Résultats.—Onzepatientesd’âgemoyen59,4ansontétéincluses, neuf(82%)avaientune vessieneurologique.Lacapacitécystomanométriquemoyenneétaitde439mL(SD:35mL).

Aucoursdelacystomanométriedevidange,8à10mesuresontétérelevées(moyenne:9,4).

La pressiondétrusorienne moyenne étaitde 1,7cmH2O(SD:2,1)pour la cystomanométrie conventionnelleetde2,3cmH2O(SD:2,7)pourlacystomanométriedevidange.L’accordentre lespressionsdétrusoriennesaucoursdesdeuxcystomanométriesétaitfortavecuncoefﬁcient decorrélationintra-classeà0,66[0,48—0,77]ainsiqueleurcorrélation(r=0,7;p<0,000001).

Conclusion.—Dansunpetitéchantillondepatients,lacystomanométriedevidangepermetune mesuredepressiondétrusoriennesimilaireàlacystomanométriederemplissage,cequipourrait constituerunmoyendecontrôledespressionsendovésicalesàdomicilechezdespatientssous autosondagesnécessitantunsuivimanométriquerégulier.

Niveaudepreuve.— 4.

Introduction

Bladderpressureassessmentisnecessaryforthediagnosis, theprognosticassessment andthemanagement ofneuro- genicbladder[1,2].Highbladderpressuresincreasetherate of urological complications andmortalityin patients with neurogenicbladderandthusmanytreatmentsareproposed inordertoimprovebladdercomplianceandreduceuninhib- iteddetrusorcontractions(anticholinergicdrugs,botulinum toxininjections,cystoplasty,sacralneuromodulation,beta- 3-agonist,posteriortibialnervestimulation)[3].

Clinicaldata,symptomsscales,qualityoflifequestion- naires, renalultrasound,biologicaltests ofrenal function andurodynamicsareusedtocontrolthetreatmentefﬁcacy

of neurogenic lower urinary tract dysfunction [4]. Filling cystometry is the usual way to record bladder pressure.

Urodynamictechniquesusingexternalpressuretransducers connectedtothepatientwithfluid-filledlinesarerecom- mended[1].Thismultichannelcystometryisperformedina specializeddepartmentwiththeinconvenienceofdelaysfor appointmentsandcostoftheurodynamicassessment.More- over, onlysome parametersare importantand takeninto accountinthefollow-upoftheseneurogenicbladders:bladder capacity, bladder compliance and maximum detrusor pressureat the endof the fillingphase.All theseparam- eters can be recorded by means of a self-assessment of bladderpressureathomewithaverysimpledevicemadeof (1)aintermittentcatheter;(2)athree-waystopcock;(3)a

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simplegraduatedtube.Thisdevicehasinfactbeenusedin thepasttoperformcystometry,inparticularintheelderly subject[5].Such adevice should providea monitoring in changesinbladderpressureinordertoinitiateadjustments intreatmentsoonerthanwouldbeachievedwhenpatients areevaluatedperiodically,butlessfrequently,intheneuro- urology department.The early detection of high detrusor pressuresmayavoidbladderdeformation,reﬂuxandupper urinarytractdeterioration.Moreover,thehomecontrolof appropriate bladder pressure may improve the patients’

qualityoflifebyreducingtheconstraintlinkedtothetime- consumingspecializedfollow-up.

Inthisstudywetestedareversesinglechannelcystom- etryperformed just aftera classical fillingcystometry by meansofadeviceallowingserialbladderpressuremeasure- mentsduringbladderemptying.Theaimofthisstudyisto assessthefeasibilityand theaccuracyof sequential mea- surementsofbladderpressureduringbladderemptyingand tocompare theevalution of bladder pressures duringthe emptyingphase withthe bladderpressures recordeddur- ingthefillingphase.Ifreversecystometryis feasible,the manometricfollow-upofoveractivedetrusorinneurological patientsunderanticholinergicorbotulinumtoxininjections couldbesimplified.

Materials and methods

Thisstudy wasconductedprospectivelybasedonthe urodynamic evaluation in a neuro-urology department of a UniversityHospitalinJanuary2017.Elevenfemalepatients underwent both a conventional supine multichannel cystometry with isotonic saline infused at 50mL/min (ﬁlling cystometry),complying withthe InternationalContinence Society (ICS) recommendations [1] and sequential measurements of bladder pressure during bladder emptying (emptyingcystometry).Patientswithdetrusoroveractivity duringthestandardcystometrywereexcludedforthispre- liminarystudy.

The emptyingcystometrywasconductedat the endof the standard cystometry when the maximum cystometric capacity was reached. The maximum cystometric capac- itywasdeﬁned,accordingtoICSrecommendation,asthe volume at which the patient feels he/she can no longer delaymicturition(hasastrongdesiretovoid)[6]orifblad- derpressurewas>60cmH2Oor if500mLhavebeen ﬁlled.

Afterreachingthemaximumcystometriccapacityandwhen the ﬁlling was stopped, the order to void was given to the patient.If no micturition was obtained (patient with intermittent catheterization only or no possibility of ini- tiating micturition), urodynamic catheter was withdrawn andaCH12urinarycatheterwasintroducedinthebladder accordingtotheusualdepartmentprocedure(usually,this catheterallowstoempty thebladder). This catheterwas connectedtoathree-waystopcock.Thesecondwayofthe stopcockpermittedtheemptyingintoameasuringcontai- ner,graduatedeach 50mL.The thirdwayofthestopcock wasconnectedviaatubeextensiontoarigidvertical70cm tube(centralvenouspressureset)graduatedeachcentime- ter.Thezeromarkeroftheverticaltubewassetattheupper edgeofthesymphysispubis(Figs.1and2).

Figure1. Schematicofemptyingcystometrydevice.1:three- waystopcock;2:verticalgraduatedtubetomeasurethebladder pressure;3:measuringcontainer,graduatedeach50mL.

Figure 2. Picture of emptying cystometry device. The green markerindicatesthezerolevelofthebladderpressure.

Formeasuringthebladderpressureatthemaximumcys- tometriccapacity,thevalvewasopenbetweenthebladder andthe graduatedtube, manometricdatawasderived by observingtheriseofthecolumnofﬂuidinthecentimeter scaletube.Then,thebladderwasemptiedof50mLbyopen- ingthetaptodrain.Then,thetapwasreconnectedtothe

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graduatedtubeandthenewpressurewasnoted.Thispro- cedurewasrepeatedevery50mLuntilthebladderhasbeen emptied.Duringtheemptyingcystometry,thepatientswere askedtorefrainfrommicturition.Sincenorectalcatheter wasusedfortheemptyingcystometry,wehypothesizedthat theemptybladderpressurecouldrepresentabdominalpres- sure.Weestimateddetrusorpressurebysubtractingempty bladderpressurefromeachmeasuredpressure,asdoneby Kaeferetal.andAndrosetal.[7,8].

We have compared each bladder pressure measured every50mLduringthe‘‘backwardscystometry’’witheach bladderpressuremeasuredevery50mLfromthemaximum capacityduringtheﬁllingcystometry.

StatisticalanalysiswascarriedoutusingR3.2.3software (RDevelopmentCoreTeam,http://www.R-project.org)and R studio version 1.0.136. Correlation between the two cystometries was evaluated using Pearson’s correlations.

Agreementbetween thedetrusor pressureduring thetwo cystometrieswasevaluated usingaintra-class correlation coefﬁcient(witha95%conﬁdenceintervalcalculatedusing thebootstrapmethod).

Thisstudywasapprovedbyalocalethicscommittee(CPP IdFII,EudraCT/ID-RCB:2015-A00125-44).

Results

Elevenfemalepatients wereincluded. Themean agewas 59.4 years old (SD 10.8 years). Nine patients (82%) had neurogenicbladderand2(18%)hadstressurinaryinconti- nencewithoutneurologicdisease.Duringthestandardﬁlling cystometry,detrusorwasstableforallpatients;meancys- tometriccapacitywas439mL(SD35mL)(Table1).

Duringtheemptyingcystometry,8to10measureswere taken(mean9.4).Nosensationparameterwasassessed(ﬁll- ingsensation,desiretovoid).

The meandetrusorpressurewas1.7cmH2O(SD2.1)for theﬁllingcystometryand2.3cmH2O(SD2.7)fortheemp- tyingcystometry.

Table1 Descriptionofthepopulation.

Mean(SD) n(%)

Age(years) 59.4(10.8)

Gender

Female 11(100)

Pathology

Multiplesclerosis 4(36)

Cervicarthrosismyelopathy 1(9)

Caudaequinasyndrome 1(9)

Otherspinalcordinjury 2(18)

Amytrophiclateralsclerosis 1(9) Stressurinaryincontinence 2(18) Neurogenicbladder

Yes 9(82)

Detrusoractivityundertreatment

Stable 11(100)

Cystometriccapacity(mL) 439(35) SD:standarddeviation;mL:milliliter

Theagreementbetweenthedetrusorpressurebetween thetwocystometrieswasgoodwithintra-classcorrelation coefﬁcient(ICC)at0.66[0.48—0.77].Thedetrusorpressure measureswerehighlycorrelatedr=0.7(P<0.000001).

In the population of patients with neurologic disease, the agreement between the two cystometries remained goodwith intra-class correlation coefﬁcient (ICC) at 0.65 [0.43—0.78].The detrusorpressure measures were highly correlatedr=0.71(P<0.000001).

Discussion

Choice of single channel cystometry

Weperformsimple cystometrywithﬂuidcolumnpressure measurementtovalidate theemptying cystometry.Single channelcystometry,inoppositionwithmultichannel(elec- tronic) cystometry, has been performed for years [5,9].

Singlechannelﬁllingcystometrywasespeciallyusedingeri- atricpopulationtoreconciletheneedtoimproveaccuracy ofdiagnosiswiththeimpracticalityorrelativeinaccessibil- ityinmany centersofmultichannelcystometry[5,10,11].

Ingeriatric population, Fonda et al.and Ouslander etal.

comparedsimplecystometrytomultichannelcystometryfor thediagnosisofdetrusoroveractivity[10,11].Thesensitiv- ityof simple cystometry was75% and the speciﬁcity was calculatedbetween79and88%[10,11].Inapopulationof middle-agedwomenwithurinaryincontinence,thesensitiv- ityofsinglecystometrywas100%andthespeciﬁcitywas83%

forthedetrusoroveractivitydiagnosis[12].Inthepresent study,the choice of single cystometry wasguided by the simplicityoftherealizationandthepossibilityofhomeper- forming.

Emptying cystometry validation

Emptyingcystometryprovidessimilarresultsof estimated detrusor pressure to ﬁlling cystometry, with high correlation and a good agreement. These results showed the goodmeasurementofdetrusorpressureduringtheempty- ing cystometry. Since all patients have a stable detrusor, thispreliminarystudydoesnotallowtheconclusionabout diagnostic performance for detrusoroveractivity. Compli- ance value can be calculated with data of the emptying cystometries,whichisanimportantparameterforthefol- lowingofneurogenicbladder.Moreover,thestudyincluded womenonly.Theemptyingcystometrymustbefurtherstud- ied in a male population with detrusor overactivity and withreducedbladder compliance.Furthermore,sensation parameterswerenotstudied.Thecystometrycurvecanbe reconstituted,inmirror,withalargersamplingofmeasures (Fig.3).

Thus, usual parameters used to evaluate manometric conditionsandtheir evolutionsin thefollow-up of neurogenic bladder, are taken into account: bladder capacity, bladdercompliance,anddetrusorpressureattheendofthe ﬁllingphase.However,thepresence(andtheamplitude)of uninhibiteddetrusorcontractionbetweeneach50mLcould be missed (whereas detrusor contractions at the precise moment of each 50mL can be noted by the observation oftherisevariationofthewatercolumninthegraduated

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Figure3. Cystometriescurvesinpatient1.Standarddeviation(SD)forpressuresmeasuresduringﬁllingcystometry=0.5cmH2O.SDfor pressuresmeasuresduringemptyingcystometry=1.1cmH2O.

tube).Inaddition,abdominalstraincanbemissedbythis technique.

The emptying mode (sudden emptyingof 50mL) could bias the bladder pressure measurement because of the implicationofvelocityonelasticity ofdetrusor[13,14].In ourstudy,thespeedoftheemptyingisabout300mL/min,it was250mL/minfastertheﬁllingat50mLduringthestan- dard cystometry [15]. A wrong estimation of the bladder pressuremeasurementmayresultofthisfastemptyingof thebladder.However,inourstudythemeandetrusorpres- sureduringtheemptyingwasgreaterthanduringﬁlling.

Interest of emptying cystometry

The emptying cystometry could be performed at home by the patient with intermittent catheterization by himself/herselforbyacaregiver.Performingemptyingcys- tometry could be difficult for some neurologic patients and should be used in a selected population of patients withprior learning in specialized department. The home settingwouldallowmorefrequent measurementstomon- itor changes in lower urinary tract function easily. The treatment adjustments could be initiated sooner in case of inadequate control. This self-urodynamic assessment by means of this emptying/reverse/backwards cystometry, may decrease health care constraint for the patient and reduce socioeconomic cost because of low cost of emptying cystometry. Patients treated by intra-detrusor botulinum toxin injections represent the target popula- tionfor emptyingcystometry in association withperiodic evaluation in neuro-urology, but less frequently. Indeed, these patients are usually under intermittent catheriza- tionand very familiar withcatheters handling. Moreover, the goal of intra-detrusor botulinum toxin injections is to obtain a perfect bladder compliance without signifi- cant variation of the bladder pressure during the filling phase. This self-urodynamic evaluation could provide a decreaseofappointmentdelay.Androsetal.,describeda homebladderpressure monitoringdevice inchildren with myelomeningocele[8].Patients or relativewere asked to

measurebladder pressureeachweek duringthecatheter- ization at fullbladder and emptybladder. Homepressure measurements were consistent with standard cystometry results[8].The patients’compliancewassatisfactory,but the authors concluded that home monitoring of bladder pressure cannotsubstitute standard cystometrybut could becomplementaryinaselectedpopulation.Inspinalcord disease,detrusoroveractivityisfrequentlyphasic.Withthe onlymeasurementofthebladderpressuresbeforeandafter emptying,thereisarisktomissphasicdetrusorcontraction.

In orderto reduce thisrisk, we choseto performfurther pressuremeasurementduringtheﬁlling.Walteretal.per- formedhomemonitoringofbladderpressureandvolumein patientwithspinalcordinjuryandmultiplesclerosis[16].

Only5patientsofthe8enrolledperformedthehomemoni- toring,sothis couldraisean adherenceissue. To fostera better compliance, emptying cystometry could replace a standard cystometry in aselected population of patients.

Furtherstudiesareneededtoassessthevalidityofempty- ingcystometryforbladderoveractivityanditsfeasibilityat home.

Conclusion

Ina small,selectedsample ofpatients,emptyingcystometryprovidessimilarresultsof detrusorpressuretoﬁlling cystometry,butmustbefurtherstudiedbeforeitcouldcon- stituteahomemonitoringofbladderpressureinaselected population of patients with intermittent catheterization.

Emptyingcystometryrepresent forthefuturean interest- ing techniqueto assesslower urinarydysfunction,reduce medico-economicalcosts,appointmentdelaysandcarebur- denforthepatient.

Disclosure of interest

Theauthorsdeclarethattheyhavenocompetinginterest.

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References

[1]SchäferW, Abrams P,Liao L, MattiassonA, Pesce F,Spang- berg A, et al. Good urodynamic practices: uroflowmetry, fillingcystometry,andpressure-flowstudies.NeurourolUrodyn 2002;21(3):261—74.

[2]DrakeMJ,ApostolidisA,CocciA,EmmanuelA,GajewskiJB, HarrisonSCW,etal.Neurogeniclowerurinarytractdysfunc- tion:clinicalmanagementrecommendationsoftheNeurologic incontinence committee of the ﬁfth International Consul- tation on Incontinence 2013. Neurourol Urodyn 2016;35(6):

657—65.

[3]DrayEV,CameronAP.Identifyingpatientswithhigh-riskneuro- genicbladder:beyonddetrusorleakpointpressure.UrolClin NorthAm2017;44(3):441—52.

[4]Nseyo U, Santiago-Lastra Y. Long-term complications of the neurogenic bladder. Urol Clin North Am 2017;44(3):

355—66.

[5]Dennis PJ, Rohner TJ, Hu TW, Igou JF, Yu LC, Kaltrei- derDL.Simpleurodynamicevaluationofincontinentelderly femalenursinghomepatients.Adescriptiveanalysis.Urology 1991;37(2):173—9.

[6]Abrams P,Cardozo L, FallM, GrifﬁthsD, Rosier P, Ulmsten U,etal.Thestandardisationofterminologyoflowerurinary tractfunction:reportfromtheStandardisationSub-committee of the International Continence Society. Neurourol Urodyn 2002;21(2):167—78.

[7]KaeferM,RosenA,DarbeyM,KellyM,BauerSB.Pressureat residualvolume:ausefuladjuncttostandardﬁllcystometry.

JUrol1997;158(3Pt2):1268—71.

[8]Andros GJ, Hatch DA, Walter JS, Wheeler JS, Schlehahn L, Damaser MS.Homebladder pressure monitoring inchildren withmyelomeningocele.JUrol1998;160(2):518—21.

[9]AbramsP,BlaivasJG,StantonSL,AndersenJT.Thestandard- isation of terminology of lower urinary tract function. The International ContinenceSocietyCommittee onStandardisa- tionofTerminology.ScandJUrolNephrolSuppl1988;114:5—19.

[10]FondaD,BrimagePJ,D’AstoliM.Simplescreeningforurinary incontinenceintheelderly:comparisonofsimpleandmulti- channelcystometry.Urology1993;42(5):536—40.

[11]OuslanderJ,LeachG,AbelsonS,StaskinD,BlausteinJ,Raz S.Simpleversusmultichannelcystometryintheevaluationof bladderfunctioninanincontinentgeriatricpopulation.JUrol 1988;140(6):1482—6.

[12]SutherstJR,BrownMC.Comparisonofsingleandmultichannel cystometryindiagnosingbladderinstability.BrMedJClinRes Educ1984;288(6432):1720—2.

[13]GrifﬁthsDJ,vanMastrigtR,vanDuylWA,CoolsaetBL.Active mechanical propertiesof the smoothmuscle of theurinary bladder.MedBiolEngComput1979;17(3):281—90.

[14]ValentiniF,NelsonP,PerrigotM.Modélisationmathématique dudétrusoretdelavessiehumaine.Annalesderéadapations etdemédecinephysique,Elsevier1989;32(2):127—35.

[15]Borrini L, Brondel M, Guinet-Lacoste A, Jousse M, Tan E, Amarenco G. Self-intermittent catheterization and voiding duration:invitro ﬂowrate assessmentofcathetersusedin self-catheterization.ProgUrol2012;22(8):482—6.

[16]Walter JS, Wheeler JS, Markley J, Chintam R, Blacker LM, DamaserMS.Homemonitoringofbladderpressureandvolume inindividualswithspinalcordinjuryandmultiplesclerosis.J SpinalCordMed1998;21(1):7—14.