Urgent PC for OAB 1/ Three Year Follow-Up 2/ Randomised Placebo Controlled Study

Neuromodulazione tibiale:indicazioni, risultati e limitiProf. Enrico Finazzi Agr

Dept. of Urology, Tor Vergata University

Tor Vergata Hospital and IRCCS S. Lucia

Rome, ITALY

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AgendaPercutaneous Tibial Nerve StimulationDefinitionHistoryMechanisms of actionRationaleMethodsIndicationsResultsPlacebo effect? Predictive factors of successWhat happens after 10-12 sessions

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PTNSDefinition

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NeuromodulationNeuromodulation is considered a normal property of the nervous system that regulates or modifies electrical impulses flowing through neural tissues Interventional neuromodulation is considered nondestructive and reversible therapy and includes the use of implanted or nonimplanted electrical stimulation systems, electrically stimulating peripheral nerves, dorsal root ganglia, the spinal cord, or the brain, and chemical neuromodulation, the infusion of chemical agents directly to the central nervous system.

David Abejn MD, Enrique Reig MD, PhD (2003) Neuromodulation 6 (1), 13.

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SISTEMA InterStimNeuromodulazione sacrale

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Neuromodulation technique of the lower urinary tract obtained with electrical stimulation of the posterior tibial nerve

Percutaneous Tibial Nerve Stimulation PTNS

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PTNSHistory

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PTNS : background

Punto noto allagopuntura tradizionale (Sp-6)Vescica

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PTNS : backgroundE difficile urinare mentre si cammina!

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PTNS : backgroundInibizione detrusoriale secondaria a stimolazione delle afferenze mieliniche dallarto posteriore nel gatto

Lindstrom, Neurourol Urodyn, 1989

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PTNS : backgroundTENS del n. tibiale in soggetti con iperattivit detrusoriale neurogena

McGuire EJ, J Urol 1983

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percSANS (Urosurge)(Eur. Urol., 1999)Urgent PC (CystoMedix)Stoller Afferent Nerve Stimulation

Marshall Stoller, MD

Bart BLH Bemelmans, MD PhDPerc. Tibial Nerve Stimulation

Urgent PC (Uroplasty)

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PTNSMechanisms of action

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Mechanisms of actionNeuromodulation is supposed to restore the control at the spinal segmental gate as well as at supraspinal sites such as the brainstem and limbic system nuclei Neuromodulation is suggested to treat overactive bladder by restoring the balance between inhibitory and excitatory control systems, peripherally and centrally

Schmidt R. Neurosurgery 1986; 19: 1041-1044

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PTNS : mechanisms of actionPTNS lowers the mast cells count in the bladder wall of the rat

Danisman A et al: Tibial nerve stimulation diminishes mast cell in the bladder wall induced by interstitial cystitis urine.Scand J Urol Nephrol. 2007;41(2):98-102.

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PTNS : mechanisms of actionElectro-acupuncture of the hind leg significantly reduces c-fos expressionConclusion: electro-acupuncture reduces spinal neuronal cell activity

Chang, Stoller, Lue et al, J. Urol. 1998

Suprapontine effects???

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Suprapontine effects of S3 neuromodulationPETDecrease of activity in areas important for bladder filling sensation and the onset of micturition (middle frontal gyrus, left temporal lobe, the right insula) Blok B: Neurourol Urodyn 2002Increase of activity of primary motor cortical areas associated with abdominal and pelvic floor musculature Blok B: Neurourol Urodyn 2003

Suprapontine effects of S3 neuromodulationLL-SSEPs

In responders pts.: reproducible LL-SSEPs have been demonstrated (in particular on somatosensory cortex).Braun PM. Eur Urol. 2002.

Significativo incremento dellampiezza delle prime due componenti dei LL-SEP (P80, P100)Non significativo incremento della terza componente (P200)

Finazzi-Agr E et al: Neurourol Urodyn. 2009;28(4):320-4.

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ConclusioniModificazione a lungo termine nei meccanismi di elaborazione dello stimolo sensitivo che si verificano dopo larrivo dellafferenza somatosensoriale in cortecciaPrima dimostrazione di un effetto sovra-pontino della PTNSRisultato long lasting (almeno 24h)

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PTNSRationale

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PTNS : razionale

Elettrostimolazione n. tibiale posterioreArea non genitaleStimolazione ambulatorialeStimolazione retrograda (afferente) dei metameri sacrali sino a S3

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PTNS: razionaleN. tibiale posterioreFibre S3flessione plantare alluce (S3)

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PTNSMethods

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PTNS: proceduraPuntura di Sp-6Ago 34 GConnessione dellago allo stimolatore Parametri di stimolazione elettrica fissi eccettoampiezzasino a ottenere una risposta motoria/sensitiva

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PTNS: proceduraTrattamento ambulatorialeUna seduta di stimolazione a settimana30 minutiPeriodo di valutazione: 12 settimane

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Stimolazione 3/w26 pazienti% successo simile a quella della stimolazione 1/wRisultati dopo 6-8 sedute (dopo 2-3 settimane anzich dopo 6-8)Finazzi Agr, Minerva Urologica 2003

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PTNSIndications

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PTNSIndicazioni:Sindrome della vescica iperattiva

Ritenzione urinaria non ostruttivaDolore pelvico cronico Cistite interstizialeVescica neurologicaIndicazioni pediatricheIncontinenza fecale

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PTNSResults in OAB

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LiteratureMeta-analysis of PTNS for urinary disorders

7/17 papers consideredNumber of daily voids 244 patients improved an average of 23% (7 papers, p