Gamma di sintomi della malattia della prostata i-PSS

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Visita Prostate Cancer

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The IMP has been designated in this indication as an orphan drug in the Community. Committee on Advanced therapies CAT has issued a classification for this product.

Combination product that includes a device, but does not involve an Advanced Therapy. To assess the efficacy of fixed dose combinations of tamsulosin OCAS 0. To assess the safety and tolerability of fixed dose combinations of tamsulosin OCAS 0. Valutare sicurezza e tollerabilita' delle combinazioni a dose fissa di tamsulosina OCAS 0.

At study entry Visit 1 : 1. Written informed consent has been obtained. Subject is willing and able to complete the micturition diary and questionnaires correctly. At randomization Visit 2 : 8. Subject continues to meet all inclusion criteria of Visit 1.

Al momento dell'inclusione nello studio Visita 1 : 1. Ottenimento del consenso informato scritto. Soggetto disponibile ed in grado di compilare in maniera corretta il diario relativo alla minzione ed i questionari. Alla randomizzazione Visita 2 : 8. Il soggetto continua a soddisfare tutti i criteri di inclusione della Visita 1. At study entry V1 Evidence of symptomatic urinary tract infection or known history or diagnosis of any of the following urinary conditions:- Recurrent symptomatic urinary tract infection -Urological Pain Syndromes gamma di sintomi della malattia della prostata i-PSS classified by the EAU Guideline on Chronic Pelvic Pain,update -Chronic prostatitis comprising type A inflammatory and type B noninflammatory -Evidence of current symptomatic or asymptomatic urolithiasis -Previous or current malignant disease of pelvic and urogenital organs with exception of carcinoma of bladder if longer than 5 years recurrence-free -Previous pelvic radiation therapy -Previous surgery to bladder neck or prostate -Bladder neck stenosis -Urethral stricture.

Narrow angle glaucoma, myasthenia gravis, severe gastrointestinal condition incl. Clinically significant significant cardiovascular or cerebrovascular diseases within 6 months prior to V1. Any other cardiovascular or cerebrovascular disease which in the opinion of the investigator makes the subject unsuitable for participation in study.

Non-drug treatment for LUTS associated with BPH or OAB,including electrostimulation therapy at start of the study or start of a bladder training program during the 2weeks prior to or during the study. Diabetic neuropathy. Planned cataract surgery during Study CL or Study CL or within 30 days after completion of any of the studies. Severe renal impairment including hemodialysis or moderate or severe hepatic impairment.

Known polyuria. Any clinically significant condition,which in the opinion of the investigator makes the subject unsuitable for the trial. Participation in any clinical trial within 30 days or limit set by national law,whichever is longer prior to randomization. Employee of Astellas, of CROs involved or of investigator site executing study.

At randomization V2 Subject did not complete micturition diary or I-PSS questionnaire according to instructions. Any clinically significant abnormal ECG,which in the opinion of the investigator makes the subject unsuitable for the trial. Any other clinically significant out of normal range result of urinalysis,biochemistry including PSA or hematology. Subject fulfills any exclusion criteria of V1.

All'inclusione nello studio V1 : 1. Glaucoma ad angolo stretto,miastenia grave,gravi patologie a livello gastrointestinale,ritenzione urinaria gamma di sintomi della malattia della prostata i-PSS gastrica o altra controindicazione all'uso di anticolinergici 5. Malattie cardiovascolari o cerebrovascolari clinicamente significative nei 6 mesi precedenti la V1 6. Qualsiasi altra patologia cardiovascolare o cerebrovascolare,che a giudizio dello sperimentatore rendano il paziente inadatto allo studio.

Trattamento non-farmacologico per LUTS associata a BPH o per iperattivita' vescicale OAB ,fra cui elettrostimolazione ad inizio studio o inizio di un training vescicale nel corso delle 2settimane precedenti o nel corso dello studio 8. Terapia a lungo termine con un dosaggio gamma di sintomi della malattia della prostata i-PSS di tali farmaci e' permessa. Neuropatia diabetica. Intervento chirurgico programmato per cataratta nel corso degli Studii CL o CL o entro 30 giorni dalla conclusione di uno dei due.

Grave insufficienza renale inclusa emodialisi o insufficienza epatica da moderata a grave. Nota poliuria. Qualsiasi patologia clinicamente significativa,che a giudizio dello sperimentatore renda il paziente inadatto allo studio. Partecipazione a qualsiasi studio clinico entro 30 giorni o il limite stabilito dalla normativa nazionale qualora il periodo previsto dalla stessa gamma di sintomi della malattia della prostata i-PSS piu' lungo prima della randomizzazione Personale Astellas,CRO coinvolte,o del centro che conduce lo studio.

Alla randomizzazione V2 Il soggetto non ha compilato il diario relativo alla minzione o il questionario I-PSS secondo istruzioni. Qualsiasi alterazione ECG clinicamente significativa,che a giudizio dello sperimentatore renda il soggetto inadatto allo studio. Altro valore alterato in maniera clinicamente significativa delle urine,del profilo biochimico incluso il PSA o dei paramentri ematologici,che a giudizio dello sperimentatore rendano il paziente inadatto allo studio.

Il soggetto presenta un criterio esclusione di V1. Primary endpoint 1: change from baseline to endpoint in total I-PSS. The trial involves single site in the Member State concerned. Definition of the end of the trial and justification where it gamma di sintomi della malattia della prostata i-PSS not the last visit of the last subject undergoing the trial. Plans for treatment or care after the subject has ended the participation in the trial if it is different from the expected normal treatment of that condition.