study to characterise the effect of tamsulosin on lower urinary tract symptoms (luts) and detrusor motor activity in patients affected by benign prostatic hyperplasia (bph) and storage urinary symptoms

Conditions: Prostatic Hyperplasia

Summary: study to evaluate the efficacy of tamsulosin on storage symptoms and detrusor motor activity in patients with luts suggestive of bph and relevant storage symptoms


Eligibility criteria:
inclusion criteria: * male outpatients aged 50-80 years * luts suggestive of bph * medical history: storage symptoms (frequency, urgency) for at least 6 months * urinary chart: * at least 8 micturitions per 24 hours on average, over the week of the screening period (check urinary chart at visit 2) * urgency (strong desire to void): at least once per 24 hours on average, over the week of the screening period (check urinary chart at visit 2) * i-pss ≥ 13 at randomisation (visit 3) * qmax: \> 4 ml/sec at randomisation (visit 3), with a voiding volume of at least 150 ml * prostate specific antigen (psa) \< 2.5 ng/ml or between 2.5 and 10 ng/ml, if cancer is ruled out with the usual procedures of each centre (visit 1; results before visit 3) * written informed consent for participation to the study exclusion criteria: * patients with a known history or a diagnosis at the time of the screening visit (visit 1) of the following conditions: * urological disturbances * medical history of pelvic surgery * palpable bladder at the physical examination, or residue urinary volume \> 400 ml * known neurological bladder disorder * bladder neck stenosis * urethral stricture * bladder or prostatic cancer * bladder stone * severe diverticulum of the bladder * symptomatic urinary tract infection during last month, or recurrent urinary tract infections (more than 2 during last year) * haematuria of unknown origin * diseases which may affect micturition (i.e., diabetes mellitus) * cardiovascular diseases (if they occurred in the last 6 months) * myocardial infarction * instable angina * clinically significant ventricular arrhythmias * heart failure (nyha classes iii/iv) * orthostatic hypotension * cerebral stroke * neurological diseases (if their severity might compromise the correct performance of the trial) * senile dementia * multiple sclerosis * parkinson's disease * psychiatric disturbances * hepatic or renal insufficiency (biochemistry values 15% outside normal lab ranges, being regarded as clinically relevant by the investigator) * clinically significant abnormality in the haematological, blood chemistry and urinary values evidenced on the samples taken at the screening visit (visit 1) * patients who are taking or have been taking α-blockers for bph or for hypertension, or phytotherapy for bph within the previous 6 weeks * patients who were taking or have been taking: * α-blockers for bph or for hypertension within the previous 4 weeks * phytotherapy for bph or mepartricin within the previous 4 weeks * finasteride within the previous 6 months * anticholinergics within the previous 4 weeks * antidiuretics within the previous 4 weeks * concomitant drugs which may influence the pharmacodynamic or pharmacokinetic properties of tamsulosin. in particular: α-blockers and mixed α-β-blockers, α- agonists, anti-cholinergics * patients who are or have been taking part in a clinical study within the previous 3 months * patients who have had hypersensitivity or allergic reactions to previously prescribed α- blocker(s) * patients judged by the investigator to be inappropriate for inclusion in the study