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

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