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
Minimum age: 50 Years.
Maximum age: 80 Years.
Gender(s): Male.
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