Prostatic Hyperplasia
Conditions
Brief 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
Interventions
DRUGTamsulosin HCl controlled release capsules
DRUGMatching placebo capsule
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in mean number of micturitions per day | Up to 12 weeks after first drug administration | As reported in the Urinary Chart |
Secondary
| Measure | Time frame |
|---|---|
| Changes in voided volume per micturition | Up to 12 weeks after first drug administration |
| Changes in International Prostate Symptom Score (I-PSS) on storage and voiding sub-scores | Up to 12 weeks after first drug administration |
| Changes in Quality of Life in BPH patients with urinary symptoms (QUIBUS) Italian Score QUIBUS Symptom Score (QUISS) -11 on storage and voiding sub-scores | Up to 12 weeks after first drug administration |
| Changes in International Index of Erectile Function (IIEF) | Up to 12 weeks after first drug administration |
| Changes in Uroflowmetry | Up to 12 weeks after first drug administration |
| Changes in mean number of urgency episodes per day | Up to 12 weeks after first drug administration |
| Changes in volume at the first contraction | Up to 12 weeks after first drug administration |
| Number of unstable contractions | Up to 12 weeks after first drug administration |
| Maximum amplitude of unstable contractions | Up to 12 weeks after first drug administration |
| Number of patients with adverse events | Up to 12 weeks after first drug administration |
| Changes in Qmax | Up to 12 weeks after first drug administration |
Outcome results
None listed