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

Study Overview
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Brief Summary
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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

Official Title
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BLADDER (BPH, LUTS And Detrusor: Dual Effect Research) Study: A Multicentre, Double-blind, Randomised, Parallel Group, Placebo-controlled Study, Aimed at Characterising 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
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Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Tamsulosin HCl controlled release capsules
* Drug: Matching placebo capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamsulosin<br> | Drug: Tamsulosin HCl controlled release capsules<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Matching placebo capsule<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mean number of micturitions per day | As reported in the Urinary Chart | Up to 12 weeks after first drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mean number of urgency episodes per day |  | Up to 12 weeks after first drug administration | 
| 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 Qmax |  | 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 |