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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Tamsulosin

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