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

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

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

Study Overview

• Status: Completed
• Conditions: Prostatic Hyperplasia
• Intervention / Treatment: Drug: Tamsulosin HCl controlled release capsules; Drug: Matching placebo capsule

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Matching placebo capsule
Experimental: Tamsulosin	Drug: Tamsulosin HCl controlled release capsules

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): April 1, 2004

Study Registration Dates

• First Submitted: September 18, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimate): September 19, 2014

Study Record Updates

• Last Update Posted (Estimate): September 19, 2014
• Last Update Submitted That Met QC Criteria: September 18, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: 527.30