Study to Evaluate the Therapeutic Action of Tamsulosin and Finasteride in Symptomatic Benign Prostatic Hyperplasia (BPH) Patients

MICTUS (Multicentre Investigation to Characterise the Effect of Tamsulosin on Urinary Symptoms): A Multicentre, Double-blind, Randomised, Parallel Group Study, Aimed at Characterising the Effect of Tamsulosin, an Uroselective α1- Receptor Blocking Agent, on the Urological Symptoms and Their Impact on General Health Status and Quality of Life in Outpatients Affected by Symptomatic Benign Prostatic Hyperplasia: Comparison With Finasteride.

Study to evaluate the therapeutic effect of tamsulosin and finasteride in symptomatic BPH patients, two medications indicated in BPH belonging to two different pharmacological classes, as evaluated from the point of view of patient's perception of his pathological condition and of the impact of the disease on general health and quality of life

Study Overview

• Status: Completed
• Conditions: Prostatic Hyperplasia
• Intervention / Treatment: Drug: Placebo; Drug: Tamsulosin; Drug: Finasteride

• Study Type: Interventional
• Enrollment (Actual): 403
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male out-patients aged 50-80 years
• IPSS >= 13 at Visit 1
• Qmax: 4-15 ml/sec at Visit 2
• Residue urinary volume > 400 ml as evaluated by ultrasonography
• SPI >= 7 at Visit 2
• Prostate Specific Antigen (PSA) value < 3 ng/ml at Visit 1, or of 3-10 ng/ml provided that prostate cancer is ruled out on the basis of the usual diagnostic procedures performed at each Centre
• Written informed consent

Exclusion Criteria:

Patients with known history or diagnosis at the time of the screening visit of the following conditions that could influence the end-points of the study:

• 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 the last month, or recurrent urinary tract infections (more than 2 during the last year); hematuria of unknown origin; diseases that may affect micturition (e.g. diabetes mellitus)

• Cardiovascular diseases - The following cardiovascular diseases if occurred in the last 6 months:

  • Myocardial infarction
  • Unstable angina
  • Clinically significant ventricular arrhythmias
  • Heart failure (NYHA classes III/IV)
  • Orthostatic hypotension
  • Cerebral stroke

• Neurological diseases

  • such as senile dementia, multiple sclerosis, Parkinson's disease, psychiatric disturbances, if their severity could have prevented the correct performance of the trial

• Hepatic or renal insufficiency

  • (Biochemistry values 15% outside normal laboratory ranges and regarded as clinically relevant by investigator)
• Clinically significant abnormalities in the results of hematologic and biochemical tests performed on blood samples drawn at the screening visit
• Patients who are taking or have been taking α-blockers for BPH or for hypertension or phytotherapy for BPH in the previous 6 weeks
• Patients who are taking or have been taking finasteride in the last 6 months
• Patients who require concomitant drugs which could influence the pharmacodynamic or pharmacokinetic properties of tamsulosin. In particular: alpha-blockers and mixed alpha-beta blockers, alpha- agonists, anti-cholinergics
• Patient who are or have been taking part in a clinical study in the previous 3 months
• Patients who have hypersensitivity or allergic reactions to previously prescribed alpha-blocker(s) or to finasteride
• 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
Experimental: Tamsulosin	Drug: Placebo; Drug: Tamsulosin
Active Comparator: Finasteride	Drug: Placebo; Drug: Finasteride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Symptom Problem Index (SPI) by means of validated patient questionnaire	Baseline, after 26 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Symptom Problem Index (SPI) - by means of validated patient questionnaire		up to 52 weeks
Change in International Prostatic Symptom Score (IPSS)	questionnaire for the self-evaluation of urinary symptoms	up to 52 weeks
Change in Qmax by means of free flow uroflowmetry		up to 52 weeks
Number of patients who withdrew due to inefficacy		up to 52 weeks
Number of patients with adverse events		up to 54 weeks
Number of patients with abnormal changes in laboratory parameters		up to 52 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 1998
• Primary Completion (Actual): November 1, 2000

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; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Steroid Synthesis Inhibitors; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; 5-alpha Reductase Inhibitors; Tamsulosin; Finasteride
• Other Study ID Numbers: 527.15