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

September 18, 2014 updated by: Boehringer Ingelheim

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Matching placebo capsule
Experimental: Tamsulosin
Drug: Tamsulosin HCl controlled release capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in mean number of micturitions per day
Time Frame: Up to 12 weeks after first drug administration
As reported in the Urinary Chart
Up to 12 weeks after first drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Changes in mean number of urgency episodes per day
Time Frame: Up to 12 weeks after first drug administration
Up to 12 weeks after first drug administration
Changes in voided volume per micturition
Time Frame: Up to 12 weeks after first drug administration
Up to 12 weeks after first drug administration
Changes in International Prostate Symptom Score (I-PSS) on storage and voiding sub-scores
Time Frame: Up to 12 weeks after first drug administration
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
Time Frame: Up to 12 weeks after first drug administration
Up to 12 weeks after first drug administration
Changes in International Index of Erectile Function (IIEF)
Time Frame: Up to 12 weeks after first drug administration
Up to 12 weeks after first drug administration
Changes in Uroflowmetry
Time Frame: Up to 12 weeks after first drug administration
Up to 12 weeks after first drug administration
Changes in Qmax
Time Frame: Up to 12 weeks after first drug administration
Up to 12 weeks after first drug administration
Changes in volume at the first contraction
Time Frame: Up to 12 weeks after first drug administration
Up to 12 weeks after first drug administration
Number of unstable contractions
Time Frame: Up to 12 weeks after first drug administration
Up to 12 weeks after first drug administration
Maximum amplitude of unstable contractions
Time Frame: Up to 12 weeks after first drug administration
Up to 12 weeks after first drug administration
Number of patients with adverse events
Time Frame: Up to 12 weeks after first drug administration
Up to 12 weeks after first drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 527.30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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