<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02245490</url>
  </required_header>
  <id_info>
    <org_study_id>527.30</org_study_id>
    <nct_id>NCT02245490</nct_id>
  </id_info>
  <brief_title>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</brief_title>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to evaluate the efficacy of tamsulosin on storage symptoms and detrusor motor activity&#xD;
      in patients with LUTS suggestive of BPH and relevant storage symptoms&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2003</start_date>
  <primary_completion_date type="Actual">April 2004</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in mean number of micturitions per day</measure>
    <time_frame>Up to 12 weeks after first drug administration</time_frame>
    <description>As reported in the Urinary Chart</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in mean number of urgency episodes per day</measure>
    <time_frame>Up to 12 weeks after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in voided volume per micturition</measure>
    <time_frame>Up to 12 weeks after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in International Prostate Symptom Score (I-PSS) on storage and voiding sub-scores</measure>
    <time_frame>Up to 12 weeks after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>Up to 12 weeks after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in International Index of Erectile Function (IIEF)</measure>
    <time_frame>Up to 12 weeks after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Uroflowmetry</measure>
    <time_frame>Up to 12 weeks after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Qmax</measure>
    <time_frame>Up to 12 weeks after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in volume at the first contraction</measure>
    <time_frame>Up to 12 weeks after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of unstable contractions</measure>
    <time_frame>Up to 12 weeks after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum amplitude of unstable contractions</measure>
    <time_frame>Up to 12 weeks after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 12 weeks after first drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">153</enrollment>
  <condition>Prostatic Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Tamsulosin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamsulosin HCl controlled release capsules</intervention_name>
    <arm_group_label>Tamsulosin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching placebo capsule</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male outpatients aged 50-80 years&#xD;
&#xD;
          -  LUTS suggestive of BPH&#xD;
&#xD;
          -  Medical history: storage symptoms (frequency, urgency) for at least 6 months&#xD;
&#xD;
          -  Urinary Chart:&#xD;
&#xD;
               -  At least 8 micturitions per 24 hours on average, over the week of the screening&#xD;
                  period (check urinary chart at Visit 2)&#xD;
&#xD;
               -  Urgency (strong desire to void): at least once per 24 hours on average, over the&#xD;
                  week of the screening period (check urinary chart at Visit 2)&#xD;
&#xD;
          -  I-PSS ≥ 13 at randomisation (Visit 3)&#xD;
&#xD;
          -  Qmax: &gt; 4 ml/sec at randomisation (Visit 3), with a voiding volume of at least 150 ml&#xD;
&#xD;
          -  Prostate Specific Antigen (PSA) &lt; 2.5 ng/ml or between 2.5 and 10 ng/ml, if cancer is&#xD;
             ruled out with the usual procedures of each centre (Visit 1; results before Visit 3)&#xD;
&#xD;
          -  Written Informed Consent for participation to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a known history or a diagnosis at the time of the screening visit (Visit&#xD;
             1) of the following conditions:&#xD;
&#xD;
          -  Urological disturbances&#xD;
&#xD;
               -  Medical history of pelvic surgery&#xD;
&#xD;
               -  Palpable bladder at the physical examination, or residue urinary volume &gt; 400 ml&#xD;
&#xD;
               -  Known neurological bladder disorder&#xD;
&#xD;
               -  Bladder neck stenosis&#xD;
&#xD;
               -  Urethral stricture&#xD;
&#xD;
               -  Bladder or prostatic cancer&#xD;
&#xD;
               -  Bladder stone&#xD;
&#xD;
               -  Severe diverticulum of the bladder&#xD;
&#xD;
               -  Symptomatic urinary tract infection during last month, or recurrent urinary tract&#xD;
                  infections (more than 2 during last year)&#xD;
&#xD;
               -  Haematuria of unknown origin&#xD;
&#xD;
               -  Diseases which may affect micturition (i.e., diabetes mellitus)&#xD;
&#xD;
          -  Cardiovascular diseases (if they occurred in the last 6 months)&#xD;
&#xD;
               -  Myocardial infarction&#xD;
&#xD;
               -  Instable angina&#xD;
&#xD;
               -  Clinically significant ventricular arrhythmias&#xD;
&#xD;
               -  Heart failure (NYHA classes III/IV)&#xD;
&#xD;
               -  Orthostatic hypotension&#xD;
&#xD;
               -  Cerebral stroke&#xD;
&#xD;
          -  Neurological diseases (if their severity might compromise the correct performance of&#xD;
             the trial)&#xD;
&#xD;
               -  Senile dementia&#xD;
&#xD;
               -  Multiple sclerosis&#xD;
&#xD;
               -  Parkinson's disease&#xD;
&#xD;
               -  Psychiatric disturbances&#xD;
&#xD;
          -  Hepatic or renal insufficiency (biochemistry values 15% outside normal lab ranges,&#xD;
             being regarded as clinically relevant by the investigator)&#xD;
&#xD;
          -  Clinically significant abnormality in the haematological, blood chemistry and urinary&#xD;
             values evidenced on the samples taken at the screening visit (Visit 1)&#xD;
&#xD;
          -  Patients who are taking or have been taking α-blockers for BPH or for hypertension, or&#xD;
             phytotherapy for BPH within the previous 6 weeks&#xD;
&#xD;
          -  Patients who were taking or have been taking:&#xD;
&#xD;
               -  α-blockers for BPH or for hypertension within the previous 4 weeks&#xD;
&#xD;
               -  phytotherapy for BPH or mepartricin within the previous 4 weeks&#xD;
&#xD;
               -  finasteride within the previous 6 months&#xD;
&#xD;
               -  anticholinergics within the previous 4 weeks&#xD;
&#xD;
               -  antidiuretics within the previous 4 weeks&#xD;
&#xD;
               -  concomitant drugs which may influence the pharmacodynamic or pharmacokinetic&#xD;
                  properties of tamsulosin. In particular: α-blockers and mixed α-β-blockers, α-&#xD;
                  agonists, anti-cholinergics&#xD;
&#xD;
          -  Patients who are or have been taking part in a clinical study within the previous 3&#xD;
             months&#xD;
&#xD;
          -  Patients who have had hypersensitivity or allergic reactions to previously prescribed&#xD;
             α- blocker(s)&#xD;
&#xD;
          -  Patients judged by the investigator to be inappropriate for inclusion in the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
    <mesh_term>Lower Urinary Tract Symptoms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tamsulosin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02245490
org study id: 527.30
nct id: NCT02245490
lead sponsor: 
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Changes in mean number of micturitions per day
time frame: Up to 12 weeks after first drug administration
description: As reported in the Urinary Chart
measure: Changes in mean number of urgency episodes per day
time frame: Up to 12 weeks after first drug administration
measure: Changes in voided volume per micturition
time frame: Up to 12 weeks after first drug administration
measure: Changes in International Prostate Symptom Score (I-PSS) on storage and voiding sub-scores
time frame: Up to 12 weeks after first drug administration
measure: 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
measure: Changes in International Index of Erectile Function (IIEF)
time frame: Up to 12 weeks after first drug administration
measure: Changes in Uroflowmetry
time frame: Up to 12 weeks after first drug administration
measure: Changes in Qmax
time frame: Up to 12 weeks after first drug administration
measure: Changes in volume at the first contraction
time frame: Up to 12 weeks after first drug administration
measure: Number of unstable contractions
time frame: Up to 12 weeks after first drug administration
measure: Maximum amplitude of unstable contractions
time frame: Up to 12 weeks after first drug administration
measure: Number of patients with adverse events
time frame: Up to 12 weeks after first drug administration
arm group label: Tamsulosin
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Tamsulosin HCl controlled release capsules
arm group label: Tamsulosin
intervention type: Drug
intervention name: Matching placebo capsule
arm group label: Placebo
criteria: 
gender: Male
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Lower Urinary Tract Symptoms
mesh term: Tamsulosin