Clinical trial NCT02245490: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostatic Hyperplasia
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-19
Enrollment: 153
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Changes in mean number of micturitions per day
timeFrame: Up to 12 weeks after first drug administration
Secondary outcomes:
measure: Changes in mean number of urgency episodes per day
timeFrame: Up to 12 weeks after first drug administration
measure: Changes in voided volume per micturition
timeFrame: Up to 12 weeks after first drug administration
measure: Changes in International Prostate Symptom Score (I-PSS) on storage and voiding sub-scores
timeFrame: 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
timeFrame: Up to 12 weeks after first drug administration
measure: Changes in International Index of Erectile Function (IIEF)
timeFrame: Up to 12 weeks after first drug administration
measure: Changes in Uroflowmetry
timeFrame: Up to 12 weeks after first drug administration
measure: Changes in Qmax
timeFrame: Up to 12 weeks after first drug administration
measure: Changes in volume at the first contraction
timeFrame: Up to 12 weeks after first drug administration
measure: Number of unstable contractions
timeFrame: Up to 12 weeks after first drug administration
measure: Maximum amplitude of unstable contractions
timeFrame: Up to 12 weeks after first drug administration
measure: Number of patients with adverse events
timeFrame: Up to 12 weeks after first drug administration
Other outcomes:
Locations:
Study officials:
References: