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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

Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostatic Hyperplasia

Intervention: Tamsulosin HCl controlled release capsules (Drug); Matching placebo capsule (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Boehringer Ingelheim

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

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Changes in mean number of micturitions per day

Secondary outcome:

Changes in mean number of urgency episodes per day

Changes in voided volume per micturition

Changes in International Prostate Symptom Score (I-PSS) on storage and voiding sub-scores

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

Changes in International Index of Erectile Function (IIEF)

Changes in Uroflowmetry

Changes in Qmax

Changes in volume at the first contraction

Number of unstable contractions

Maximum amplitude of unstable contractions

Number of patients with adverse events

Eligibility

Minimum age: 50 Years. Maximum age: 80 Years. Gender(s): Male.

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

Locations and Contacts

Additional Information

Starting date: January 2003
Last updated: September 18, 2014

Page last updated: August 20, 2015

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