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

NCT02245490 | Completed Phase 4

• 1 other identifier: 527.30
• Study Type: interventional
• Target: 153
• Locations: 0 countries
• Sites: N/A

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

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Changes in mean number of micturitions per day

  As reported in the Urinary Chart

  Up to 12 weeks after first drug administration

Secondary Outcomes (11)

• Changes in mean number of urgency episodes per day

  Up to 12 weeks after first drug administration

• Changes in voided volume per micturition

  Up to 12 weeks after first drug administration

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

  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

  Up to 12 weeks after first drug administration

• Changes in International Index of Erectile Function (IIEF)

  Up to 12 weeks after first drug administration

Study Arms (2)

Tamsulosin

EXPERIMENTAL

Drug: Tamsulosin HCl controlled release capsules

Placebo

PLACEBO COMPARATOR

Drug: Matching placebo capsule

Interventions

Tamsulosin HCl controlled release capsules DRUG

Tamsulosin

Matching placebo capsule DRUG

Placebo

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 19, 2014
• Study Start: January 1, 2003
• Primary Completion: April 1, 2004
• Last Updated: September 19, 2014

Record last verified: 2014-09