Propiverine hydrochloride extended release (ER): Tolerability in patients with LUTS and BPS/BPHA randomised, double-blind, placebo-controlled, multi-centre clinical trial - not applicable

• Conditions: Patients suffering from LUTS (Lower Urinary Tract Symptoms) and BPS/BPH (Benign Prostatic Syndrome/Benign Prostatic Hyperplasia

• Registration Number: EUCTR2004-000871-33-CZ
• Lead Sponsor: Apogepha Arzneimittel GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

- Male patients with Lower Urinary Tract Symptoms
- Residual urine in a range of 30 - 80 ml
- Urinary stream in a range of 10 - 18 ml/s
- IPSS Score in a range of 8 - 17
- Micturition volume 150 - 600 ml
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Prostate cancer (PSA > 4 ng/ml, unless negative prostate biopsy within last 12 months)
- Acute urinary tract infection (=10^5 bacteria/ml urine, acute history of urinary tract infection within 3 months)
- Medication: 5 alpha reductase inhibitor, alpha blocker, phytotherapy for BPS/BPH
- Concomitant medication known to interfere with the trial medication or the goals of the trial
- Indwelling urinary catheter
- Diseases or congenital anomalies of the nervous system (e.g. neurological musculo-sceletal disorders, spina bifida)
- Anomalies of the lower genitourinary tract (e.g. fistulas, urethral stricture, etc.)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified