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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000871-33-CZ

Enrollment

120

Registered

2004-10-13

Start date

2004-12-02

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Name: not applicable Product Code: not applicable Pharmaceutical Form: Capsule* INN or Proposed INN: Propiverine hydrochloride extended release (ER) Concentration unit: mg milligram(s) Concent

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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.)

Design outcomes

Primary

Measure	Time frame
Main Objective: Tolerability of propiverine hydrochloride;Secondary Objective: None;Primary end point(s): Residual urine	—

Countries

Czech Republic

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026