Propiverine hydrochloride in children suffering from overactive bladder and urinary incontinence. A randomised, double-blind, placebo-controlled, parallel grouped multicentre clinical trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001243-30-CZ

Enrollment

490

Registered

2004-11-04

Start date

2004-12-09

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

children suffering from overactive bladder and urinary incontinence

Interventions

Trade Name: Mictonetten Product Name: Mictonetten Pharmaceutical Form: Coated tablet INN or Proposed INN: Propiverine hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - male and female Caucasian children aged 6 – 10 years - suffering from overactive bladder - who voluntarily signed informed consent and who have parental consent - body weight between 17 – 45 kg - micturition frequency of at least 8 micturitions / day - incontinence episodes (at least 1 within 7 days) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: - bladder capacity in ml equal/more than (age+1) x 30 ml - post void residual urine > 10 ml - treatment of overactive bladder in the past 28 days - urinary tract infection - enuresis nocturna - dysfunctional voiding and detrusor-sphincter-dyssynergy

Design outcomes

Primary

Measure	Time frame
Main Objective: to demonstrate superiority of efficacy of Propiverine hydrochloride compared to placebo in children suffering from overactive bladder with urinary incontinence in terms of micturition frequency per day;Secondary Objective: Efficacy and safety;Primary end point(s): micturition frequency per day	—

Countries

Austria, Czech Republic, Netherlands, Sweden

Outcome results

None listed

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