Dose-Escalating Study of Propiverine Hydrochloride in Children Suffering From Overactive Bladder

Dose-Escalating Study of Propiverine Hydrochloride (Mictonetten®) in Children Suffering From Frequency-Urgency-Syndrome and Urinary Incontinence Indicative of Detrusor Overactivity (Overactive Bladder)

The open-label dose-escalating two-centre study was designed to assess the pharmacokinetics as well as safety, tolerability and efficacy parameters of propiverine in patients 5-10 years of age suffering from frequency-urgency-syndrome and urinary incontinence indicative of detrusor overactivity (overactive bladder) for determination of the recommended dose in children.

Main Inclusion Criteria:

• Micturition Frequency ≥6 micturitions during awake period
• Urge Incontinence Episodes ≥1/week
• Urgency Episodes ≥1/day

Main Exclusion Criteria:

• Contraindication to anticholinergic therapy
• Repeated measurement of Post Void Residual ≥20 mL
• Nocturnal Enuresis
• Clinically significant cardiovascular, hepatic, renal, gastrointestinal or hematological disease, psychiatric disorder or diabetes insipidus
• Anatomical abnormalities of the urinary tract