Overactive Bladder
Conditions
Keywords
propiverine, anticholinergics, urinary incontinence, overactive bladder, children, dose-finding in children aged 5-10 years
Brief summary
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.
Interventions
coated tablets containing 5 mg consecutive dose escalation of 5 mg, 10 mg or 15 mg propiverine b.i.d.
Sponsors
APOGEPHA Arzneimittel GmbH
Study design
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of propiverine and its main metabolite propiverine N-oxide at steady state: Ctrough, Cmax, Tmax, AUC0-8h. Children were separated into 3 groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability of propiverine. Efficacy: Changes from baseline: voiding frequency, incontinence and urgency episodes,voided volume. Safety: Post Void Residual (PVR),adverse events,laboratory values (urine, blood), ECG. | two weeks |
Outcome results
None listed