Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence

Urinary Incontinence Clinical Trial

Official title:

Treatment With Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence: Results of a Randomized Placebo-Controlled Phase III Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00603343
• Other study ID #: EudraCT-Number 200400124330
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2008
• Last updated: January 16, 2008
• Start date: June 2004
• Est. completion date: December 2006

Study information

• Verified date: January 2008
• Source: APOGEPHA Arzneimittel GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Agency for Health and Food SafetyCzech Republic: State Institute for Drug ControlNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Romania: Ministry of Public HealthSlovakia: State Institute for Drug ControlSweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

The study was conducted between 2004 and 2006 to prove efficacy and tolerability of the antimuscarinic propiverine compared to placebo in children suffering from non-neurogenic overactive bladder and urinary incontinence.

Description:

This clinical trial showed superior efficacy of propiverine over placebo and convincing tolerability for the treatment of children suffering from OAB and urinary incontinence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: December 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 10 Years

Eligibility

Inclusion Criteria:

• voiding frequency 8 or above per day

• at least one incontinence episode per day

• age between 5-10 years

• body weight between 17 and 45 kg

Exclusion Criteria:

• normal age expected bladder capacity

• PVR more than 10 ml

• dysfunctional voiding

• neurogenic disorders

• UTI, constipation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Children
• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Drug:
• Mictonetten 5 mg, coated tablet
propiverine 10 mg b.i.d. (17-27.9 kg BW) or propiverine 15 mg b.i.d. (28-45.0 kg BW)
• placebo
placebo corresponding to body weight

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
APOGEPHA Arzneimittel GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	voiding frequency		before therapy and at end of therapy	No
Secondary	voided volume		before and at end of treatment	No
Secondary	incontinence episodes per day		before and at end of therapy	No
Secondary	safety parameters: acute urinary retention, post void residual urine, urinalysis, ECG, blood pressure, pulse rate		before and at end of treatment	Yes