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

A

Apogepha

Status and phase

Completed
Phase 3

Conditions

Children
Urinary Incontinence
Overactive Bladder

Treatments

Drug: Mictonetten 5 mg, coated tablet
Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00603343
EudraCT-Number 200400124330

Details and patient eligibility

About

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.

Full 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.

Enrollment

303 patients

Sex

All

Ages

5 to 10 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

303 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Treatment:
Drug: Mictonetten 5 mg, coated tablet
2
Placebo Comparator group
Treatment:
Drug: placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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