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Completed

NCT Number: NCT00603343

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

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.

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Key information

Conditions

Overactive Bladder Children Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mictonetten 5 mg, coated tablet

Drug

propiverine 10 mg b.i.d. (17-27.9 kg BW) or propiverine 15 mg b.i.d. (28-45.0 kg BW)

Other names: Mictonetten

Placebo

Drug

placebo corresponding to body weight

Primary outcomes

  1. voiding frequency

    Time frame: before therapy and at end of therapy

Secondary outcomes

  1. voided volume

    Time frame: before and at end of treatment

  2. incontinence episodes per day

    Time frame: before and at end of therapy

  3. safety parameters: acute urinary retention, post void residual urine, urinalysis, ECG, blood pressure, pulse rate

    Time frame: before and at end of treatment

Sponsors and collaborators

Lead sponsor

APOGEPHA Arzneimittel GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jan 29, 2008
Registry last updated
Jan 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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