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Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University of Aarhus.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00175123
First received: September 9, 2005
Last updated: February 19, 2009
Last verified: February 2009
History of Changes
  Purpose

The purpose of this study is to examine how injection of botulinum toxin in the bladder affects bladder function. The trial is carried out in children born with malformation of the spinal cord and subsequent overactive bladders. The purpose of treating the bladder (with different drugs) is to prevent damage to the kidneys and renal function. The aim of this study is to compare a conventionally used drug (oxybutynin) with botulinum toxin. The hypothesis of the study is that botulinum toxin is equal to oxybutynin in the treatment of overactive bladder.


Condition Intervention Phase
Myelomeningocele
Bladder, Neurogenic
 Drug: Botulinum A toxin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 4 Study of the Effect of Botulinum-A Toxin Injected in Neurogenic Overactive Bladders of Children Born With Myelomeningocele

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Bladder capacity and pressures: measures from cystometry [ Time Frame: at 4 weeks and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary continence: score from an incontinence rating scale [ Time Frame: 2 days before and 4 weeks and 6 months after ] [ Designated as safety issue: No ]
  • Constipation: score on the Bristol scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2005
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Botulinum A toxin
    Intravesical injection. 12 IE/kg b.w.
Detailed Description:

Neurogenic bladder is often seen in children with myelomeningocele, tumors in the spinal canal, or a traumatized spinal cord. The majority of the patients have high pressure bladders which can lead to reflux and frequent infections in the urinary tract. Although children experience insufficient bladder emptying, many of them also experience urinary incontinence and have to perform clean intermittent catheterization (CIC). If no intervention is made, the children are at high risk of renal deterioration.

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Myelomeningocele
  • Neurogenic bladder with untreated leak point pressures > 40 mmH2O
  • Treated with oxybutynin or other parasympatholytics

Exclusion Criteria:

  • Acute urinary tract infection
  • Compromised neuromuscular transmission
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175123

Locations
Denmark
Department of Urology, Aarhus University Hospital, Section Skejby
Aarhus, Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Bettina Jorgensen, MD Department of Urology, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: Bettina Jorgensen, MD, Aarhus University
ClinicalTrials.gov Identifier: NCT00175123     History of Changes
Other Study ID Numbers: Botox, J.nr.2612-2319, J.nr.20030155
Study First Received: September 9, 2005
Last Updated: February 19, 2009
Health Authority: Denmark: Danish Medicines Agency
United States: Institutional Review Board

Keywords provided by University of Aarhus:
Myelomeningocele
Neurogenic Bladder
Intervention
Botulinum A toxin
Oxybutynin

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Meningomyelocele
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Neural Tube Defects
 Nervous System Malformations
Congenital Abnormalities
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013