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

Drug Information available for: OnabotulinumtoxinA

Genetic and Rare Diseases Information Center resources: Myelomeningocele

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:

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:


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

ClinicalTrials.gov processed this record on March 03, 2015

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