Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele - Full Text View

Sponsors and Collaborators:	University of Aarhus Aarhus University Hospital
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00175123

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 IV

MedlinePlus related topics: Botox

Drug Information available for: Clostridium botulinum toxin Oxybutynin Oxybutynin chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
Official Title:	Phase 4 Study of the Effect of Botulinum-A Toxin Injected in Neurogenic Overactive Bladders of Children Born With Myelomeningocele

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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175123

Contacts

Contact: Bettina Jorgensen, MD	+45 89495511	bettina.jorgensen@ki.au.dk
Contact: Troels Munch Jorgensen, Professor, MD	+45 89495511	tmj@dadlnet.dk

Locations

Denmark, Aarhus N
Department of Urology, Aarhus University Hospital, Section Skejby	Recruiting
Aarhus, Aarhus N, Denmark, 8200
Contact: Bettina Jorgensen, MD +45 89495511 bettina.jorgensen@ki.au.dk
Sub-Investigator: Bettina Jorgensen, MD
Principal Investigator: Troels Munch Jorgensen, Professor, MD

Sponsors and Collaborators

University of Aarhus

Aarhus University Hospital

Investigators

Principal Investigator:

Bettina Jorgensen, MD

Department of Urology, Aarhus University Hospital

More Information

Responsible Party:	Aarhus University ( Bettina Jorgensen, MD )
Study ID Numbers:	Botox, J.nr.2612-2319, J.nr.20030155
Study First Received:	September 9, 2005
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00175123
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

Study placed in the following topic categories:

Oxybutynin
Urinary Bladder, Neurogenic
Neural Tube Defects
Urinary Bladder, Overactive
Cystocele
Nervous System Malformations
Meningocele
Urinary Bladder Diseases

Meningomyelocele
Signs and Symptoms
Botulinum Toxins
Urologic Diseases
Neurologic Manifestations
Neural tube defect, folate-sensitive
Botulinum Toxin Type A
Congenital Abnormalities

Additional relevant MeSH terms:

Physiological Effects of Drugs
Nervous System Diseases
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009