Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Myelomeningocele; Bladder, Neurogenic	Drug: Botulinum A toxin	Phase 4

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (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
Study Start Date :	May 2005
Estimated Primary Completion Date :	March 2008
Estimated Study Completion Date :	June 2008

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:

Drug: Botulinum A toxin
Intravesical injection. 12 IE/kg b.w.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Bladder capacity and pressures: measures from cystometry [ Time Frame: at 4 weeks and 6 months ]

Secondary Outcome Measures :

1. Urinary continence: score from an incontinence rating scale [ Time Frame: 2 days before and 4 weeks and 6 months after ]
2. Constipation: score on the Bristol scale [ Time Frame: 4 weeks ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	2 Years to 16 Years (Child)
Sexes Eligible for Study:	All
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	September 15, 2005
Last Update Posted:	February 20, 2009
Last Verified:	February 2009

Keywords provided by University of Aarhus:

Myelomeningocele; Neurogenic Bladder; Intervention; Botulinum A toxin; Oxybutynin

Additional relevant MeSH terms:

Urinary Bladder, Neurogenic; Meningomyelocele; Spina Bifida Cystica; Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Signs and Symptoms; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Spinal Dysraphism	Botulinum Toxins, Type A; onabotulinumtoxinA; abobotulinumtoxinA; Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents