Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele

NCT ID: NCT00175123

Last Updated: 2009-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2008-06-30

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.

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.

Conditions

Myelomeningocele; Bladder, Neurogenic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Botulinum A toxin

Intravesical injection. 12 IE/kg b.w.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Aarhus University

Principal Investigators

Bettina Jorgensen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, Aarhus University Hospital

Locations

Department of Urology, Aarhus University Hospital, Section Skejby

Aarhus, Aarhus N, Denmark

Countries

Denmark

Other Identifiers

J.nr.2612-2319

Identifier Type: -

Identifier Source: secondary_id

J.nr.20030155

Identifier Type: -

Identifier Source: secondary_id

Botox

Identifier Type: -

Identifier Source: org_study_id