Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele

Myelomeningocele Clinical Trial

Official title:

Phase 4 Study of the Effect of Botulinum-A Toxin Injected in Neurogenic Overactive Bladders of Children Born With Myelomeningocele

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00175123
• Other study ID #: Botox
• Secondary ID: J.nr.2612-2319J.
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 9, 2005
• Last updated: February 19, 2009
• Start date: May 2005
• Est. completion date: June 2008

Study information

• Verified date: February 2009
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bladder, Neurogenic
• Meningomyelocele
• Myelomeningocele
• Urinary Bladder, Neurogenic

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Urology, Aarhus University Hospital, Section Skejby	Aarhus	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder capacity and pressures: measures from cystometry		at 4 weeks and 6 months	No
Secondary	Urinary continence: score from an incontinence rating scale		2 days before and 4 weeks and 6 months after	No
Secondary	Constipation: score on the Bristol scale		4 weeks	No