Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele

Sponsor

University of Aarhus (Other)

Overall Status

Unknown status

CT.gov ID

NCT00175123

Collaborator

Aarhus University Hospital (Other)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Anticipated 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 1, 2005

Anticipated Primary Completion Date :

Mar 1, 2008

Anticipated Study Completion Date :

Jun 1, 2008

Outcome Measures

Primary Outcome Measures

Bladder capacity and pressures: measures from cystometry [at 4 weeks and 6 months]

Secondary Outcome Measures

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