Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele

Condition(s) targeted: Myelomeningocele; Bladder, Neurogenic

Intervention: Botulinum A toxin (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: University of Aarhus

Official(s) and/or principal investigator(s):
Bettina Jorgensen, MD, Principal Investigator, Affiliation: Department of Urology, Aarhus University Hospital

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.

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

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

Primary outcome: Bladder capacity and pressures: measures from cystometry

Secondary outcome:

Urinary continence: score from an incontinence rating scale

Constipation: score on the Bristol scale

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.

Minimum age: 2 Years. Maximum age: 16 Years. Gender(s): Both.

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

Department of Urology, Aarhus University Hospital, Section Skejby, Aarhus, Aarhus N 8200, Denmark

Starting date: May 2005
Last updated: February 19, 2009