Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele

NCT00175123 | Unknown Phase 4

• 3 other identifiers: BotoxJ.nr.2612-2319J.nr.20030155
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelomeningocele; Bladder, Neurogenic

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Bladder capacity and pressures: measures from cystometry

  at 4 weeks and 6 months

Secondary Outcomes (2)

• 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

Interventions

Botulinum A toxin DRUG

Intravesical injection. 12 IE/kg b.w.

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Myelomeningocele
• Neurogenic bladder with untreated leak point pressures \> 40 mmH2O
• Treated with oxybutynin or other parasympatholytics

You may not qualify if:

• Acute urinary tract infection
• Compromised neuromuscular transmission

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of Urology, Aarhus University Hospital, Section Skejby

Aarhus, Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Meningomyelocele; Urinary Bladder, Neurogenic

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Bettina Jorgensen, MD

  Department of Urology, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: May 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 20, 2009

Record last verified: 2009-02

Locations

DK (1)