Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00175123 |
Recruitment Status : Unknown
Verified February 2009 by University of Aarhus.
Recruitment status was: Active, not recruiting
First Posted : September 15, 2005
Last Update Posted : February 20, 2009
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myelomeningocele Bladder, Neurogenic | Drug: Botulinum A toxin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 2005 |
Estimated Primary Completion Date : | March 2008 |
Estimated Study Completion Date : | June 2008 |

- Drug: Botulinum A toxin
Intravesical injection. 12 IE/kg b.w.
- Bladder capacity and pressures: measures from cystometry [ Time Frame: at 4 weeks and 6 months ]
- Urinary continence: score from an incontinence rating scale [ Time Frame: 2 days before and 4 weeks and 6 months after ]
- Constipation: score on the Bristol scale [ Time Frame: 4 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175123
Denmark | |
Department of Urology, Aarhus University Hospital, Section Skejby | |
Aarhus, Aarhus N, Denmark, 8200 |
Principal Investigator: | Bettina Jorgensen, MD | Department of Urology, Aarhus University Hospital |
Responsible Party: | Bettina Jorgensen, MD, Aarhus University |
ClinicalTrials.gov Identifier: | NCT00175123 |
Other Study ID Numbers: |
Botox J.nr.2612-2319 J.nr.20030155 |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | February 20, 2009 |
Last Verified: | February 2009 |
Myelomeningocele Neurogenic Bladder Intervention Botulinum A toxin Oxybutynin |
Urinary Bladder, Neurogenic Meningomyelocele Spina Bifida Cystica Neurologic Manifestations Nervous System Diseases Urinary Bladder Diseases Urologic Diseases Neural Tube Defects Nervous System Malformations Congenital Abnormalities Spinal Dysraphism |
Botulinum Toxins, Type A abobotulinumtoxinA Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents |