Prevention of renal and bladder damage in children with spina bifida by means of early injections with Botulinum-Toxin-A (Botox): a pilot study. - Early Botox in SB patients.

Erasmus MC, Universitair Medisch Centrum Rotterdam0 sites10 target enrollmentTBD

ConditionsNeurogenic bladder function disease in spina bifida patients spastic bladder in spina bifida patients.10029299 10029305 10004994

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Neurogenic bladder function disease in spina bifida patients
Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam
Enrollment: 10
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

Erasmus MC, Universitair Medisch Centrum Rotterdam

Eligibility Criteria

Inclusion Criteria

•The study group exists of newborns with MMC who are treated with the standard treatment (CIC and anticholinergics). The minimal age at inclusion is 3 months. This is because of the minimal diameter of the urethra which is necessary for cystoscopy.;The historical control group exists of MMC patients who have not been treated with Botox and who were born between 1998 and 2008\.

Exclusion Criteria

•The exclusion criteria for the study group are:
•\- Patients with swallowing or breathing problems for which medical treatment is or was necessary.
•\- Muscle diseases such as myasthenia gravis, amyotrophic lateral sclerosis or the Syndrome of Eaton\-Lambert.;For the historical group the database of (parents of) patients who object against the use of their medical records for research purposes.

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Prevention of renal and bladder damage in children with spina bifida by means of early injections with Botulinum-Toxin-A (Botox): a pilot study.eurogenic bladder function disease in spina bifida patients.MedDRA version: 16.1Level: LLTClassification code 10030685Term: Open spina bifidaSystem Organ Class: 100000004850MedDRA version: 16.1Level: LLTClassification code 10041531Term: Spina bifida without mention of hydrocephalusSystem Organ Class: 100000004850MedDRA version: 16.1Level: LLTClassification code 10029280Term: Neurogenic bladder, not otherwise specifiedSystem Organ Class: 100000004857Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

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