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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00175123
Date of registration: 09/09/2005
Prospective Registration: No
Primary sponsor: University of Aarhus
Public title: Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele
Scientific title: Phase 4 Study of the Effect of Botulinum-A Toxin Injected in Neurogenic Overactive Bladders of Children Born With Myelomeningocele
Date of first enrolment: May 2005
Target sample size: 30
Recruitment status: Active, not recruiting
URL:  http://clinicaltrials.gov/show/NCT00175123
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention  
Phase:  Phase 4
Countries of recruitment
Denmark
Contacts
Name:     Bettina Jorgensen, MD
Address: 
Telephone:
Email:
Affiliation:  Department of Urology, Aarhus University Hospital
Key inclusion & exclusion 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



Age minimum: 2 Years
Age maximum: 16 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Myelomeningocele
Bladder, Neurogenic
Intervention(s)
Drug: Botulinum A toxin
Primary Outcome(s)
Bladder capacity and pressures: measures from cystometry [Time Frame: at 4 weeks and 6 months]
Secondary Outcome(s)
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]
Secondary ID(s)
J.nr.20030155
Botox
J.nr.2612-2319
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Aarhus University Hospital
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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