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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00175123
Other study ID # Botox
Secondary ID J.nr.2612-2319J.
Status Active, not recruiting
Phase Phase 4
First received September 9, 2005
Last updated February 19, 2009
Start date May 2005
Est. completion date June 2008

Study information

Verified date February 2009
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines AgencyUnited States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date June 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 2 Years to 16 Years
Eligibility 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

Study Design

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


Intervention

Drug:
Botulinum A toxin
Intravesical injection. 12 IE/kg b.w.

Locations

Country Name City State
Denmark Department of Urology, Aarhus University Hospital, Section Skejby Aarhus Aarhus N

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bladder capacity and pressures: measures from cystometry at 4 weeks and 6 months No
Secondary Urinary continence: score from an incontinence rating scale 2 days before and 4 weeks and 6 months after No
Secondary Constipation: score on the Bristol scale 4 weeks No
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