Behandling med botulinumtoxin vid neurogen blåsfunktionsstörning

Conditions: The trial addresses patients with severe symptoms of neurogenic detrusor overactivity (urgency and/or urge incontinence). Eligible are those patients who have failed conservative treatment such as behavioral techniques, physiotherapy, intermittent catheterisation or pharmacotherapy.

Registration Number: EUCTR2005-003068-47-SE

Lead Sponsor: Region Skåne, Universitetssjukhuset i Lund, Urologiska kliniken

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

Inclusion Criteria

Written informed content.
Neurogenic bladder dysfunction secondary to neurologic injury or neurologic disease such as spinal cord injury, multiple sclerosis, myelomeningocele or Parkinson’s disease.
Men and women over 18 years of age.
The patient should have failed on conservative treatment such as behavioral techniques, physiotherapy, intermittent catheterisation or pharmacotherapy.
Symptoms assessed with voiding diary, pad test and quality of life-questionnaires.
Lower urinary tract function assessed with standard urodynamic studies (cystometry).
The patient should be judged as suitable for injection therapy by the investigator.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Detrusor injection therapy with Botulinum toxin A within 6 months prior to study start.
Injection therapy with Botulinum toxin A on other indication within 3 months prior to study start or planned during the study period.
Previous inclusion in this study.
Allergy against Botulinum toxin A.
Pregnant (planned or actual) or breast-feeding women. Fertile women must use contraception such as oral contraceptive pill or combination of pessary and condoms etc.
History of non-compliance to medical regimens or patients who are not compliant with protocol requirements or unable to keep a a diary or unable to fill in questionnaires.
Any other medical condition which can interfer with the treatment or the result of the study.
Treatment with non-registered drug within 3 months prior to study start.