EUCTR2005-003068-47-SE
Active, not recruiting
Not Applicable
Behandling med botulinumtoxin vid neurogen blåsfunktionsstörning
Region Skåne, Universitetssjukhuset i Lund, Urologiska kliniken0 sites40 target enrollmentJuly 13, 2005
DrugsBotox
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- 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.
- Sponsor
- Region Skåne, Universitetssjukhuset i Lund, Urologiska kliniken
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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