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Clinical Trials/EUCTR2005-003068-47-SE
EUCTR2005-003068-47-SE
Active, Not Recruiting
N/A

Behandling med botulinumtoxin vid neurogen blåsfunktionsstörning

Region Skåne, Universitetssjukhuset i Lund, Urologiska kliniken0 sites40 target enrollmentJuly 13, 2005
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ConditionsThe 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.
DrugsBotox

Overview

Phase
N/A
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
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 13, 2005
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Region Skåne, Universitetssjukhuset i Lund, Urologiska kliniken

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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