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.
Conditions
Interventions
Trade Name: Botox
Product Name: Botox
Pharmaceutical Form: Solution for injection
Sponsors
Region Skåne, Universitetssjukhuset i Lund, Urologiska kliniken
Eligibility
Sex/Gender
All
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to evaluate the effect of treatment with detrusor injection of Botolinum toxin A (Botox®) on quality of life in patients with severe neurogenic detrusor overactivity.;Secondary Objective: The secondary objective of the trial is to assess the effect of treatment with detrusor injection of Botolinum toxin A (Botox®) on health economic parameters in patients with severe neurogenic detrusor overactivity.;Primary end point(s): Number of voids (either voluntary or by intermittent catheterisation) per 24 hours.. Number of incontinence episodes or wet pads per 24 hours. Number of incontinence-free days. Quality of life assessed with questionnaires (I-QOL, Euro-QoL and a investigator-constructed, non-validated questionnaire). Health economic parameters (direct and indirect costs, cost per QUALY, Quality Adjusted Life Year). Urodynamic parameters (maximum cystometric capacity, volume at first involuntary detrusor contraction and maximum amplitude of detrusor contraction). Safety parameters (conventional preoperative assessment and registration of adverse effects). | — |
Countries
Sweden
Outcome results
None listed