E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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.
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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).
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Evaluation of Quality of Life and Health Economics |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial ends with the last visit of the last patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 8 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |