E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Overactive bladder syndrome is characterized by a combination of urinary frequency, urgency and urge incontinence.
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Aim of proposed investigation.
The aim is to measure the efficacy and tolerability of Botulinum A Toxin in the treatment of detrusor overactivity, and examine whether there is a relationship between the severity and aetiology of pre-treatment detrusor overactivity and the response obtained.
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Inclusion criteria.
Patients with urodynamically proven detrusor overactivity. This must be on conventional CMG or VCMG - not ambulatory monitoring This may be of congenital, neuropathic or idiopathic aetiology. Previous failed treatment with conservative and standard medical therapy. Patients who might otherwise be considered for neuromodulation, augmentation or diversion surgery. A subgroup of patients with known neurogenic detrusor overactivity who already have indwelling suprapubic catheters may also be studied.
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E.4 | Principal exclusion criteria |
Exclusions.
Patients < 18 years of age. Patients with proven bladder outflow obstruction on urodynamics. Any patients with generalised disorder of muscle activity eg; Myaesthenia Gravis. Serious concomitant illness. Patients with bleeding disorders. Pregnant or breast feeding patients. Patients who would not tolerate intermittent self catheterisation (this excludes the subgroup who already have indwelling suprapubic catheters). Patients in whom stress incontinence is the primary symptom. Previous failure of Botulinum toxin therapy. Acute urinary infection. Any other bladder pathology demonstrated at the time of cystoscopy (includes trauma, stones, tumour).
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy parameters of the study.
Primary efficacy measures will be changes from: Baseline median daily frequency. Baseline median leakage episodes. Baseline median number of daily catheterizations. Baseline global Kings HQ score. Baseline domain scores for Kings HQ. Baseline ICIQ-SF and Quality of Life and Symptoms Distress Inventory scores.
Success for an individual is defined as an improvement of 20% in any of these parameters.
Secondary efficacy parameters will be changes in: Volume at first overactive contraction. Maximum detrusor pressure whilst voiding. Detrusor compliance. Maximum cystometric capacity. Post-void residual urine.
For patients who have initially improved but then fail, further treatment will be offered, and the cycle of assessment and follow-up repeated.
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
A prospective, single institution, observational study. Two cohorts of patients (those with idiopath |
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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 | Information not present in EudraCT |
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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Patients Visits to the Hospital.
1st Visit – Baseline visit. 2nd Visit – Admission to Day case ward for treatment. 3rd Visit- 7-day post treatment. 4th, 5th, 6th Visits – At 2, 6 and 9 (end of trial) months post treatment for assessment of progress.
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |