Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy and safety of a single dose of 750 U of Dysport compared to placebo for the improvement in the daily incontinence episode frequency for each administration mode in subjects suffering from neurogenic detrusor overactivity following spinal cord injury or multiple sclerosis.

Official Title
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A Phase IIa, Multicentre, Double Blind, Single Dose, Parallel Group, Placebo Controlled, Clinical Pilot Study to Assess the Efficacy and Safety of a Single Dose, Intra-Detrusor Injections of 750 Units of Dysport® in Subjects Suffering From Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis.

Conditions
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Detrusor Muscle Hyperactivity

Intervention / Treatment
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* Biological: Botulinum toxin type A
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject, family member or care giver was willing and able to perform clean intermittent catheterisation (CIC) for the duration of the study Inadequate response or refractory to anticholinergic medication Botulinum Toxin naive for intradetrusor injections and with no previous treatment with Botulinum Toxin of any type, within 3 months prior to study entry for any other condition Have a minimum of 2 incontinences per day calculated as the average daily incontinence episode frequency (IEF) over the 3 days preceding the baseline visit Exclusion Criteria: Significant Baseline renal and/or urinary tract pathology Previous treatment with any endovesical pharmacology agent including detrusor Botulinum Toxin injection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dysport 750 U (15 injection sites)<br> | Biological: Botulinum toxin type A<br>* 750 U intra detrusor injection on Day 1 (single dose)<br>* Other names: AbobotulinumtoxinA (Dysport®);|
| Placebo Comparator: Placebo (15 injection sites)<br> | Drug: Placebo<br>* Intra detrusor injection on Day 1 (single dose)<br>|
| Experimental: Dysport 750 U (30 injection sites)<br> | Biological: Botulinum toxin type A<br>* 750 U intra detrusor injection on Day 1 (single dose)<br>* Other names: AbobotulinumtoxinA (Dysport®);|
| Placebo Comparator: Placebo (30 injection sites)<br> | Drug: Placebo<br>* Intra detrusor injection on Day 1 (single dose)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Incontinence Episode Frequency (IEF) |  | Baseline and Day 84 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urodynamics: Maximum Cystometric Capacity | Maximum Cystometric Capacity is an urodynamic parameter that indicates the volume at which a patient feels he (she) can no longer delay release of urine from the urinary bladder. Baseline urodynamics exams done at screening visit. | Baseline, Days 14, 42 and 84 | 
| Urodynamics:Maximum Detrusor Pressure | Maximum Detrusor Pressure is an urodynamic parameter that is the maximum value of the pressure within the bladder which is measured during the filling phase of the urodynamic exam. Baseline urodynamics exams done at screening visit. | Baseline, Days 14, 42 and 84 | 
| Physician's Global Assessment Score of Treatment Response | The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'. | Day 14 | 
| Physician's Global Assessment Score of Treatment Response | The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'. | Day 42 | 
| Physician's Global Assessment Score of Treatment Response | The subject's treatment response was assessed by the physician and graded as 'markedly worse', 'much worse', 'worse', 'slightly worse', 'no change', 'slightly improved', 'improved', 'much improved', or 'markedly improved'. | Day 84 | 
| Quality of Life (QoL) Total Summary Score | Mean Change from Baseline in Short Form (SF)-Qualiveen Questionnaire Calculated Total Score. The SF-Qualiveen questionnaire is a specific health related QoL questionnaire validated for urinary disorders in subjects with neurological conditions containing 8 items looking at four scales: limitations (2 items); constraints (2 items); fears (2 items) and feelings (2 items). The 8 items each having a 5-point Likert-type scale ranging from 0=Not at all to 4=Extremely for the first 6 items, from 0=Never to 4=Always for item 7 and from 0=Always to 4=Never for item 8. The score per scale has been calculated as the mean of the two items. In case of one missing item among the 2 items for a given scale, the score has not been calculated. Total score has been calculated as the mean of all the items completed among the 8 items. Lower scores indicate a better QoL (i.e. no limitations, fears, constraints, or negative feelings) and higher scores indicate poorer QoL. | Baseline, 14, 42 and 84 | 
| Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection | Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain. | Baseline | 
| Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure | Pain assessment using the VAS. The VAS is a 100-mm (10-cm) scoring scale. Score range on VAS is from 0 to 100 where zero [0] indicates no pain and 100 indicates worst possible pain. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Detrusor Muscle Overactivity