Botulinum toxin type A
Biological750 U intra detrusor injection on Day 1 (single dose)
Other names: AbobotulinumtoxinA (Dysport®)
Completed
NCT Number: NCT01357980
Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Faculty Hospital Motol, Prague, Czechia
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Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Placebo
DrugIntra detrusor injection on Day 1 (single dose)
Primary outcomes
-
Daily Incontinence Episode Frequency (IEF)
Time frame: Baseline and Day 84
Secondary outcomes
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Urodynamics: Maximum Cystometric Capacity
Time frame: Baseline, Days 14, 42 and 84
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.
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Urodynamics:Maximum Detrusor Pressure
Time frame: Baseline, Days 14, 42 and 84
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.
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Physician's Global Assessment Score of Treatment Response
Time frame: Day 14
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'.
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Physician's Global Assessment Score of Treatment Response
Time frame: Day 42
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'.
-
Physician's Global Assessment Score of Treatment Response
Time frame: Day 84
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'.
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Quality of Life (QoL) Total Summary Score
Time frame: Baseline, 14, 42 and 84
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.
-
Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection
Time frame: Baseline
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.
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Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure
Time frame: Baseline
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.
Sponsors and collaborators
Lead sponsor
Ipsen
Industry
Registry information
Official study title
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.
Important dates
- Study start
- 2011
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- May 23, 2011
- Registry last updated
- Sep 27, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.