Detrusor Muscle Hyperactivity
Conditions
Keywords
Detrusor Muscle Overactivity
Brief summary
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.
Interventions
BIOLOGICALBotulinum toxin type A
750 U intra detrusor injection on Day 1 (single dose)
DRUGPlacebo
Intra detrusor injection on Day 1 (single dose)
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daily Incontinence Episode Frequency (IEF) | Baseline and Day 84 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urodynamics:Maximum Detrusor Pressure | 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. |
| Physician's Global Assessment Score of Treatment Response | 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'. |
| Urodynamics: Maximum Cystometric Capacity | 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. |
| Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection | 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. |
| Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure | 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. |
| Quality of Life (QoL) Total Summary Score | 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. |
Countries
Czechia, France, Germany, Italy, Poland
Participant flow
Recruitment details
Patients were recruited at 22 centres in six countries (Austria, the Czech Republic, Germany, France, Italy and Poland), including 17 centres in five countries (the Czech Republic, Germany, France, Italy and Poland) which enrolled patients.
Pre-assignment details
A screening visit was performed four to seven days prior to Baseline (Day -7 to Day -4). At Baseline, 47 subjects were randomised in a ratio of 5:2:5:2 to one of the four treatment groups.
Participants by arm
| Arm | Count |
|---|---|
| Dysport 750 U (15 Injection Sites) Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose) | 14 |
| Placebo (15 Injection Sites) Placebo: Intra detrusor injection on day 1 (single dose) | 6 |
| Dysport 750 U (30 Injection Sites) Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose) | 16 |
| Placebo (30 Injection Sites) Placebo: Intra detrusor injection on day 1 (single dose) | 6 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Consent withdrawn | 0 | 0 | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Dysport 750 U (15 Injection Sites) | Placebo (15 Injection Sites) | Dysport 750 U (30 Injection Sites) | Placebo (30 Injection Sites) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 41.1 years STANDARD_DEVIATION 12.1 | 46.5 years STANDARD_DEVIATION 10.7 | 50.5 years STANDARD_DEVIATION 11.1 | 40.8 years STANDARD_DEVIATION 10.6 | 47.9 years STANDARD_DEVIATION 11.6 |
| Number of Subjects Using Anticholinergics | 9 participants | 5 participants | 9 participants | 5 participants | 28 participants |
| Number of subjects with Spinal Cord Injury (SCI) or Multiple Sclerosis (MS) MS | 5 participants | 2 participants | 9 participants | 4 participants | 20 participants |
| Number of subjects with Spinal Cord Injury (SCI) or Multiple Sclerosis (MS) SCI | 9 participants | 4 participants | 7 participants | 2 participants | 22 participants |
| Sex: Female, Male Female | 7 Participants | 2 Participants | 12 Participants | 2 Participants | 23 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 4 Participants | 4 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 16 | 3 / 7 | 11 / 17 | 4 / 7 |
| serious Total, serious adverse events | 5 / 16 | 0 / 7 | 1 / 17 | 0 / 7 |
Outcome results
Primary
Daily Incontinence Episode Frequency (IEF)
Time frame: Baseline and Day 84
Population: Analysis based on number of subjects in the Intent to Treat (ITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport 750 U (15 Injection Sites) | Daily Incontinence Episode Frequency (IEF) | Baseline | 4.21 episodes per day | Standard Deviation 2.32 |
| Dysport 750 U (15 Injection Sites) | Daily Incontinence Episode Frequency (IEF) | Change from baseline to Day 84 | -3.51 episodes per day | Standard Deviation 2.8 |
| Placebo (15 Injection Sites) | Daily Incontinence Episode Frequency (IEF) | Baseline | 3.33 episodes per day | Standard Deviation 2.87 |
| Placebo (15 Injection Sites) | Daily Incontinence Episode Frequency (IEF) | Change from baseline to Day 84 | -1.05 episodes per day | Standard Deviation 2.95 |
| Dysport 750 U (30 Injection Sites) | Daily Incontinence Episode Frequency (IEF) | Change from baseline to Day 84 | -2.86 episodes per day | Standard Deviation 1.43 |
| Dysport 750 U (30 Injection Sites) | Daily Incontinence Episode Frequency (IEF) | Baseline | 3.23 episodes per day | Standard Deviation 1.26 |
| Placebo (30 Injection Sites) | Daily Incontinence Episode Frequency (IEF) | Change from baseline to Day 84 | -3.40 episodes per day | Standard Deviation 1.49 |
| Placebo (30 Injection Sites) | Daily Incontinence Episode Frequency (IEF) | Baseline | 4.40 episodes per day | Standard Deviation 1.55 |
Comparison: Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.p-value: 0.1195% CI: [-3.47, 0.39]ANCOVA
Comparison: Comparison of the average Daily IEF change from baseline to DAY 84 using ANCOVA with the baseline average daily IEF value as covariate.p-value: 0.0795% CI: [-1.27, 0.05]ANCOVA
Secondary
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.
Time frame: Baseline
Population: Analysis based on number of subjects in the Safety population with a valid value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dysport 750 U (15 Injection Sites) | Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection | 2.7 mm | Standard Deviation 9 |
| Placebo (15 Injection Sites) | Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection | 12.2 mm | Standard Deviation 21.5 |
| Dysport 750 U (30 Injection Sites) | Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection | 1.3 mm | Standard Deviation 2.6 |
| Placebo (30 Injection Sites) | Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection | 6.7 mm | Standard Deviation 16.3 |
Secondary
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.
Time frame: Baseline
Population: Analysis based on number of subjects in the Safety population with a valid value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dysport 750 U (15 Injection Sites) | Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure | 13.7 mm | Standard Deviation 19.3 |
| Placebo (15 Injection Sites) | Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure | 11.0 mm | Standard Deviation 19.9 |
| Dysport 750 U (30 Injection Sites) | Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure | 15.8 mm | Standard Deviation 19.7 |
| Placebo (30 Injection Sites) | Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure | 10.0 mm | Standard Deviation 24.5 |
Secondary
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'.
Time frame: Day 14
Population: Analysis based on number of subjects in the Intent to Treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | No change | 2 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly improved | 0 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much improved | 4 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much worse | 0 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly improved | 4 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly worse | 0 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Improved | 3 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Worse | 0 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly worse | 1 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Worse | 0 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly improved | 0 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | No change | 3 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly improved | 0 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much improved | 1 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly worse | 0 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Improved | 1 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much worse | 0 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly worse | 1 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Worse | 0 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly worse | 0 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Improved | 4 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly worse | 0 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much worse | 0 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | No change | 1 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly improved | 0 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much improved | 8 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly improved | 3 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Improved | 2 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly improved | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much worse | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly worse | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much improved | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly improved | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | No change | 3 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly worse | 1 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Worse | 0 participants |
Comparison: Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch's t-test for independent samples.p-value: 0.05Satterthwaite-Welch's t-test
Comparison: Comparison of the Physician's Global Assessment score at DAY 14 using a two sided Satterthwaite-Welch's t-test for independent samples.p-value: <0.01Satterthwaite-Welch's t-test
Secondary
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'.
Time frame: Day 42
Population: Analysis based on number of subjects in the Intent to Treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly worse | 0 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly worse | 0 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly improved | 5 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Improved | 3 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly improved | 0 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | No change | 1 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Worse | 0 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much worse | 0 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much improved | 5 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Improved | 1 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly worse | 0 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much improved | 1 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly improved | 0 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much worse | 0 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Worse | 0 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly worse | 1 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | No change | 3 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly improved | 0 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much worse | 0 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | No change | 0 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly worse | 1 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Improved | 4 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly worse | 0 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly improved | 4 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly improved | 0 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much improved | 7 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Worse | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Improved | 3 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much worse | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly improved | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly worse | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly worse | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Worse | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | No change | 3 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much improved | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly improved | 0 participants |
Comparison: Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch's t-test for independent samples.p-value: 0.01Satterthwaite-Welch's t-test
Comparison: Comparison of the Physician's Global Assessment score at DAY 42 using a two sided Satterthwaite-Welch's t-test for independent samples.p-value: <0.01Satterthwaite-Welch's t-test
Secondary
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'.
Time frame: Day 84
Population: Analysis based on number of subjects in the Intent to Treat (ITT) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly worse | 0 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Worse | 0 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much improved | 6 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly worse | 0 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much worse | 0 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly improved | 3 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Improved | 2 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | No change | 1 participants |
| Dysport 750 U (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly improved | 2 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly worse | 0 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much improved | 1 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much worse | 0 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly improved | 0 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Worse | 1 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly worse | 0 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | No change | 2 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly improved | 1 participants |
| Placebo (15 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Improved | 1 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | No change | 1 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly worse | 0 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much worse | 0 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Improved | 4 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly improved | 0 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Worse | 0 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly improved | 4 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly worse | 0 participants |
| Dysport 750 U (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much improved | 7 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly improved | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Markedly worse | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much worse | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Worse | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | No change | 4 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly improved | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Improved | 2 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Much improved | 0 participants |
| Placebo (30 Injection Sites) | Physician's Global Assessment Score of Treatment Response | Slightly worse | 0 participants |
Comparison: Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.p-value: 0.05Satterthwaite-Welch's t-test
Comparison: Comparison of the Physician's Global Assessment score at DAY 84 using a two sided Satterthwaite-Welch's t-test for independent samples.p-value: <0.01Satterthwaite-Welch's t-test
Secondary
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.
Time frame: Baseline, 14, 42 and 84
Population: Analysis based on number of subjects in the Intent to Treat (ITT) population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport 750 U (15 Injection Sites) | Quality of Life (QoL) Total Summary Score | Baseline | 2.4 score on a scale | Standard Deviation 0.7 |
| Dysport 750 U (15 Injection Sites) | Quality of Life (QoL) Total Summary Score | Change from baseline to D14 | -1.1 score on a scale | Standard Deviation 0.9 |
| Dysport 750 U (15 Injection Sites) | Quality of Life (QoL) Total Summary Score | Change from baseline to D42 | -1.0 score on a scale | Standard Deviation 0.8 |
| Dysport 750 U (15 Injection Sites) | Quality of Life (QoL) Total Summary Score | Change from baseline to D84 | -1.3 score on a scale | Standard Deviation 1 |
| Placebo (15 Injection Sites) | Quality of Life (QoL) Total Summary Score | Change from baseline to D84 | -0.2 score on a scale | Standard Deviation 0.7 |
| Placebo (15 Injection Sites) | Quality of Life (QoL) Total Summary Score | Baseline | 2.7 score on a scale | Standard Deviation 0.6 |
| Placebo (15 Injection Sites) | Quality of Life (QoL) Total Summary Score | Change from baseline to D42 | -0.6 score on a scale | Standard Deviation 1.2 |
| Placebo (15 Injection Sites) | Quality of Life (QoL) Total Summary Score | Change from baseline to D14 | -0.2 score on a scale | Standard Deviation 1 |
| Dysport 750 U (30 Injection Sites) | Quality of Life (QoL) Total Summary Score | Change from baseline to D42 | -1.2 score on a scale | Standard Deviation 0.8 |
| Dysport 750 U (30 Injection Sites) | Quality of Life (QoL) Total Summary Score | Change from baseline to D14 | -0.8 score on a scale | Standard Deviation 0.8 |
| Dysport 750 U (30 Injection Sites) | Quality of Life (QoL) Total Summary Score | Baseline | 2.4 score on a scale | Standard Deviation 0.8 |
| Dysport 750 U (30 Injection Sites) | Quality of Life (QoL) Total Summary Score | Change from baseline to D84 | -1.2 score on a scale | Standard Deviation 0.9 |
| Placebo (30 Injection Sites) | Quality of Life (QoL) Total Summary Score | Baseline | 2.3 score on a scale | Standard Deviation 1 |
| Placebo (30 Injection Sites) | Quality of Life (QoL) Total Summary Score | Change from baseline to D14 | -0.5 score on a scale | Standard Deviation 1.3 |
| Placebo (30 Injection Sites) | Quality of Life (QoL) Total Summary Score | Change from baseline to D42 | -0.6 score on a scale | Standard Deviation 1.1 |
| Placebo (30 Injection Sites) | Quality of Life (QoL) Total Summary Score | Change from baseline to D84 | -0.7 score on a scale | Standard Deviation 1.1 |
Comparison: Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.p-value: <0.0195% CI: [-1.91, -0.35]ANCOVA
Comparison: Comparison of the Quality of Life Total Summary score change from baseline to DAY 14 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.p-value: 0.795% CI: [-1.26, 0.9]ANCOVA
Comparison: Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.p-value: 0.395% CI: [-1.56, 0.52]ANCOVA
Comparison: Comparison of the Quality of Life Total Summary score change from baseline to DAY 42 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.p-value: 0.395% CI: [-1.47, 0.52]ANCOVA
Comparison: Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.p-value: <0.0195% CI: [-2.02, -0.73]ANCOVA
Comparison: Comparison of the Quality of Life Total Summary score change from baseline to DAY 84 using ANCOVA with the baseline Quality of Life Total Summary score as covariate.p-value: 0.495% CI: [-1.35, 0.55]ANCOVA
Secondary
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.
Time frame: Baseline, Days 14, 42 and 84
Population: Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport 750 U (15 Injection Sites) | Urodynamics: Maximum Cystometric Capacity | Baseline (n=14,5,16,6) | 281 mL | Standard Deviation 186 |
| Dysport 750 U (15 Injection Sites) | Urodynamics: Maximum Cystometric Capacity | Change from baseline to D84 (n=14,5,16,6) | 150 mL | Standard Deviation 174 |
| Dysport 750 U (15 Injection Sites) | Urodynamics: Maximum Cystometric Capacity | Change from baseline to D14 (n=14,5,16,6) | 186 mL | Standard Deviation 160 |
| Dysport 750 U (15 Injection Sites) | Urodynamics: Maximum Cystometric Capacity | Change from baseline to D42 (n=14,6,15,6) | 163 mL | Standard Deviation 208 |
| Placebo (15 Injection Sites) | Urodynamics: Maximum Cystometric Capacity | Change from baseline to D42 (n=14,6,15,6) | 45 mL | Standard Deviation 64 |
| Placebo (15 Injection Sites) | Urodynamics: Maximum Cystometric Capacity | Baseline (n=14,5,16,6) | 287 mL | Standard Deviation 112 |
| Placebo (15 Injection Sites) | Urodynamics: Maximum Cystometric Capacity | Change from baseline to D84 (n=14,5,16,6) | 12.5 mL | Standard Deviation 26 |
| Placebo (15 Injection Sites) | Urodynamics: Maximum Cystometric Capacity | Change from baseline to D14 (n=14,5,16,6) | -36 mL | Standard Deviation 140 |
| Dysport 750 U (30 Injection Sites) | Urodynamics: Maximum Cystometric Capacity | Change from baseline to D42 (n=14,6,15,6) | 185 mL | Standard Deviation 174 |
| Dysport 750 U (30 Injection Sites) | Urodynamics: Maximum Cystometric Capacity | Change from baseline to D14 (n=14,5,16,6) | 169 mL | Standard Deviation 92 |
| Dysport 750 U (30 Injection Sites) | Urodynamics: Maximum Cystometric Capacity | Change from baseline to D84 (n=14,5,16,6) | 196 mL | Standard Deviation 135 |
| Dysport 750 U (30 Injection Sites) | Urodynamics: Maximum Cystometric Capacity | Baseline (n=14,5,16,6) | 288 mL | Standard Deviation 144 |
| Placebo (30 Injection Sites) | Urodynamics: Maximum Cystometric Capacity | Baseline (n=14,5,16,6) | 220 mL | Standard Deviation 55 |
| Placebo (30 Injection Sites) | Urodynamics: Maximum Cystometric Capacity | Change from baseline to D14 (n=14,5,16,6) | -33 mL | Standard Deviation 88 |
| Placebo (30 Injection Sites) | Urodynamics: Maximum Cystometric Capacity | Change from baseline to D84 (n=14,5,16,6) | 50 mL | Standard Deviation 145 |
| Placebo (30 Injection Sites) | Urodynamics: Maximum Cystometric Capacity | Change from baseline to D42 (n=14,6,15,6) | 3 mL | Standard Deviation 94 |
Comparison: Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.p-value: <0.0195% CI: [69.6, 369.5]ANCOVA
Comparison: Comparison of the maximum Cystometric Capacity change from baseline to DAY 14 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.p-value: <0.0195% CI: [140.9, 307.4]ANCOVA
Comparison: Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.p-value: 0.0995% CI: [-20, 254]ANCOVA
Comparison: Comparison of the maximum Cystometric Capacity change from baseline to DAY 42 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.p-value: <0.0195% CI: [94.3, 353.1]ANCOVA
Comparison: Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.p-value: 0.0195% CI: [34.7, 242.2]ANCOVA
Comparison: Comparison of the maximum Cystometric Capacity change from baseline to DAY 84 using ANCOVA with the baseline maximum Cystometric Capacity as covariate.p-value: <0.0195% CI: [53.2, 319.4]ANCOVA
Secondary
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.
Time frame: Baseline, Days 14, 42 and 84
Population: Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dysport 750 U (15 Injection Sites) | Urodynamics:Maximum Detrusor Pressure | Baseline (n=14,5,15,6) | 59 cm water (cm H20) | Standard Deviation 44 |
| Dysport 750 U (15 Injection Sites) | Urodynamics:Maximum Detrusor Pressure | Change from baseline to D14 (n=14,5,16,6) | -24 cm water (cm H20) | Standard Deviation 53 |
| Dysport 750 U (15 Injection Sites) | Urodynamics:Maximum Detrusor Pressure | Change from baseline to D42 (n=14,6,15,6) | -41 cm water (cm H20) | Standard Deviation 40 |
| Dysport 750 U (15 Injection Sites) | Urodynamics:Maximum Detrusor Pressure | Change from baseline to D84 (n=13,5,16,6) | -26 cm water (cm H20) | Standard Deviation 46 |
| Placebo (15 Injection Sites) | Urodynamics:Maximum Detrusor Pressure | Change from baseline to D14 (n=14,5,16,6) | -4 cm water (cm H20) | Standard Deviation 18 |
| Placebo (15 Injection Sites) | Urodynamics:Maximum Detrusor Pressure | Change from baseline to D42 (n=14,6,15,6) | -0.0 cm water (cm H20) | Standard Deviation 14 |
| Placebo (15 Injection Sites) | Urodynamics:Maximum Detrusor Pressure | Change from baseline to D84 (n=13,5,16,6) | 4 cm water (cm H20) | Standard Deviation 18 |
| Placebo (15 Injection Sites) | Urodynamics:Maximum Detrusor Pressure | Baseline (n=14,5,15,6) | 53 cm water (cm H20) | Standard Deviation 40 |
| Dysport 750 U (30 Injection Sites) | Urodynamics:Maximum Detrusor Pressure | Change from baseline to D42 (n=14,6,15,6) | -24 cm water (cm H20) | Standard Deviation 24 |
| Dysport 750 U (30 Injection Sites) | Urodynamics:Maximum Detrusor Pressure | Change from baseline to D14 (n=14,5,16,6) | -27 cm water (cm H20) | Standard Deviation 22 |
| Dysport 750 U (30 Injection Sites) | Urodynamics:Maximum Detrusor Pressure | Change from baseline to D84 (n=13,5,16,6) | -20 cm water (cm H20) | Standard Deviation 23 |
| Dysport 750 U (30 Injection Sites) | Urodynamics:Maximum Detrusor Pressure | Baseline (n=14,5,15,6) | 46 cm water (cm H20) | Standard Deviation 28 |
| Placebo (30 Injection Sites) | Urodynamics:Maximum Detrusor Pressure | Change from baseline to D84 (n=13,5,16,6) | 12 cm water (cm H20) | Standard Deviation 29 |
| Placebo (30 Injection Sites) | Urodynamics:Maximum Detrusor Pressure | Change from baseline to D14 (n=14,5,16,6) | 27 cm water (cm H20) | Standard Deviation 48 |
| Placebo (30 Injection Sites) | Urodynamics:Maximum Detrusor Pressure | Baseline (n=14,5,15,6) | 70 cm water (cm H20) | Standard Deviation 23 |
| Placebo (30 Injection Sites) | Urodynamics:Maximum Detrusor Pressure | Change from baseline to D42 (n=14,6,15,6) | 10 cm water (cm H20) | Standard Deviation 42 |
Comparison: Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.p-value: 0.2595% CI: [-66.6, 18.9]ANCOVA
Comparison: Comparison of the maximum Detrusor Pressure change from baseline to DAY 14 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.p-value: <0.0195% CI: [-112.9, -21.2]ANCOVA
Comparison: Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.p-value: 0.0395% CI: [-65.6, -4.6]ANCOVA
Comparison: Comparison of the maximum Detrusor Pressure change from baseline to DAY 42 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.p-value: 0.0195% CI: [-89.5, -12.4]ANCOVA
Comparison: Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.p-value: <0.0195% CI: [-53.7, -11]ANCOVA
Comparison: Comparison of the maximum Detrusor Pressure change from baseline to DAY 84 using ANCOVA with the baseline Maximum Detrusor Pressure as covariate.p-value: <0.0195% CI: [-76.6, -14.1]ANCOVA