Trial Outcomes & Findings for Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis (NCT NCT01357980)
NCT ID: NCT01357980
Last Updated: 2022-09-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Baseline and Day 84
Results posted on
2022-09-27
Participant Flow
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.
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.
Participant milestones
| Measure |
Dysport 750 U (15 Injection Sites)
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (15 Injection Sites)
Placebo: Intra detrusor injection on day 1 (single dose)
|
Dysport 750 U (30 Injection Sites)
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (30 Injection Sites)
Placebo: Intra detrusor injection on day 1 (single dose)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
7
|
17
|
7
|
|
Overall Study
COMPLETED
|
16
|
6
|
16
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Dysport 750 U (15 Injection Sites)
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (15 Injection Sites)
Placebo: Intra detrusor injection on day 1 (single dose)
|
Dysport 750 U (30 Injection Sites)
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (30 Injection Sites)
Placebo: Intra detrusor injection on day 1 (single dose)
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
0
|
|
Overall Study
Consent withdrawn
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Neurogenic Detrusor Overactivity Following Spinal Cord Injury or Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Dysport 750 U (15 Injection Sites)
n=14 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (15 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
Dysport 750 U (30 Injection Sites)
n=16 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (30 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
46.5 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
50.5 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
40.8 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
47.9 years
STANDARD_DEVIATION 11.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Number of subjects with Spinal Cord Injury (SCI) or Multiple Sclerosis (MS)
SCI
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
2 participants
n=4 Participants
|
22 participants
n=21 Participants
|
|
Number of subjects with Spinal Cord Injury (SCI) or Multiple Sclerosis (MS)
MS
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
4 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Number of Subjects Using Anticholinergics
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
5 participants
n=4 Participants
|
28 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 84Population: Analysis based on number of subjects in the Intent to Treat (ITT) population.
Outcome measures
| Measure |
Dysport 750 U (15 Injection Sites)
n=14 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (15 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
Dysport 750 U (30 Injection Sites)
n=16 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (30 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
|---|---|---|---|---|
|
Daily Incontinence Episode Frequency (IEF)
Baseline
|
4.21 episodes per day
Standard Deviation 2.32
|
3.33 episodes per day
Standard Deviation 2.87
|
3.23 episodes per day
Standard Deviation 1.26
|
4.40 episodes per day
Standard Deviation 1.55
|
|
Daily Incontinence Episode Frequency (IEF)
Change from baseline to Day 84
|
-3.51 episodes per day
Standard Deviation 2.80
|
-1.05 episodes per day
Standard Deviation 2.95
|
-2.86 episodes per day
Standard Deviation 1.43
|
-3.40 episodes per day
Standard Deviation 1.49
|
SECONDARY outcome
Timeframe: Baseline, Days 14, 42 and 84Population: Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.
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.
Outcome measures
| Measure |
Dysport 750 U (15 Injection Sites)
n=14 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (15 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
Dysport 750 U (30 Injection Sites)
n=16 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (30 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
|---|---|---|---|---|
|
Urodynamics: Maximum Cystometric Capacity
Baseline (n=14,5,16,6)
|
281 mL
Standard Deviation 186
|
287 mL
Standard Deviation 112
|
288 mL
Standard Deviation 144
|
220 mL
Standard Deviation 55
|
|
Urodynamics: Maximum Cystometric Capacity
Change from baseline to D14 (n=14,5,16,6)
|
186 mL
Standard Deviation 160
|
-36 mL
Standard Deviation 140
|
169 mL
Standard Deviation 92
|
-33 mL
Standard Deviation 88
|
|
Urodynamics: Maximum Cystometric Capacity
Change from baseline to D42 (n=14,6,15,6)
|
163 mL
Standard Deviation 208
|
45 mL
Standard Deviation 64
|
185 mL
Standard Deviation 174
|
3 mL
Standard Deviation 94
|
|
Urodynamics: Maximum Cystometric Capacity
Change from baseline to D84 (n=14,5,16,6)
|
150 mL
Standard Deviation 174
|
12.5 mL
Standard Deviation 26
|
196 mL
Standard Deviation 135
|
50 mL
Standard Deviation 145
|
SECONDARY outcome
Timeframe: Baseline, Days 14, 42 and 84Population: Analysis based on number (n) of subjects with a valid value in the Intent-to-Treat (ITT) population for the respective treatment groups.
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.
Outcome measures
| Measure |
Dysport 750 U (15 Injection Sites)
n=14 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (15 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
Dysport 750 U (30 Injection Sites)
n=16 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (30 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
|---|---|---|---|---|
|
Urodynamics:Maximum Detrusor Pressure
Baseline (n=14,5,15,6)
|
59 cm water (cm H20)
Standard Deviation 44
|
53 cm water (cm H20)
Standard Deviation 40
|
46 cm water (cm H20)
Standard Deviation 28
|
70 cm water (cm H20)
Standard Deviation 23
|
|
Urodynamics:Maximum Detrusor Pressure
Change from baseline to D14 (n=14,5,16,6)
|
-24 cm water (cm H20)
Standard Deviation 53
|
-4 cm water (cm H20)
Standard Deviation 18
|
-27 cm water (cm H20)
Standard Deviation 22
|
27 cm water (cm H20)
Standard Deviation 48
|
|
Urodynamics:Maximum Detrusor Pressure
Change from baseline to D42 (n=14,6,15,6)
|
-41 cm water (cm H20)
Standard Deviation 40
|
-0.0 cm water (cm H20)
Standard Deviation 14
|
-24 cm water (cm H20)
Standard Deviation 24
|
10 cm water (cm H20)
Standard Deviation 42
|
|
Urodynamics:Maximum Detrusor Pressure
Change from baseline to D84 (n=13,5,16,6)
|
-26 cm water (cm H20)
Standard Deviation 46
|
4 cm water (cm H20)
Standard Deviation 18
|
-20 cm water (cm H20)
Standard Deviation 23
|
12 cm water (cm H20)
Standard Deviation 29
|
SECONDARY outcome
Timeframe: Day 14Population: Analysis based on number of subjects in the Intent to Treat (ITT) population.
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'.
Outcome measures
| Measure |
Dysport 750 U (15 Injection Sites)
n=14 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (15 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
Dysport 750 U (30 Injection Sites)
n=16 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (30 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
|---|---|---|---|---|
|
Physician's Global Assessment Score of Treatment Response
Markedly worse
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physician's Global Assessment Score of Treatment Response
Much worse
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physician's Global Assessment Score of Treatment Response
Worse
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physician's Global Assessment Score of Treatment Response
Slightly worse
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Physician's Global Assessment Score of Treatment Response
No change
|
2 participants
|
3 participants
|
1 participants
|
3 participants
|
|
Physician's Global Assessment Score of Treatment Response
Slightly improved
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physician's Global Assessment Score of Treatment Response
Improved
|
3 participants
|
1 participants
|
4 participants
|
2 participants
|
|
Physician's Global Assessment Score of Treatment Response
Much improved
|
4 participants
|
1 participants
|
8 participants
|
0 participants
|
|
Physician's Global Assessment Score of Treatment Response
Markedly improved
|
4 participants
|
0 participants
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 42Population: Analysis based on number of subjects in the Intent to Treat (ITT) population.
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'.
Outcome measures
| Measure |
Dysport 750 U (15 Injection Sites)
n=14 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (15 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
Dysport 750 U (30 Injection Sites)
n=16 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (30 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
|---|---|---|---|---|
|
Physician's Global Assessment Score of Treatment Response
Markedly worse
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physician's Global Assessment Score of Treatment Response
Much worse
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physician's Global Assessment Score of Treatment Response
Worse
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physician's Global Assessment Score of Treatment Response
Slightly worse
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Physician's Global Assessment Score of Treatment Response
No change
|
1 participants
|
3 participants
|
0 participants
|
3 participants
|
|
Physician's Global Assessment Score of Treatment Response
Slightly improved
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physician's Global Assessment Score of Treatment Response
Improved
|
3 participants
|
1 participants
|
4 participants
|
3 participants
|
|
Physician's Global Assessment Score of Treatment Response
Much improved
|
5 participants
|
1 participants
|
7 participants
|
0 participants
|
|
Physician's Global Assessment Score of Treatment Response
Markedly improved
|
5 participants
|
0 participants
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 84Population: Analysis based on number of subjects in the Intent to Treat (ITT) population.
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'.
Outcome measures
| Measure |
Dysport 750 U (15 Injection Sites)
n=14 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (15 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
Dysport 750 U (30 Injection Sites)
n=16 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (30 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
|---|---|---|---|---|
|
Physician's Global Assessment Score of Treatment Response
No change
|
1 participants
|
2 participants
|
1 participants
|
4 participants
|
|
Physician's Global Assessment Score of Treatment Response
Slightly improved
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Physician's Global Assessment Score of Treatment Response
Markedly worse
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physician's Global Assessment Score of Treatment Response
Much worse
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physician's Global Assessment Score of Treatment Response
Worse
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Physician's Global Assessment Score of Treatment Response
Slightly worse
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Physician's Global Assessment Score of Treatment Response
Improved
|
2 participants
|
1 participants
|
4 participants
|
2 participants
|
|
Physician's Global Assessment Score of Treatment Response
Much improved
|
6 participants
|
1 participants
|
7 participants
|
0 participants
|
|
Physician's Global Assessment Score of Treatment Response
Markedly improved
|
3 participants
|
0 participants
|
4 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 14, 42 and 84Population: Analysis based on number of subjects in the Intent to Treat (ITT) population.
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.
Outcome measures
| Measure |
Dysport 750 U (15 Injection Sites)
n=14 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (15 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
Dysport 750 U (30 Injection Sites)
n=16 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (30 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
|---|---|---|---|---|
|
Quality of Life (QoL) Total Summary Score
Baseline
|
2.4 score on a scale
Standard Deviation 0.7
|
2.7 score on a scale
Standard Deviation 0.6
|
2.4 score on a scale
Standard Deviation 0.8
|
2.3 score on a scale
Standard Deviation 1.0
|
|
Quality of Life (QoL) Total Summary Score
Change from baseline to D14
|
-1.1 score on a scale
Standard Deviation 0.9
|
-0.2 score on a scale
Standard Deviation 1.0
|
-0.8 score on a scale
Standard Deviation 0.8
|
-0.5 score on a scale
Standard Deviation 1.3
|
|
Quality of Life (QoL) Total Summary Score
Change from baseline to D42
|
-1.0 score on a scale
Standard Deviation 0.8
|
-0.6 score on a scale
Standard Deviation 1.2
|
-1.2 score on a scale
Standard Deviation 0.8
|
-0.6 score on a scale
Standard Deviation 1.1
|
|
Quality of Life (QoL) Total Summary Score
Change from baseline to D84
|
-1.3 score on a scale
Standard Deviation 1.0
|
-0.2 score on a scale
Standard Deviation 0.7
|
-1.2 score on a scale
Standard Deviation 0.9
|
-0.7 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis based on number of subjects in the Safety population with a valid value.
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.
Outcome measures
| Measure |
Dysport 750 U (15 Injection Sites)
n=14 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (15 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
Dysport 750 U (30 Injection Sites)
n=15 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (30 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
|---|---|---|---|---|
|
Pain Visual Analogue Scale (VAS) Score: Before Treatment Injection
|
2.7 mm
Standard Deviation 9.0
|
12.2 mm
Standard Deviation 21.5
|
1.3 mm
Standard Deviation 2.6
|
6.7 mm
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis based on number of subjects in the Safety population with a valid value.
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.
Outcome measures
| Measure |
Dysport 750 U (15 Injection Sites)
n=14 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (15 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
Dysport 750 U (30 Injection Sites)
n=14 Participants
Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
|
Placebo (30 Injection Sites)
n=6 Participants
Placebo: Intra detrusor injection on day 1 (single dose)
|
|---|---|---|---|---|
|
Pain Visual Analogue Scale (VAS) Score: During Treatment Injection Procedure
|
13.7 mm
Standard Deviation 19.3
|
11.0 mm
Standard Deviation 19.9
|
15.8 mm
Standard Deviation 19.7
|
10.0 mm
Standard Deviation 24.5
|
Adverse Events
Dysport 750 U (15 Injection Sites)
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo (15 Injection Sites)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dysport 750 U (30 Injection Sites)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo (30 Injection Sites)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dysport 750 U (15 Injection Sites)
n=16 participants at risk
Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)
|
Placebo (15 Injection Sites)
n=7 participants at risk
Placebo: Intra detrusor injection on day 1 (single dose)
|
Dysport 750 U (30 Injection Sites)
n=17 participants at risk
Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)
|
Placebo (30 Injection Sites)
n=7 participants at risk
Placebo: Intra detrusor injection on day 1 (single dose)
|
|---|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • 98 days.
|
0.00%
0/7 • 98 days.
|
5.9%
1/17 • Number of events 1 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
6.2%
1/16 • Number of events 1 • 98 days.
|
0.00%
0/7 • 98 days.
|
0.00%
0/17 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
18.8%
3/16 • Number of events 3 • 98 days.
|
0.00%
0/7 • 98 days.
|
0.00%
0/17 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Number of events 1 • 98 days.
|
0.00%
0/7 • 98 days.
|
0.00%
0/17 • 98 days.
|
0.00%
0/7 • 98 days.
|
Other adverse events
| Measure |
Dysport 750 U (15 Injection Sites)
n=16 participants at risk
Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)
|
Placebo (15 Injection Sites)
n=7 participants at risk
Placebo: Intra detrusor injection on day 1 (single dose)
|
Dysport 750 U (30 Injection Sites)
n=17 participants at risk
Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)
|
Placebo (30 Injection Sites)
n=7 participants at risk
Placebo: Intra detrusor injection on day 1 (single dose)
|
|---|---|---|---|---|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/16 • 98 days.
|
0.00%
0/7 • 98 days.
|
5.9%
1/17 • Number of events 1 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
General disorders
Asthenia
|
0.00%
0/16 • 98 days.
|
0.00%
0/7 • 98 days.
|
11.8%
2/17 • Number of events 2 • 98 days.
|
28.6%
2/7 • Number of events 2 • 98 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Number of events 1 • 98 days.
|
0.00%
0/7 • 98 days.
|
0.00%
0/17 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
Infections and infestations
Bacteriuria
|
6.2%
1/16 • Number of events 1 • 98 days.
|
0.00%
0/7 • 98 days.
|
0.00%
0/17 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
Renal and urinary disorders
Bladder Pain
|
0.00%
0/16 • 98 days.
|
14.3%
1/7 • Number of events 1 • 98 days.
|
0.00%
0/17 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
Investigations
Blood urine present
|
0.00%
0/16 • 98 days.
|
0.00%
0/7 • 98 days.
|
0.00%
0/17 • 98 days.
|
14.3%
1/7 • Number of events 1 • 98 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Number of events 1 • 98 days.
|
0.00%
0/7 • 98 days.
|
0.00%
0/17 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
Infections and infestations
Escherichia sepsis
|
6.2%
1/16 • Number of events 1 • 98 days.
|
0.00%
0/7 • 98 days.
|
0.00%
0/17 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/16 • 98 days.
|
0.00%
0/7 • 98 days.
|
5.9%
1/17 • Number of events 1 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/16 • 98 days.
|
0.00%
0/7 • 98 days.
|
5.9%
1/17 • Number of events 1 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/16 • 98 days.
|
0.00%
0/7 • 98 days.
|
5.9%
1/17 • Number of events 1 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
Infections and infestations
Gastroenteritis
|
6.2%
1/16 • Number of events 1 • 98 days.
|
0.00%
0/7 • 98 days.
|
0.00%
0/17 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/16 • 98 days.
|
14.3%
1/7 • Number of events 1 • 98 days.
|
0.00%
0/17 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • 98 days.
|
14.3%
1/7 • Number of events 1 • 98 days.
|
0.00%
0/17 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
General disorders
Influenza like illness
|
0.00%
0/16 • 98 days.
|
0.00%
0/7 • 98 days.
|
5.9%
1/17 • Number of events 1 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/16 • 98 days.
|
0.00%
0/7 • 98 days.
|
5.9%
1/17 • Number of events 1 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
Investigations
Neutrophil count increased
|
6.2%
1/16 • Number of events 1 • 98 days.
|
0.00%
0/7 • 98 days.
|
0.00%
0/17 • 98 days.
|
0.00%
0/7 • 98 days.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Number of events 1 • 98 days.
|
0.00%
0/7 • 98 days.
|
17.6%
3/17 • Number of events 3 • 98 days.
|
14.3%
1/7 • Number of events 1 • 98 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place