Adults 5 to 17, any sex, with Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1Primary· Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Baseline
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
2.66
± 0.876
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
2.97
± 1.135
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
3.99
± 5.492
Change from Baseline to Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
-1.19
± 1.156
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
-1.39
± 1.585
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
-2.19
± 5.738
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 2Primary· Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Baseline
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
2.57
± 0.937
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
2.80
± 0.915
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
3.83
± 4.623
Change from Baseline to Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
-1.07
± 2.092
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
-1.70
± 1.331
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
-1.64
± 1.906
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 3Primary· Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Baseline
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
2.48
± 0.228
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
2.94
± 0.923
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
3.80
± 4.678
Change from Baseline to Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
-1.92
± 0.858
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
-1.73
± 1.057
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
-2.74
± 4.833
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (STEAEs)Secondary· First injection on Day 1 in Study 120 through completion of Study 121 (Up to 108 weeks)
An adverse event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to medicinal (investigational) product. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of e
TEAEs
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
23
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
31
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
19
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
7
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
34
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
31
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
4
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
10
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
21
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
3
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
2
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
4
STEAEs
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
2
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
3
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
1
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
0
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
5
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
6
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
0
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
1
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
2
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
0
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
0
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
0
Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 1Secondary· Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily incontinence episodes were averaged during the 2-day period. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
≥50% Reduction from Baseline to Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
53.3
34.33 – 71.66
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
55.6
38.10 – 72.06
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
52.2
30.59 – 73.18
≥75% Reduction from Baseline to Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
30.0
14.73 – 49.40
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
41.7
25.51 – 59.24
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
39.1
19.71 – 61.46
≥90% Reduction from Baseline to Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
26.7
12.28 – 45.89
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
30.6
16.35 – 48.11
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
30.4
13.21 – 52.92
≥100% Reduction from Baseline to Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
26.7
12.28 – 45.89
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
27.8
14.20 – 45.19
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
26.1
10.23 – 48.41
Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 2Secondary· Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily incontinence episodes were averaged during the 2-day period. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
≥50% Reduction from Baseline to Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
66.7
22.28 – 95.67
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
65.9
50.08 – 79.51
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
58.8
40.70 – 75.35
≥75% Reduction from Baseline to Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
50.0
11.81 – 88.19
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
43.2
28.35 – 58.97
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
47.1
29.78 – 64.87
≥90% Reduction from Baseline to Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
50.0
11.81 – 88.19
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
27.3
14.96 – 42.79
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
41.2
24.65 – 59.30
≥100% Reduction from Baseline to Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
50.0
11.81 – 88.19
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
25.0
13.19 – 40.34
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
38.2
22.17 – 56.44
Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 3Secondary· Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily incontinence episodes were averaged during the 2-day period. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
≥50% Reduction from Baseline at Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
60.0
14.66 – 94.73
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
75.0
47.62 – 92.73
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
69.7
51.29 – 84.41
≥75% Reduction from Baseline at Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
60.0
14.66 – 94.73
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
37.5
15.20 – 64.57
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
39.4
22.91 – 57.86
≥90% Reduction from Baseline at Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
60.0
14.66 – 94.73
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
18.8
4.05 – 45.65
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
33.3
17.96 – 51.83
≥100% Reduction from Baseline at Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
60.0
14.66 – 94.73
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
18.8
4.05 – 45.65
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
30.3
15.59 – 48.71
Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 1Secondary· Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1
The change in urine volume at first morning catherization was recorded by the participant in a bladder diary in the 2 consecutive days during the week prior to the study visit. The daily values were averaged during the 2-day period. A positive change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
14.68
± 88.146
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
39.88
± 72.787
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
96.90
± 120.429
Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 2Secondary· Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2
The change in urine volume at first morning catherization was recorded by the participant in a bladder diary in the 2 consecutive days during the week prior to the study visit. The daily values were averaged during the 2-day period. A positive change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
7.92
± 148.597
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
79.53
± 106.794
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
35.34
± 98.209
Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 3Secondary· Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3
The change in urine volume at first morning catherization was recorded by the participant in a bladder diary in the 2 consecutive days during the week prior to the study visit. The daily values were averaged during the 2-day period. A positive change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
58.50
± 22.749
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
57.86
± 74.762
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
92.39
± 147.322
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 1Secondary· Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1
Urinary incontinence was defined as involuntary loss of urine. Night time urinary incontinence was recorded by the participant on the bladder diary as a presence or absence of urinary leakage upon waking, for 2 consecutive days in the week prior to the week 6 visit. Night time was defined as the time between going to bed to sleep for the night and waking up to start the day. The percentage of participants with night time urinary incontinence is presented in categories 0, 1, and 2 nights. Data are summarized under the respective treatments that participants received in the corresponding treatme
0 Nights of Incontinence at Baseline
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
0.0
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
15.4
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
4.3
0 Nights of Incontinence at Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
30.0
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
37.8
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
25.0
1 Night of Incontinence at Baseline
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
12.9
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
2.6
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
17.4
1 Night of Incontinence at Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
20.0
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
16.2
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
29.2
2 Nights of Incontinence at Baseline
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
87.1
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
82.1
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
78.3
2 Nights of Incontinence at Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
50.0
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
45.9
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
45.8
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 2Secondary· Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2
Urinary incontinence was defined as involuntary loss of urine. Night time urinary incontinence was recorded by the participant on the bladder diary as a presence or absence of urinary leakage upon waking, for 2 consecutive days in the week prior to the week 6 visit. Night time was defined as the time between going to bed to sleep for the night and waking up to start the day. The percentage of participants with night time urinary incontinence is presented in categories 0, 1, and 2 nights. Data are summarized under the respective treatments that participants received in the corresponding treatme
0 Nights of Incontinence at Baseline
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
0.0
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
8.9
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
5.9
0 Nights of Incontinence at Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
66.7
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
34.1
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
23.5
1 Night of Incontinence at Baseline
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
22.2
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
6.7
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
8.8
1 Night of Incontinence at Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
16.7
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
22.7
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
8.8
2 Nights of Incontinence at Baseline
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
77.8
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
84.4
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
85.3
2 Nights of Incontinence at Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
16.7
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
43.2
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
67.6
Adverse events — posted to ClinicalTrials.gov
Time frame: First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA (botulinum toxin Type A; BOTOX®) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in participants who successfully completed Study 191622-120 (NCT01852045).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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· Phase 1
· completed
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· Phase 4
· completed
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· Phase 2
· not yet recruiting
NCT06499688 — A Phase III Study to Evaluate the Efficacy and Safety of Recombinant Botulinum Toxin Type A for Injection in the Treatme
· Phase 3
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allergan
Last refreshed: 12 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01852058.