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 Baseline in Daily Average Frequency of Daytime Urinary Incontinence EpisodesPrimary· Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 2 consecutive days (normalized to a 12-hour daytime period) prior to the study visit. Daytime was defined as the time between waking up to start the day and first morning catheterization and going to bed to sleep for the night. The number of incontinence episodes were averaged daily during this period. A negative change from Baseline indicates improvement. Least squares estimates were based on an Analysis of Covariance (ANCOVA) model.
Group
Value
95% CI
OnabotulinumtoxinA 50 U
-1.30
± 0.205
OnabotulinumtoxinA 100 U
-1.30
± 0.189
OnabotulinumtoxinA 200 U
-1.34
± 0.245
Number of Participants With Treatment Emergent Adverse Events (TEAE)Secondary· First study treatment to 12 weeks after last treatment (Up to 48 weeks after first study injection)
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 the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is defined as any new adverse event or worsening of an existing condition after initiation of t
Group
Value
95% CI
OnabotulinumtoxinA 50 U
27
OnabotulinumtoxinA 100 U
33
OnabotulinumtoxinA 200 U
23
Change From Baseline in Average Urine Volume at First Morning CatheterizationSecondary· Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
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. A positive change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model.
Group
Value
95% CI
OnabotulinumtoxinA 50 U
21.93
± 14.676
OnabotulinumtoxinA 100 U
34.90
± 13.580
OnabotulinumtoxinA 200 U
87.49
± 17.808
Percentage of Participants With Night Time Urinary IncontinenceSecondary· Baseline (Day -28 to Day -1), Week 6
Urinary incontinence was defined as involuntary loss of urine and the presence or absence of night time urinary incontinence was recorded by the participant in a bladder diary in the 2 consecutive days (normalized to a 12-hour daytime period) during the week prior to the study 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, 2 nights).
Baseline (BL): 0 nights of incontinence
Group
Value
95% CI
OnabotulinumtoxinA 50 U
0.0
OnabotulinumtoxinA 100 U
13.3
OnabotulinumtoxinA 200 U
3.6
BL: 1 night of incontinence
Group
Value
95% CI
OnabotulinumtoxinA 50 U
13.2
OnabotulinumtoxinA 100 U
2.2
OnabotulinumtoxinA 200 U
14.3
BL: 2 nights of incontinence
Group
Value
95% CI
OnabotulinumtoxinA 50 U
86.8
OnabotulinumtoxinA 100 U
84.4
OnabotulinumtoxinA 200 U
82.1
Week 6: 0 nights of incontinence
Group
Value
95% CI
OnabotulinumtoxinA 50 U
30.6
OnabotulinumtoxinA 100 U
32.6
OnabotulinumtoxinA 200 U
28.6
Week 6: 1 night of incontinence
Group
Value
95% CI
OnabotulinumtoxinA 50 U
16.7
OnabotulinumtoxinA 100 U
16.3
OnabotulinumtoxinA 200 U
28.6
Week 6: 2 nights of incontinence
Group
Value
95% CI
OnabotulinumtoxinA 50 U
52.8
OnabotulinumtoxinA 100 U
51.2
OnabotulinumtoxinA 200 U
42.9
Change From Baseline in Maximum Cystometric Capacity (MCC)Secondary· Baseline (Day -28 to Day -1) to Week 6
The MCC was defined by urodynamics, as the volume infused before the participant felt they could no longer delay micturition (has a strong desire to void), had a leakage, or 500 mL was instilled. A positive change from Baseline indicates improvement (increase) in the maximum volume of urine the bladder holds. Least squares estimates were based on an ANCOVA model.
Group
Value
95% CI
OnabotulinumtoxinA 50 U
62.06
± 14.339
OnabotulinumtoxinA 100 U
48.57
± 13.549
OnabotulinumtoxinA 200 U
63.55
± 17.363
Percentage of Participants With Involuntary Detrusor Contractions (IDC)Secondary· Baseline (Day -28 to -1) and Week 6
Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the presence of involuntary detrusor contractions upon filling. A reduction in IDCs from Baseline to Week 6 indicates improvement.
Baseline
Group
Value
95% CI
OnabotulinumtoxinA 50 U
94.4
81.34 – 99.32
OnabotulinumtoxinA 100 U
88.1
74.37 – 96.02
OnabotulinumtoxinA 200 U
92.6
75.71 – 99.09
Week 6
Group
Value
95% CI
OnabotulinumtoxinA 50 U
61.8
43.56 – 77.83
OnabotulinumtoxinA 100 U
44.7
28.62 – 61.70
OnabotulinumtoxinA 200 U
46.4
27.51 – 66.13
Change From Baseline in Maximum Detrusor Pressure During the First IDC (PdetMax1stIDC) in Participants With IDCSecondary· Baseline (Day-28 to Day-1) to Week 6
Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model.
Group
Value
95% CI
OnabotulinumtoxinA 50 U
-7.64
± 5.301
OnabotulinumtoxinA 100 U
-12.13
± 5.573
OnabotulinumtoxinA 200 U
-5.46
± 8.267
Change From Baseline in Maximum Detrusor Pressure (PdetMax) During the Storage PhaseSecondary· Baseline (Day 1) to Week 6
Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates were based on an ANCOVA model.
Group
Value
95% CI
OnabotulinumtoxinA 50 U
-12.88
± 3.793
OnabotulinumtoxinA 100 U
-20.09
± 3.632
OnabotulinumtoxinA 200 U
-27.31
± 4.557
Change From Baseline in Detrusor Leak Point Pressure (DLPP) During the Storage PhaseSecondary· Baseline (Day -28 to -1) to Week 6
DLPP was defined as the lowest detrusor pressure at which urine leakage occurs in the absence of either a detrusor contraction or increased intra-abdominal pressure. Urodynamic tests were performed by site personnel qualified for performing pressure/flow cystometry. The results were verified by an independent central reviewer. Cystometry was used to measures the pressure inside of the bladder to see how well the bladder was working. A negative change from Baseline indicates improvement. Least squares estimates are based on an ANCOVA model.
Group
Value
95% CI
OnabotulinumtoxinA 50 U
9.50
± 2.121
OnabotulinumtoxinA 100 U
-39.00
± 0.000
OnabotulinumtoxinA 200 U
12.00
± 0.000
Time to Participant Request for RetreatmentSecondary· 48 weeks
Time from treatment on Day 1 to request for retreatment was estimated. For those participants who did not request retreatment, their data was censored using the date of their last study visit.
Group
Value
95% CI
OnabotulinumtoxinA 50 U
30.6
23.10 – 39.10
OnabotulinumtoxinA 100 U
24.1
18.10 – 27.60
OnabotulinumtoxinA 200 U
29.6
16.30 – 37.30
Time to Participant Qualification for RetreatmentSecondary· 48 weeks
In order to qualify for retreatment, the criteria listed below must be fulfilled at the qualification for retreatment visit: Participant/parent/caregiver requests retreatment, participant has a total of at least 2 daytime urinary incontinence episodes over the 2-day bladder diary collection period, at least 12 weeks has elapsed since treatment 1 and participant has not experienced a serious treatment-related adverse event at any time.
Group
Value
95% CI
OnabotulinumtoxinA 50 U
35.0
23.10 – 39.10
OnabotulinumtoxinA 100 U
25.0
20.00 – 32.10
OnabotulinumtoxinA 200 U
29.6
16.30 – 38.00
Adverse events — posted to ClinicalTrials.gov
Time frame: First study treatment to 12 weeks after last treatment (Up to 48 weeks after first study injection).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will evaluate the 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric participants between the ages of 5 to 17 years to determine if 1 or more doses were safe and effective.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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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: 21 November 2019
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/NCT01852045.