CClinicalTrials.gg
Sign In
CompletedNCT01852045Updated Nov 21, 2019Results posted

Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients

A Phase 3 interventional study of OnabotulinumtoxinA in Urinary Incontinence, sponsored by Allergan. Completed at 31 sites in 8 countries. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-11-21.

Sponsored by Allergan · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
5 Years to 17 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Urinary Incontinence
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 114 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Urinary incontinence due to neurogenic detrusor overactivity
  • Regularly using clean intermittent catheterization to empty the bladder

Exclusion criteria

Exclusion Criteria:

  • Surgery of the spinal cord within 6 months
  • Diagnosis of cerebral palsy
  • Current or planned use of a baclofen pump
  • Current or planned use of an electrostimulation/neuromodulation device for urinary incontinence
  • Use of an indwelling catheter for urinary incontinence instead of using clean intermittent catheterization to empty the bladder
  • Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype within 3 months for any other condition or use
  • Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
114 participants (actual)

Study arms

  • Experimental
    OnabotulinumtoxinA 50 U

    OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 (NCT01852058) if qualified.

    Biological: OnabotulinumtoxinA

  • Experimental
    OnabotulinumtoxinA 100 U

    OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.

    Biological: OnabotulinumtoxinA

  • Experimental
    OnabotulinumtoxinA 200 U

    OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1. Participants were eligible for retreatment in study 191622-121 if qualified.

    Biological: OnabotulinumtoxinA

Interventions

  • BiologicalOnabotulinumtoxinA

    OnabotulinumtoxinA injected into the detrusor wall on Day 1.

    Also known as: BOTOX®, botulinum toxin Type A

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes

    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.

    Time frame: Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6

Secondary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAE)

    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 treatment.

    Time frame: First study treatment to 12 weeks after last treatment (Up to 48 weeks after first study injection)

  2. Change From Baseline in Average Urine Volume at First Morning Catheterization

    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.

    Time frame: Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6

  3. Percentage of Participants With Night Time Urinary Incontinence

    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).

    Time frame: Baseline (Day -28 to Day -1), Week 6

  4. Change From Baseline in Maximum Cystometric Capacity (MCC)

    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.

    Time frame: Baseline (Day -28 to Day -1) to Week 6

  5. Percentage of Participants With Involuntary Detrusor Contractions (IDC)

    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.

    Time frame: Baseline (Day -28 to -1) and Week 6

  6. Change From Baseline in Maximum Detrusor Pressure During the First IDC (PdetMax1stIDC) in Participants With IDC

    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.

    Time frame: Baseline (Day-28 to Day-1) to Week 6

  7. Change From Baseline in Maximum Detrusor Pressure (PdetMax) During the Storage Phase

    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.

    Time frame: Baseline (Day 1) to Week 6

  8. Change From Baseline in Detrusor Leak Point Pressure (DLPP) During the Storage Phase

    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.

    Time frame: Baseline (Day -28 to -1) to Week 6

  9. Time to Participant Request for Retreatment

    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.

    Time frame: 48 weeks

  10. Time to Participant Qualification for Retreatment

    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.

    Time frame: 48 weeks

07

Results

Posted Oct 30, 2019

Participant flow

Participant flow — Overall Study
MilestoneOnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 U
Started394530
Mitt population384530
Safety population384530
Completed334126
Not completed644
Withdrew: Adverse event100
Withdrew: Lack of efficacy300
Withdrew: Lost to follow-up011
Withdrew: Withdrawal by subject101
Withdrew: Other miscellaneous reasons132

Outcome measures

PrimaryChange From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes

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.

Time frame:
Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
Reported as:
Least squares mean · urinary incontinence episodes per day
Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes
urinary incontinence episodes per dayOnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 U
Change From Baseline in Daily Average Frequency of Daytime Urinary Incontinence Episodes-1.30 ± 0.205-1.30 ± 0.189-1.34 ± 0.245
Statistical analysis
  • OnabotulinumtoxinA 50 U vs OnabotulinumtoxinA 100 U · ANCOVA · p = 0.9949 · Least squares mean difference: 0.00 · 95% CI -0.549 to 0.545Least squares estimates and contrast t-test were based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.
  • OnabotulinumtoxinA 50 U vs OnabotulinumtoxinA 200 U · ANCOVA · p = 0.9123 · Least squares mean difference: -0.04 · 95% CI -0.673 to 0.602Least squares estimates and contrast t-test were based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.
SecondaryNumber of Participants With Treatment Emergent Adverse Events (TEAE)

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 treatment.

Time frame:
First study treatment to 12 weeks after last treatment (Up to 48 weeks after first study injection)
Reported as:
Count of participants · Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE)
ParticipantsOnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 U
Number of Participants With Treatment Emergent Adverse Events (TEAE)273323
SecondaryChange From Baseline in Average Urine Volume at First Morning Catheterization

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.

Time frame:
Baseline (Day -28 to Day -1) to 2 consecutive days prior to Week 6
Reported as:
Least squares mean · milliliters (mL)
Change From Baseline in Average Urine Volume at First Morning Catheterization
milliliters (mL)OnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 U
Change From Baseline in Average Urine Volume at First Morning Catheterization21.93 ± 14.67634.90 ± 13.58087.49 ± 17.808
Statistical analysis
  • OnabotulinumtoxinA 50 U vs OnabotulinumtoxinA 100 U · ANCOVA · p = 0.5117 · Least squares mean difference: 12.97 · 95% CI -26.120 to 52.064Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.
  • OnabotulinumtoxinA 50 U vs OnabotulinumtoxinA 200 U · ANCOVA · p = 0.0055 · Least squares mean difference: 65.57 · 95% CI 19.711 to 111.421Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.
SecondaryPercentage of Participants With Night Time Urinary Incontinence

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).

Time frame:
Baseline (Day -28 to Day -1), Week 6
Reported as:
Number · percentage of participants
Percentage of Participants With Night Time Urinary Incontinence
percentage of participantsOnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 U
Baseline (BL): 0 nights of incontinence0.013.33.6
BL: 1 night of incontinence13.22.214.3
BL: 2 nights of incontinence86.884.482.1
Week 6: 0 nights of incontinence30.632.628.6
Week 6: 1 night of incontinence16.716.328.6
Week 6: 2 nights of incontinence52.851.242.9
SecondaryChange From Baseline in Maximum Cystometric Capacity (MCC)

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.

Time frame:
Baseline (Day -28 to Day -1) to Week 6
Reported as:
Least squares mean · mL
Change From Baseline in Maximum Cystometric Capacity (MCC)
mLOnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 U
Change From Baseline in Maximum Cystometric Capacity (MCC)62.06 ± 14.33948.57 ± 13.54963.55 ± 17.363
Statistical analysis
  • OnabotulinumtoxinA 50 U vs OnabotulinumtoxinA 100 U · ANCOVA · p = 0.4948 · Least squares mean difference: -13.49 · 95% CI -52.605 to 25.626Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.
  • OnabotulinumtoxinA 50 U vs OnabotulinumtoxinA 200 U · ANCOVA · p = 0.9471 · Least squares mean difference: 1.49 · 95% CI -43.012 to 45.991Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.
SecondaryPercentage of Participants With Involuntary Detrusor Contractions (IDC)

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.

Time frame:
Baseline (Day -28 to -1) and Week 6
Reported as:
Number · percentage of participants
Percentage of Participants With Involuntary Detrusor Contractions (IDC)
percentage of participantsOnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 U
Baseline94.4 (81.34 to 99.32)88.1 (74.37 to 96.02)92.6 (75.71 to 99.09)
Week 661.8 (43.56 to 77.83)44.7 (28.62 to 61.70)46.4 (27.51 to 66.13)
Statistical analysis
  • OnabotulinumtoxinA 50 U vs OnabotulinumtoxinA 100 U · Cochran-Mantel-Haenszel · p = 0.2027 (P-values for pairwise comparisons are obtained from 2-sided CMH test, stratified by age (\<12 years or \>=12 years), baseline daytime urinary incontinence episodes (\<=6 or \>6) and anticholinergic therapy (yes/no).) · Relative risk: 0.7 · 95% CI 0.45 to 1.14
  • OnabotulinumtoxinA 50 U vs OnabotulinumtoxinA 200 U · Cochran-Mantel-Haenszel · p = 0.1564 (P-values for pairwise comparisons are obtained from a 2-sided CMH test, stratified by age (\< 12 years or \>= 12 years), baseline daytime urinary incontinence episodes (\<= 6 or \> 6) and anticholinergic therapy (yes/no).) · Relative risk: 0.8 · 95% CI 0.40 to 1.21
SecondaryChange From Baseline in Maximum Detrusor Pressure During the First IDC (PdetMax1stIDC) in Participants With IDC

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.

Time frame:
Baseline (Day-28 to Day-1) to Week 6
Reported as:
Least squares mean · centimeters of water (cm H2O)
Change From Baseline in Maximum Detrusor Pressure During the First IDC (PdetMax1stIDC) in Participants With IDC
centimeters of water (cm H2O)OnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 U
Change From Baseline in Maximum Detrusor Pressure During the First IDC (PdetMax1stIDC) in Participants With IDC-7.64 ± 5.301-12.13 ± 5.573-5.46 ± 8.267
Statistical analysis
  • OnabotulinumtoxinA 50 U vs OnabotulinumtoxinA 100 U · ANCOVA · p = 0.5524 · Least squares mean difference: -4.49 · 95% CI -19.648 to 10.669Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.
  • OnabotulinumtoxinA 50 U vs OnabotulinumtoxinA 200 U · ANCOVA · p = 0.8313 · Least squares mean difference: 2.18 · 95% CI -18.427 to 22.795Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.
SecondaryChange From Baseline in Maximum Detrusor Pressure (PdetMax) During the Storage Phase

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.

Time frame:
Baseline (Day 1) to Week 6
Reported as:
Least squares mean · cm H2O
Change From Baseline in Maximum Detrusor Pressure (PdetMax) During the Storage Phase
cm H2OOnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 U
Change From Baseline in Maximum Detrusor Pressure (PdetMax) During the Storage Phase-12.88 ± 3.793-20.09 ± 3.632-27.31 ± 4.557
Statistical analysis
  • OnabotulinumtoxinA 50 U vs OnabotulinumtoxinA 100 U · ANCOVA · p = 0.1737 · Least squares mean difference: -7.21 · 95% CI -17.653 to 3.238Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.
  • OnabotulinumtoxinA 50 U vs OnabotulinumtoxinA 200 U · ANCOVA · p = 0.0157 · Least squares mean difference: -14.43 · 95% CI -26.061 to -2.793Least squares estimates and contrast t-test are based on ANCOVA model with baseline value as covariate and treatment group, age, baseline daytime urinary incontinence episodes, anticholinergic therapy at baseline as factors.
SecondaryChange From Baseline in Detrusor Leak Point Pressure (DLPP) During the Storage Phase

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.

Time frame:
Baseline (Day -28 to -1) to Week 6
Reported as:
Mean · cm H2O
Change From Baseline in Detrusor Leak Point Pressure (DLPP) During the Storage Phase
cm H2OOnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 U
Change From Baseline in Detrusor Leak Point Pressure (DLPP) During the Storage Phase9.50 ± 2.121-39.00 ± 0.00012.00 ± 0.000
SecondaryTime to Participant Request for Retreatment

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.

Time frame:
48 weeks
Reported as:
Median · weeks
Time to Participant Request for Retreatment
weeksOnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 U
Time to Participant Request for Retreatment30.6 (23.10 to 39.10)24.1 (18.10 to 27.60)29.6 (16.30 to 37.30)
SecondaryTime to Participant Qualification for Retreatment

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.

Time frame:
48 weeks
Reported as:
Median · weeks
Time to Participant Qualification for Retreatment
weeksOnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 U
Time to Participant Qualification for Retreatment35.0 (23.10 to 39.10)25.0 (20.00 to 32.10)29.6 (16.30 to 38.00)

Adverse events

Collected over First study treatment to 12 weeks after last treatment (Up to 48 weeks after first study injection). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
OnabotulinumtoxinA 50 U0/38 (0%)4/38 (10.5%)27/38 (71.1%)
OnabotulinumtoxinA 100 U0/45 (0%)3/45 (6.7%)33/45 (73.3%)
OnabotulinumtoxinA 200 U0/30 (0%)2/30 (6.7%)23/30 (76.7%)
Most frequent serious events
Most frequent serious events
EventOnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 U
Urinary tract infectionInfections and infestations2/382/450/30
EpididymitisInfections and infestations0/380/451/30
OrchitisInfections and infestations0/380/451/30
HypertensionVascular disorders0/380/451/30
CystitisInfections and infestations1/380/450/30
Postoperative wound infectionInfections and infestations1/380/450/30
Arteriovenous fistula thrombosisInjury, poisoning and procedural complications1/380/450/30
Encephalitis viralInfections and infestations0/381/450/30
HydrocephalusNervous system disorders0/381/450/30
Most frequent other events
Showing 10 of 18
Most frequent other events
EventOnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 U
Urinary tract infectionInfections and infestations9/3813/457/30
BacteriuriaInfections and infestations6/387/456/30
HeadacheNervous system disorders1/387/452/30
NasopharyngitisInfections and infestations0/381/454/30
LeukocyturiaRenal and urinary disorders1/383/454/30
PyrexiaGeneral disorders2/384/450/30
PharyngitisInfections and infestations3/383/450/30
DiarrhoeaGastrointestinal disorders1/383/452/30
VomitingGastrointestinal disorders1/383/450/30
GastroenteritisInfections and infestations2/383/451/30

Baseline characteristics

All enrolled participants.

Age, Continuous
Age, Continuous(years)OnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 UTotal
Mean11.4 ± 3.4510.8 ± 3.2611.9 ± 3.1311.3 ± 3.29
Sex: Female, Male
Sex: Female, Male(Participants)OnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 UTotal
Female19151549
Male20301565
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)OnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 UTotal
White29342285
Black or African American63211
Asian1214
Hispanic1337
Other2327
Daily Daytime Average Frequency of Urinary Incontinence Episodes
Daily Daytime Average Frequency of Urinary Incontinence Episodes(urinary incontinence episodes per day)OnabotulinumtoxinA 50 UOnabotulinumtoxinA 100 UOnabotulinumtoxinA 200 UTotal
Mean2.81 (0.8 to 6.7)2.99 (1.3 to 6.1)3.68 (0.5 to 29.5)3.16 (0.5 to 29.5)
08

Study locations

31 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
  • Children's Hospital of Orange County
    Orange, California 92868, United States
  • Ann & Robert H. Lurie Children's Hospital of Chicago
    Chicago, Illinois 60611, United States
  • Riley Hospital for Children
    Indianapolis, Indiana 46032, United States
  • William Beaumont Hospital Research Institute
    Royal Oak, Michigan 48073, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Pediatric Urology Associates, PC
    Tarrytown, New York 10591, United States
  • McKay Urology Carolinas Medical Center
    Charlotte, North Carolina 28207, United States
  • Duke University Health System
    Durham, North Carolina 27710, United States
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
  • Oklahoma Childrens Hospital
    Oklahoma City, Oklahoma 73104, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Children's Hospital of Wisconsin
    Milwaukee, Wisconsin 53226, United States
  • UZ Antwerpen
    Antwerpen, 2650, Belgium
  • UZ Gent , Urology
    Gent, 9000, Belgium
  • UZ Leuven
    Leuven, 3000, Belgium
  • McMaster University Medical Centre
    Hamilton, Ontario L8N 3Z5, Canada
  • CHU Sainte-Justine
    Montreal, Quebec H3T 1C5, Canada
  • Fakultni nemocnice Hradec Kralove
    Hradec Králové, 50005, Czechia
  • Fakultni nemocnice Olomouc
    Olomouc, 77520, Czechia
  • Hopital Pellegrin - Enfants
    Bordeaux, 33076, France
  • CHU de Limoges - Hopital Mere et l'Enfant
    Limoges, 87000, France
  • Hopital Trousseau
    Paris, 75012, France
  • Necker Enfants Malades Hospital
    Paris, 75015, France
  • Seconda Università di Napoli
    Caserta, 80138, Italy
  • IRCCS Ospedale Pediatrico Bambino Gesu
    Roma, 00165, Italy
  • Copernicus Podmiot Leczniczy Sp. z o. o., Kliniczny Oddzial Chirurgii i Urologii Dzieci i Mlodziezy GUMed
    Gdansk, 80-803, Poland
  • Specjalistyczny Gabinet Lekarski
    Poznan, 61-512, Poland
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
    Wroclaw, 50-369, Poland
  • Ankara University Medical Faculty Cebeci Hospital
    Ankara, 6100, Turkey
09

References and documents

Study documents

  • Statistical analysis plan · Nov 12, 2018
  • Study protocol · Sep 27, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01852045
Lead sponsor
Allergan
Responsible party
Sponsor
First posted
May 13, 2013
Start date
Jul 2, 2013
Primary completion
Oct 11, 2018
Completion
Oct 11, 2018
Results posted
Oct 30, 2019
Last update
Nov 21, 2019

Study contacts

Margarita Furmanov
study director · Allergan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Urinary Incontinence→

Other studies from this sponsor

Allergan

Start the discussion