Phase 3
N=95
A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity
Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT01852058 ↗Enrolled (actual)
95
Serious AEs
8.0%
Results posted
May 2020
Primary outcome: Primary: Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1 — 2.66; 2.97; 3.99; -1.19 urinary incontinence episodes per day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OnabotulinumtoxinA (Biological)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1 |
2.66; 2.97; 3.99; -1.19; -1.39; -2.19 | — |
| PRIMARY Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 2 |
2.57; 2.80; 3.83; -1.07; -1.70; -1.64 | — |
| PRIMARY Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 3 |
2.48; 2.94; 3.80; -1.92; -1.73; -2.74 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (STEAEs) |
23; 31; 19; 7; 34; 31 | — |
| SECONDARY Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 1 |
53.3; 55.6; 52.2; 30.0; 41.7; 39.1 | — |
| SECONDARY Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 2 |
66.7; 65.9; 58.8; 50.0; 43.2; 47.1 | — |
| SECONDARY Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 3 |
60.0; 75.0; 69.7; 60.0; 37.5; 39.4 | — |
| SECONDARY Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 1 |
14.68; 39.88; 96.90 | — |
| SECONDARY Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 2 |
7.92; 79.53; 35.34 | — |
| SECONDARY Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 3 |
58.50; 57.86; 92.39 | — |
| SECONDARY Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 1 |
0.0; 15.4; 4.3; 30.0; 37.8; 25.0 | — |
| SECONDARY Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 2 |
0.0; 8.9; 5.9; 66.7; 34.1; 23.5 | — |
| SECONDARY Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 3 |
0.0; 12.5; 5.9; 20.0; 31.3; 21.2 | — |
| SECONDARY Average Time to Participant's Request for Retreatment |
24.55; 24.64; 25.43 | — |
| SECONDARY Average Time to Participant's Qualification for Retreatment |
25.38; 25.43; 26.29 | — |
| SECONDARY Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 1 |
80.0; 80.0; 75.0 | — |
| SECONDARY Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 2 |
75.0; 97.6; 83.3 | — |
| SECONDARY Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 3 |
100; 80.0; 84.8 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Successfully completed participation in Study 191622-120
- Aged ≥ 5 years to ≤ 17 years at the time of entry into Study 191622-120
- Regularly using clean intermittent catheterization to empty the bladder
Exclusion Criteria
- Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- 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 for any other condition since entering study 191622-120
Data sourced from ClinicalTrials.gov (NCT01852058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.