Phase 4
N=120
Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence
Urinary Bladder, Overactive · Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT03052764 ↗Enrolled (actual)
120
Serious AEs
4.8%
Results posted
Dec 2019
Primary outcome: Primary: Change From Baseline in Daily Average Number of Urinary Incontinence Episodes — -2.99; -0.42 incontinence episodes per day — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- onabotulinumtoxinA (Biological); Placebo (saline) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Daily Average Number of Urinary Incontinence Episodes |
-2.99; -0.42 | <.0001 sig |
| SECONDARY Percentage of Participants Who Achieved Complete Continence |
13.9; 2.7 | — |
| SECONDARY Change From Baseline in Daily Average Number of Micturition Episodes |
-2.25; -0.01 | <.0001 sig |
| SECONDARY Change From Baseline in Daily Average Number of Urgency Episodes |
-2.79; -0.23 | <.0001 sig |
| SECONDARY Change From Baseline in Daily Average Number of Nocturia Episodes |
-0.53; 0.17 | 0.0004 sig |
| SECONDARY Percentage of Participants Who Have a Positive Treatment Response on the Treatment Benefit Scale (TBS) |
74.0; 17.6 | — |
Summary
This study will evaluate the efficacy and safety of onabotulinumtoxinA 100 U (BOTOX®), compared to placebo, when injected into the bladder using an alternative injection paradigm in reducing the number of daily urinary incontinence episodes in patients with overactive bladder (OAB) and urinary incontinence whose symptoms have not been adequately managed with an anticholinergic.
Eligibility Criteria
Inclusion Criteria
- Participant weighs ≥ 40 kg (88 lb)
- Participant has symptoms of Over Active Bladder (OAB) (frequency and urgency) with urinary incontinence for a period of at least 6 months immediately prior to screening.
Exclusion Criteria
- Participant has symptoms of OAB due to any known neurological reason (eg, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.)
- Participant has received pharmacologic therapy to treat symptoms of OAB, including nocturia, within 7 days of the start of the screening period procedures
- Participant uses clean intermittent catheterization (CIC) or indwelling catheter to manage urinary incontinence
- Participant has been treated with any intravesical pharmacologic agent (eg, capsaicin, resiniferatoxin) within 12 months of Day 1
- Participant has had previous or current botulinum toxin therapy of any serotype for any urological condition
- Participant has had previous or current botulinum toxin therapy of any serotype for any non-urological condition within 12 weeks of Day 1
- Participant has been immunized for any botulinum toxin serotype
- Participant has history or evidence of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
- Participant has an active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening
- Participant has a history or current diagnosis of bladder cancer or other urothelial malignancy
- Participant is male with previous or current diagnosis of prostate cancer
- Participant has a history of 2 or more urinary tract infections (UTIs) within 6 months of Day 1 or is taking prophylactic antibiotics to prevent chronic UTIs
- Participant has current or previous uninvestigated hematuria
- Participant has hemophilia, or other clotting factor deficiencies, or disorders that cause bleeding diathesis
- Participant cannot withhold any antiplatelet, anticoagulant therapy or medications with anticoagulant effects for 3 days prior to Day 1
- Participant has a known allergy or sensitivity to any botulinum toxin preparation
- Participant has any medical condition that may put him/her at increased risk with exposure to BOTOX® including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- Participant has current swallowing or breathing difficulties.
Data sourced from ClinicalTrials.gov (NCT03052764). 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.