Phase 2
N=383
BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
Urinary Incontinence · Overactive Bladder With Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT03320850 ↗Enrolled (actual)
383
Serious AEs
1.8%
Results posted
Aug 2021
Primary outcome: Primary: Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day — -2.72; -1.62; -0.89; -1.52 episodes per day — p=0.0845
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OnabotulinumtoxinA and Hydrogel admixture (Drug); Placebo and Hydrogel admixture (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day |
-2.72; -1.62; -0.89; -1.52; -1.85 | 0.0845 |
| PRIMARY Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period |
6; 4; 4; 10; 6; 25 | — |
| SECONDARY Stage 2: Change From Baseline in the Average Number of Micturition Episodes Per Day |
-1.64; -0.91; -0.86; -1.00; -1.11 | 0.2361 |
| SECONDARY Stage 2: Change From Baseline in the Average Volume Voided Per Micturition |
12.61; 5.56; 4.61; 11.28; 21.94 | 0.5911 |
Summary
This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.
Eligibility Criteria
Inclusion Criteria
- Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
- Inadequate response or limiting side effects with pharmacotherapy for the treatment of OAB
Exclusion Criteria
- Overactive Bladder caused by neurological condition
- Patient has predominance of stress incontinence
- History or evidence of pelvic or urological abnormality
- Prior use of BOTOX for any urological condition
Data sourced from ClinicalTrials.gov (NCT03320850). 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.