drugset / Trial / NCT03052764

Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence

NCT03052764

Phase 4 Completed 120 enrolled Allergan
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2016-12-12
Primary completion
2018-12-10
Completion
2018-12-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic 100 iu Other

Indications