Conditions: Overactive Bladder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 254
Healthy volunteers: no

Brief summary:
This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.

Detailed description:

Arms:
arm 1: OnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable). arm 2: Placebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).

Interventions: intervention 1: onabotulinumtoxinA intervention 2: Normal saline
Intervention descriptions: intervention 1: OnabotulinumtoxinA (BOTOX®) injected into the detrusor. intervention 2: Normal saline (placebo) injected into the detrusor.

Protocol document: