OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder (COMFORT)

Allergan

Status and phase: Completed; Phase 4

Conditions: Overactive Bladder

Treatments: Biological: onabotulinumtoxinA; Drug: Normal saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT01945489

GMA-OAB-113

Details and patient eligibility

About

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.

Enrollment: 254 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary incontinence for at least 6 months prior to screening.

Exclusion criteria

• Symptoms of OAB due to a neurological reason
• Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening
• Use of Clean Intermittent Catheterization (CIC) or indwelling catheter to manage urinary incontinence
• Use of botulinum toxin therapy of any serotype for any urological condition
• Use of botulinum toxin therapy of any serotype for any non-urological condition in the 12 weeks prior to screening
• History of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
• Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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254 participants in 2 patient groups

OnabotulinumtoxinA

Experimental group

Description:

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).

Treatment:

Biological: onabotulinumtoxinA

Placebo/OnabotulinumtoxinA

Other group

Description:

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).

Treatment:

Drug: Normal saline

Biological: onabotulinumtoxinA