Overview

This trial is active, not recruiting.

Condition overactive bladder
Treatments onabotulinumtoxina, normal saline
Phase phase 4
Sponsor Allergan
Start date October 2013
End date May 2016
Trial size 254 participants
Trial identifier NCT01945489, GMA-OAB-113

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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).
onabotulinumtoxina BOTOX®
OnabotulinumtoxinA (BOTOX®) injected into the detrusor.
(Other)
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).
onabotulinumtoxina BOTOX®
OnabotulinumtoxinA (BOTOX®) injected into the detrusor.
normal saline
Normal saline (placebo) injected into the detrusor.

Primary Outcomes

Measure
Percentage of Participants who Achieve a 100% Reduction in Urinary Incontinence Episodes
time frame: Baseline, Week 12
Change from Baseline in Number of Episodes of Urinary Incontinence
time frame: Baseline, Week 12

Secondary Outcomes

Measure
King's Health Questionnaire (KHQ) domain scores
time frame: Week 12
Number of Micturition Episodes
time frame: Week 12
Number of Daily Urgency Episodes
time frame: Week 12
Number of Nocturia Episodes
time frame: Week 12

Eligibility Criteria

Male or female participants at least 18 years old.

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 information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Allergan.