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

Completed · Phase 4 · Has a placebo group

Conditions studied: Overactive Bladder

In brief

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.

Key facts

Study ID

NCT01945489

Run by

Allergan

People needed

254

Starts

2013-10-28

Expected to finish

2017-01-05

Last updated by the study team

2017-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Urologic Clinics of North Alabama — Huntsville, Alabama, United States
• Alaska Urological Institute dba Alaska Clinical Research Center — Anchorage, Alaska, United States
• South Orange County Medical Research Center — Laguna Hills, California, United States
• University of Southern California — Los Angeles, California, United States
• Genesis Research LLC — San Diego, California, United States
• U. Colorado, School of Med. — Aurora, Colorado, United States
• Genitourinary Surgical Consultants — Denver, Colorado, United States
• Urology Associates of Norwalk — Norwalk, Connecticut, United States
• Sunrise Medical Research — Lauderdale Lakes, Florida, United States
• Bladder and Prostate Health Investigations, LLC — Miramar, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Urology Health Team, PLLC — Ocala, Florida, United States
• Southeastern Research Group, Inc. — Tallahassee, Florida, United States
• Atlanta Medical Research Institute — Alpharetta, Georgia, United States
• Northeast Indiana — Fort Wayne, Indiana, United States
• Urogynecology Associates — Indianapolis, Indiana, United States
• Deaconess Clinic, Inc. — Newburgh, Indiana, United States
• Urology of Indiana, LLC — Noblesville, Indiana, United States
• Regional Urology, LLC — Shreveport, Louisiana, United States
• Chesapeake Urology Research Associates — Owings Mills, Maryland, United States
• Brooklyn Urology Research Group — Brooklyn, New York, United States
• Accumed Research — Garden City, New York, United States
• Manhattan Medical Research — New York, New York, United States
• Premier Medical Group of the Hudson Valley — Newburgh, New York, United States
• Advanced Urology Centers of NY A division of IMP — Plainview, New York, United States

Full record on ClinicalTrials.gov

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