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

Completed · Phase 4 · Has a placebo group

Conditions studied: Urinary Bladder, Overactive, Urinary Incontinence

In brief

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.

Key facts

Study ID

NCT03052764

Run by

Allergan

People needed

120

Starts

2016-12-12

Expected to finish

2018-12-10

Last updated by the study team

2019-12-24

Who can join

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

You may qualify if…

• Participant weighs ≥ 40 kg (88 lb)
• Participant has symptoms of Over Active Bladder (OAB) (frequency and urgency) with urinary incontinence for a period of at least 6 months immediately prior to screening.

You may not qualify if…

• Participant has symptoms of OAB due to any known neurological reason (eg, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.)
• Participant has received pharmacologic therapy to treat symptoms of OAB, including nocturia, within 7 days of the start of the screening period procedures
• Participant uses clean intermittent catheterization (CIC) or indwelling catheter to manage urinary incontinence
• Participant has been treated with any intravesical pharmacologic agent (eg, capsaicin, resiniferatoxin) within 12 months of Day 1
• Participant has had previous or current botulinum toxin therapy of any serotype for any urological condition
• Participant has had previous or current botulinum toxin therapy of any serotype for any non-urological condition within 12 weeks of Day 1
• Participant has been immunized for any botulinum toxin serotype
• Participant has history or evidence of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
• Participant has an active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening
• Participant has a history or current diagnosis of bladder cancer or other urothelial malignancy
• Participant is male with previous or current diagnosis of prostate cancer
• Participant has a history of 2 or more urinary tract infections (UTIs) within 6 months of Day 1 or is taking prophylactic antibiotics to prevent chronic UTIs
• Participant has current or previous uninvestigated hematuria
• Participant has hemophilia, or other clotting factor deficiencies, or disorders that cause bleeding diathesis
• Participant cannot withhold any antiplatelet, anticoagulant therapy or medications with anticoagulant effects for 3 days prior to Day 1
• Participant has a known allergy or sensitivity to any botulinum toxin preparation
• Participant has any medical condition that may put him/her at increased risk with exposure to BOTOX® including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
• Participant has current swallowing or breathing difficulties.

Where it is running

• Orange County Urology Associates — Laguna Hills, California, United States
• Tower Urology — Los Angeles, California, United States
• University of California, Irvine Medical Center — Orange, California, United States
• Genitourinary Surgical Consultants — Denver, Colorado, United States
• East Coast Institute for Research, LLC — Jacksonville, Florida, United States
• PMG Research of Christie Clinic — Champaign, Illinois, United States
• Deaconess Clinic, Inc. — Evansville, Indiana, United States
• Women's Health Advantage — Fort Wayne, Indiana, United States
• Urogynecology Associates — Indianapolis, Indiana, United States
• Urology of Indiana — Noblesville, Indiana, United States
• Iowa Clinic — West Des Moines, Iowa, United States
• Regional Urology — Shreveport, Louisiana, United States
• Chesapeake Urology — Owings Mills, Maryland, United States
• Beyer Research — Kalamazoo, Michigan, United States
• Michigan Institute of Urology, P.C. — Troy, Michigan, United States
• Adult and Pediatric Urology — Omaha, Nebraska, United States
• Premier Urology LLC — Edison, New Jersey, United States
• Western New York Urology Associates — Cheektowaga, New York, United States
• Manhattan Medical Research — New York, New York, United States
• Advanced Urology Centers of NY A division of IMP — Plainview, New York, United States
• Premier Medical Group of the Hudson Valley — Poughkeepsie, New York, United States
• Alliance Urology Specialists — Greensboro, North Carolina, United States
• Sandhills Medical Center — Hamlet, North Carolina, United States
• PMG Research of Wilmington — Wilmington, North Carolina, United States
• Urologic Consultants of Southeastern Pennsylvania — Bala-Cynwyd, Pennsylvania, United States

Full record on ClinicalTrials.gov

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