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



Status:Completed
Conditions:Overactive Bladder, Urology
Therapuetic Areas:Gastroenterology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:2/23/2019
Start Date:December 12, 2016
End Date:December 10, 2018

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence (LO-BOT)

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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
34
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1000 West Hamlet Avenue
Hamlet, North Carolina 28345
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11701 San Jose Blvd # 32
Jacksonville, Florida 32223
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Albuquerque, New Mexico 87109
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Bala-Cynwyd, Pennsylvania 19004
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Champaign, Illinois 61820
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Charlotte, North Carolina 28207
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Cheektowaga, New York 14225
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Dallas, Texas 75231
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Denver, Colorado 80220
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10 Parsonage Road
Edison, New Jersey 08837
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Evansville, Indiana 47713
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Fort Wayne, Indiana 46825
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Franklin, Tennessee 37067
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Greensboro, North Carolina
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Kalamazoo, Michigan 49009
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Laguna Hills, California 92653
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Los Angeles, California 90048
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Mountlake Terrace, Washington 98043
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New York, New York 10016
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Noblesville, Indiana 46062
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Omaha, Nebraska 68114
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Owings Mills, Maryland 21117
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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Richmond, Virginia 23235
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Richmond, Virginia 23235
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570 Egg Harbor Road
Sewell, New Jersey 08080
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Shreveport, Louisiana 71106
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Virginia Beach, Virginia 23462
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West Des Moines, Iowa 50266
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1907 Tradd Ct
Wilmington, North Carolina 28401
(910) 799-5500
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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2010 Baldwin Lane
Winston-Salem, North Carolina 27103
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