Clareo Health | Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence
Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence
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Lead
Allergan
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
