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โ† Trials
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Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A

RecruitingPhase 4Ages 18 Years - anyFemaleUniversity of South Florida
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In plain words

What the trial is, and whether it could suit you

Currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to 20 injections for the treatment of overactive bladder or urgency urinary incontinence refractory to medical treatment.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Women \>=18 years of age with diagnosis of urinary urgency, urinary frequency, urgency urinary incontinence, overactive bladder. * Procedure scheduled in either the outpatient clinic or the operating room to be performed without use of sedation, general, or neuraxial anesthesia. Exclusion Criteria: * Male gender. * Women \<18 years of age. * Non-English speaking. * Pregnancy (patient will self-report pregnancy). * Participant has symptoms of overactive bladder due to any known neurological reason (e.g. spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.) * Participant uses clean intermittent catheterization or indwelling catheter to manage urinary incontinence. * Participant has a history or current diagnosis of bladder cancer or other urothelial malignancy. * Participant has a known allergy or sensitivity to any botulinum toxin preparation. * Participant has any medical condition that may put her at increased risk with exposure to onabotulinumtoxin A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis. * Participant is scheduled for administration of onabotulinumtoxin A with use of sedation, general, or neuraxial anesthesia.
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What it tests

  • OnabotulinumtoxinA 100 UNT
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Where

2 sites
MedStar Washington Hospital Center
Washington D.C., United States
University of South Florida Health South Tampa Center for Advanced Healthcare
Tampa, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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