Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A

  • STATUS
    Recruiting
  • End date
    Jun 1, 2021
  • participants needed
    60
  • sponsor
    University of South Florida
Updated on 11 November 2020
Investigator
Eric S Chang, MD
Primary Contact
MedStar Washington Hospital Center (5.4 mi away) Contact
+1 other location
anesthesia
incontinence
overactive bladder
urinary urgency
onabotulinumtoxina
intravesical injections
onabotulinumtoxina 100 unt

Summary

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.

Description

The intradetrusor injection of onabotulinumtoxin A for treatment of idiopathic overactive bladder and urgency urinary incontinence refractory to anticholinergic or -agonist treatment was approved by the United States Food and Drug Administration (FDA) in 2013. Since then, multiple randomized placebo-controlled trials have demonstrated the effectiveness of the treatment. Currently, Allergan, Inc. and the FDA recommend the intravesical administration of onabotulinumtoxin A with dilution to 100 units/10 mL with preservative-free 0.9% Sodium Chloride Injection, as 20 injections of 0.5 mL each. Currently, in clinical practice there has been no standardization in the number of intravesical injections, with a single dose of onabotulinumtoxin A being administered in as few as 1 injection to as many as 40 injections into the detrusor muscle. Given the increasing use of this treatment modality, the investigators aim to compare patient outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to the recommended 20 injections for the treatment of idiopathic overactive bladder or urgency urinary incontinence refractory to medical treatment.

Details
Treatment OnabotulinumtoxinA 100 UNT
Clinical Study IdentifierNCT04305743
SponsorUniversity of South Florida
Last Modified on11 November 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have any of these conditions: Nocturia or Urge Incontinence or Frequent Nighttime Urination (Nocturia) or Overactive Bladder or Urinary Incontinence or Urinary Frequency More Than ...?
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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