Status:
RECRUITING
Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
Medstar Health Research Institute
Conditions:
Urinary Bladder, Overactive
Incontinence, Urge
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 tr...
Detailed Description
The intradetrusor injection of onabotulinumtoxin A for treatment of idiopathic overactive bladder and urgency urinary incontinence refractory to anticholinergic or β-agonist treatment was approved by ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04305743
Start Date
October 9 2019
End Date
June 1 2021
Last Update
November 5 2020
Active Locations (2)
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1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
2
University of South Florida Health South Tampa Center for Advanced Healthcare
Tampa, Florida, United States, 33606