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.
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.
Male gender.
Women <18 years of age.
Non-English speaking.
Pregnancy (patient will self-report pregnancy).
Parallel
OnabotulinumtoxinA 100 UNT
DrugIntradetrusor onabotulinumtoxin A is administered cystoscopically with 100 unit dose given as either 5 or 20 injections in a single procedure based on the arm the participant is randomized into.
Pain from procedure: score
Pain score as rated on a 10-point visual analog scale within 5 minutes of procedure completion
Duration of procedure
Total time of procedure defined as time cystoscope is introduced into the bladder to the time the cystoscope is removed from the bladder after completion of all injections
Positive treatment response
The percentage of patients with a positive treatment response based on answering a Global Response Assessment given 6 weeks after completion of procedure
Urinary tract infections
Percentage of patients with culture-proven post-procedure urinary tract infections within 12 weeks of procedure
Urinary retention
Percentage of patients with post-procedure urinary retention requiring clean intermittent catheterization within 12 weeks of procedure
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University of South Florida
Lead sponsor
Medstar Health Research Institute
Collaborator
