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

RecruitingPhase 4

Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A for Treatment of Overactive Bladder: a Multi-center Randomized Controlled Trial

Who can join

Ages 18 and older · Women

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: University of South Florida · Participants: 60 · Started: Oct 9, 2019

Contact the study team

Official record on ClinicalTrials.gov — NCT04305743

Locations in the U.S.

District of ColumbiaMedStar Washington Hospital Center, Washington D.C.
FloridaUniversity of South Florida Health South Tampa Center for Advanced Healthcare, Tampa

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.