Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A (NCT04305743) | Clinical Trial Compass
RecruitingPhase 4
Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
United States60 participantsStarted 2019-10-09
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Pain from procedure: score
Timeframe: Within 5 minutes of procedure completion