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

Launched by UNIVERSITY OF SOUTH FLORIDA · Mar 11, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different ways of giving a treatment called onabotulinumtoxin A for women who have problems with overactive bladders, such as frequent urination or sudden urges to go. The trial compares giving this treatment in 5 injections versus 20 injections, both using the same total dose. The goal is to see which method is better for reducing pain after the procedure and improving symptoms.

To be eligible for this trial, participants need to be women aged 18 and older who experience urinary urgency or frequency and can have the procedure done without sedation. Unfortunately, men and women under 18 cannot participate, nor can those who have certain medical conditions or are currently pregnant. Women who join the study can expect to receive the treatment in an outpatient setting, and they will be monitored to see how well the different injection methods work for their bladder issues. This study is currently recruiting participants, so if you or someone you know might be interested, it could be a good opportunity to help improve bladder treatment options.

Gender

FEMALE

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.