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

• Status: Recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Florida
• Collaborators: Medstar Health Research Institute; Washington Hospital Center
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A

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.