Urinary Bladder, Overactive Clinical Trial
Official title:
Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A for Treatment of Overactive Bladder: a Multi-center Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 1, 2021 |
Est. primary completion date | January 1, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of South Florida Health South Tampa Center for Advanced Healthcare | Tampa | Florida |
United States | MedStar Washington Hospital Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | Medstar Health Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain from procedure: score | Pain score as rated on a 10-point visual analog scale within 5 minutes of procedure completion | Within 5 minutes of procedure completion | |
Secondary | 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 | Procedure time | |
Secondary | 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 | 6 weeks post-procedure | |
Secondary | Urinary tract infections | Percentage of patients with culture-proven post-procedure urinary tract infections within 12 weeks of procedure | 12 weeks post-procedure | |
Secondary | Urinary retention | Percentage of patients with post-procedure urinary retention requiring clean intermittent catheterization within 12 weeks of procedure | 12 weeks post-procedure |
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