Comparing pain from different numbers of bladder injections of Botox
Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A for Treatment of Overactive Bladder: a Multi-center Randomized Controlled Trial
This study is testing whether getting 5 or 20 Botox injections for overactive bladder causes more pain in women who haven't found relief from other treatments.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of South Florida Academic / other |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT04305743 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the outcomes of patients receiving a 100 unit dose of onabotulinumtoxin A for the treatment of overactive bladder and urgency urinary incontinence, specifically evaluating the difference in post-procedural pain between those receiving 5 versus 20 intravesical injections. The treatment is intended for women aged 18 and older who have not responded to other medical therapies. The study will be conducted in outpatient settings without sedation, ensuring a direct comparison of injection techniques. The goal is to establish a standardized approach to the administration of this treatment, which has seen varied practices in clinical settings.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with a diagnosis of urinary urgency, frequency, or incontinence who have not responded to other treatments.
Not a fit: Patients who are male, under 18 years old, or have specific neurological conditions or bladder cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more effective and less painful treatment protocol for women suffering from overactive bladder and urgency urinary incontinence.
How similar studies have performed: Previous studies have demonstrated the effectiveness of onabotulinumtoxin A for treating overactive bladder, but this specific comparison of injection numbers is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Washington D.C., District of Columbia and 1 other locations
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (Recruiting)
- University of South Florida Health South Tampa Center for Advanced Healthcare — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Eric S Chang, MD — University of South Florida
- Study coordinator: Eric S Chang, MD
- Email: ericchang@usf.edu
- Phone: 813-259-8500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.