Comparing pain from different numbers of bladder injections of Botox
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
Run by University of South Florida · NCT04305743 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | University of South Florida Academic / other |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Status | Recruiting |
| Started | October 9, 2019 |
| Main results expected | January 1, 2021 |
| Study ends | June 1, 2021 |
| Registry record updated | November 5, 2020 |
| Trial ID | NCT04305743 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have demonstrated the effectiveness of onabotulinumtoxin A for treating overactive bladder, but this specific comparison of injection numbers is novel.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating a new device for treating overactive bladder and bowel dysfunction
This study is testing a new device that uses electrical stimulation to see if it can help people with overactive bladder and bowel issues feel better.
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This study is testing a new device to see if it can help women with overactive bladder and bowel issues feel better by using electrical stimulation.
-
Treatment for Overactive Bladder in Men
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Evaluation of eCoin for treating urgency urinary incontinence
This study is testing whether an implanted device called eCoin can help people with urgency urinary incontinence feel better over the long term.
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Comparing bladder therapies for older women with urinary incontinence
This study is testing whether two different bladder treatments can help older women with urinary incontinence feel better compared to a placebo.
-
Compare two bladder medicines and placebo for urgency incontinence in older women
This study tests whether tolterodine ER or mirabegron help with urinary and aging-related outcomes in older women with urgency-predominant incontinence, compared with placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.