NCT04305743 Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
| NCT ID | NCT04305743 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of South Florida |
| Condition | Urinary Bladder, Overactive |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2019-10-09 |
| Primary Completion | 2021-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2019-10-09 with a primary completion date of 2021-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Eric S Chang, MD
PRINCIPAL INVESTIGATOR
University of South Florida
Frequently Asked Questions
Who can join the NCT04305743 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Urinary Bladder, Overactive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04305743 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04305743 currently recruiting?
Yes, NCT04305743 is actively recruiting participants. Contact the research team at ericchang@usf.edu for enrollment information.
Where is the NCT04305743 trial being conducted?
This trial is being conducted at Washington D.C., United States, Tampa, United States.
Who is sponsoring the NCT04305743 clinical trial?
NCT04305743 is sponsored by University of South Florida. The principal investigator is Eric S Chang, MD at University of South Florida. The trial plans to enroll 60 participants.