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Toxin
Injection of OnabotulinumtoxinA (BTX-A) for Urinary Tract Infection
Phase 4
Waitlist Available
Led By Melissa Kaufman, MD, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 18 years of age
Medication refractory OAB, identified per American Urological Association guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks post-injection
Awards & highlights
Study Summary
This trial will compare different antibiotic protocols given around the time of injection of OnabotulinumtoxinA to study their affect on the rate of urinary tract infection.
Eligible Conditions
- Urinary Tract Infection
- Overactive Bladder
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 weeks post injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks post injection
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post Procedural- Urinary Tract Infection
Secondary outcome measures
Recurrent Urinary Tract Infection
Urinary Retention
Trial Design
2Treatment groups
Experimental Treatment
Group I: Periprocedural Antibiotics OnlyExperimental Treatment2 Interventions
Patients receive a one-time dose of antibiotics at the time of injection, prior to injection.
Group II: Extended AntibioticsExperimental Treatment3 Interventions
Patients receive a peri-procedural dose of antibiotics and an extended (3-day) course of antibiotics to be taken post-procedurally.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
850 Previous Clinical Trials
669,105 Total Patients Enrolled
Society of Urodynamics, Female Pelvic Medicine and Urogenital ReconstructionUNKNOWN
1 Previous Clinical Trials
29 Total Patients Enrolled
The Allergan FoundationUNKNOWN
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