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NCT04754737 · ClinicalTrials.gov registry record · NA
Antibiotic Usage Prior to OnabotulinumtoxinA Injection
A NA study of Overactive Bladder and UTI, sponsored by Benaroya Research Institute.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT04754737 is a NA study of Overactive Bladder and UTI that is actively recruiting participants, run by Benaroya Research Institute. The registered enrollment target is 200 participants, roughly in line with the 207-participant average among 45 other Overactive Bladder trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT04754737, a NA study of Overactive Bladder and UTI, is actively recruiting participants, sponsored by Benaroya Research Institute.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
Intradetrusor injection of onabotulinumtoxinA, which is performed through a cystoscopic procedure, has been demonstrated to be efficacious in the treatment of both neurogenic and non-neurogenic overactive bladder (OAB), and is FDA approved as a treatment for overactive bladder. Intradetrusor of onabotulinumtoxinA is currently standard of care of patients with OAB who have persistent OAB symptoms despite behavioral therapies and oral medication treatments for OAB. As one of the main adverse events associated with intradetrusor injection of onabotulinumtoxinA is UTI, and published guidelines for cystoscopic procedures with manipulation recommend the use of prophylactic antibiotics, a single dose of prophylactic antibiotic is administered prior to this procedure. However, these recommendations are primarily based on data from randomized controlled trials (RCTs) involving antimicrobial prophylaxis during transurethral resection of the prostate. A previously published prospective study demonstrated that the rate of post-procedural UTI did not differ amongst patients with neurogenic bladder who did not receive prophylactic antibiotics and were asymptomatic for UTI, regardless of whether they had sterile urine cultures or asymptomatic bacteriuria, suggesting that patients who are not symptomatic for UTI may not require antibiotic prophylaxis prior to intradetrusor onabotulinumtoxinA injection. Studies have reported that up to 50% of antibiotic usage is inappropriate, leading to unnecessary exposure of patients to potential complications of antibiotic therapy, including Clostridium difficile infection which can cause recurrent diarrhea that may progress to sepsis and death, increasing antibiotic resistances, as well as dermal/allergic and gastro-intestinal manifestations. Therefore, in an effort to optimize antibiotic use, the investigators propose a prospective, randomized study to formally evaluate the differences in UTI frequency in subjects who have a negative urinalysi
Conditions Studied
Interventions
- OTHER No antibiotic
- OTHER Prophylactic antibiotic
- PROCEDURE cystoscopic injection of onabotulinumtoxinA
Study Locations (1)
New York
- Stony Brook Medicine - Stony Brook
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-03-23 |
| Est. Completion | 2026-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04754737
The ClinicalTrials.gov registry entry for NCT04754737 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 207-participant average among 45 other Overactive Bladder trials with a reported enrollment target. The listed sponsor is Benaroya Research Institute, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Overactive Bladder appearing as the primary indexed condition, and to 3 interventions - of which No antibiotic is the first listed.
NCT04754737 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT04754737 about?
NCT04754737 is a clinical study titled "Antibiotic Usage Prior to OnabotulinumtoxinA Injection". Intradetrusor injection of onabotulinumtoxinA, which is performed through a cystoscopic procedure, has been demonstrated to be efficacious in the treatment of both neurogenic and non-neurogenic overactive bladder (OAB), and is FDA approved as a treatment for overactive bladder. Intradetrusor of onab...
What is the current status of trial NCT04754737?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2021-03-23. Estimated completion is 2026-12.
What conditions does trial NCT04754737 study?
This clinical trial studies the following conditions: Overactive Bladder, UTI, Antibiotic Stewardship, Onabotulinumtoxin A.
What interventions are being tested in trial NCT04754737?
The interventions under investigation include: No antibiotic (OTHER), Prophylactic antibiotic (OTHER), cystoscopic injection of onabotulinumtoxinA (PROCEDURE).
Who is sponsoring clinical trial NCT04754737?
This trial is sponsored by Benaroya Research Institute, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04754737 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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