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NCT05719285 · ClinicalTrials.gov registry record · Phase 4
Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection
A Phase 4 study of Overactive Bladder and Overactive Bladder Syndrome, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05719285: Completed Phase 4 study of Overactive Bladder and Overactive Bladder Syndrome, sponsored by The Cleveland Clinic.
NCT05719285 is a Phase 4 study of Overactive Bladder and Overactive Bladder Syndrome that has completed, run by The Cleveland Clinic. The registered enrollment target is 100 participants, below the 205-participant average among 46 other Overactive Bladder trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05719285, a Phase 4 study of Overactive Bladder and Overactive Bladder Syndrome, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to evaluate the outcomes of differing durations of antibiotic prophylaxis with bladder onabotulinumtoxinA injection in patients with refractory overactive bladder. The main question it aims to answer are: • Is the incidence of post-procedure UTI similar between single-dose and multi-day durations of peri-procedural antibiotics? Participants will be randomized to single-dose versus multi-day dose of antibiotic prophylaxis with bladder onabotulinumtoxinA injection. Researchers will compare incidence of UTI in each group to see if there is a significant difference.
Primary Outcome
To assess this aim, the rate of postoperative urinary tract infection (UTI) within 4 weeks following bladder onabotulinumtoxinA injection will be compared between groups. Noninferiority will be declared if the incidence of UTI in the single dose group is not more than UTI incidence in the multiple dose group within statistical variability, by the prespecified noninferiority margin.
Conditions Studied
Interventions
- DRUG Single-Dose Antibiotic
- DRUG Multi-Dose Antibiotic
Study Locations (1)
Ohio
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-12-06 |
| Est. Completion | 2023-06-08 |
| Phase | Phase 4 |
What the finished NCT05719285 record still lists
NCT05719285 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 205-participant average among 46 other Overactive Bladder trials with a reported enrollment target (51% lower).
The record links to 4 conditions, with Overactive Bladder appearing as the primary indexed condition, and to 2 interventions - of which Single-Dose Antibiotic is the first listed.
NCT05719285 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05719285 about?
NCT05719285 is a clinical study titled "Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection". The goal of this clinical trial is to evaluate the outcomes of differing durations of antibiotic prophylaxis with bladder onabotulinumtoxinA injection in patients with refractory overactive bladder. The main question it aims to answer are: • Is the incidence of post-procedure UTI similar between s...
What is the current status of trial NCT05719285?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2022-12-06. Estimated completion is 2023-06-08.
What conditions does trial NCT05719285 study?
This clinical trial studies the following conditions: Overactive Bladder, Overactive Bladder Syndrome, Urinary Incontinence, Urge, Urge Incontinence.
What interventions are being tested in trial NCT05719285?
The interventions under investigation include: Single-Dose Antibiotic (DRUG), Multi-Dose Antibiotic (DRUG).
Who is sponsoring clinical trial NCT05719285?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05719285 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05719285's enrollment target sits among peer trials
100 23rd of 46 higher than 22 of 46 other Overactive Bladder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Overactive Bladder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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