Phase 4
Completed N=100
Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection
Overactive Bladder · Overactive Bladder Syndrome · Urge Incontinence · Urinary Incontinence, Urge
Source: ClinicalTrials.gov NCT05719285 ↗
Enrolled (actual)
100
Serious AEs
1.0%
Results posted
Jan 2024
Primary outcomePrimary: Establish Noninferiority of the Single Dose Antibiotic Administration to the Multi-dose Antibiotic Administration. — 1; 1 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Establish Noninferiority of the Single Dose Antibiotic Administration to the Multi-dose Antibiotic Administration. |
1; 1 | — |
| SECONDARY Antibiotic Adverse Events |
0; 0 | — |
| SECONDARY Symptomatic Urinary Retention |
0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with planned in-office bladder onabotulinumtoxinA injection
- Men or Women Age ≥ 18
- Able to read, speak, and write in English
- No contraindication to injection of onabotulinumtoxinA - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation
- Willingness and ability to initiate intermittent catheterization post-treatment if required
- No contraindication to oral antibiotics
- No active antibiotic therapy for any indication at the time of onabotulinumtoxinA injection
- Have not participated in this study before
Exclusion Criteria
- Any type of catheterization to empty the bladder
- Unwillingness or inability to initiate intermittent catheterization post-treatment if required
- Less than 3 months since last bladder onabotulinumtoxinA injection
- Pregnant and/or breastfeeding
- Active symptomatic UTI the day of the procedure - new or worsening frequency, urgency, dysuria, hematuria, suprapubic/flank pain, fevers or chills
- History of recurrent UTI
- Prior development of urinary retention or incomplete bladder emptying after bladder onabotulinumtoxinA injection requiring catheterization of any type
Data sourced from ClinicalTrials.gov (NCT05719285). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.