Evaluating antibiotic use before onabotulinumtoxinA injections for overactive bladder
Optimizing Antibiotic Use in Treatment of Overactive Bladder: Evaluating the Need for Prophylactic Antibiotics Prior to OnabotulinumtoxinA Injection in Patients Without Urinary Tract Infection
This study is testing if giving antibiotics before onabotulinumtoxinA injections helps or is needed for adults with overactive bladder who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Benaroya Research Institute Academic / other |
| Locations | 1 site (Stony Brook, New York) |
| Trial ID | NCT04754737 on ClinicalTrials.gov |
What this trial studies
This study investigates the necessity of prophylactic antibiotics prior to intradetrusor injections of onabotulinumtoxinA in patients with overactive bladder (OAB). It aims to optimize antibiotic usage by comparing outcomes between patients receiving antibiotics and those who do not. The study includes adults diagnosed with OAB who have not responded to standard therapies and ensures participants are not symptomatic for urinary tract infections (UTIs) at the time of injection. By addressing the appropriateness of antibiotic use, the study seeks to reduce unnecessary complications associated with antibiotic therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with OAB who have failed first and second line therapies.
Not a fit: Patients who have recently used antibiotics or are symptomatic for UTIs will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective management of antibiotic use, reducing the risk of complications and antibiotic resistance in patients undergoing treatment for OAB.
How similar studies have performed: While studies have shown success in antibiotic stewardship in other surgical contexts, this specific approach to OAB treatment is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 * Diagnosis of OAB who have failed 1st and 2nd line therapies per the AUA/SUFU OAB guidelines (including bladder training, dietary modification and pharmacotherapy with an anticholinergic and/or beta-3 agonist) * Not symptomatic for UTI at the time of injection * Negative urinalysis at the time of the injection defined as: negative for nitrites and leukocyte esterace, with urine white blood cell count less than 5 per high-power field * Consent to participate in the study. Exclusion Criteria: * Antibiotic usage within 48 hours prior to intradetrusor onabotulinumtoxinA injection * Women who are pregnant or planning to become pregnant, women who are breastfeeding * Concurrent use of onabotulinumtoxinA injection with maximum cumulative dose exceeding 400 units in a 3-month interval.
Where this trial is running
Stony Brook, New York
- Stony Brook Medicine — Stony Brook, New York, United States (Recruiting)
Study contacts
- Principal investigator: Justina Tam, MD — Stony Brook Medicine
- Study coordinator: Justina Tam, MD
- Email: justina.tam@stonybrookmedicine.edu
- Phone: 6314441910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.