Prophylactic Antibiotics for Outpatient Urethral Bulking
Starting soon · Phase 4
Conditions studied: Urinary Tract Infections, Stress Urinary Incontinence, Urinary Incontinence
In brief
The purpose of this study is to evaluate whether taking prophylactic (preventative) antibiotics at the time of standard of care clinic-based urethral bulking reduces the risk of post-procedural urinary tract infection (UTI).
Key facts
- Study ID
- NCT07501065
- Run by
- University of Miami
- People needed
- 150
- Starts
- 2026-06-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-03-30
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Women ≥ 18 years of age.
- Patients evaluated by a pelvic floor specialist (either urogynecologist or urologist) at the University of Miami with plans to undergo urethral bulking with Bulkamid for stress urinary incontinence or mixed urinary incontinence (stress predominant).
- Negative testing for UTI in pre-procedural work-up (including either negative urine culture or urine dip negative for infection).
- Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan)
- Fluent in English or Spanish
- Able and willing to provide informed consent
You may not qualify if…
- Contraindications to both oral antibiotics including antibiotic allergies or significant renal disease (GFR <30)
- Patient undergoing additional pelvic organ prolapse procedures or other urologic procedures concomitantly
- Recurrent UTIs, defined as 3 or more UTIs within the past 12 months or 2 UTIs within the past 6 months
- Patients currently taking daily antibiotic prophylaxis for any reason
- Pelvic organ prolapse stage greater than 2
- Patients with immunosuppression due to underlying medical conditions
- Patients who are pregnant
- Recent antibiotic treatment within one week of the procedure
- Unable or unwilling to provide informed consent or complete study procedures
Where it is running
- Desai Sethi Urology Institute — Miami, Florida, United States
- University of Miami Hospitals and Clinics — Miami, Florida, United States
Full record on ClinicalTrials.gov
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