NCT07501065PHASE4Recruiting
Prophylactic Antibiotics for Outpatient Urethral Bulking
University of Miami
Start Date
8/1/2026
Completion Date
12/1/2028
Summary
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* 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 (infection is defined as the presence of nitrites and/or pyuria with \>1+ leukocyte esterase on dipstick or \>5 WBC/HPF).
* Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan) before the procedure
* Fluent in English or Spanish
* Able and willing to provide informed consent
Exclusion Criteria:
* 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 that also involve insertion \[KB2.1\]of a foreign object
* 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
* 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
Interventions
DRUG
Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg)
Conditions
Urinary Tract InfectionsStress Urinary IncontinenceUrinary Incontinence
Locations
Desai Sethi Urology Institute
Miami, Florida 33136
United States
University of Miami Hospitals and Clinics
Miami, Florida 33136
United States