Home › Urinary Tract Infections › NCT07501065
Prophylactic Antibiotics for Outpatient Urethral Bulking
RecruitingPhase 4
Prophylactic Antibiotics for Outpatient Urethral Bulking: Impact on Post-Procedural Urinary Tract Infection Rates
Who can join
Ages 18 and older · Women
Full eligibility criteria
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
About the study
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).
What is being tested
- Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg) (drug)
Sponsor: University of Miami · Participants: 150 · Started: 2026-08
Contact the study team
- Katherine Amin, MD · Phone: (305) 243-6590
- Elena Cortizas, MS · Phone: (305) 243-3593
Official record on ClinicalTrials.gov — NCT07501065
Locations in the U.S.
| Florida | Desai Sethi Urology Institute, Miami University of Miami Hospitals and Clinics, Miami |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.