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NCT07501065
Prophylactic Antibiotics for Outpatient Urethral Bulking
Conditions: Urinary Tract Infections, Stress Urinary Incontinence, Urinary Incontinence
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 150
Sponsor: University of Miami
Location: Desai Sethi Urology Institute Miami Florida
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
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 \
Source: ClinicalTrials.gov (NCT07501065). StuddyBuddy aggregates publicly available trial information.