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Recruiting 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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07501065). StuddyBuddy aggregates publicly available trial information.