Who is eligible for clinical trial NCT07501065?

Participants must meet protocol criteria for Urinary Tract Infections. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07501065 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-18

Prophylactic Antibiotics for Outpatient Urethral Bulking (NCT07501065)

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: University of Miami

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (9 items).

Location: Desai Sethi Urology Institute — Miami, Florida

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

Desai Sethi Urology Institute — Miami, Florida
University of Miami Hospitals and Clinics — Miami, Florida

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗