Prophylactic antibiotics to reduce post-procedure UTIs after urethral bulking

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 interventional trial enrolled women 18 and older who are planned to undergo urethral bulking with Bulkamid for stress- or mixed-stress urinary incontinence. Participants receive one of several prophylactic antibiotics at the time of the standard clinic-based procedure to see if this lowers post-procedure infection risk. Eligibility requires no current UTI, adequate post-void residual volume, and ability to consent, with fluency in English or Spanish. The study is conducted at the University of Miami and Desai Sethi Urology Institute in Florida, led by University of Miami investigators. Outcomes focus on whether prophylactic antibiotics reduce post-procedural UTIs compared with expected rates without prophylaxis.

Why it matters

Who can join: the full rules

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

Where it's running

• Desai Sethi Urology Institute
  Miami, Florida, United States Recruiting
• University of Miami Hospitals and Clinics
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Katherine Amin, MD — University of Miami
• Study coordinator: Katherine Amin, MD
• Email: katherine.amin@med.miami.edu
• Phone: (305) 243-6590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.