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Preventing UTIs After Urethral Bulking

This study is looking at whether a single dose of antibiotics can help prevent urinary tract infections (UTIs) after a urethral bulking procedure. Urethral bulking is a treatment for stress urinary incontinence (leaking urine when you cough, sneeze, or laugh) or mixed urinary incontinence. You would receive either Bactrim (800/160 mg) or Macrobid (100mg) if you are allergic to sulfonamides, at the time of your procedure. The study aims to see how many participants get a UTI within six weeks after the procedure. This study is for women aged 18 and older who are planning to have urethral bulking at the University of Miami. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 150 women. Participants will receive one of two specific antibiotic medications.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for six weeks after the urethral bulking procedure to check for urinary tract infections.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07501065

Prophylactic Antibiotics for Outpatient Urethral Bulking

Recruiting
PHASE4Ages 18+InterventionalPrevention
University of Miami
~150 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of post-procedural urinary tract infection (UTI) within six weeks following urethral bulking procedure
Measured over 6 Weeks

Conditions

Urinary Tract Infections
Stress Urinary Incontinence
Urinary Incontinence

Explore related trials

Genuine stress incontinenceMixed urinary incontinence

Where it's being run

2 sites across 1 states
Florida2

Study leadership

  • Katherine Amin, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Katherine Amin, MD
[email protected]
(305) 243-6590
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of post-procedural urinary tract infection (UTI) within six weeks following urethral bulking procedure6 Weeks

    The occurrence of urinary tract infection (UTI) within 6 weeks post-procedure will be compared between patients who receive prophylactic oral antibiotics administered in clinic at the time of urethral bulking and those who do not receive antibiotic prophylaxis. UTI will be defined by clinical diagnosis documented in the medical record, with or without supporting urine culture results.