What this study is
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).
What's being tested
- Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg)
Intervention · DRUG
Participants will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim), Keflex (500 mg cephalexin), Cipro (250 mg ciprofloxacin), or if allergic to sulfonamides, a single oral dose of Macrobid (100 mg nitrofurantoin) at the time of the urethral bulking procedure.
Study details
- Official title
- Prophylactic Antibiotics for Outpatient Urethral Bulking: Impact on Post-Procedural Urinary Tract Infection Rates
- Sponsor
- University of Miami
- Conditions
- Urinary Tract Infections · Stress Urinary Incontinence · Urinary Incontinence
- Enrolling
- 150 people
- Starts
- 2026-08-19
- Est. completion
- 2028-12
- Design
- Open-label, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openContact for every open site
- Katherine Amin, MD · Principal investigator
Desai Sethi Urology Institute
Miami, Florida, United States
- Elena Cortizas, MS · Contact(305) 243-3593ecortizas@med.miami.edu
RecruitingUniversity of Miami Hospitals and Clinics
Miami, Florida, United States
- Elena Cortizas, MS · Contact305-243-3593
Recruiting
Study team
Sponsor
University of Miami
Study ID 20260233
Principal investigator
Katherine Amin, MD
University of Miami
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.