NCT07501065 · University of Miami
Prophylactic Antibiotics for Outpatient Urethral Bulking
What this study is about
The purpose of this study is to evaluate whether taking prophylactic (preventative) antibiotics at the time of the usual treatment clinic-based urethral bulking reduces the risk of post-procedural urinary tract infection (UTI).
View original scientific description
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).
Interventions
DRUG
Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg)
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.
Primary outcome measures
Incidence of post-procedural urinary tract infection (UTI) within six weeks following urethral bulking procedure
Time frame: 6 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Miami, Florida
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 20, 2026 · Source of record for eligibility and locations