Prophylactic Antibiotics for Outpatient Urethral Bulking

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).

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress Urinary Incontinence Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Desai Sethi Urology Institute, Miami, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg)

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.

Other names: Sulfamethoxazole, Trimethoprim, Nitrofurantoin, Cephalexin, Ciprofloxacin

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Cortizas, MS

CONTACT

[email protected]

(305) 243-3593

Katherine Amin, MD

CONTACT

[email protected]

(305) 243-6590

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Prophylactic Antibiotics for Outpatient Urethral Bulking: Impact on Post-Procedural Urinary Tract Infection Rates

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Mar 30, 2026
Registry last updated: Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed