Prophylactic Antibiotics for Outpatient Urethral Bulking

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Incontinence; Urinary Tract Infections; Stress Urinary Incontinence
• Intervention / Treatment: Drug: Bactrim (800/160 mg) or Macrobid (100mg)

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Katherine Amin, MD; Phone Number: (305) 243-6590; Email: katherine.amin@med.miami.edu
• Study Contact Backup: Name: Elena Cortizas, MS; Phone Number: (305) 243-3593; Email: ecortizas@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University Of Miami Hospitals And Clinics
      • Principal Investigator: Katherine Amin, MD
      • Contact: Elena Cortizas, MS; Phone Number: 305-243-3593
    • Miami, Florida, United States, 33136
      • Desai Sethi Urology Institute
      • Principal Investigator: Katherine Amin, MD
      • Contact: Elena Cortizas, MS; Phone Number: (305) 243-3593; Email: ecortizas@med.miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).
• Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan)
• 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
• 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
• Pelvic organ prolapse stage greater than 2
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prophylactic Antibiotic Group; Participants in this group will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim) or if allergic to sulfonamides, a single oral dose of Macrobid (100 mg nitrofurantoin) at the time of standard of care clinic based urethral bulking procedure.	Drug: Bactrim (800/160 mg) or Macrobid (100mg); Participants will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim) or if allergic to sulfonamides, a single oral dose of Macrobid (100 mg nitrofurantoin) at the time of the urethral bulking procedure.; Other Names: Nitrofurantoin; Trimethoprim; Sulfamethoxazole
No Intervention: No Prophylactic Antibiotic Group; Participants in this group will not receive prophylactic antibiotics at the time of standard of care clinic based urethral bulking procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of post-procedural urinary tract infection (UTI) within six weeks following urethral bulking procedure	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.	6 Weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Katherine Amin, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Infections; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Urinary Incontinence, Stress; Urinary Tract Infections; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutical Preparations; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amides; Aniline Compounds; Amines; Pyrimidines; Benzene Derivatives; Drug Combinations; Nitro Compounds; Benzenesulfonamides; Sulfonamides; Sulfanilamides; Sulfones; Furans; Nitrofurans; Trimethoprim; Sulfamethoxazole; Trimethoprim, Sulfamethoxazole Drug Combination; Nitrofurantoin
• Other Study ID Numbers: 20260233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No