Prophylactic Antibiotics for Outpatient Urethral Bulking

NCT07501065 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 20260233
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Urinary Tract Infections; Stress Urinary Incontinence; Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Prophylactic Antibiotic Group

EXPERIMENTAL

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)

No Prophylactic Antibiotic Group

NO INTERVENTION

Participants in this group will not receive prophylactic antibiotics at the time of standard of care clinic based urethral bulking procedure.

Interventions

Bactrim (800/160 mg) or Macrobid (100mg) DRUG

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.

Also known as: Sulfamethoxazole, Trimethoprim, Nitrofurantoin

Prophylactic Antibiotic Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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).
• 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

You may not qualify 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
• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (2)

Desai Sethi Urology Institute

Miami, Florida, 33136, United States

Location

University of Miami Hospitals and Clinics

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections; Urinary Incontinence, Stress; Urinary Incontinence

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination; Nitrofurantoin; Sulfamethoxazole; Trimethoprim

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Nitrofurans; Nitro Compounds; Furans

Study Officials

• Katherine Amin, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Amin, MD

CONTACT

(305) 243-6590; katherine.amin@med.miami.edu

Elena Cortizas, MS

CONTACT

(305) 243-3593; ecortizas@med.miami.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Urology

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)