Prophylactic Antibiotics for Outpatient Urethral Bulking
NCT07501065 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2026-03-30
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
Interventions
- 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.
Sponsors & Collaborators
-
University of Miami
lead OTHER
Principal Investigators
-
Katherine Amin, MD · University of Miami
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2028-06-30
- Completion
- 2028-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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