Prophylactic Antibiotics for Outpatient Urethral Bulking

NCT07501065 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-03-30

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07501065 on ClinicalTrials.gov