The Effectiveness of Prophylactic Antibiotics for Urethral Bulking

Last updated: April 4, 2025
Sponsor: Atlantic Health System
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urinary Tract Infections

Enuresis

Urinary Incontinence

Treatment

No antibiotics

Prophylactic antibiotics

Clinical Study ID

NCT06261736
2107044-1
  • Ages > 18
  • Female

Study Summary

The goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients scheduled to undergo a urethral bulking procedure

  • Age 18 ≥ over

Exclusion

Exclusion Criteria:

  • History of recurrent urinary tract infections

  • Known history of urinary retention

  • Allergies or contraindications to multiple antibiotics

  • Inability to tolerate oral antibiotics

  • Concomitant surgical procedures at the time of urethral bulking

  • Pregnant or breastfeeding

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: No antibiotics
Phase:
Study Start date:
October 24, 2023
Estimated Completion Date:
January 31, 2026

Study Description

Urethral bulking is a minimally invasive surgical treatment option for stress urinary incontinence (SUI). One commonly reported post-procedural complication is urinary tract infection (UTI). UTI rates are variable where studies have reported rates from as low as 0% to as high as 40%. Along with this variability, the instructional inserts for various bulking agents have inconsistent recommendations for use of prophylactic antibiotics. The American Urologic Association recommends antimicrobial prophylaxis for cystourethroscopy procedures involving minor manipulation. Currently, there are no clear guidelines regarding the utility of prophylactic antibiotics for urethral bulking. The objective of our study is to determine the effectiveness of prophylactic antibiotics in urethral bulking for reducing post procedural UTIs.

Connect with a study center

  • Atlantic Health

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

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