NCT06261736

The Effectiveness of Prophylactic Antibiotics for Urethral Bulking

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Atlantic Health System · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Stress Urinary Incontinence
• Postoperative Urinary Tract Infection
• Urethral Bulking

Interventions

Type	Name	Description
OTHER	Prophylactic antibiotics	These participants will be given a single dose of an oral antibiotic prior to the procedure.
OTHER	No antibiotics	These participants will not be given an antibiotic prior to the procedure.

Timeline

• Start date: 2023-10-24
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2024-02-15
• Last updated: 2025-04-08

Locations

1 site across 1 country: United States