The Effectiveness of Prophylactic Antibiotics for Urethral Bulking

Not Applicable

Recruiting

• Conditions: Postoperative Urinary Tract Infection; Urethral Bulking; Stress Urinary Incontinence
• Interventions: Other: No antibiotics; Other: Prophylactic antibiotics

• Registration Number: NCT06261736
• Lead Sponsor: Atlantic Health System

Brief 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.

Study Timeline

• Study Start: 2023-10-24
• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-08
• Study First Posted: 2024-02-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Patients scheduled to undergo a urethral bulking procedure
• Age 18 ≥ over

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No antibiotic group	No antibiotics	Those randomized to this group will not receive an antibiotic prior to the urethral bulking procedure.
Antibiotic Group	Prophylactic antibiotics	Those randomized to this group will receive a one-time dose of an oral antibiotic prior to the urethral bulking procedure. The antibiotic will be based on the participants' allergies, medical history, and current medication list.

Primary Outcome Measures

Name	Time	Method
Rate of urinary tract infection (UTI)	Within 4 weeks after the procedure	The rate of UTI based on symptoms and a positive urine culture

Secondary Outcome Measures

Name	Time	Method
Rates of other postoperative complications	Within 4 weeks after the procedure	The rate of other complications (bleeding, discomfort, etc)
Rate of postoperative urinary retention	Within 4 weeks after the procedure	The rate of postoperative urinary retention

Trial Locations

Locations (1)

Atlantic Health; 🇺🇸 Morristown, New Jersey, United States