The Effectiveness of Prophylactic Antibiotics for Urethral Bulking

Atlantic Health System

Status: Enrolling

Conditions: Postoperative Urinary Tract Infection; Stress Urinary Incontinence; Urethral Bulking

Treatments: Other: No antibiotics; Other: Prophylactic antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT06261736

2107044-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Antibiotic Group

Experimental group

Description:

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.

Treatment:

Other: Prophylactic antibiotics

No antibiotic group

Other group

Description:

Those randomized to this group will not receive an antibiotic prior to the urethral bulking procedure.

Treatment:

Other: No antibiotics