The Effectiveness of Prophylactic Antibiotics for Urethral Bulking
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Atlantic Health System
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Rate of urinary tract infection (UTI)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Antibiotic Group
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.
Intervention: Prophylactic antibiotics (Other)
Outcomes
Primary Outcomes
Rate of urinary tract infection (UTI)
Time Frame: Within 4 weeks after the procedure
The rate of UTI based on symptoms and a positive urine culture
Secondary Outcomes
- Rates of other postoperative complications(Within 4 weeks after the procedure)
- Rate of postoperative urinary retention(Within 4 weeks after the procedure)
Investigators
Erika Wasenda
MD
Atlantic Health System