Actively Recruiting
The Effectiveness of Prophylactic Antibiotics for Urethral Bulking
Led by Atlantic Health System · Updated on 2025-04-08
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether giving antibiotics before urethral bulking surgery helps reduce the chance of urinary tract infections (UTIs) afterward. Urethral bulking is a minimally invasive treatment for stress urinary incontinence, but UTIs are a common complication with rates reported between 0% and 40%. There are no clear guidelines about using antibiotics before this procedure, so this study aims to clarify their effectiveness in preventing UTIs. Participants will be randomly assigned to one of two groups. One group will receive a single dose of oral antibiotics before the urethral bulking procedure, chosen based on their allergies and medical history. The other group will not receive antibiotics before the procedure. The study compares these two approaches to see if antibiotics reduce post-procedure infections. During the study, participants will be monitored for urinary tract infections, urinary retention, and other complications for up to four weeks after the procedure. Researchers will evaluate the rate of UTIs within this period as the primary outcome. Participants will receive regular assessments to track any post-procedure issues and ensure their safety throughout the study period.
CONDITIONS
Brief Title
The Effectiveness of Prophylactic Antibiotics for Urethral Bulking
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled to undergo a urethral bulking procedure
- Age 18 years or older
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo the urethral bulking procedure. Those in the antibiotic group receive a one-time dose of oral antibiotics prior to the procedure, while those in the no antibiotic group do not receive antibiotics.
1 procedure visit (in-person)
Duration - 4 weeks
Participants are monitored for urinary tract infections and other post-procedural complications following the urethral bulking procedure.
Follow-up visits as needed within 4 weeks after the procedure
Trial Site Locations
Total: 1 location
1
Atlantic Health
Morristown, New Jersey, United States, 07960
Actively Recruiting
Research Team
T
Tess Gao, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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