The Effectiveness of Prophylactic Antibiotics for Urethral Bulking
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prophylactic antibiotics, No antibiotics.
- Who it may be relevant to
- Registry conditions: Stress Urinary Incontinence, Postoperative Urinary Tract Infection, Urethral Bulking. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Rate of urinary tract infection (UTI) [Time frame: Within 4 weeks after the procedure]
Secondary outcome measures (2)
- Rate of postoperative urinary retention [Time frame: Within 4 weeks after the procedure]
- Rates of other postoperative complications [Time frame: Within 4 weeks after the procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Atlantic Health — Morristown
Identifiers
NCT: NCT06261736 · 2107044-1