Stress Urinary Incontinence, Postoperative Urinary Tract Infection, Urethral Bulking
Conditions
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.
Interventions
These participants will be given a single dose of an oral antibiotic prior to the procedure.
OTHERNo antibiotics
These participants will not be given an antibiotic prior to the procedure.
Sponsors
Atlantic Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of postoperative urinary retention | Within 4 weeks after the procedure | The rate of postoperative urinary retention |
| Rates of other postoperative complications | Within 4 weeks after the procedure | The rate of other complications (bleeding, discomfort, etc) |
Countries
United States
Contacts
Primary ContactTess Gao, MD
Outcome results
None listed