Stress Urinary Incontinence, Urinary Incontinence, Urinary Tract Infections
Conditions
Brief summary
The purpose of this study is to evaluate whether taking prophylactic (preventative) antibiotics at the time of standard of care clinic-based urethral bulking reduces the risk of post-procedural urinary tract infection (UTI).
Interventions
DRUGBactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg)
Participants will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim), Keflex (500 mg cephalexin), Cipro (250 mg ciprofloxacin), or if allergic to sulfonamides, a single oral dose of Macrobid (100 mg nitrofurantoin) at the time of the urethral bulking procedure.
Sponsors
University of Miami
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
* Women ≥ 18 years of age. * Patients evaluated by a pelvic floor specialist (either urogynecologist or urologist) at the University of Miami with plans to undergo urethral bulking with Bulkamid for stress urinary incontinence or mixed urinary incontinence (stress predominant). * Negative testing for UTI in pre-procedural work-up, including either negative urine culture or urine dip negative for infection (infection is defined as the presence of nitrites and/or pyuria with \>1+ leukocyte esterase on dipstick or \>5 WBC/HPF). * Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan) before the procedure * Fluent in English or Spanish * Able and willing to provide informed consent
Exclusion criteria
* Contraindications to both oral antibiotics including antibiotic allergies or significant renal disease (GFR \<30) * Patient undergoing additional pelvic organ prolapse procedures or other urologic procedures concomitantly that also involve insertion \[KB2.1\]of a foreign object * Recurrent UTIs, defined as 3 or more UTIs within the past 12 months or 2 UTIs within the past 6 months * Patients currently taking daily antibiotic prophylaxis for any reason * Patients with immunosuppression due to underlying medical conditions * Patients who are pregnant * Recent antibiotic treatment within one week of the procedure * Unable or unwilling to provide informed consent or complete study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-procedural urinary tract infection (UTI) within six weeks following urethral bulking procedure | 6 Weeks | The occurrence of urinary tract infection (UTI) within 6 weeks post-procedure will be compared between patients who receive prophylactic oral antibiotics administered in clinic at the time of urethral bulking and those who do not receive antibiotic prophylaxis. UTI will be defined by clinical diagnosis documented in the medical record, with or without supporting urine culture results. |
Countries
United States
Contacts
CONTACTKatherine Amin, MD
CONTACTElena Cortizas, MS
PRINCIPAL_INVESTIGATORKatherine Amin, MD
University of Miami
Outcome results
None listed