Prophylactic Antibiotics for Outpatient Urethral Bulking
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Miami
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg)
DrugParticipants 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Prophylactic Antibiotic GroupExperimental treatment 1 intervention
Group B: No Prophylactic Antibiotic GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Incidence of post-procedural urinary tract infection (UTI) within six weeks following urethral bulking procedure
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.
Time frame
6 WeeksSponsors and contacts
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Source ClinicalTrials.gov