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Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts 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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Prophylactic Antibiotic Group 		Participants in this group 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 standard of care clinic-based urethral bulking procedure.
  • Drug: Bactrim (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.
    Other names:
    • Sulfamethoxazole
    • Trimethoprim
    • Nitrofurantoin
    • Cephalexin
    • Ciprofloxacin
No Intervention
No Prophylactic Antibiotic Group 		Participants in this group will not receive prophylactic antibiotics at the time of standard of care clinic based urethral bulking procedure.

Recruiting Locations

Desai Sethi Urology Institute
Miami, Florida 33136
Contact:
Elena Cortizas, MS
(305) 243-3593
ecortizas@med.miami.edu

University of Miami Hospitals and Clinics
Miami, Florida 33136
Contact:
Elena Cortizas, MS
305-243-3593

More Details

Status
Recruiting
Sponsor
University of Miami

Study Contact

Katherine Amin, MD
(305) 243-6590
katherine.amin@med.miami.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.