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Prophylactic Antibiotics for Outpatient Urethral Bulking

RecruitingPhase 4

Sponsor: University of Miami

Conditions: Urinary Tract Infections, Stress Urinary Incontinence, Urinary Incontinence

Interventions: Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg)

Countries: United States

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (2)

Miami, Florida, United States
Miami, Florida, United States