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Prophylactic Antibiotics for Outpatient Urethral Bulking

NCT07501065 — Phase 4, Recruiting, 150 participants, University of Miami

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Prophylactic Antibiotics for Outpatient Urethral Bulking: Impact on Post-Procedural Urinary Tract Infection Rates

RegistryNCT07501065
StatusRecruiting
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: none, prevention
Enrollment150 (Estimated)
SponsorUniversity of Miami (Other)
ConditionsUrinary Tract Infections, Stress Urinary Incontinence, Urinary Incontinence
InterventionsBactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg) (Drug)
Datesstart 2026-08-01 (estimated), primary completion 2028-06-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-03-30, last updated 2026-08-20
Locations2 sites in United States

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-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).

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+Arms and interventions

ArmTypeInterventionsDescription
Prophylactic Antibiotic GroupExperimentalDrug: Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg)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.
No Prophylactic Antibiotic GroupNo interventionParticipants in this group will not receive prophylactic antibiotics at the time of standard of care clinic based urethral bulking procedure.
  • Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg) (Drug), also known as Sulfamethoxazole, Trimethoprim, Nitrofurantoin, Cephalexin, Ciprofloxacin: 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.

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

Sex: Female, ages: 18 Years to any

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)

FacilityCityCountryStatus
Desai Sethi Urology InstituteMiami, FloridaUnited StatesRecruiting
University of Miami Hospitals and ClinicsMiami, FloridaUnited StatesRecruiting

+Investigators

My Notes