Recruiting

Prophylactic Antibiotics

Sponsor:

University of Miami

Code:

NCT07501065

Conditions

Urinary Tract Infections

Stress Urinary Incontinence

Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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).

Conditions

Urinary Tract Infections

Stress Urinary Incontinence

Urinary Incontinence

Study ID

NCT07501065

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Incidence of post-procedural urinary tract infection (UTI) within six weeks following urethral bulking procedure [ Time Frame: 6 Weeks ]

Central Contacts and Locations

Central contacts

Katherine Amin, MD

(305) 243-6590katherine.amin@med.miami.edu

Elena Cortizas, MS

(305) 243-3593ecortizas@med.miami.edu

Locations

Desai Sethi Urology Institute

Recruiting

Miami, Florida, United States, 33136

Contacts

Elena Cortizas, MS

(305) 243-3593ecortizas@med.miami.edu

Principal Investigator:

Katherine Amin, MD

University of Miami Hospitals and Clinics

Recruiting

Miami, Florida, United States, 33136

Contacts

Elena Cortizas, MS

305-243-3593

Principal Investigator:

Katherine Amin, MD

More Information

Sponsor

University of Miami

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-08-20.