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RecruitingNCT07501065Updated Aug 20, 2026

Prophylactic Antibiotics for Outpatient Urethral Bulking

A Phase 4 interventional study of Bactrim (800/160 mg), Keflex (500 mg), Cipro (250 mg), or Macrobid (100mg) in Urinary Tract Infections, Stress Urinary Incontinence and Urinary Incontinence, sponsored by University of Miami. Recruiting at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by University of Miami · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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).

02

Conditions studied

  • Urinary Tract Infections
  • Stress Urinary Incontinence
  • Urinary Incontinence
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study 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.

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

  • 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

  • DrugBactrim (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.

    Also known as: Sulfamethoxazole, Trimethoprim, Nitrofurantoin, Cephalexin, Ciprofloxacin

05

What researchers measure

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 Weeks

06

Study locations

2 of 2 sites recruiting
  • Desai Sethi Urology Institute
    Miami, Florida 33136, United States
    • Elena Cortizas, MS · Contact · ecortizas@med.miami.edu · (305) 243-3593
    • Katherine Amin, MD · Principal investigator
    Recruiting
  • University of Miami Hospitals and Clinics
    Miami, Florida 33136, United States
    • Elena Cortizas, MS · Contact · 305-243-3593
    • Katherine Amin, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07501065
Lead sponsor
University of Miami
Responsible party
Katherine Amin (Assistant Professor of Clinical Urology, University of Miami) — Principal investigator
First posted
Mar 30, 2026
Start date
Aug 2026 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Aug 20, 2026

Study contacts

Katherine Amin, MD
Contact
katherine.amin@med.miami.edu
(305) 243-6590
Elena Cortizas, MS
Contact
ecortizas@med.miami.edu
(305) 243-3593
Katherine Amin, MD
principal investigator · University of Miami

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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