Prophylactic Antibiotics for Outpatient Urethral Bulking

University of Miami

Status and phase: Not yet enrolling; Phase 4

Conditions: Urinary Tract Infections; Stress Urinary Incontinence; Urinary Incontinence

Treatments: Drug: Bactrim (800/160 mg) or Macrobid (100mg)

Study type: Interventional

Funder types: Other

Identifiers

NCT07501065

20260233

Details and patient eligibility

About

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).

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).
• Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan)
• 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
• 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
• Pelvic organ prolapse stage greater than 2
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Prophylactic Antibiotic Group

Experimental group

Description:

Participants in this group will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim) 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.

Treatment:

Drug: Bactrim (800/160 mg) or Macrobid (100mg)

No Prophylactic Antibiotic Group

No Intervention group

Description:

Participants in this group will not receive prophylactic antibiotics at the time of standard of care clinic based urethral bulking procedure.