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RECRUITING Phase 4 ClinicalTrials.gov

Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study)

Sponsor: Ohio State University • ClinicalTrials.gov ID: NCT06706362

Registry updated: 2026-10-13
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Description

The primary aim of this study is to assess the utility of prophylactic oral antibiotics at time of Bulkamid transurethral bulking to reduce the incidence of urinary tract infection (UTI) in the immediate postoperative period. The secondary aims of the study include assessing UTI rates and success rates if patients require temporary indwelling catheter versus intermittent self-catheterization (ISC).

Interventions

  • Bactrim or Macrobid (Drug)
    Participants will be assigned to Bactrim or Macrobid depending on participants' allergies
  • Placebo (Drug)
    Participants will be assigned to identical appearing placebo

Eligibility criteria

Inclusion Criteria * Patients evaluated by a pelvic floor specialist (either urogynecologist or urologist) at The Ohio State University with plans to undergo urethral bulking with Bulkamid for stress urinary incontinence or mixed urinary incontinence (stress predominant). * Negative testing for UTI in pre-operative work-up (including either negative urine culture or urine dip negative for infection). * Office evaluation with evidence of SUI either with urodynamic studies (UDS) or positive cough stress test (CST). * Post-void residual volume of 150 mL or less (measured by either catheterization or bladder scan) Exclusion Criteria * Contraindications to both oral antibiotics including antibiotic allergies or significant renal disease * 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 * Non-English speaking patients * Pregnant patients * Pelvic organ prolapse stage greater than 2 * Patients with immunosuppression due to underlying medical conditions * Recent antibiotic treatment within one week of the procedure

Conditions

Stress Urinary Incontinence

Locations

  • The Ohio State University Wexner Medical Center OB/GYN Female Pelvic Medicine and Reconstructive Surgery — Columbus, Ohio, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record