RecruitingPhase 4NCT06706362

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

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

Sponsor

Ohio State University

Enrollment

138 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

Stress Urinary Incontinence

Summary

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).

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria4

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 Criteria9

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

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Interventions

DRUGBactrim or Macrobid

Participants will be assigned to Bactrim or Macrobid depending on participants' allergies

DRUGPlacebo

Participants will be assigned to identical appearing placebo

Locations(1)

The Ohio State University Wexner Medical Center OB/GYN Female Pelvic Medicine and Reconstructive Surgery

Columbus, Ohio, United States

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NCT06706362

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