Giving a single oral antibiotic dose with Bulkamid urethral bulking.

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

This will see if one dose of oral antibiotics given before Bulkamid urethral bulking lowers early urinary tract infections in people treated for stress‑predominant urinary incontinence.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 138 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Ohio State University (Academic / other)
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT06706362 on ClinicalTrials.gov

What this trial studies

Adults scheduled for Bulkamid urethral bulking are randomized and blinded to receive either a single preoperative oral antibiotic (trimethoprim/sulfamethoxazole or nitrofurantoin based on allergy) or a placebo. The primary outcome is the rate of postoperative urinary tract infection in the immediate postoperative period. Secondary analyses will compare UTI rates and treatment success between patients discharged with an indwelling catheter versus those using intermittent self‑catheterization and will examine whether number of injection sites correlates with outcomes. Patients complete validated symptom and satisfaction questionnaires before the procedure, at 6 weeks, and at 1 year to track symptom improvement and patient satisfaction.

Who should consider this trial

Good fit: Ideal candidates are people evaluated at The Ohio State University who plan to undergo Bulkamid urethral bulking for stress or stress‑predominant mixed urinary incontinence, have a negative preoperative UTI test, and a post‑void residual ≤150 mL.

Not a fit: Patients with recurrent UTIs, contraindications or allergies to the study antibiotics, those undergoing additional pelvic procedures, or those already on daily antibiotics are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, giving a single prophylactic oral antibiotic at the time of Bulkamid could reduce early postoperative urinary tract infections and improve recovery.

How similar studies have performed: Perioperative antibiotics have reduced UTI risk in some urologic procedures, but prophylaxis specifically for Bulkamid urethral bulking has limited prior data and is not well established.

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

Where this trial is running

Columbus, Ohio

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

Study contacts

• Principal investigator: Susanne Taege, MD — Ohio State University
• Study coordinator: Susanne Taege, MD

Conditions Stress Urinary Incontinence; Bulkamid; Urinary tract infections; Bactrim; Macrobid; Urethral bulking