Giving a single oral antibiotic dose with Bulkamid urethral bulking.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: Susanne.Taege@osumc.edu
• Phone: 614-293-4643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.