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

Launched by OHIO STATE UNIVERSITY · Nov 22, 2024

Keywords

ClinConnect Summary

The Bulkamid Study is a clinical trial that aims to find out if taking antibiotics before a specific procedure called urethral bulking (using a substance called Bulkamid) can help prevent urinary tract infections (UTIs) in women with stress urinary incontinence. Stress urinary incontinence is a condition that causes leakage of urine during activities like coughing, sneezing, or exercising. The study will also look at whether the way patients manage their bladder after the procedure—using a catheter that stays inside or one they use themselves—affects UTI rates and treatment success.

To participate in this study, women aged 18 to 262 who are evaluated by a pelvic floor specialist and have been diagnosed with stress urinary incontinence may be eligible, provided they do not have a current UTI, have no significant medical issues that would prevent them from taking antibiotics, and are not undergoing other major surgeries at the same time. Participants can expect to be carefully monitored for UTI occurrences following their procedure and will contribute to important research that could improve care for other women facing similar issues in the future.

Gender

FEMALE

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