Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkam
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 requ
| Condition(s) | Stress Urinary Incontinence |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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). |
| Who can participate | 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 proc |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Lead sponsor | Ohio State University |
| Locations | Columbus, Ohio, United States |
| Start date | 2025-09-15 |
| NCT ID | NCT06706362 |
| Official listing | https://clinicaltrials.gov/study/NCT06706362 |