drugset / Trial / NCT06706362

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

NCT06706362

Phase 4 Recruiting 138 enrolled Ohio State University
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2025-09-15
Primary completion
2027-04-15
Completion
2027-10-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nitrofurantoin Unknown 100 mg Oral
Comparator trimethoprim/sulfamethoxazole Unknown Oral