Clinical Trial

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

Recruiting Phase 4
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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).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-11-22; most recent amendment 2025-10-02.
Status change: Not Yet Recruiting → Recruiting 2025-10-02
Trial Details
NCT Number NCT06706362
Lead Sponsor Ohio State University
Conditions Stress Urinary Incontinence
Enrollment 138 participants
Start Date 2025-09-15
Primary Completion 2027-04-15 (estimated)
Study Completion 2027-10-15 (estimated)
Updated on ClinicalTrials.gov 2025-10-08