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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 15, 2025 to Sep 15, 2025
    • Site details revised
    v4
  3. Start date: Apr 15, 2025 to Jul 15, 2025v3
  4. Start date: Dec 15, 2024 to Apr 15, 2025
    • Primary completion date: Dec 15, 2026 to Apr 15, 2027
    • Study completion date: Jun 15, 2027 to Oct 15, 2027
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06706362
Lead Sponsor Ohio State University
Conditions
(from sponsor)		 Stress Urinary Incontinence
Related terms Urinary Incontinence, Stress, Urinary Tract Infections
Enrollment 138 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov