Status:
RECRUITING
Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study)
Lead Sponsor:
Ohio State University
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief 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 immedi...
Detailed Description
Specific Aim 1: To determine if receiving prophylactic oral antibiotics at time of urethral bulking reduces the risk of post-operative urinary tract infection (UTI). Patients will be randomized and b...
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
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2027
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT06706362
Start Date
September 15 2025
End Date
October 15 2027
Last Update
October 8 2025
Active Locations (1)
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1
The Ohio State University Wexner Medical Center OB/GYN Female Pelvic Medicine and Reconstructive Surgery
Columbus, Ohio, United States, 43210