Actively Recruiting
Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study)
Led by Ohio State University · Updated on 2025-10-08
138
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients evaluated by a pelvic floor specialist at The Ohio State University planning urethral bulking with Bulkamid for stress urinary incontinence or mixed urinary incontinence (stress predominant)
- Negative urine test for urinary tract infection before surgery (urine culture or dip negative for infection)
- Evidence of stress urinary incontinence from urodynamic studies or positive cough stress test
- Post-void residual urine volume of 150 mL or less measured by catheterization or bladder scan
You will not qualify if you...
- Allergy to oral antibiotics or significant kidney disease
- Undergoing additional pelvic organ prolapse or other urologic procedures at the same time
- Recurrent urinary tract infections (3 or more in past 12 months or 2 in past 6 months)
- Currently taking daily antibiotics to prevent infection
- Non-English speaking
- Pregnant
- Pelvic organ prolapse stage higher than 2
- Immunosuppressed due to medical conditions
- Received antibiotics within one week before the procedure
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Ohio State University Wexner Medical Center OB/GYN Female Pelvic Medicine and Reconstructive Surgery
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
S
Susanne Taege, MD
CONTACT
S
Shirley Dong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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