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Prophylactic Antibiotics for Urethral Bulking with Bulkamid

This study is looking at whether taking antibiotics (Bactrim or Macrobid) right before a urethral bulking procedure with Bulkamid can help prevent urinary tract infections (UTIs) afterward. Urethral bulking is a treatment for stress urinary incontinence (SUI), which is when you leak urine with activities like coughing or sneezing. You could be eligible if you are a woman between 18 and 50 years old, are planning to have this procedure at The Ohio State University, and do not have a UTI before your surgery. The main goal is to see if antibiotics reduce UTIs within 6 weeks after the procedure. The study also looks at how different factors, like needing a temporary catheter, affect your improvement from the procedure and your satisfaction.

Study design
This is an interventional study where 138 participants will be randomly assigned to receive either an antibiotic (Bactrim or Macrobid) or a placebo (an inactive pill that looks the same). Participants will not know if they are receiving the antibiotic or the placebo.
What's involved
You will receive a pill (antibiotic or placebo) before your procedure. You will also complete surveys before the procedure, 6 weeks after, and 1 year after.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 1 year after their procedure, with the primary outcome measured at 6 weeks.

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NCT06706362

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

Recruiting
PHASE4Ages 18–50InterventionalTreatment
Ohio State University
~138 participants
Updated 2025-10-08 on ClinicalTrials.gov
What's tested:Bactrim or MacrobidPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Risk of post operative urinary tract infections (UTI)
Measured over 6 weeks after the procedure

Conditions

Stress Urinary Incontinence

Explore related trials

Genuine stress incontinenceMixed urinary incontinence

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Susanne Taege, MD · PRINCIPAL_INVESTIGATOR · Ohio State University

Who to contact

Susanne Taege, MD
[email protected]
614-293-4643
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Risk of post operative urinary tract infections (UTI)6 weeks after the procedure

    Intervention (pre-operative oral antibiotics) and placebo groups will be compared for the risk of post-operative UTIs following urethral bulking procedures performed in the operating room. Patients who have symptoms, concerning for UTI during the immediate 6 week postoperative period will be asked to give a urine sample for culture. UTIs which are culture proven and symptomatic will be treated per individual provider preference. Positive urine cultures will be defined as cultures with greater than 50,000 CFU for voided specimens and greater than 5,000 CFU for catheter specimens. If a patient's urine culture is positive for mixed flora and cannot be speciated further by our microbiology laboratory, they will be asked to present for a straight catheter specimen in the office for definitive diagnosis; this is an established protocol which is already standard in our practice. All positive cultures during this time period will be recorded.