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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorOhio State University

About this trial

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).

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Bactrim or Macrobid
  • Placebo

Treatment groups

138 Participants
are divided into 2 treatment groups

Sponsors and collaborators