Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid
Ohio State University
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 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).
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 blinded into two arms: oral antibiotic versus placebo. Patients will receive either the placebo pill or oral antibiotic in the pre-operative holding area prior to their procedure. Oral antibiotics will include trimethoprim/sulfamethoxazole (Bactrim, first line) or nitrofurantoin (Macrobid, second line), determined by patient allergies. Specific Aim 2: To assess if factors such as patient discharge…
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- No
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 catheterizatio…
Interventions
- DrugBactrim or Macrobid
Participants will be assigned to Bactrim or Macrobid depending on participants' allergies
- DrugPlacebo
Participants will be assigned to identical appearing placebo
Location
- The Ohio State University Wexner Medical Center OB/GYN Female Pelvic Medicine and Reconstructive SurgeryColumbus, Ohio