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

What this Trial Is About

Researchers are evaluating the use of preventive oral antibiotics at the time of urethral bulking with Bulkamid to lower the chance of urinary tract infections (UTIs) right after surgery in women with stress urinary incontinence or mixed urinary incontinence (stress predominant). The study aims to see if antibiotics reduce post-operative UTIs and also to understand how factors like catheter use after surgery and the number of injection sites affect incontinence improvement and patient satisfaction at 6 weeks and 1 year after the procedure. Participants will be randomly assigned to receive either a single dose of oral antibiotics (Bactrim or Macrobid, chosen based on allergies) or a placebo pill just before their urethral bulking procedure. The study is blinded, so neither patients nor doctors will know which treatment is given. Surveys including validated urogynecologic questionnaires will be completed before surgery, and then at 6 weeks and 1 year afterward to assess urinary symptoms, improvement, and satisfaction. During the study, participants will be monitored for urinary tract infections up to 6 weeks after the procedure, and side effects and satisfaction will be assessed up to 1 year. Researchers will collect information from questionnaires and clinical evaluations to measure treatment effects and patient outcomes. The trial is led by Ohio State University and plans to follow participants for outcomes related to infection risk and urinary function after urethral bulking with Bulkamid.

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