RecruitingPhase 4NCT06706362

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

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

Sponsor

Ohio State University

Enrollment

138 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

Stress Urinary Incontinence

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).

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bactrim or Macrobid and a drug called Placebo for people with stress urinary incontinence. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

Locations(1)

The Ohio State University Wexner Medical Center OB/GYN Female Pelvic Medicine and Reconstructive Surgery

Columbus, Ohio, United States

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NCT06706362

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