Evaluating the use of antibiotics during urethral bulking procedures
The Effectiveness of Prophylactic Antibiotics for Urethral Bulking
NA · Atlantic Health System · NCT06261736
This study is testing whether giving antibiotics before urethral bulking procedures can help prevent urinary tract infections in people with stress urinary incontinence.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Atlantic Health System (other) |
| Locations | 1 site (Morristown, New Jersey) |
| Trial ID | NCT06261736 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of prophylactic antibiotics in reducing the incidence of urinary tract infections (UTIs) following urethral bulking procedures for stress urinary incontinence. Urethral bulking is a minimally invasive surgical option, but post-procedural UTIs can occur at varying rates. The study will compare outcomes between patients receiving prophylactic antibiotics and those who do not. The goal is to provide clearer guidelines on the use of antibiotics in this context.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for a urethral bulking procedure.
Not a fit: Patients with a history of recurrent urinary tract infections or those who cannot tolerate oral antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced rates of post-procedural urinary tract infections for patients undergoing urethral bulking.
How similar studies have performed: While there is variability in UTI rates post-urethral bulking, this specific approach to using prophylactic antibiotics has not been extensively tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled to undergo a urethral bulking procedure * Age 18 ≥ over Exclusion Criteria: * History of recurrent urinary tract infections * Known history of urinary retention * Allergies or contraindications to multiple antibiotics * Inability to tolerate oral antibiotics * Concomitant surgical procedures at the time of urethral bulking * Pregnant or breastfeeding
Where this trial is running
Morristown, New Jersey
- Atlantic Health — Morristown, New Jersey, United States (RECRUITING)
Study contacts
- Principal investigator: Erika Wasenda, MD — Atlantic Health System
- Study coordinator: Tess Gao, MD
- Email: tess.gao@atlantichealth.org
- Phone: 973-971-7267
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stress Urinary Incontinence, Postoperative Urinary Tract Infection, Urethral Bulking