Comparing methenamine and antibiotics to prevent urinary tract infections after mid-urethral sling surgery
Is Methenamine Prophylaxis for Urinary Tract Infection After Midurethral Sling as Effective as Antibiotic Prophylaxis? A Randomized Controlled Trial
This study tests whether using methenamine instead of antibiotics can help prevent urinary tract infections in women after they have surgery for stress urinary incontinence.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | Atlantic Health System Academic / other |
| Locations | 1 site (Morristown, New Jersey) |
| Trial ID | NCT06810687 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of methenamine prophylaxis compared to traditional antibiotic prophylaxis in preventing urinary tract infections (UTIs) following mid-urethral sling (MUS) procedures for stress urinary incontinence (SUI). The study aims to address the high incidence of post-operative UTIs, which can occur in 21-34% of patients after MUS placement. By evaluating methenamine, a urinary antiseptic that does not contribute to antibiotic resistance, the trial seeks to promote antibiotic stewardship while ensuring patient safety. Participants will be female patients aged 18 and older undergoing MUS procedures, and they will receive either methenamine or antibiotics post-operatively.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who are scheduled to undergo a mid-urethral sling procedure.
Not a fit: Patients with recurrent urinary tract infections, active UTIs, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer alternative to antibiotics for preventing UTIs, reducing the risk of antibiotic resistance.
How similar studies have performed: While previous studies have shown the effectiveness of antibiotic prophylaxis, this approach using methenamine is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female 2. Age ≥ 18 3. Patients undergoing mid-urethral sling procedure Exclusion Criteria: 1. Medication intolerance or allergy to study medications 2. Renal impairment with GFR \<30 3. Breast feeding 4. Pregnancy 5. Recurrent urinary tract infections 6. Active urinary tract infection 7. Immunosuppressive disease 8. Interstitial cystitis
Where this trial is running
Morristown, New Jersey
- Atlantic Health — Morristown, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Rena Ow, MD
- Email: rena.ow@atlantichealth.org
- Phone: 9739717267
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.