Comparing methenamine and antibiotics to prevent urinary tract infections after mid-urethral sling surgery
Official title: Is Methenamine Prophylaxis for Urinary Tract Infection After Midurethral Sling as Effective as Antibiotic Prophylaxis? A Randomized Controlled Trial
Run by Atlantic Health System · NCT06810687 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | Women only |
| Enrollment | 190 (estimated) |
| Sponsor | Atlantic Health System Academic / other |
| Locations | 1 site (Morristown, New Jersey) |
| Status | Recruiting |
| Started | January 30, 2025 |
| Main results expected | July 30, 2027 |
| Study ends | January 30, 2028 |
| Registry record updated | February 7, 2025 |
| Trial ID | NCT06810687 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 18 and older who are scheduled to undergo a mid-urethral sling procedure.
✕Probably not a fit
Patients with recurrent urinary tract infections, active UTIs, or those who are pregnant or breastfeeding may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Atlantic Health
Morristown, New Jersey, United States Recruiting
Study contacts
- Study coordinator: Rena Ow, MD
- Email: rena.ow@atlantichealth.org
- Phone: 9739717267
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.