NCT06810687 Is Methenamine Prophylaxis for Urinary Tract Infection After Midurethral Sling as Effective as Antibiotic Prophylaxis?
| NCT ID | NCT06810687 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Atlantic Health System |
| Condition | Urinary Tract Infection (Diagnosis) |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2025-01-30 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 190 participants in total. It began in 2025-01-30 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Stress urinary incontinence (SUI) affects at least 40% of women in the United States. Synthetic polypropylene mid-urethral slings (MUS) are the gold standard treatment for SUI. Post-operative urinary tract infections (UTI) are one of the most common complications after MUS placement. Some studies have demonstrated that MUS placement can increase the risk of UTI up to 21-34%. Post-operative UTI can lead to significant healthcare and patient burden. This additional burden further contributes to an estimated annual cost of $1.6 billion for UTI management in the United States. With increased antibiotic usage, there is simultaneous increase in bacterial resistance leading to treatment refractory UTI. The investigators prescribe post-operative antibiotics prophylactically for 3 days after MUS placement with or without concurrent pelvic reconstructive surgery based on prior literature recommending post-operative prophylaxis. There is a greater emphasis on limiting antibiotic use given the trend of development of bacterial resistance. There are studies supporting alternatives such as methenamine for recurrent UTI prophylaxis treatment, but there are limited studies evaluating methenamine for UTI prophylaxis after MUS.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06810687 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 100 Years, studying Urinary Tract Infection (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06810687 currently recruiting?
Yes, NCT06810687 is actively recruiting participants. Contact the research team at rena.ow@atlantichealth.org for enrollment information.
Where is the NCT06810687 trial being conducted?
This trial is being conducted at Morristown, United States.
Who is sponsoring the NCT06810687 clinical trial?
NCT06810687 is sponsored by Atlantic Health System. The trial plans to enroll 190 participants.