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Is Methenamine Prophylaxis for Urinary Tract Infection After Midurethral Sling as Effective as Antibiotic Prophylaxis?
Is Methenamine Prophylaxis for Urinary Tract Infection After Midurethral Sling as Effective as Antibiotic Prophylaxis? A Randomized Controlled Trial
Who can join
Ages 18 to 100 · Women · Healthy volunteers welcome
Full 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
About the study
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.
What is being tested
- Methenamine Hippurate 1g BD (drug)
- Antibiotic prophylaxis (other)
Sponsor: Atlantic Health System · Participants: 190 · Started: Jan 30, 2025
Contact the study team
- Rena Ow, MD · Phone: 9739717267
Official record on ClinicalTrials.gov — NCT06810687
Locations in the U.S.
| New Jersey | Atlantic Health, Morristown |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.