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Urinary Tract Infection (Diagnosis)Kidney and urinaryDrug

What this study is

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's being tested

  • Methenamine Hippurate 1g BD

    Intervention · DRUG

  • Antibiotic prophylaxis

    Intervention · OTHER

Both interventions

Antibiotic prophylaxis

Study details

Official title
Is Methenamine Prophylaxis for Urinary Tract Infection After Midurethral Sling as Effective as Antibiotic Prophylaxis? A Randomized Controlled Trial
Sponsor
Atlantic Health System
Conditions
Urinary Tract Infection (Diagnosis)
Enrolling
190 people
Starts
2025-01-30
Est. completion
2028-01-30
Design
Open-label, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗