RecruitingNot ApplicableNCT06810687

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


Sponsor

Atlantic Health System

Enrollment

190 participants

Start Date

Jan 30, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 100 Years

Inclusion Criteria3

  • Female
  • Age ≥ 18
  • Patients undergoing mid-urethral sling procedure

Exclusion Criteria8

  • Medication intolerance or allergy to study medications
  • Renal impairment with GFR <30
  • Breast feeding
  • Pregnancy
  • Recurrent urinary tract infections
  • Active urinary tract infection
  • Immunosuppressive disease
  • Interstitial cystitis

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Interventions

DRUGMethenamine Hippurate 1g BD

Antibiotic prophylaxis

OTHERAntibiotic prophylaxis

Antibiotic prophylaxis


Locations(1)

Atlantic Health

Morristown, New Jersey, United States

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NCT06810687


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