Urinary Track Infection Prevention After Urogynecological Surgery
Condition: Urinary Tract Infections; Urinary Retention Postoperative; Pelvic Organ Prolapse
MeSH terms: Infections; Urinary Tract Infections; Urinary Retention; Prolapse; Pelvic Organ Prolapse
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is randomized double-blinded placebo-controlled trial to access oral Methenamine
      Hippurate (MH) in combination with cranberry capsules is superior to cranberry capsules alone
      in prevention of UTI in patients with transient post-operative urinary retention requiring a
      Foley catheter after pelvic reconstructive surgery.
    

Detailed description: 
      Urinary tract infections (UTIs) are one of the most common bacterial infections in women. It
      is estimated that 1.6 billion dollars are spent on UTI treatment each year. Antibiotics have
      been the mainstay of treatment of UTIs, however frequent use has increased the prevalence of
      antibiotic resistant organisms. Therefore, focus has shifted to non-antibiotic therapy for
      UTI prophylaxis.

      Methenamine Hippurate (MH) has been studied for decades due to its potential role in
      prevention of UTI. While not technically an antibiotic, MH works via its bacteriostatic
      action in the bladder. Benefits of MH are the lack of development of resistance, and the
      selective nature of this drug to the urinary system only. However, MH is best used in
      conjunction with an acidifying agent to increase its bioavailability (such as cranberry
      capsules or other acidic products). The usage of MH has been studied in various populations,
      has been seen to be effective in short-term catheterization. Usage of cranberry as
      prophylaxis for UTI is controversial; however, results have been favorable in the
      post-operative gynecological population.

      Post-operative urinary retention (POUR) occurs frequently in patients who undergo
      incontinence and pelvic prolapse surgery. Although the definition of POUR can vary between
      clinicians, it is reported as 2.5-24% to as high as 43% after tension-free transvaginal mesh
      sling placement. This population is at also at high risk for UTI due to advanced age and
      menopausal status. Moreover, using a catheter longer than 2 days incurs a 2-fold increased
      risk of development of UTI with an estimated 5% increase in bacteriuria each day of
      catheterization.

      In hopes to decrease the overuse of antibiotics and decrease the likelihood of antibiotic
      resistance, we propose that the use of MH and cranberry can reflect a potential benefit in
      this population of short-term indwelling Foley catheter use and help reduce the incidence of
      post-operative UTI after pelvic surgery.

      The patients will then be randomized to either receive cranberry capsules and placebo OR
      cranberry capsules and Methenamine Hippurate.
    

Intervention name(s): Methenamine Hippurate 1 g tablet; Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): Methenamine Hippurate (study drug) is an FDA approved medication in the prevention of UTI. Methenamine Hippurate 1g contains Hippuric acid salt of Methenamine (hexamethylene tetramine), Magnesium Stearate, Povidone, Saccharin Sodium, FD&C Yellow No. 5 (tartrazine) (www.iodine.com/drug/hiprex/fda-package-insert).; Placebo is a tablet that will be provided to you that looks like the study drug but does not contain any medication. These pills are comprised of gelatin and minimal amounts of lactose powder. The pills are designed to have no effect on the patient.
Intervention MeSH terms: Methenamine; Methenamine hippurate; Methenamine mandelate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention