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
Intervention: Methenamine Hippurate 1 g tablet; Placebo tablet
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: This is randomized double-blinded placebo-controlled trial, and both patients and investigators are blinded. However, a research nurse will not be blinded to the group allocation, and the research nurse will order each patient's medication to the inpatient pharmacy based on the study randomization scheme.
Enrollment: 185.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who undergo major pelvic organ prolapse surgery that are diagnosed with POUR
             via failed retrograde void trial and require an indwelling Foley catheter upon
             hospital discharge.

        Exclusion Criteria:

          -  Unwillingness to participate in the study

          -  Inability to understand English

          -  Pregnant women

          -  Patient personal history of nephrolithiasis, urogenital anomaly, neurogenic bladder,
             chronic renal insufficiency (GFR <60 ml/min/1.73 m² or serum creatinine level >1.03
             for >3months), sarcoidosis, and severe hepatic insufficiency

          -  Currently (prior 3 months) undergoing medical management for recurrent UTI or
             interstitial cystitis

          -  Active urinary tract infection

          -  Patient history of taking Warfarin (Coumadin)

          -  Intraoperative bladder injury or cystotomy

          -  Physical or mental impairment that would affect the subject's ability to take
             medications daily or fill out questionnaires

          -  Reported allergy to any of the ingredients in the cranberry, MH, or placebo pill