Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs
Condition: Urinary Tract Infections, Recurrent
MeSH terms: Urinary Tract Infections; Recurrence; Reinfection
Study type: Interventional
Phase: Phase 4

Summary: 
      Several methods are available for use in the prevention of recurrent urinary tract infections
      (UTIs) over the past few decades. These methods include suppressive antibiotics, estrogen
      cream, methenamine hippurate, d-mannose, cranberry, probiotics, and vitamin C. Of these, the
      majority of the literature is in favor of use of suppressive antibiotics for preventing UTIs.
      However, this data is now about 10 years old. Increasing use of antibiotics over the years
      has lead to increased resistance of bacteria. In addition, long-term antibiotic use has
      several adverse effects, some life-threatening. There is recent literature evaluating the use
      of several of the alternatives to suppressive antibiotics with mixed results. A comparative
      study of the efficacy of methenamine hippurate to suppressive antibiotics is lacking in the
      current literature. Several early partly-randomized trials done with methenamine hippurate
      have shown promising results, but are only as recent as 1987. The primary objective of this
      prospective, randomized study is to determine whether there is a significant difference in
      the prevention of recurrent UTIs when given either methenamine hippurate or daily suppressive
      antibiotics. The secondary objective of this study is to determine how well patients are able
      to tolerate each of these medications and what adverse effects are observed in a given 1 year
      time period. The long-term goals of this study are to find an alternative to using
      suppressive antibiotics, potentially with a lower adverse effect profile and less of the
      dangers of long term antibiotic use. Finding an alternative to suppressive antibiotics would
      also tackle the issue of antibiotic resistance.
    

Detailed description: 
      Hypothesis:

      The hypothesis of this study is that the group taking trimethoprim will have a lower
      recurrence rate than those taking methenamine hippurate based on the literature. The
      investigators aim to identify to what degree that difference is and whether or not it is an
      acceptable difference given the greater degree of an antibiotic resistance.

      Objectives:

      The primary objective of this prospective, randomized study is to determine whether there is
      a significant difference in the prevention of recurrent UTIs when given either methenamine
      hippurate or daily suppressive antibiotics independent of vaginal estrogen use.

      The secondary objective of this study is to determine how well patients are able to tolerate
      each of these medications and what adverse effects are observed in a 1 year time period.

      Specific Aims:

        1. Identify if there is a differential impact on prevention of recurrent UTIs when treated
           with either trimethoprim or methenamine hippurate in a 6 and 12 month period.

        2. Identify adverse reactions in each group.

        3. Determine whether or not estrogen has a more additive effect to trimethoprim or
           methenamine hippurate in post-menopausal women.

        4. Identify how well tolerated the study medications are and whether or not the size of the
           pills or the frequency of taking them prevents patients from continuing therapy.
    

Intervention name(s): Trimethoprim; Methenamine hippurate
Intervention type(s): Drug; Drug
Intervention description(s): suppressive antibiotic. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study).; antiseptic used in the prevention of recurrent UTIs. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study).
Other intervention name(s): Trimpex; Hiprex
Intervention MeSH terms: Trimethoprim; Methenamine; Methenamine hippurate; Methenamine mandelate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients diagnosed with recurrent urinary tract infections are recruited into this study.
Masking: None (Open Label)
Primary purpose: Prevention