Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs
Condition: Urinary Tract Infections, Recurrent
MeSH terms: Urinary Tract Infections; Recurrence; Reinfection
Intervention: Trimethoprim; Methenamine hippurate
Intervention description: 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).
Intervention MeSH terms: Trimethoprim; Methenamine; Methenamine hippurate; Methenamine mandelate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
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)
Enrollment: 92.0
Sex: Female
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  recurrent UTI: at least 2 in the past 6 months or 3 in past year (culture positive)

          -  must have been symptomatic with dysuria, urgency, frequency, suprapubic pain,
             hematuria, malodorous urine

          -  treated for last UTI and negative urine culture on entry into study

          -  English speaking

        Exclusion Criteria:

          -  pregnancy

          -  urinary tract abnormalities (eg kidney stones)

          -  acute pyelonephritis

          -  renal insufficiency or failure

          -  known allergy to medications

          -  prophylaxis for post-coital recurrent UTIs