Efficacy and Mechanism of Action of Methenamine Hippurate (Hiprex™) in Women With Recurring Urinary Tract Infections.

Last updated: January 3, 2025
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Terminated

Phase

4

Condition

Urinary Tract Infections

Treatment

Hiprex

Clinical Study ID

NCT04709601
STU-2020-0725
  • Ages 50-85
  • Female

Study Summary

The purpose of this study is to measure the concentration of formaldehyde in the urine of women with recurrent urinary tract infections on Hiprex; and then, assuming its urinary presence is confirmed at the proper acid urinary pH, evaluate if such a therapy has favorable effects in decreasing the rate of recurrent urinary tract infections over time.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Female

  2. Age 50 - 85

  3. Have RUTIs (at least 2 UTIs within the past 6 months or 3 within the past year) -

Exclusion

Exclusion Criteria:

  1. Being on antibiotics at baseline (i.e. suppressive therapy or antibiotic therapy forurinary or non-urinary infections)

  2. Neurogenic bladder condition

  3. Using urinary catheters (including Foley catheter, intermittent catheterization, andsuprapubic catheter)

  4. Uncontrolled diabetes (HbA1c > 9)

  5. Chronic renal failure defined as serum creatinine > 1.5 mg/dL

  6. History of liver disease

  7. Patients from out of town, in whom follow-up will not be possible

  8. Pregnancy

  9. Allergy to Hiprex

  10. Inability to take Hiprex reliably at home, such as having psychosis, dementia, orswallowing disorders

  11. Non-English speakers -

Study Design

Total Participants: 14
Treatment Group(s): 1
Primary Treatment: Hiprex
Phase: 4
Study Start date:
January 04, 2021
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • UT-Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

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