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

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04709601
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
34.9
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Mechanism of Action of Methenamine Hippurate (Hiprex™) in the Management of Recurrent Urinary Tract Infections in Women
Actual Study Start Date :
Jan 4, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1 - Patients with negative and positive urine culture

Drug: Hiprex
Patients with negative urine culture will be prescribed Hiprex 1 g PO BID x 1 yr and patients with a positive urine culture will be prescribed antibiotics.
Other Names:
  • Methenanime hippurate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Urinary Tract Infections [1 year]

      It would be measured by counting the positive urine cultures, or UTI-like episodes requiring antibiotic treatment during the 1 year of the study period.

    Secondary Outcome Measures

    1. Number of oral anti-biotic usage [1 year]

      Number of oral-antibiotics use to treat symptomatic UTI episodes

    2. Number of hospital re-admissions [1 year]

      Number of hospitalizations due to urosepsis and pyelonephritis

    3. Number of adverse events related to Hiprex [1 year]

      Number of participants who experience adverse events >= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCA version 5.0

    4. Urine acidity levels [1 year]

      Urine acidity levels will be measured by urinary pH at each visit.

    5. Number of urinary tract infection episodes [up to 2 years]

      Diagnose of UTI will be measured for this outcome

    6. Severity of UTI symptoms as measured by the UTI Symptom Assessment questionnaire [1 year]

      UTI Symptom Assessment questionnaire measures severity of UTI symptoms. Possible score range from 0 to 3 (0= Did not have 1= Mild 2=Moderate, and 3=Severe), higher score indicates higher severity of UTI symptoms

    7. Duration of intervals between UTI episodes [1 year]

      Duration of intervals will be measured between one UTI episode to the next UTI episode

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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 Criteria:

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

    2. Neurogenic bladder condition

    3. Using urinary catheters (including Foley catheter, intermittent catheterization, and suprapubic 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, or swallowing disorders

    11. Non-English speakers -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UT-Southwestern Medical Center Dallas Texas United States 75390

    Sponsors and Collaborators

    • University of Texas Southwestern Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Philippe Zimmern, Professor of Urology, University of Texas Southwestern Medical Center
    ClinicalTrials.gov Identifier:
    NCT04709601
    Other Study ID Numbers:
    • STU-2020-0725
    First Posted:
    Jan 14, 2021
    Last Update Posted:
    Jul 8, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Urinary Tract Infections

    Study Results

    No Results Posted as of Jul 8, 2022