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

Phase 4TerminatedNCT04709601

University of Texas Southwestern Medical Center14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Urinary Tract Infections

Interventions

HiprexDRUG

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.

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

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 -

Locations (1)

UT-Southwestern Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Number of Urinary Tract Infections

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.

Time frame: 1 year

Secondary Outcomes

Frequency of Oral Antibiotic Use

Total number of calendar days on which a participant received one or more doses of an oral antibiotics

Time frame: 1 year

Number of Participants That Used Oral Anti-biotic

Number of participants who used oral-antibiotics to treat symptomatic UTI episodes during 1 year of Hiprex administration

Time frame: 1 year

Number of Hospital Re-admissions at 1 Year

Number of hospital re-admissions at 1 year due to urosepsis and pyelonephritis.

Time frame: 1 year

Frequency and Severity of Adverse Events Related to Hiprex

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

Time frame: 1 year

Urine Acidity Levels

Urine acidity levels will be measured by urinary pH at each visit. Lower pH will yield a better outcome.

Time frame: 1 year

Number of Urinary Tract Infection Episodes

Number of UTI episodes will be measured for this outcome.

Time frame: up to 1 year

Number of Urinary Tract Infection Episodes

Data from ClinicalTrials.gov

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