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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Mechanism of Action of Methenamine Hippurate (Hiprex™) in the Management of Recurrent Urinary Tract Infections in Women

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Drug: Hiprex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Age 50 - 85 Have RUTIs (at least 2 UTIs within the past 6 months or 3 within the past year) - Exclusion Criteria: Being on antibiotics at baseline (i.e. suppressive therapy or antibiotic therapy for urinary or non-urinary infections) Neurogenic bladder condition Using urinary catheters (including Foley catheter, intermittent catheterization, and suprapubic catheter) Uncontrolled diabetes (HbA1c > 9) Chronic renal failure defined as serum creatinine > 1.5 mg/dL History of liver disease Patients from out of town, in whom follow-up will not be possible Pregnancy Allergy to Hiprex Inability to take Hiprex reliably at home, such as having psychosis, dementia, or swallowing disorders Non-English speakers -

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - Patients with negative and positive urine culture<br> | Drug: Hiprex<br>* 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.<br>* Other names: Methenanime hippurate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oral anti-biotic usage | Number of oral-antibiotics use to treat symptomatic UTI episodes | 1 year | 
| Number of hospital re-admissions | Number of hospitalizations due to urosepsis and pyelonephritis | 1 year | 
| Number of adverse events related to Hiprex | Number of participants who experience adverse events >= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCA version 5.0 | 1 year | 
| Urine acidity levels | Urine acidity levels will be measured by urinary pH at each visit. | 1 year | 
| Number of urinary tract infection episodes | Diagnose of UTI will be measured for this outcome | up to 2 years | 
| Severity of UTI symptoms as measured by the UTI Symptom Assessment questionnaire | 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 | 1 year | 
| Duration of intervals between UTI episodes | Duration of intervals will be measured between one UTI episode to the next UTI episode | 1 year |