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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2024-12-31

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.

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Detailed Description

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Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1 - Patients with negative and positive urine culture

Group Type EXPERIMENTAL

Hiprex

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Methenanime hippurate

Eligibility Criteria

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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 -

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No