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

Phase 4

Terminated

• Conditions: Urinary Tract Infections
• Interventions: Drug: Hiprex

• Registration Number: NCT04709601
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-17
• Study Start: 2021-01-04
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 14

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) -

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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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1 - Patients with negative and positive urine culture	Hiprex	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of hospital re-admissions	1 year	Number of hospitalizations due to urosepsis and pyelonephritis
Number of urinary tract infection episodes	up to 2 years	Diagnose of UTI will be measured for this outcome
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
Duration of intervals between UTI episodes	1 year	Duration of intervals will be measured between one UTI episode to the next UTI episode
Number of oral anti-biotic usage	1 year	Number of oral-antibiotics use to treat symptomatic UTI episodes
Urine acidity levels	1 year	Urine acidity levels will be measured by urinary pH at each visit.
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

Trial Locations

Locations (1)

UT-Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States