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

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

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 Overview

• Status: Recruiting
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Drug: Hiprex

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Philippe Zimmern, MD; Phone Number: 214/645-8787; Email: Philippe.Zimmern@UTSouthwestern.edu
• Study Contact Backup: Name: Sonobia Garrett; Phone Number: 214/645-8482; Email: Sonobia.Garrett@UTSouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT-Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: STU-2020-0725

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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