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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04709601
• Other study ID #: STU-2020-0725
• Status: Recruiting
• Phase: Phase 4
• Start date: January 4, 2021
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Philippe Zimmern, MD
• Phone: 214/645-8787
• Email: Philippe.Zimmern[@]UTSouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
United States	UT-Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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