- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04709601
Efficacy and Mechanism of Action of Methenamine Hippurate (Hiprex™) in Women With Recurring Urinary Tract Infections.
February 2, 2024 updated by: Philippe Zimmern, University of Texas Southwestern Medical Center
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
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
-
Texas
-
Dallas, Texas, United States, 75390
- Recruiting
- UT-Southwestern Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional 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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Urinary Tract Infections
Time Frame: 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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of oral anti-biotic usage
Time Frame: 1 year
|
Number of oral-antibiotics use to treat symptomatic UTI episodes
|
1 year
|
Number of hospital re-admissions
Time Frame: 1 year
|
Number of hospitalizations due to urosepsis and pyelonephritis
|
1 year
|
Number of adverse events related to Hiprex
Time Frame: 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
|
1 year
|
Urine acidity levels
Time Frame: 1 year
|
Urine acidity levels will be measured by urinary pH at each visit.
|
1 year
|
Number of urinary tract infection episodes
Time Frame: up to 2 years
|
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
Time Frame: 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
|
1 year
|
Duration of intervals between UTI episodes
Time Frame: 1 year
|
Duration of intervals will be measured between one UTI episode to the next UTI episode
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Hiprex
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