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

Primary Purpose

Urinary Tract Infections

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Hiprex

About this trial

This is an interventional treatment trial for Urinary Tract Infections

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 -

Sites / Locations

UT-Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group 1 - Patients with negative and positive urine culture

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of oral anti-biotic usage

Number of oral-antibiotics use to treat symptomatic UTI episodes

Number of hospital re-admissions

Number of hospitalizations due to urosepsis and pyelonephritis

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

Urine acidity levels

Urine acidity levels will be measured by urinary pH at each visit.

Number of urinary tract infection episodes

Diagnose of UTI will be measured for this outcome

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

Duration of intervals between UTI episodes

Duration of intervals will be measured between one UTI episode to the next UTI episode

Full Information

NCT ID

NCT04709601

First Posted

December 17, 2020

Last Updated

July 19, 2023

Sponsor

University of Texas Southwestern Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04709601

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 4, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Tract Infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 - Patients with negative and positive urine culture

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Hiprex

Other Intervention Name(s)

Methenanime hippurate

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Urinary Tract Infections

Description

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.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Number of oral anti-biotic usage

Description

Number of oral-antibiotics use to treat symptomatic UTI episodes

Time Frame

1 year

Title

Number of hospital re-admissions

Description

Number of hospitalizations due to urosepsis and pyelonephritis

Time Frame

1 year

Title

Number of adverse events related to Hiprex

Description

Number of participants who experience adverse events >= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCA version 5.0

Time Frame

1 year

Title

Urine acidity levels

Description

Urine acidity levels will be measured by urinary pH at each visit.

Time Frame

1 year

Title

Number of urinary tract infection episodes

Description

Diagnose of UTI will be measured for this outcome

Time Frame

up to 2 years

Title

Severity of UTI symptoms as measured by the UTI Symptom Assessment questionnaire

Description

Time Frame

1 year

Title

Duration of intervals between UTI episodes

Description

Duration of intervals will be measured between one UTI episode to the next UTI episode

Time Frame

1 year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Philippe Zimmern, MD

Phone

214/645-8787

Philippe.Zimmern@UTSouthwestern.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Sonobia Garrett

Phone

214/645-8482

Sonobia.Garrett@UTSouthwestern.edu

Facility Information:

Facility Name

UT-Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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