Hiprex for Recurring Urinary Tract Infections

Overseen By Philippe Zimmern, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of Texas Southwestern Medical Center

Must be taking: Hiprex

Must not be taking: Antibiotics

Disqualifiers: Neurogenic bladder, Catheters, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

14 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you are not on antibiotics at the start, but it does not specify about other medications. If you are taking antibiotics, you would need to stop them before joining the trial.

Is Hiprex (methenamine hippurate) safe for humans?

In a study with young girls using Hiprex for a year, no side effects were observed, although some complained about the taste. ^{1 2 3 4 5}

How does the drug Hiprex differ from other treatments for recurring urinary tract infections?

Hiprex (methenamine hippurate) is unique because it is used as a long-term preventive treatment for urinary tract infections, reducing the frequency of infections without causing bacterial resistance or significant side effects, unlike traditional antibiotics that can lead to resistance. ^{1 6 7 8 9}

What is the purpose of this trial?

This trial aims to see if Hiprex, which releases bacteria-killing formaldehyde in urine, can help women who frequently get urinary tract infections by reducing their recurrence. Hiprex has been compared with another treatment for preventing these infections, showing similar results.

Research Team

Philippe Zimmern, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for women aged 50-85 who have had at least two urinary tract infections in the last six months or three in the past year. They must be able to take Hiprex at home and speak English. Women with liver disease, allergies to Hiprex, uncontrolled diabetes, chronic renal failure, or those on antibiotics are excluded.

Inclusion Criteria

I am between 50 and 85 years old.

I am female.

I have had at least 2 UTIs in the last 6 months or 3 in the last year.

Exclusion Criteria

Inability to take Hiprex reliably at home, such as having psychosis, dementia, or swallowing disorders

I have a history of liver disease.

I have a condition that affects how my bladder functions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Methenamine Hippurate (Hiprex™) to measure formaldehyde concentration and evaluate its effects on recurrent urinary tract infections

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Hiprex

Trial Overview The study tests how effective Methenamine Hippurate (Hiprex) is for women with recurring UTIs by measuring formaldehyde levels in urine and observing if it reduces infection rates over time when taken under proper conditions.

Participant Groups

Group I: Group 1 - Patients with negative and positive urine culture Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Findings from Research

In a study of 20 girls aged 5-12 with recurrent urinary tract infections, treatment with methenamine hippurate (Hiprex) for 12 months significantly reduced the average number of infections from 3.1 to 0.7 per year (p < 0.001).

After stopping the treatment, the infection rate increased to 1.4 per year, indicating that methenamine hippurate is effective for long-term prevention of urinary tract infections, with minimal side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term prophylaxis with methenamine hippurate in girls with recurrent urinary tract infections. Petersen, S.[2019]

Antibacterials used to treat urinary tract infections commonly cause gastrointestinal side effects, which can result from various mechanisms such as irritation of the bowel and changes in gut flora.

Among the treatments reviewed, beta-lactams, nitrofurantoin, and fosfomycin are considered relatively safe, as they have a low incidence of serious toxicity despite causing some minor side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A perspective on the safety of antibacterials used to treat urinary tract infections. Reeves, DS.[2019]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Long-term prophylaxis with methenamine hippurate in girls with recurrent urinary tract infections. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Methenamine hippurate compared with antibiotic prophylaxis to prevent recurrent urinary tract infections in women: the ALTAR non-inferiority RCT. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Long-term antibiotics for prevention of recurrent urinary tract infection in older adults: systematic review and meta-analysis of randomised trials. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A perspective on the safety of antibacterials used to treat urinary tract infections. [2019]

5. England pubmed.ncbi.nlm.nih.gov

High-dosage co-amoxiclav in a single dose versus 7 days of co-trimoxazole as treatment of uncomplicated lower urinary tract infection in women. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Methenamine hippurate ('Hiprex') in the treatment of chronic urinary tract infections: a trial in a geriatric hospital. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Recurrent uncomplicated urinary tract infections in women: a review. [2012]

8. United States pubmed.ncbi.nlm.nih.gov

Recurrent urinary tract infection in women: emerging concepts regarding etiology and treatment considerations. [2019]

9. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Some aspects of the treatment of persistent lower urinary tract infections in women]. [2018]