What side effects are associated with this type of intervention?

Methenamine, used for preventing recurrent UTIs, releases formaldehyde in acidic urine, which can cause bladder irritation and gastrointestinal disturbances such as nausea and upset stomach. Common antibiotics for UTIs, like trimethoprim-sulfamethoxazole and nitrofurantoin, may cause side effects including gastrointestinal upset, allergic reactions, and, less commonly, more severe effects like liver toxicity or pulmonary issues. Patients should discuss potential side effects with their healthcare provider to choose the most appropriate treatment.

What prior FDA approvals exist?

Methenamine Hippurate (Hiprex) is an FDA-approved treatment for urinary tract infections that works by releasing formaldehyde in acidic urine, which has antibacterial properties. Other FDA-approved treatments for UTIs typically include antibiotics such as trimethoprim-sulfamethoxazole, nitrofurantoin, and fosfomycin. These antibiotics work through different mechanisms, such as inhibiting bacterial cell wall synthesis or protein synthesis, to effectively treat and prevent UTIs.

What other types of research exist?

Promising novel alternatives to Hiprex for UTI treatment in 2024 include: 1) Fosfomycin, which inhibits bacterial cell wall synthesis and is effective against a broad range of uropathogens. 2) D-mannose, a sugar that prevents bacterial adhesion to the urinary tract lining, reducing infection risk. 3) Probiotics, which help maintain a healthy balance of bacteria in the urinary tract. 4) Vaccines targeting uropathogenic E. coli, which are currently under development and show potential in preventing recurrent UTIs.

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Anti-infective Agent

Hiprex for Recurring Urinary Tract Infections

Phase 4

Recruiting

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 50 - 85

Female

Must not have

Neurogenic bladder condition

Uncontrolled diabetes (HbA1c > 9)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of taking Hiprex may include digestive issues like nausea or upset stomach, allergic reactions for those sensitive to its ingredients, and less commonly changes in urine color.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 85 years old.

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I am female.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that affects how my bladder functions.

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My diabetes is not under control (HbA1c > 9).

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My kidney function is impaired with a creatinine level over 1.5 mg/dL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Urinary Tract Infections

Secondary study objectives

Duration of intervals between UTI episodes

Number of adverse events related to Hiprex

Number of hospital re-admissions

+4 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Group 1 - Patients with negative and positive urine cultureExperimental Treatment1 Intervention

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Methenamine Hippurate (Hiprex) treats UTIs by releasing formaldehyde in acidic urine, which has strong antibacterial effects. This is significant for UTI patients as it directly kills bacteria in the urinary tract, helping to reduce infection rates. Maintaining an acidic urinary pH is crucial for Methenamine's effectiveness, emphasizing the need for dietary and lifestyle adjustments. Other common treatments, such as antibiotics like nitrofurantoin and trimethoprim-sulfamethoxazole, work by inhibiting bacterial growth and replication. Understanding these mechanisms aids in selecting the most effective treatment and managing UTIs efficiently.

Heparin as antibacterial agent in rabbit bladder.Urothelial acetylcholine involvement in ATP-induced contractile responses of the rat urinary bladder.Intravesical hyaluronic acid treatment improves bacterial cystitis and reduces cystitis-induced hypercontractility in rats.