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Hiprex trial for recurrent UTIs halted early – little data to go on

NCT ID NCT04709601

Disease control Sponsor: University of Texas Southwestern Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aimed to see if Hiprex (methenamine hippurate) could reduce recurrent urinary tract infections in women aged 50 to 85. Participants took Hiprex daily for a year, and researchers counted infections and antibiotic use. However, the trial was terminated early with only 14 participants, so we have very limited information on whether it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
methenamine hippurate (Hiprex)
What this could lead to
If it worked, this could offer a non-antibiotic option to reduce recurrent urinary tract infections in older women.
What could go wrong
The trial was terminated early and enrolled only 14 participants, so results are very limited. It is unclear if Hiprex effectively prevents UTIs or reduces antibiotic use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

14 people

The number who actually took part.

Started

Jan 2021

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 85 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 -

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Conditions

The condition(s) this trial relates to.

urinary tract infection urinary tract infections, recurrent, susceptibility to

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Urinary tract infections

Contacts and locations

Locations

  • UT-Southwestern Medical Center

    Dallas, Texas, 75390, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.