Study of methenamine hippurate compared to a drug combination for preventing recurrent urinary tract infections in women

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What is this study about?

This study focuses on women who experience recurrent urinary tract infections, which are frequent infections in the urinary system. The goal of the study is to determine if using methenamine hippurate as a way to prevent these infections is an effective alternative to using traditional antibiotics. Antibiotics are medicines used to kill bacteria, but using them frequently can sometimes lead to antimicrobial resistance, a situation where bacteria change so that the medicine no longer works against them.

Participants in the study will be assigned to receive different treatments to prevent further infections. One group will receive methenamine hippurate, while other groups will receive standard antibiotic treatments such as cefalexin, sulfamethoxazole and trimethoprim, or fosfomycin trometamol. These medications are taken by mouth over a period of time to see which method is better at reducing the number of symptomatic infection episodes and preventing the growth of multidrug-resistant bacteria, which are germs that are difficult to kill with standard medicines.

Who Can Join the Study?

You must be a woman.
You must be between the ages of 18 and 85 years.
You must have recurrent urinary tract infections, which means you have frequent bladder or kidney infections.
To qualify, you must be starting antibiotic prophylaxis, which is a treatment where medicine is taken regularly to prevent infections from happening.
You must have had at least two or more urinary tract infection episodes in the last 6 months.
Alternatively, you must have had at least three or more urinary tract infection episodes in the last year.
Alternatively, you can qualify if you had fewer than three infections in the last year but experienced one or more severe episodes that required you to stay in the hospital.
You must provide written informed consent, which means you have read all the study information and signed a document agreeing to participate.

Who Cannot Join the Study?

Being pregnant or planning to become pregnant during the 12 months after joining the study.
Thinking you will not be able to finish the full 12-month follow-up period, which is the time when doctors check on your progress.
Having any health problem that the doctor believes might make it hard to see if the treatment is working or might prevent you from finishing the study.
Currently breastfeeding.
Having anatomical abnormalities of the urinary tract, which means the physical shape or structure of your bladder or the tubes that carry urine is not normal.
Using any urinary devices, such as a bladder catheter (a tube used to drain urine from the bladder) or a nephrostomy (a tube placed through the skin into the kidney to drain urine).
Having chronic renal failure, which is long-term kidney damage, with a glomerular filtration rate (GFR) below 40 mL/min. The GFR is a measurement used to check how well your kidneys are filtering waste from your blood.
Having hepatic cirrhosis, which is serious scarring of the liver, specifically categorized as Child–Pugh class B or C, which are scales used to measure the severity of liver disease.
Having hyperuricemia, which means having too much uric acid in your blood, or having a history of gout attacks, which is a type of painful swelling caused by uric acid crystals in the joints.
Taking regular medicine to change the acidity of your body or stomach, such as alkalinizing agents (medicines that make body fluids less acidic) or antacids (medicines that reduce stomach acid), including sodium bicarbonate, citrates, almagate, acetazolamide, or other carbonic anhydrase inhibitors (a specific type of medicine that affects how your body manages acids and bases).
Being unable to swallow or take oral medication, which refers to medicine taken by mouth.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country
Hospital Del Mar	Barcelona	Spain
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Hospital Universitari Joan XXIII De Tarragona	Tarragona	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitario De Cruces	Barakaldo	Spain
Hkhiamir Vkga ddwicpjj	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	05.01.2026

Trial locations

Investigated drugs:

Methenamine hippurate is the main treatment being tested in this study. It is a non-antibiotic medicine used to help prevent repeated urinary tract infections by making the urine less hospitable to bacteria.

Cephalexin is an antibiotic used in this study as a comparison to see how well it prevents urinary tract infections compared to the test treatment.

Septrin is a combination antibiotic used in this study to compare its effectiveness in preventing urinary tract infections against the test treatment.

Fosfomycin trometamol is an antibiotic used in this study to serve as a comparison for preventing recurrent urinary tract infections.

Investigated diseases:

Urinary tract infection

Recurrent urinary tract infections – This condition involves repeated infections of the urinary system, which includes the bladder and kidneys. It occurs when bacteria enter the urinary tract and cause inflammation. In many cases, these infections return multiple times over a period of months or years. The process typically begins with bacteria attaching to the lining of the urinary tract and multiplying. This can lead to symptoms such as discomfort or a frequent urge to urinate.

Trial ID:

2025-523922-42-00

Protocol code:

RUTI-MET

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of methenamine hippurate compared to a drug combination for preventing recurrent urinary tract infections in women

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?