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Clinical trial to evaluate the clinical and microbiological impact of methenamine hippurate as an alternative prophylaxis in recurrent urinary tract infections in women
EU CTIS ID: 2025-523922-42-00
What this study is testing
The main objective of the study is to determine whether non-antibiotic prophylaxis with methenamine hippurate (MH) is an effective alternative strategy to antibiotics for the management of women with recurrent urinary tract infections (rUTIs). 6.2.1. Primary objectives: To determine the non-inferiority of methenamine hippurate compared to antibiotic prophylaxis in reducing the incidence of symptomatic UTI episodes in women with rUTIs during the 6-month prophylaxis period. To determine whether prophylaxis with methenamine hippurate is associated with a lower selection of antimicrobial resistance compared to antibiotic prophylaxis.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- To be a woman
- Ages between 18 and 85 years, inclusive.
- Patients requiring initiation of antibiotic prophylaxis for recurrent urinary tract infections (rUTIs) due to meeting one of the following conditions: Two or more UTI episodes in the past 6 months. Three or more UTI episodes in the past year. Patients with fewer than three UTI episodes in the past year but who have experienced one or more severe episodes requiring hospitalization during that period.
- The patient provides written informed consent.
You likely can't join if
- Pregnant women or those planning to become pregnant within the 12 months following inclusion.
- Anticipated inability to complete the 12-month follow-up period.
- Any condition that, in the investigator’s opinion, may interfere with the evaluation of the response or make it unlikely for the patient to complete the follow-up period.
- Breastfeeding
- Anatomical abnormalities of the urinary tract.
- Presence of urinary devices (e.g., bladder catheter, nephrostomy, etc.).
See the full eligibility criteria
- To be a woman
- Ages between 18 and 85 years, inclusive.
- Patients requiring initiation of antibiotic prophylaxis for recurrent urinary tract infections (rUTIs) due to meeting one of the following conditions: Two or more UTI episodes in the past 6 months. Three or more UTI episodes in the past year. Patients with fewer than three UTI episodes in the past year but who have experienced one or more severe episodes requiring hospitalization during that period.
- The patient provides written informed consent.
- Pregnant women or those planning to become pregnant within the 12 months following inclusion.
- Anticipated inability to complete the 12-month follow-up period.
- Any condition that, in the investigator’s opinion, may interfere with the evaluation of the response or make it unlikely for the patient to complete the follow-up period.
- Breastfeeding
- Anatomical abnormalities of the urinary tract.
- Presence of urinary devices (e.g., bladder catheter, nephrostomy, etc.).
- Chronic renal failure with a glomerular filtration rate (GFR) below 40 mL/min.
- Hepatic cirrhosis, Child–Pugh class B or C.
- Hyperuricemia or a history of gout attacks.
- Regular treatment with alkalinizing or antacid agents such as sodium bicarbonate, citrates, almagate (Almax®), acetazolamide, or other carbonic anhydrase inhibitors.
- Inability to take oral medication.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.