METHENAMINE HIPPURATE for Recurrent urinary tract infection

Inclusion criteria

• {"criterion_text":"- To be a woman\n- Ages between 18 and 85 years, inclusive.\n- 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.\n- The patient provides written informed consent."}

Exclusion criteria

• {"criterion_text":"- Pregnant women or those planning to become pregnant within the 12 months following inclusion.\n- Anticipated inability to complete the 12-month follow-up period.\n- 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.\n- Breastfeeding\n- Anatomical abnormalities of the urinary tract.\n- Presence of urinary devices (e.g., bladder catheter, nephrostomy, etc.).\n- Chronic renal failure with a glomerular filtration rate (GFR) below 40 mL/min.\n- Hepatic cirrhosis, Child–Pugh class B or C.\n- Hyperuricemia or a history of gout attacks.\n- Regular treatment with alkalinizing or antacid agents such as sodium bicarbonate, citrates, almagate (Almax®), acetazolamide, or other carbonic anhydrase inhibitors.\n- Inability to take oral medication."}

Primary endpoints

• {"endpoint_text":"- Primary clinical variable: number of recurrent symptomatic UTI episodes during the 6-month treatment period.","definition_or_measurement_approach":"Count of recurrent symptomatic UTI episodes occurring during the 6-month prophylaxis/treatment period."}
• {"endpoint_text":"- Primary microbiological variable: number of patients with isolates showing an MDR (multidrug-resistant) profile at 6 months of treatment.","definition_or_measurement_approach":"Number of patients with microbiological isolates characterized as MDR at the 6-month timepoint of treatment."}

Secondary endpoints

• {"endpoint_text":"- Number of symptomatic UTI episodes at 12 months of follow-up.","definition_or_measurement_approach":"Count of symptomatic UTI episodes occurring during the 12-month follow-up period."}
• {"endpoint_text":"- Percentage of severe infection episodes (urosepsis and/or septic shock), bacteremia, and hospitalizations due to UTI during the treatment period (6 months) and the follow-up period (12 months).","definition_or_measurement_approach":"Proportion of participants experiencing severe infections (urosepsis/septic shock), bacteremia, or UTI-related hospitalizations during the 6-month treatment and 12-month follow-up periods."}
• {"endpoint_text":"- Patient satisfaction assessed through general and UTI-specific quality-of-life questionnaires.","definition_or_measurement_approach":"Assessment via validated general and UTI-specific QoL/satisfaction questionnaires (as specified in protocol)."}
• {"endpoint_text":"- Percentage of adverse events by organ system and their intensity.","definition_or_measurement_approach":"Proportion and classification of adverse events by organ system and severity/intensity according to protocol definitions."}
• {"endpoint_text":"- Number of antibiotic courses during follow-up.","definition_or_measurement_approach":"Count of antibiotic treatment courses received by participants during the follow-up period."}
• {"endpoint_text":"- Percentage of patients with isolates showing a DTR (difficult-to-treat resistance) profile, ESBL-producing isolates, or carbapenemase-producing isolates in both groups.","definition_or_measurement_approach":"Proportion of participants with isolates characterized as DTR, ESBL-producing, or carbapenemase-producing as determined by microbiological testing."}
• {"endpoint_text":"- Percentage of alpha and beta diversity in the vaginal microbiota according to study group.","definition_or_measurement_approach":"Analysis of vaginal microbiota diversity (alpha and beta diversity metrics) comparing study groups as per microbiome analysis methods in protocol."}

Spain

Earliest CTIS Part Ii Submission Date

20-03-2026

Latest Decision Or Authorization Date

25-03-2026

Processing Time Days

5

Number Of Sites

9

Number Of Participants

204

Primary sponsor

Full Name

Consorci Mar Parc De Salut De Barcelona

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain