Clinical trial to evaluate the clinical and microbiological impact of methenamine hippurate as an alternative prophylaxis in recurrent urinary tract infections in women

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Consorci Mar Parc De Salut De Barcelona

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Decision date (initial)

2026-03-25

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

ISCIII

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

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.

Secondary objectives 9

1. To determine the number of symptomatic UTI episodes during the 12-month follow-up period.
2. To determine the incidence of severe infections (urosepsis, septic shock) and hospitalizations related to urinary tract infection during the study period, according to the type of prophylaxis received.
3. To evaluate the psychosocial impact associated with recurrent UTIs using quality-of-life scales. Satisfaction and perceived changes with the prophylaxis will be assessed and compared between groups.
4. To evaluate the incidence of adverse events related to the prophylactic regimens used.
5. To determine the number of antibiotic days in both groups (total antibiotic days, prophylactic antibiotic days, and therapeutic antibiotic days).
6. To characterize the microbiological profile of pathogens isolated from urine cultures, rectal, and vaginal swabs.
7. To determine changes in the resistance patterns of isolates during the study follow-up.
8. To determine changes in vaginal microbiota composition (alpha and beta diversity) according to the prophylaxis received.
9. To perform a specific analysis of the subgroup of immunosuppressed patients included in the study. Sub-analyses will also be conducted according to the hormonal stage of the women (premenopausal vs. perimenopausal/menopausal).

Conditions and MedDRA coding

recurrent urine infections

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. To be a woman
2. Ages between 18 and 85 years, inclusive.
3. 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.
4. The patient provides written informed consent.

Exclusion criteria 11

1. Pregnant women or those planning to become pregnant within the 12 months following inclusion.
2. Breastfeeding
3. Anatomical abnormalities of the urinary tract.
4. Presence of urinary devices (e.g., bladder catheter, nephrostomy, etc.).
5. Chronic renal failure with a glomerular filtration rate (GFR) below 40 mL/min.
6. Hepatic cirrhosis, Child–Pugh class B or C.
7. Hyperuricemia or a history of gout attacks.
8. Regular treatment with alkalinizing or antacid agents such as sodium bicarbonate, citrates, almagate (Almax®), acetazolamide, or other carbonic anhydrase inhibitors.
9. Inability to take oral medication.
10. Anticipated inability to complete the 12-month follow-up period.
11. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Primary clinical variable: number of recurrent symptomatic UTI episodes during the 6-month treatment period. Primary microbiological variable: number of patients with isolates showing an MDR (multidrug-resistant) profile at 6 months of treatment.

Secondary endpoints 7

1. Number of symptomatic UTI episodes at 12 months of follow-up.
2. 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).
3. Patient satisfaction assessed through general and UTI-specific quality-of-life questionnaires.
4. Percentage of adverse events by organ system and their intensity.
5. Number of antibiotic courses during follow-up.
6. Percentage of patients with isolates showing a DTR (difficult-to-treat resistance) profile, ESBL-producing isolates, or carbapenemase-producing isolates in both groups.
7. Percentage of alpha and beta diversity in the vaginal microbiota according to study group.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Consorci Mar Parc De Salut De Barcelona

Sponsor organisation

Consorci Mar Parc De Salut De Barcelona

Address

Passeig Maritim De La Barceloneta 25-29

City

Barcelona

Postcode

08003

Country

Spain

Scientific contact point

Organisation

Consorci Mar Parc De Salut De Barcelona

Contact name

Silvia Inés Gómez-Zorrilla Martín

Public contact point

Organisation

Consorci Mar Parc De Salut De Barcelona

Contact name

Silvia Inés Gómez-Zorrilla Martín

Locations

1 EU/EEA country · 9 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications