NCT07202949

Brief Summary

Chronic Urinary Tract Infection (UTI) is a type of UTI where symptoms are constant and occur every day, unlike recurrent UTIs, which come and go with symptom-free breaks in between. Current treatment for chronic UTI within the NHS is based on recommended guidelines for recurrent UTI. The standard approach typically includes one of the following treatments:

  • Long-term, prophylactic (low) dose daily antibiotic (where medication is used at low doses to try to prevent symptoms reoccurring).
  • Long-term use of a urinary antiseptic (which helps keep your urine bacteria free), called methenamine hippurate. These often do not work for people with chronic UTI, and symptoms can persist. Moreover, standard urine tests may fail to detect infections, making diagnosis and treatment more challenging. The EAT-UP trial will investigate whether longer courses of treatment (higher) dose antibiotics combined with methenamine hippurate (a urinary antiseptic) are a more effective treatment at reducing levels of infection and symptoms than standard of care treatments (as described above).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for phase_2

Timeline
18mo left

Started Feb 2026

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Feb 2026Nov 2027

First Submitted

Initial submission to the registry

September 16, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

February 26, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

April 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

September 16, 2025

Last Update Submit

April 20, 2026

Conditions

Chronic Urinary Tract Infection

Keywords

Urinary Tract InfectionAntibioticsUrological Diseasesmethenamine hippurateCefalexinNitrofurantoinTrimethoprimAmoxicillinChronic Urinary Tract InfectionUTI

Outcome Measures

Primary Outcomes (1)

  • Change in urinary white blood cell (WBC) count from baseline to Week 12.

    Urinary white blood cell (WBC) count, measured using fresh urine microscopy, will be used as the principal biomarker to indicate urinary tract inflammation.

    Baseline, Week 4, Week 8, Week 12

Secondary Outcomes (38)

  • Changes in EuroQol EQ-5D 5-Level Health Related Quality of Life Questionnaire (EQ-5D-5L) scores at week 12, adjusted for baseline

    Baseline, Week 12

  • Changes in ICIQ Lower Urinary Tract Symptoms quality of life (ICIQ-LUTSqol)

    Baseline, Week 4, Week 8, Week 12

  • Changes in Whittington 39-point Lower Urinary Tract Symptoms (W-39 LUTS) scores at week 12, adjusted for baseline

    Baseline, Week 4, Week 8, Week 12

  • Patient Global Impression of Improvement (PGI-I) scores at week 12.

    Week 4, Week 8, Week 12

  • Participant satisfaction with medication using Lübeck Medication Satisfaction (LMS) Questionnaire scores at week 12

    Week 12

  • +33 more secondary outcomes

Study Arms (2)

Treatment dose antibiotic in combination with methenamine hippurate

EXPERIMENTAL
Drug: Treatment dose antibiotic in combination with methenamine hippurate

Prophylactic dose antibiotic or methenamine hippurate monotherapy

ACTIVE COMPARATOR
Drug: Prophylactic dose antibiotic or methenamine hippurate monotherapy

Interventions

Treatment dose antibiotic in combination with methenamine hippurateDRUG

Arm A includes treatment with one of three treatment dose antibiotic options, selected by the treating clinician, in combination with methenamine hippurate. Participants allocated to this arm will receive combination therapy, consisting of one of the following antibiotics: * Cefalexin (500mg four times daily), or * Nitrofurantoin (100mg twice daily), or * Trimethoprim (200mg twice daily) in combination with Methenamine Hippurate (1g twice daily) for 12 weeks.

Treatment dose antibiotic in combination with methenamine hippurate
Prophylactic dose antibiotic or methenamine hippurate monotherapyDRUG

Arm B includes treatment with one of four prophylactic dose antibiotics or methenamine hippurate, but not both, selected by the treating clinician. Participants in this arm will receive monotherapy of one of the following: * Amoxicillin (250mg once daily), or * Cefalexin (125mg once daily), or * Nitrofurantoin (50mg once daily), or * Trimethoprim (100mg once daily), or * Methenamine Hippurate (1g twice daily) for 12 weeks.

Prophylactic dose antibiotic or methenamine hippurate monotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of chronic UTI, without structural or functional urinary tract abnormality\*, defined as daily persistent symptoms affecting storage (urinary frequency, urgency or urge incontinence) and urinary tract pain symptoms (including bladder pain, urethral pain, or dysuria), for at least 3 months prior to the screening visit, with previously associated transient symptomatic improvement to antibiotic treatment for UTI, which in the opinion of the delegated clinician is secondary to chronic urinary tract infection.
  • A fresh urine microscopy examination showing ≥20 white blood cells/µl of urine at the screening visit.
  • Female\*\* patients.
  • Aged ≥18 years.
  • Screening blood result of eGFR ≥45ml/min/1.73m2.
  • Able and willing to attend trial visits and comply with all study procedures for the duration of the trial.
  • Able and willing to provide informed consent prior to any study related assessments and/or procedures.
  • A structural or functional abnormality may include kidney reflux, current or long-term catheter use, renal transplant, diversion surgery, renal stones, grade 2 or above utero-vaginal prolapse or incomplete bladder emptying.
  • For the purposes of this trial, a female will be defined as an individual assigned female at birth who has a female urinary tract.

You may not qualify if:

  • Inability to take at least one of the following antibiotics: Cefalexin, Nitrofurantoin, or Trimethoprim, at prophylactic and treatment dose according to NICE guidelines, and/or the Summary of Product Characteristics (such as hepatic or renal dysfunction), or any other medical contraindications.
  • Inability to take methenamine hippurate due to medical contraindications.
  • Current use of immune-modulating drugs for the treatment of chronic illnesses such as rheumatoid arthritis, chronic lung disease, any other autoimmune conditions or cancer.
  • Current use of Sodium-Glucose Transport Protein 2 (SGLT2) inhibitors\*.
  • A current diagnosis of bladder cancer.
  • A diagnosis of an active sexually transmitted infection or a recent diagnosis of a sexually transmitted infection within the last 3 months of the screening visit.
  • Previous use of an antibiotic at treatment dose as per NICE guidelines for more than 14 consecutive days for treatment of UTI in the last 3 months prior to the screening visit.
  • Pregnancy (or planned pregnancy during trial participation) and/or breastfeeding.
  • Women of childbearing potential that are unable/unwilling to use an acceptable method of contraception (as described in section 3.4.1) to avoid pregnancy for the duration of the trial and for 1 week after the last dose of trial medication.
  • Current participation in another clinical trial of a device, interventional medicinal product, advanced therapy, or surgical procedure; or previous participation within 6 months of the screening visit.
  • Any medical condition or previous treatment which in the investigator's opinion compromises the potential participant's ability to participate.
  • Patient's must not have taken a Sodium-Glucose Transport Protein 2 (SGLT2) inhibitor within 24 hours before the screening visits to be eligible for the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

NOT YET RECRUITING

University College London Hospital (UCLH), UCLH NHS Foundation Trust

London, United Kingdom

NOT YET RECRUITING

Whittington Hospital, Whittington Health NHS Trust

London, United Kingdom

RECRUITING

St Mary's Hospital, Manchester University NHS Foundation Trust

Manchester, United Kingdom

NOT YET RECRUITING

Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

RECRUITING

MeSH Terms

Conditions

Urinary Tract InfectionsUrologic Diseases

Interventions

methenamine hippurate

Condition Hierarchy (Ancestors)

InfectionsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

EAT-UP Trial Team

CONTACT

020 3108 5298cctu.eat-up@ucl.ac.uk

Liz Deane

CONTACT

liz.deane@ucl.ac.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2025

First Posted

October 2, 2025

Study Start

February 26, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

April 23, 2026

Record last verified: 2026-02

Locations

GB(5)