A Phase 2 interventional study of Treatment dose antibiotic in combination with methenamine hippurate and Prophylactic dose antibiotic or methenamine hippurate monotherapy in Chronic Urinary Tract Infection, sponsored by University College, London. Recruiting at 5 sites in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by University College, London · Phase 2, Interventional, and Treatment
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:
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).
EAT-UP is a UK multi-centre, randomised, open label, parallel-group, superiority, interventional phase II trial, aiming to recruit 192 female participants. Participants will undergo screening to evaluate their eligibility to participate in the trial. If eligible, participants will be randomly assigned into one of two groups:
Group 1 will receive a treatment dose antibiotic in combination with the urinary antiseptic, methenamine hippurate (1 g twice daily). The treating clinician will select one of the following antibiotics based on the individual needs of the participant, such as their medical history, concomitant medications and any known allergies:
Group 2 will receive a low-dose prophylactic antibiotic or the urinary antiseptic, methenamine hippurate. The treating clinician will select one of the following treatments based on the individual needs of the participant, such as their medical history, concomitant medications and any known allergies:
Participants will be taking trial medication for 12 weeks and will be required to attend clinic for assessments every 4 weeks. Participant will complete questionnaires and provide blood, urine, and perineal (the area between the vagina and anus) swabs samples.
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
This study's planned enrollment of 192 is above the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 14, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Able and willing to provide 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.
Exclusion Criteria:
Any medical condition or previous treatment which in the investigator's opinion compromises the potential participant's ability to participate.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Treatment dose antibiotic in combination with methenamine hippurate
Drug: Prophylactic dose antibiotic or methenamine hippurate monotherapy
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.
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.
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.
Time frame: Baseline, Week 4, Week 8, Week 12
Changes in EuroQol EQ-5D 5-Level Health Related Quality of Life Questionnaire (EQ-5D-5L) scores at week 12, adjusted for baseline
The EQ-5D-5L is a participant self-reported questionnaire which evaluates the generic quality of life at the time of completion. It comprises of a 5 item questionnaire (assessing - mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and a visual analogue scale (VAS). Each dimension assessed has 5 response scales to select from: no problems, slight problems, moderate problems, severe problems, and extreme problems
Time frame: Baseline, Week 12
Changes in ICIQ Lower Urinary Tract Symptoms quality of life (ICIQ-LUTSqol)
The ICIQ Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) is designed to assess the impact of lower urinary tract symptoms (LUTS) on a patient's quality of life. It consists of 19 items that explore various aspects of daily living affected by LUTS, including physical, social, emotional, and psychological domains. Responses are measured using a Likert scale, allowing clinicians and researchers to quantify the burden of symptoms and evaluate changes over time.
Time frame: 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
The Whittington 39-point Lower Urinary Tract Symptoms (W-39 LUTS) is a questionnaire designed to assess participant's experiences of lower urinary tract symptoms (LUTS). It consists of 39 items that explore the following LUTS symptom groups: Urgency, Pain, Stress Incontinence and Voiding.
Time frame: Baseline, Week 4, Week 8, Week 12
Patient Global Impression of Improvement (PGI-I) scores at week 12.
The Patient Global Impression of Improvement (PGI-I) is used to assess a participant's perception of change in their condition following treatment. It consists of a single-item questionnaire where patients rate their overall improvement on a 7-point Likert scale, ranging from "very much better" to "very much worse."
Time frame: Week 4, Week 8, Week 12
Participant satisfaction with medication using Lübeck Medication Satisfaction (LMS) Questionnaire scores at week 12
The Lübeck Medication Satisfaction (LMS) Questionnaire is designed to assess participant satisfaction with their trial medication. It comprises 18 items that evaluate satisfaction across domains such as effectiveness, side effects, ease of use, and overall contentment.
Time frame: Week 12
Treatment adherence assessed by the MARS-5 questionnaire at weeks 4, 8 and 12.
The Medication Adherence Report Scale (MARS-5) is a self-report questionnaire used to assess medication adherence behaviour in participants with chronic conditions. It includes 5 items that measure both intentional and unintentional non-adherence, such as forgetting to take medication or altering doses. Each item is rated on a 5-point Likert scale, with higher scores indicating better adherence.
Time frame: Week 4, Week 8 and Week 12
Frequency of rescue therapy use for participants requiring further treatment escalation for an acute flare of symptoms at 12
Participants will be prescribed rescue therapies, typically short courses of antibiotics at higher doses than their assigned treatment arm, in response to acute symptom flares. The use and effectiveness of these therapies will be reviewed at each trial visit.
Time frame: Week 4, Week 8 and Week 12
Changes in urine culture species, cfu/ml count, sensitivities and resistance profiles at week 12, adjusted for baseline
Urine samples will be submitted to the central laboratory for testing to evaluate the changes in the type of bacteria found in the urine, the amount of bacteria and how the bacteria is responding to antibiotics (including resistance).
Time frame: Baseline and Week 12
Changes in Perineal swab analyses of E.coli identified, sensitivities and resistance profiles at week 12, adjusted for baseline
A swab will be taken from the area between the vagina and anus (this is called the perineal area) either by the participant (self-swab) or with assistance from the local research team. The swab will be submitted to the central laboratory for testing. The tests will be used to measure any changes in how bacteria in the gut responds to antibiotics (also known as antimicrobial resistance).
Time frame: Baseline and Week 12
Safety and tolerability of the intervention as indicated by changes in pulse (bpm) from baseline to Week 12
Vital signs
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in blood pressure (mmHg) from baseline to week 12
Vital signs
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in temperature (°) from baseline to week 12
Vital signs
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in respiratory rate (breaths per minute)from baseline to week 12
Vital signs
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in weight (kg) from baseline to week 12
Vital signs
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Haemoglobin (g/dL) from baseline to week 12
Standard diagnostic laboratory test (Full Blood Count)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Red Blood Cell Count (10^12/L) from baseline to week 12
Standard diagnostic laboratory test (Full Blood Count)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Platelets (10^9/L) from baseline to week 12
Standard diagnostic laboratory test (Full Blood Count)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in total White Blood Cell Count (10^9/L) from baseline to week 12
Standard diagnostic laboratory test (Full Blood Count)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Neutrophils (10^9/L) from baseline to week 12
Standard diagnostic laboratory test (Full Blood Count)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Lymphocytes (10^9/L) from baseline to week 12
Standard diagnostic laboratory test (Full Blood Count)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Monocytes (10^9/L) from baseline to week 12
Standard diagnostic laboratory test (Full Blood Count)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Eosinophils (10^9/L) from baseline to week 12
Standard diagnostic laboratory test (Full Blood Count)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Basophils (10^9/L) from baseline to week 12
Standard diagnostic laboratory test (Full Blood Count)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Albumin (g/L) from baseline to week 12
Standard diagnostic laboratory test (Biochemistry)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Total Bilirubin (µmol/L) from baseline to week 12
Standard diagnostic laboratory test (Biochemistry)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Alanine Transaminase (ALT) (IU/L) from baseline to week 12
Standard diagnostic laboratory test (Biochemistry)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Alkaline Phosphatase (ALP) (IU/L) from baseline to week 12
Standard diagnostic laboratory test (Biochemistry)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Calcium (mmol/L) from baseline to week 12
Standard diagnostic laboratory test (Biochemistry)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Carbon dioxide (bicarbonate) (mmol/L) from baseline to week 12
Standard diagnostic laboratory test (Biochemistry)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Chloride (mmol/L) from baseline to week 12
Standard diagnostic laboratory test (Biochemistry)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Creatinine (µmol/L) from baseline to week 12
Standard diagnostic laboratory test (Biochemistry)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Estimated Glomerular Filtration Rate (eGFR) (ml/min/1.72m²) from baseline to week 12
Standard diagnostic laboratory test (Biochemistry)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Glucose (mmol/L) from baseline to week 12
Standard diagnostic laboratory test (Biochemistry)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Phosphorus inorganic (phosphate) (mmol/L) from baseline to week 12
Standard diagnostic laboratory test (Biochemistry)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Potassium (mmol/L) from baseline to week 12
Standard diagnostic laboratory test (Biochemistry)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Sodium (mmol/L) from baseline to week 12
Standard diagnostic laboratory test (Biochemistry)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by changes in Urea (mmol/L) from baseline to week 12
Standard diagnostic laboratory test (Biochemistry)
Time frame: Baseline, Week 4, Week 8 and Week 12
Safety and tolerability of the intervention as indicated by the occurrence / severity of treatment related Adverse Events assessed by CTCAE v5.0 from baseline to week 12
Number of participants with treatment related adverse events assessed by CTCAE v5.0 from baseline to week 12
Time frame: Baseline, Week 4, Week 8 and Week 12
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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