Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
20 participants
INTERVENTIONAL
2026-01-31
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Treatment phase A
Methenamine Hippurate 1g BD for 6 months
Methenamine Hippurate 1g BD
Methenamine Hippurate 1g BD for 6 months
Treatment phase B
Methenamine Hippurate 1g BD + Vitamin C 1g BD for 6 months
Methenamine Hippurate 1g BD + Vitamin C 1g BD
Methenamine Hippurate 1g BD + Vitamin C 1g BD for 6 months
Treatment phase C
Methenamine 1g BD for 6 months
Methenamine Hippurate 1g BD
Methenamine Hippurate 1g BD for 6 months
Interventions
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Methenamine Hippurate 1g BD
Methenamine Hippurate 1g BD for 6 months
Methenamine Hippurate 1g BD + Vitamin C 1g BD
Methenamine Hippurate 1g BD + Vitamin C 1g BD for 6 months
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years
* Recurrent proven UTI, defined as "two or more proven infections in six months or three or more infections in six months"
* Willing and able to give fully informed consent
* Patients suitable for prophylaxis following discussion with their clinician.
* No contra-indications to treatment with methenamine hippurate or Vitamin C
* All women will have undergone standard diagnostic work-up and have followed routine conservative UTI prevention measures.
* A working email address to be used to submit urine pH results
* Willing and able to comply with the study procedures
* Females of childbearing potential must be willing to use a highly effective method of contraception (hormonal or barrier method of birth control; abstinence; sterilisation or vasectomised partner)
Exclusion Criteria
* Women who are pregnant or breast-feeding
* Contraindications to methenamine hippurate as described in BNF: known allergy, gout, severe metabolic acidosis, severe dehydration, eGFR less than 10 ml/min, severe hepatic impairment
* Currently using vitamin C containing supplement or cranberry extract tablets
* Women using urinary alkalinisation agents, e.g potassium citrate, sodium bicarbonate
* Currently receiving any form of bladder instillation or intradetrusor Onabotulinum Toxin A injections
* Patients already on low-dose antibiotics or methenamine hippurate (due to delay that will be incurred by 3-month washout period)
* Indwelling urinary catheter in situ or performing clean intermittent self-catheterisation
* Correctable urinary tract abnormalities, e.g., urinary tract calculi, urinary retention
* Formation of ileal conduit or augmented bladder
* Neurogenic bladder dysfunction
* Hyperoxaluria
18 Years
FEMALE
No
Sponsors
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University Hospitals of North Midlands NHS Trust
OTHER
Responsible Party
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Locations
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University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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3399
Identifier Type: -
Identifier Source: org_study_id
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