Urinary Tract Infections
Conditions
Brief summary
A single centre proof of concept study to assess whether Vitamin C improves the efficacy of Methenamine Hippurate (Hiprex®) in the prophylaxis of recurrent urinary tract infections (rUTIs) in women
Interventions
DRUGMethenamine Hippurate 1g BD + Vitamin C 1g BD
Methenamine Hippurate 1g BD + Vitamin C 1g BD for 6 months
Methenamine Hippurate 1g BD for 6 months
Sponsors
University Hospitals of North Midlands NHS Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female * 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
* Males * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of UTIs | 24 months | The incidence of symptomatic UTI during each six-month treatment phase of either methenamine hippurate alone or methenamine hippurate plus vitamin C |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine pH | 24 months | Measurement of urine pH during each treatment phase |
Countries
United Kingdom
Contacts
CONTACTAviva Ogbolosingha
Outcome results
None listed