Vitamin C and Hiprex in rUTI

Launched by UNIVERSITY HOSPITALS OF NORTH MIDLANDS NHS TRUST · Nov 26, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to see if adding Vitamin C can make a medication called Methenamine Hippurate (Hiprex®) more effective in preventing recurrent urinary tract infections (rUTIs) in women. Recurrent UTIs are defined as having two or more infections in six months or three or more infections in that same time frame. The trial is specifically for women aged 18 years and older who have a history of these infections and are willing to follow the study's procedures.

To participate in the trial, you must be a woman with a proven history of recurrent UTIs and able to give your informed consent. You'll also need to have tried standard prevention methods for UTIs before joining the study. Participants will be asked to submit urine pH results via email and must be willing to use reliable birth control if they could become pregnant. The trial is not yet recruiting but aims to provide new insights into improving UTI prevention for women.

Gender

FEMALE

Eligibility criteria

• 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