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Not yet recruiting NCT06710899

Vitamin C and Hiprex in rUTI

Early Phase I Interventional Urinary Tract Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Methenamine Hippurate 1g BD, Methenamine Hippurate 1g BD + Vitamin C 1g BD.
Who it may be relevant to
Registry conditions: Urinary Tract Infections. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Does Vitamin C Improve the Efficacy of Methenamine Hippurate (Hiprex®) in Prophylaxis of Recurrent Urinary Tract Infections? A Proof of Concept Study

Overview

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

  • Drug Methenamine Hippurate 1g BD
    Methenamine Hippurate 1g BD for 6 months
  • Drug Methenamine Hippurate 1g BD + Vitamin C 1g BD
    Methenamine Hippurate 1g BD + Vitamin C 1g BD for 6 months

Primary outcome measures

  • Frequency of UTIs [Time frame: 24 months]
Secondary outcome measures (1)
  • Urine pH [Time frame: 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • University Hospitals of North Midlands NHS Trust — Stoke-on-Trent

Identifiers

NCT: NCT06710899 · 3399

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗