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NCT Number: NCT06710899

Vitamin C and Hiprex in rUTI

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methenamine Hippurate 1g BD

Drug

Methenamine Hippurate 1g BD for 6 months

Methenamine Hippurate 1g BD + Vitamin C 1g BD

Drug

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

Primary outcomes

  1. Frequency of UTIs

    Time frame: 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 outcomes

  1. Urine pH

    Time frame: 24 months

    Measurement of urine pH during each treatment phase

Study contacts

Contact information is provided by the study sponsor or research team.

Aviva Ogbolosingha

CONTACT

[email protected]

01782 675380

Sponsors and collaborators

Lead sponsor

University Hospitals of North Midlands NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2027
Study completion
2028
First posted
Nov 29, 2024
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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