Vitamin C and Hiprex in rUTI

Early Phase 1

Not yet recruiting

• Conditions: Urinary Tract Infections
• Interventions: Drug: Methenamine Hippurate 1g BD; Drug: Methenamine Hippurate 1g BD + Vitamin C 1g BD

• Registration Number: NCT06710899
• Lead Sponsor: University Hospitals of North Midlands NHS Trust

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-11-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Study Start: 2025-03
• Primary Completion: 2026-04
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Treatment phase A	Methenamine Hippurate 1g BD	Methenamine Hippurate 1g BD for 6 months
Treatment phase B	Methenamine Hippurate 1g BD + Vitamin C 1g BD	Methenamine Hippurate 1g BD + Vitamin C 1g BD for 6 months
Treatment phase C	Methenamine Hippurate 1g BD	Methenamine 1g BD for 6 months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Urine pH	24 months	Measurement of urine pH during each treatment phase

Trial Locations

Locations (1)

University Hospitals of North Midlands NHS Trust; 🇬🇧 Stoke-on-Trent, Staffordshire, United Kingdom