Vitamin C and Hiprex in rUTI

NCT ID: NCT06710899

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-01-31

Brief Summary

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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

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Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment phase A

Methenamine Hippurate 1g BD for 6 months

Group Type EXPERIMENTAL

Methenamine Hippurate 1g BD

Intervention Type DRUG

Methenamine Hippurate 1g BD for 6 months

Treatment phase B

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

Group Type EXPERIMENTAL

Methenamine Hippurate 1g BD + Vitamin C 1g BD

Intervention Type DRUG

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

Treatment phase C

Methenamine 1g BD for 6 months

Group Type EXPERIMENTAL

Methenamine Hippurate 1g BD

Intervention Type DRUG

Methenamine Hippurate 1g BD for 6 months

Interventions

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Methenamine Hippurate 1g BD

Methenamine Hippurate 1g BD for 6 months

Intervention Type DRUG

Methenamine Hippurate 1g BD + Vitamin C 1g BD

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals of North Midlands NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, Staffordshire, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Aviva Ogbolosingha

Role: CONTACT

01782 675380

Other Identifiers

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3399

Identifier Type: -

Identifier Source: org_study_id

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