NCT06710899

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
12mo left

Started Jan 2027

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
2.1 years until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

November 26, 2024

Last Update Submit

February 10, 2026

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (1)

  • Frequency of UTIs

    The incidence of symptomatic UTI during each six-month treatment phase of either methenamine hippurate alone or methenamine hippurate plus vitamin C

    24 months

Secondary Outcomes (1)

  • Urine pH

    24 months

Study Arms (3)

Treatment phase A

EXPERIMENTAL

Methenamine Hippurate 1g BD for 6 months

Drug: Methenamine Hippurate 1g BD

Treatment phase B

EXPERIMENTAL

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

Drug: Methenamine Hippurate 1g BD + Vitamin C 1g BD

Treatment phase C

EXPERIMENTAL

Methenamine 1g BD for 6 months

Drug: Methenamine Hippurate 1g BD

Interventions

Methenamine Hippurate 1g BDDRUG

Methenamine Hippurate 1g BD for 6 months

Treatment phase ATreatment phase C
Methenamine Hippurate 1g BD + Vitamin C 1g BDDRUG

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

Treatment phase B

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of North Midlands NHS Trust

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

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

methenamine hippurateAscorbic Acid

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Central Study Contacts

Aviva Ogbolosingha

CONTACT

01782 675380aviva.ogbolosingha@uhnm.nhs.uk

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2024

First Posted

November 29, 2024

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations

GB(1)