Health TrialsbyHealthPanel

Vitamin C and Hiprex in rUTI

ConditionUrinary Tract Infections
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospitals of North Midlands NHS Trust

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

20 Participants
are divided into 3 treatment groups
Group A: Treatment phase AExperimental treatment 1 intervention
Group B: Treatment phase BExperimental treatment 1 intervention
Group C: Treatment phase CExperimental treatment 1 intervention

Trial outcomes

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

Time frame
24 months

Secondary outcomes

1

Urine pH

Measurement of urine pH during each treatment phase

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospitals of North Midlands NHS Trust

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: