D-mannose to prevent recurrent urinary tract infections

Not Applicable

Completed

• Conditions: rinary tract infection; Urological and Genital Diseases

• Registration Number: ISRCTN13283516
• Lead Sponsor: niversity of Oxford

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33441350/ protocol (added 15/01/2021) 2024 Results article in https://doi.org/10.1001/jamainternmed.2024.0264 (added 09/04/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-22
• Study Completion: 2021-09-30
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 598

Inclusion Criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Participant is able to comply with study procedures
3. Female, aged 18 years or above
4. Presented to ambulatory care with symptoms consistent with UTI three or more times in the last year or two or more times in the last six months

Exclusion Criteria

1. Female participant who is pregnant, lactating or planning pregnancy during the course of the study
2. Formal diagnosis of interstitial cystitis or overactive bladder syndrome
3. Prophylactic antibiotics started in the last 3 months and unwilling to discontinue, or intention to start during the next 6 months
4. Currently using D-mannose and unwilling to discontinue for the duration of the study
5. Nursing home resident. Residential home residents will not be excluded
6. Catheterised, including intermittent self-catheterisation
7. Use of Uromune (an ‘immunostimulant’)
8. Participants who have participated in a research study involving an investigational product in the past twelve weeks
9. Previous participation in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of women experiencing at least one further episode of clinically suspected UTI for which they contact ambulatory care (Out of hour (OOH) primary care, in hours primary care, ambulance or A and E). Assessed by medical notes review within 6 months of study entry.