Urinary tract infection Urological and Genital Diseases
Conditions
Interventions
This is a two-arm, individually randomised, double-blind placebo-controlled trial. Women will be randomised 1:1 into either placebo or intervention:
Placebo: women will take 2 grams (due to difference
Sponsors
University of Oxford
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures: 1. Number of days of moderately bad (or worse) symptoms of UTI, assessed using a participant diary throughout the study 2. Time to next consultation with a clinically suspected UTI, assessed during a notes review 6 months after study entry 3. Number of clinically suspected UTIs, assessed during a notes review 6 months after study entry 4. Number of microbiologically proven UTIs, assessed during a notes review 6 months after study entry 5. Number of antibiotic courses for UTI; DDD and total mg by antibiotic type, assessed during a notes review 6 months after study entry 6. Report of consumption of antibiotics using diary during periods of infection, recorded in the participant diary throughout the study 7. Proportion of women with a resistant uropathogen cultured during an episode of acute infection, assessed during a notes review 6 months after study entry 8. Hospital admissions related to UTI, assessed during a notes review 6 months after study entry 9. Quality of life recorded in the participant diary at baseline, 6 months and during UTI episodes on day 1, 3 and 5 10. Healthcare utilisation recorded in the participant diary and during a notes review 6 months after study entry 11. Acceptability and process evaluation conducted via telephone interviews with up to 25 women throughout the study Tertiary outcome measures: 1. Antibiotic usage and urine culture results in the five years prior to study entry, assessed during a notes review 6 months after study entry 2. Urine culture results for samples sent during the study period, recorded in the lab results 3. (Dependent on further funding): Patterns of microbial presence as demonstrated by Next Generation DNA Sequencing in RUTI, exploring association between frequency of infection and microbial presence and evaluating the impact of D-mannose on microbial presence, assessed throughout study | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed