ACTRN12619000183189.

Study name	The effectiveness of D‐mannose in patients with high risk of recurrent urinary tract infections
Methods	Study design Parallel RCT Study duration and follow‐up 24 weeks follow‐up Study dates Not yet recruiting
Participants	General information Country: Australia Setting: single centre Inclusion criteria: female ≥ 60 years; diagnosed with DM; adequate kidney function as determined by treating medical officer; diagnosed with recurrent UTI defined as 2 or more infections in 6 months or 3 or more infections in 12 months; currently free of UTI (determined by absence of clinical symptoms); able to give valid consent; available to attend a maximum of eight appointments at Sir Charles Gairdner Hospital Exclusion criteria: current UTI or receiving treatment for UTI; unable to give valid consent; heavily dependent on medical care; multiple co‐morbidities (co‐morbidities > 3 as determined by the Charlston Index); unable to attend appointments; unable to read/write English Target sample size: 50
Interventions	Treatment group Single dose of 2.5 g of D‐mannose will be dissolved in water and drunk every evening for 24 weeks Compliance: allocated container holding the intervention will be weighed before being given to participants. Participants will be asked to return for 6 further follow‐up appointments (1/month) with the research nurse and bring the same container with them. The container will be re‐weighed and documented. Comparison to baseline weight will be performed and an estimate of dose taken in grams for the monthly period will be calculated Control group The placebo is 2.5 g of white powder (Guar gum) identical in appearance to D‐mannose to be dissolved in water and drunk in the evening Co‐interventions or additional treatments None reported Follow‐up details 24 weeks
Outcomes	Outcomes to be assessed at weeks 4, 8, 12, 16, 20 and 24 Percentage of patients developing a UTI in the study period determined by urinalysis, clinical symptoms and microculture Assessed at monthly follow‐ups (weeks 4, 8, 12, 16, 20 and 24) Time (days) to UTI Assessed at monthly follow‐ups (weeks 4, 8, 12, 16, 20 and 24) Change in continence scores measured by BBUSQ At baseline and week 24 Patient satisfaction with treatment measured on 0‐10 VAS Assessed at monthly follow‐ups (weeks 4, 8, 12, 16, 20 and 24) Patient likelihood of continuing treatment measured on 0‐10 VAS Assessed at monthly follow‐ups (weeks 4, 8, 12, 16, 20 and 24) The effect of treatment on blood glucose management in diabetic patients. This will be measured by comparing before‐study blood levels of HbA1c performed every second month via pathology and daily blood sugar levels (recorded by patients from a finger prick) to levels taken during the study period. Both HbA1c and daily blood sugar levels are part of standard clinical care Assessed every 2nd monthly visit (weeks 4, 12, 20 and 24)
Starting date	Unknown
Contact information	Dr Vicki Patton Sir Charles Gairdner Hospital Level 1 Harry Perkins Research Institute Nedlands WA 6009 Australia +61 861510753 vickip04@gmail.com
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