ACTRN12616001619437.

Study name	D‐mannose for prophylaxis against urinary tract infection in spinal cord injury: pilot randomised control study
Methods	Study design Parallel, open‐label RCT Study duration and follow‐up 3 months treatment Study dates In progress
Participants	General information Country: New Zealand Setting: single centre Inclusion criteria: patients admitted to Auckland Spinal Rehab Unit. All new admissions to the spinal unit, neurogenic bladder needing catheter on admission; aged ≥ 14 years; females and males Exclusion criteria: repeat admission, no evidence of neurogenic bladder on admission Target sample size: 40
Interventions	Treatment group D‐mannose 1 g oral tablet 3 times/day for 3 months (to monitor adherence, weekly check of medication chart and patient interview) Control group Standard care for neurogenic bladder practised in the spinal unit: catheter care, early commencement of intermittent catheterization program in appropriate cases, hygiene, good fluid intake with the aim of 1.5 to 2 litres and education For 3 months Co‐interventions or additional treatments None Follow‐up details 3 months
Outcomes	Rate ratio of UTI: number of UTI/total catheter days Number of UTI: will be assessed by clinical symptoms like temperature more than 38, pain, urinary leakage with positive urine culture Catheter days: total number of days patients needing to use a catheter to manage their bladder Frequency ratio of CUTI: number of episodes of CUTI between treatment and control group Number of episodes of UTI: number of symptomatic UTI; this will be assessed by clinical symptoms like fever (temperature > 38°C), pain and urinary leakage with positive urine culture Acute transfer to tertiary Hospital for UTI between two groups Medical records and hospital admission records will be reviewed Time to first UTI between both groups Medical records review Temperature‐associated CUTI (UTI symptoms and associated temperature elevation) between groups Temperature‐associated UTI: defined as temperature > 38°C, which is measured using an ear thermometer with positive urine culture
Starting date	Recruitment completed
Contact information	Dr Suresh Subramanian Auckland Spinal rehab unit 30 Bairds Road Otara 1640 Auckland New Zealand +64 9 2709000 Sureshbabu.Subramanian@middlemore.co.nz
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