The effectiveness of D-Mannose in patients with high risk of recurrent urinary tract infections

Not Applicable

• Conditions: Metabolic and Endocrine - Diabetes; rinary tract infection; Recurrent urinary tract infection; Diabetes mellitus; Urinary tract infection; Renal and Urogenital - Other renal and urogenital disorders; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12619000183189
• Lead Sponsor: Sir Charles Gairdner Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-08
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Female
Aged over 60 years
Diagnosed with diabetes mellitus
Adequate renal 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 greater than 3 as determined by the Charlston Index)
Unable to attend appointments
Unable to read / write English
Unable to comply with study protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients developing a UTI in the trial period determined by urinalysis, clinical symptoms and micro culture.[Assessed at monthly followups (week 4, week 8, week 12, week 16, week 20 and week 24)]

Secondary Outcome Measures

Name	Time	Method
Time (days) to urinary tract infection[Assessed at monthly followups (week 4, week 8, week 12, week 16, week 20 and week 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 followups (week 4, week 8, week 12, week 16, week 20 and week 24)];Patient likelihood of continuing treatment measured on 0-10 VAS[Assessed at monthly followups (week 4, week 8, week 12, week 16, week 20 and week 24)];The effect of treatment on blood glucose management in diabetic patients . This will be measured by comparing before study blood levels of glycosolated Hb performed every second month via pathology and daily blood sugar levels (recorded by patients from finger prick) to levels taken during the study period. Both glycosolated Hb and daily blood sugar levels are part of standard clinical care. [Assessed every 2nd monthly visit (week 4, week 12, week 20 and week 24). ]