RUTISS-Diary and RUTISS-65 Study
Research type
Research Study
Full title
Developing and Validating Two New Patient-Reported Outcome Measures of Recurrent Urinary Tract Infection Symptoms: A Symptoms Diary and Adapted Measure for Older Adults
IRAS ID
366353
Contact name
Katherine Finlay
Contact email
Sponsor organisation
University of Reading
Duration of Study in the UK
1 years, 6 months, 24 days
Research summary
400 million people globally each year are affected by Urinary Tract Infections (UTIs), with annual recurrence ranging from 24-50%. Recurrent UTIs (rUTIs) are defined as having at least two infections in six months, or three within one year. These repeated infections can significantly negatively impact quality of life, and repeated use of antibiotics can lead to antibiotic resistance. Standard urine culture may present results that are not consistent with a person's symptoms, hence the urgent need for quantifiable rUTI Patient Reported Outcome Measures (PROMs).
Currently, measures exist for acute infection (e.g. cystitis) but not rUTI. We recently developed and published two rUTI PROMs (the Recurrent Urinary Tract Infection Symptom Scale (RUTISS) and Recurrent Urinary Tract Infection Impact Questionnaire (RUTIIQ)). However, neither has been adapted for daily symptom tracking or tailored to the needs of older adults. As a result, there is no rapid assessment tool that individuals living with rUTI (or their healthcare professionals) to analyse how rUTI symptoms change daily or to suitably assess adults over 65 years.
Therefore, this collaborative study between the University of Reading and Royal Berkshire NHS Foundation Trust aims to develop, validate and pilot two new PROMs: 1) an adaptation of the RUTISS in daily diary format (RUTISS-Diary); and 2) an adapted RUTISS measure tailored for observational reporting of rUTI symptoms in older adults (RUTISS-65). To validate these measures, this study will comprise of test-retest pilot trial of the new measures with 200 rUTI patients at a single NHS site. All participants will complete the RUTISS-Diary everyday for the initial 7 days and at day 14 follow-up. Participants aged 65 years and older will also complete the RUTISS-65 on days 1 and 2.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
26/NE/0098
Date of REC Opinion
21 May 2026
REC opinion
Favourable Opinion