RUTISS-Diary and RUTISS-65 Study

Developing and Validating Two New Patient-Reported Outcome Measures of Recurrent Urinary Tract Infection Symptoms: A Symptoms Diary and Adapted Measure for Older Adults

Existing patient-reported outcome measures assess acute urinary tract infection but do not support daily symptom tracking in recurrent UTI (rUTI) or meet the needs of older adults. This single-site study will develop and validate two adapted measures: the RUTISS-Diary for daily symptom monitoring and the RUTISS-65 for reporting symptoms in adults aged 65 years and over. Approximately 200 participants with rUTI will complete the RUTISS-Diary daily for 7 days and again on day 14. Participants aged 65 years and over will also complete the RUTISS-65 on days 1 and 2 to assess its reliability and validity.

400 million people globally each year are affected by Urinary Tract Infections (UTIs) (Yang et al., 2022), with annual recurrence ranging from 24-50% (Foxman, 2014). Recurrent UTI (rUTI), defined as at least two UTIs in six months or at least three in one year (Bonkat et al., 2020), negatively affects quality of life (Wagenlehner et al., 2018) and repeat treatment risks antimicrobial resistance (Ormeño et al., 2022). Standard urine culture may present results discrepant with symptoms (Harding et al., 2022), hence the urgent need for quantifiable rUTI Patient Reported Outcome Measures (PROMs). Measures exist for acute infection (e.g. cystitis (Alidjanov et al., 2018) but not rUTI. We recently developed, published and commercially licensed two rUTI PROMs (the Recurrent Urinary Tract Infection Symptom Scale; RUTISS (Newlands et al., 2023) and the Recurrent Urinary Tract Infection Impact Questionnaire; RUTIIQ; Newlands et al., 2023b). 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. This study aims to develop, validate and pilot two PROMs: 1) an adaptation of the RUTISS in daily diary format (RUTISS-Diary); and 2) an adapted RUTISS measure adapted for observational reporting of rUTI symptoms in older adults (RUTISS-65).

To inform the items of the RUTISS-Diary and RUTISS-65, extensive multiphase, mixed-methods preparatory work has been completed to ensure the items are informed from both patient and clinician perspectives. Phase 1 comprised of one-to-one interviews conducted with clinical experts working with older adults experiencing recurrent urinary tract infections (inclusive of urology, microbiology and geriatrics, N = 10, completed, UoR ethics ref: 2025-039-KF). This was accompanied by a literature review specific to older adult experiences of rUTI and patient interviews with outpatient members of Live UTI Free (N = 20, completed, UoR ethics ref: 2024-071-KF). Phase 2 consisted of two-rounds of HCP expert panel Delphi-surveys (N = 11) and cognitive interviews with expert patients (N = 25) for refinement of the measures (completed, UoR ethics ref: 2025-039-KF). These first phases are complete, informing the items of the RUTISS-Diary and RUTISS-65. The present study therefore aims to test and validate these measures to ensure they are reliable and are able to detect meaningful change.

Inclusion for RUTISS-Diary:

• Participants must be 18 years and older
• All participants must have native/bilingual or advanced fluency in English.
• Access to a computer/mobile device for survey completion.
• Symptoms-led diagnosis: Participants must report that they experience recurrent UTI episodes or symptoms. They must report the minimum of 2 UTIs in 6 months or 3 in 12 months, in line with the rUTI diagnostic criteria (European Association of Urology, 2020).

Inclusion for RUTISS- 65:

• Participants must be 65 years and older
• Access to a computer/mobile device for survey completion, paper copy available upon request.
• All participants must have native/bilingual or advanced fluency in English.
• Symptoms-led diagnosis: Participants must report that they experience recurrent UTI episodes or symptoms. They must report the minimum of 2 UTIs in 6 months or 3 in 12 months, in line with the rUTI diagnostic criteria (European Association of Urology, 2020).

Exclusion criteria (for RUTISS-Diary and RUTISS-65)

• Participants must not report a current diagnosis of interstitial cystitis (measured in demographics questionnaire).
• Symptoms of cognitive confusion or dementia.
• No active malignancy e.g. bladder or prostate cancer
• Participants must not report beginner or intermediate level fluency in English. Future work will be done to translate the PROMs into alternative languages.
• In addition to the interstitial cystitis exclusion question, participants will also be asked in the demographic questionnaire if they are pregnant or have an indwelling catheter or use intermittent self-catheterisation. Participants who report "yes" to either of these will be excluded from participation.