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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patient Satisfaction; Pain, Chronic; Urology; Urological Diseases
• Intervention / Treatment: Other: Non-interventional Patient Reported Outcome Measure Development (RUTISS-Diary); Other: Non-interventional Patient Reported Outcome Measure Development (RUTISS-65)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Katherine A Finlay, PhD, CPsychol; Phone Number: 0118 378 8523; Email: katherine.finlay@reading.ac.uk
• Study Contact Backup: Name: Lydia V Tidmarsh, PhD; Phone Number: 0118 378 8523; Email: l.v.tidmarsh@reading.ac.uk

Study Locations

• United Kingdom
  • Reading, United Kingdom
    • Royal Berkshire NHS Foundation Trust
  • Reading, United Kingdom, RG6 6ET
    • University of Reading
    • Contact: Katherine A Finlay, PhD, CPsychol; Phone Number: 0118 378 8523; Email: katherine.finlay@reading.ac.uk
    • Contact: Lydia V Tidmarsh, PhD; Phone Number: 0118 378 8523; Email: l.v.tidmarsh@reading.ac.uk
    • Principal Investigator: Bob Yang, FRCS (UROL), MBBS, BSC (HONS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The target patient population consists of adults with a minimum of 2 UTIs in 6 months or a minimum of 3 UTIs in 12 months.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RUTISS-Diary (Cohort A); All rUTI patients of any age	Other: Non-interventional Patient Reported Outcome Measure Development (RUTISS-Diary); RUTISS-Diary
RUTISS-65 (Cohort B); rUTI patients aged 65 years and over	Other: Non-interventional Patient Reported Outcome Measure Development (RUTISS-Diary); RUTISS-Diary; Other: Non-interventional Patient Reported Outcome Measure Development (RUTISS-65); RUTISS-65

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test-retest reliability	Primary outcome measures will include the test-retest reliability and construct validity of the instrument. Test-retest reliability will be assessed by calculating intraclass correlation coefficients (ICCs) for each subscale at each time point.	RUTISS-Diary: From day 1 to day 7 and day 1 to day 14. RUTISS-65: From day 1 to day 2.
Construct validity	Construct validity will be examined using correlation analyses between the subscales of the study measures and relevant comparative measures.	RUTISS-Diary: From day 1 to day 7 and day 1 to day 14. RUTISS-65: From day 1 to day 2.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity to change	Secondary outcome measures will assess the responsiveness (sensitivity to change) of the RUTISSdiary and RUTISS-65 using both anchor-based and distribution-based approaches, in line with COSMIN recommendations for continuous outcome measures (COSMIN, 2019).	RUTISS-Diary: From day 1 to day 7 and day 1 to day 14. RUTISS-65: From day 1 to day 2.

Collaborators and Investigators

• Sponsor: Katherine Finlay
• Collaborators: Royal Berkshire NHS Foundation Trust
• Investigators: Study Director: Katherine A Finlay, PhD, CPsychol, University of Reading; Principal Investigator: Bob Yang, FRCS (UROL), MBBS, BSC (HONS), Royal Berkshire NHS Foundation Trust

Publications and helpful links

General Publications

• Foxman B. Urinary tract infection syndromes: occurrence, recurrence, bacteriology, risk factors, and disease burden. Infect Dis Clin North Am. 2014 Mar;28(1):1-13. doi: 10.1016/j.idc.2013.09.003. Epub 2013 Dec 8.
• Newlands AF, Roberts L, Maxwell K, Kramer M, Price JL, Finlay KA. Development and psychometric validation of a patient-reported outcome measure of recurrent urinary tract infection impact: the Recurrent UTI Impact Questionnaire. Qual Life Res. 2023 Jun;32(6):1745-1758. doi: 10.1007/s11136-023-03348-7. Epub 2023 Feb 6.
• Newlands AF, Kramer M, Roberts L, Maxwell K, Price JL, Finlay KA. Confirmatory structural validation and refinement of the Recurrent Urinary Tract Infection Symptom Scale. BJUI Compass. 2023 Oct 4;5(2):240-252. doi: 10.1002/bco2.297. eCollection 2024 Mar.
• Alidjanov JF, Naber KG, Abdufattaev UA, Pilatz A, Wagenlehner FME. Reevaluation of the Acute Cystitis Symptom Score, a Self-Reporting Questionnaire. Part I. Development, Diagnosis and Differential Diagnosis. Antibiotics (Basel). 2018 Jan 15;7(1):6. doi: 10.3390/antibiotics7010006.
• Harding C, Mossop H, Homer T, Chadwick T, King W, Carnell S, Lecouturier J, Abouhajar A, Vale L, Watson G, Forbes R, Currer S, Pickard R, Eardley I, Pearce I, Thiruchelvam N, Guerrero K, Walton K, Hussain Z, Lazarowicz H, Ali A. Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial. BMJ. 2022 Mar 9;376:e068229. doi: 10.1136/bmj-2021-0068229.
• Ormeno MA, Ormeno MJ, Quispe AM, Arias-Linares MA, Linares E, Loza F, Ruiz J, Pons MJ. Recurrence of Urinary Tract Infections due to Escherichia coli and Its Association with Antimicrobial Resistance. Microb Drug Resist. 2022 Feb;28(2):185-190. doi: 10.1089/mdr.2021.0052. Epub 2021 Aug 27.
• Wagenlehner F, Wullt B, Ballarini S, Zingg D, Naber KG. Social and economic burden of recurrent urinary tract infections and quality of life: a patient web-based study (GESPRIT). Expert Rev Pharmacoecon Outcomes Res. 2018 Feb;18(1):107-117. doi: 10.1080/14737167.2017.1359543. Epub 2017 Jul 31.
• Yang X, Chen H, Zheng Y, Qu S, Wang H, Yi F. Disease burden and long-term trends of urinary tract infections: A worldwide report. Front Public Health. 2022 Jul 27;10:888205. doi: 10.3389/fpubh.2022.888205. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Estimated): July 8, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 24, 2027

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: UTI; PROMs; burden; rUTI; urinary; recurrent urinary tract infection; outcome measure; assessment tools
• Additional Relevant MeSH Terms: Urogenital Diseases; Pain; Neurologic Manifestations; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Chronic Pain; Urologic Diseases; Urinary Tract Infections; Patient Satisfaction
• Other Study ID Numbers: 2026-028-KF; IRAS ID: 366353 (Other Grant/Funding Number: HRA and HCRW)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Confidential patient records. Anonymous records will be shared only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No