RUTISS-Diary and RUTISS-65 Study

NCT07698041 | Not Yet Recruiting

• 2 other identifiers: 2026-028-KFIRAS ID: 366353
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Urology; Urological Diseases; Patient Satisfaction; Pain, Chronic

Keywords

recurrent urinary tract infection; rUTI; outcome measure; PROMs; urinary; UTI; burden; assessment tools

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Sensitivity to change

  RUTISS-Diary: From day 1 to day 7 and day 1 to day 14. RUTISS-65: From day 1 to day 2.

Study Arms (2)

RUTISS-Diary (Cohort A)

All rUTI patients of any age

Other: Non-interventional Patient Reported Outcome Measure Development (RUTISS-Diary)

RUTISS-65 (Cohort B)

rUTI patients aged 65 years and over

Other: Non-interventional Patient Reported Outcome Measure Development (RUTISS-Diary); Other: Non-interventional Patient Reported Outcome Measure Development (RUTISS-65)

Interventions

Non-interventional Patient Reported Outcome Measure Development (RUTISS-Diary) OTHER

RUTISS-Diary

RUTISS-65 (Cohort B); RUTISS-Diary (Cohort A)

Non-interventional Patient Reported Outcome Measure Development (RUTISS-65) OTHER

RUTISS-65

RUTISS-65 (Cohort B)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Katherine Finlay: lead
• Royal Berkshire NHS Foundation Trust: collaborator

Study Sites (2)

University of Reading

Reading, RG6 6ET, United Kingdom

Location

Royal Berkshire NHS Foundation Trust

Reading, United Kingdom

Location

Related Publications (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.

  PMID: 36740638 BACKGROUND

• 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.

  PMID: 38371201 BACKGROUND

• 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.

  PMID: 30720775 BACKGROUND

• 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.

  PMID: 35264408 BACKGROUND

• 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.

  PMID: 34449257 BACKGROUND

• 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.

  PMID: 28737469 BACKGROUND

• 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.

  PMID: 24484571 BACKGROUND

• 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.

  PMID: 35968451 BACKGROUND

MeSH Terms

Conditions

Urologic Diseases; Patient Satisfaction; Chronic Pain; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections

Study Officials

• Katherine A Finlay, PhD, CPsychol

  University of Reading

  STUDY DIRECTOR

• Bob Yang, FRCS (UROL), MBBS, BSC (HONS)

  Royal Berkshire NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine A Finlay, PhD, CPsychol

CONTACT

0118 378 8523; katherine.finlay@reading.ac.uk

Lydia V Tidmarsh, PhD

CONTACT

0118 378 8523; l.v.tidmarsh@reading.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Health Psychology

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 13, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 24, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)