RUTISS-Diary and RUTISS-65 Study
Not yet recruitingNCT07698041
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official 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
- Conditions
- Urology
- Urological Diseases
- Patient Satisfaction
- Pain, Chronic
- Interventions
- Other: Non-interventional Patient Reported Outcome Measure Development (RUTISS-Diary)
- Other: Non-interventional Patient Reported Outcome Measure Development (RUTISS-65)
- Sponsor
- Katherine Finlay
- Collaborators
- Royal Berkshire NHS Foundation Trust
- Organization
- University of Reading
- Start date
- 2026-07-08
- Primary completion
- 2027-06-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United Kingdom
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07698041