RUTISS-Diary and RUTISS-65 Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKatherine Finlay
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Non-interventional Patient Reported Outcome Measure Development (RUTISS-Diary)
Other interventionRUTISS-Diary
Non-interventional Patient Reported Outcome Measure Development (RUTISS-65)
Other interventionRUTISS-65
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: RUTISS-Diary (Cohort A)1 intervention
Group B: RUTISS-65 (Cohort B)2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
RUTISS-Diary: From day 1 to day 7 and day 1 to day 14. RUTISS-65: From day 1 to day 2.2
Construct validity
Construct validity will be examined using correlation analyses between the subscales of the study measures and relevant comparative measures.
Time frame
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
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).
Time frame
RUTISS-Diary: From day 1 to day 7 and day 1 to day 14. RUTISS-65: From day 1 to day 2.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Katherine Finlay
Lead sponsor
University of Reading
Sponsor institution
Royal Berkshire NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov
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