RUTISS-Diary and RUTISS-65 Study (NCT07698041) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
RUTISS-Diary and RUTISS-65 Study
United Kingdom200 participantsStarted 2026-07-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Test-retest reliability
Timeframe: 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
Timeframe: RUTISS-Diary: From day 1 to day 7 and day 1 to day 14. RUTISS-65: From day 1 to day 2.