RUTISS-Diary and RUTISS-65 Study

Sponsor
Katherine Finlay
Study ID
NCT07698041
Status
Not Yet Recruiting

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Conditions

  • Pain, Chronic
  • Patient Satisfaction
  • Urological Diseases
  • Urology

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 13, 2026
Start date
Jul 8, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Dec 24, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: RUTISS-Diary (Cohort A)
    All rUTI patients of any age
  • Arm: RUTISS-65 (Cohort B)
    rUTI patients aged 65 years and over

Primary Outcome Measure

Test-retest reliability [ Time Frame: RUTISS-Diary: From day 1 to day 7 and day 1 to day 14. RUTISS-65: From day 1 to day 2. ]

Central Contacts

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