The Recurrent Urinary Tract Infection Symptom Scale (RUTISS)

Urinary Tract infections (UTIs) affect more than 400 million people every year globally, with over 100 million people suffering from recurrent UTIs (rUTI). Recurrent UTIs are defined by the European Association of Urology (EAU) and the American Urological Association (AUA) as experiencing 2 or more UTIs in 6 months, or 3 or more in a year.

Previously, there were no validated PROMs that specifically assess the patient experience of living with rUTI. Although other PROMs have been developed to assess symptoms of acute UTI, they fail to measure the frequency of UTI symptoms, or cover the breadth of symptoms experienced by people with rUTI.

The RUTISS was developed in collaboration with researchers at the University of Reading, Live UTI Free, and Patient-Centred Research and Data Insights (PARED Insights). Live UTI Free is a research and patient advocacy organisation that creates and delivers evidence-based resources about recurrent and chronic UTI to the vast UTI patient community, whilst also driving forward patient-focused UTI research and recruitment. PARED Insights provides advanced health psychology and PRO research expertise to researchers and clinicians working in urology and other women’s health areas and is dedicated to highlighting the patient voice and perspective.

Associated Impact Questionnaire

The RUTISS is designed to be used independently, or alongside the Recurrent Urinary Tract Infection Impact Questionnaire (RUTIIQ). The RUTIIQ is designed to measure the patient experience of the psychosocial impact of living with rUTI. The RUTIIQ is an 18-item measure developed to evaluate the patient-reported impact of rUTI on key quality of life domains, including personal wellbeing and mental health, socialising, work and activity engagement, sexual wellbeing, and patient satisfaction with rUTI healthcare. It is recommended that the RUTISS and RUTIIQ are administered together, in order to capture a full evaluation of both patient-reported rUTI symptoms and quality of life impact.

A simple to use scoring system is utilised throughout, with the added flexibility of scoring and reporting across individual domains, as well as an overall RUTISS severity score. A scoring table and calculation tool are provided in the RUTISS scoring guide.

• Section B – A single global rating of change in symptom severity score, scored from -5 (“Very much worse”) to 0 (“No change”) to +5 (“Very much better”). A positive score indicates an improvement in symptoms within the past 24 hours, whilst a negative score indicates relative worsening.
• Section C – Individual domain scores can be computed by summing the scored responses within a single domain (e.g., urinary symptoms). A RUTISS severity score can be obtained from the sum of all section C responses, divided by 11, and multiplied by 10. This will generate a range from 0 to 100, with higher scores indicating greater overall severity of UTI symptoms and pain.

Further written guidance on scoring and administration of the RUTISS are provided on completion of a licence to use the RUTISS.

The RUTISS was designed, developed and validated in accordance with the best practice methods recommended by the Food and Drug Administration (FDA) and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative. A four-stage approach followed the initial development of the RUTISS items, informed by literature review and current UTI diagnostic guidelines.

• Stage 1 utilised the Delphi consensus method to gain feedback on the initial RUTISS items from expert rUTI clinicians in the UK, USA, and Canada.
• Stage 2 involved one-to-one cognitive interviews with people living with recurrent UTI, gaining their feedback on the relevance and clarity of RUTISS items in order to make refinements.
• In Stage 3, 240 people living with rUTI in 24 countries participated in an online pilot study, completing the draft RUTISS and other existing measures to for exploratory psychometric testing of the RUTISS.
• Stage 4 collected further RUTISS data from a new test sample, comprising 389 people living with rUTI in 37 countries. This final stage facilitated confirmatory psychometric analysis and refinement of the RUTISS, resulting in the optimised 15-item questionnaire that is available to licence.

Further details of the development and validation methodology employed to create the RUTISS can be found in the publications referenced on the right-hand side of this page, under ‘Key references’.

The RUTISS has been applied to monitor people living with rUTI within research studies and as part of routine clinical practice. Using the RUTISS facilitates evaluation and monitoring of key patient-reported outcomes, identifying opportunities to enhance rUTI care and management, as well as informing patient-clinician interactions to improve shared decision making on care pathways and patient-centred care. The RUTISS may be used to determine the success of new and existing treatment options and interventions.

• Paper and pen completion
• Digital (eCOA) completion, upon request. See drop down menu below (Modes of Administration) for further information on eCOA / digital migrations.

Please enquire.

REDCap files of the RUTISS are availble to licensed users.

Vitaccess are an authorsied provider of an eCOA version of the RUTIIQ.

Please ensure that if your proposed use of the RUTISS involves a digital reproduction, then when you request a licence to use the RUTISS you must inform us of your interntion to create a digitised (eCOA) version. 

Digital versions (eCOA) will be subject to review and, if sucessful, authorisation by InSpired Health Outcomes (IHO) prior to use an eCOA version. The review by IHO will be of screenshots you provide to IHO in English.

Fees may be applicable to eCOA reviews, please do enquire but any fees will be made clear during the licence process. If fees are applicable, then they are for a maximum of 2 review rounds. If further rounds of review are required, then those extra reviews are billable at £250 per round. 

IHO endeavour to respond to (commercial) eCOA review requests within 5 working days.

• Scoring and administration instructions
• Concept Elaboration Document (to assist in translating the RUTISS)

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Standard licenses are available at no cost for most academic research and other non-commercial uses. For other uses, we will advise on any licensing costs based on the details you provide in the Licence Request Form.