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Completed

NCT Number: NCT05086900

Developing a PROM for Recurrent Urinary Tract Infection

This study aims to develop and validate the first set of patient-reported outcome measures for recurrent urinary tract infection (UTI): the Recurrent UTI Symptom Scale and the Recurrent UTI Impact Questionnaire. These tools could be used in clinical practice, clinical trials and research to gather an insight into a patient's perspective of their recurrent UTI symptom severity and its impact on their life, as well as determining any possible improvement or other change in their condition due to interventions (e.g. antibiotic treatment).

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Key information

Conditions

Urologic Diseases Behavior Chronic Pain Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Health Behavior Male Urogenital Diseases Neurologic Manifestations Pain Pain, Chronic Pathological Conditions, Signs and Symptoms Patient Satisfaction Sexual Dysfunction Sexual Dysfunction, Physiological Signs and Symptoms Treatment Adherence and Compliance Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Reading

Reading, Berkshire, RG6 7BE, United Kingdom

About this study

Urinary tract infection (UTI) is a highly prevalent infection, most frequently affecting females. Recurrent UTI, a chronic condition defined as experiencing two or more UTIs in six months or three or more in twelve months, is associated with significant symptom burden and lowered quality of life. In addition to this personal impact, the effects span more widely to issues such as increased healthcare costs, work absenteeism, and antimicrobial resistance.

There are currently no validated patient-reported outcome measures to assess recurrent UTI symptoms and impact. These measures are much needed to encourage a more patient-centred approach to recurrent UTI treatment and care, which could be especially important given evidence that current routine testing approaches, and thus treatment approaches, are not sufficient alone.

This mixed-methods study aims to consult both clinicians and patients in order to develop and validate the first set of patient-reported outcome measures for recurrent UTI.

Outline:

Phase I: Concept elicitation Conduct a literature review and examine the findings of an international qualitative study exploring the experience of over 2,000 people living with recurrent UTI.

Phase II: Initial development and item generation Develop draft questionnaire items, instructions, and scale response options in line with current healthcare guidance and conclusions from Phase I.

Phase III: Modified Delphi method with 10-20 expert clinicians Screen the draft questionnaires by two rounds of a modified Delphi method, assessing item and instruction clarity and relevance for recurrent UTI.

Use qualitative comments and content validity indices to refine existing items, and remove or add new ones where appropriate.

Phase IV: Cognitive interviews with 25-30 patients Conduct one-to-one cognitive interviews using a think aloud and verbal probing procedure to verify the content validity and clarity of the new measures from the patient's perspective.

Summarise and analyse the interview transcripts using the Questionnaire Appraisal System and content analysis, used to refine the measures before Phase V.

Phase V: Two-part online pilot with 100+ patients Conduct a cross-sectional survey in which participants complete the new recurrent UTI measures and comparable existing standardised measures for each subscale (e.g. UTI Symptom Assessment). Participants will complete this twice, 24 hours apart.

Verify the psychometric properties of the new measures, including exploratory factor analysis, internal consistency, test-retest reliability, and criterion validity.

Optimise the measures for clinical and research purposes based on these analyses.

Please note: Phase III (with expert rUTI clinicians) and Phase IV (with rUTI patients) resulted in qualitative data, and as such the results are not reported in this record. For more information about the results from these phases, please see the references provided.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinicians (Phase III only):

  • Aged at least 18 years old.
  • Specialist doctor or nurse in the field of urology or a closely related discipline OR general health doctor or nurse.
  • Minimum of 3 years of direct experience treating patients with recurrent UTI.

Patients (Phases IV and V):

  • Aged at least 18 years old.
  • Experiences recurrent UTI as defined by the European Association of Urology: minimum of 2 UTIs in 6 months or minimum of 3 UTIs in 12 months.

Exclusion criteria

Patients:

  • Current diagnosis of interstitial cystitis.
  • Non-fluent or non-advanced level of English.
  • Current pregnancy.
  • Current use of urinary catheterisation.

Treatment and study plan

Non-interventional Cross-sectional Patient Reported Outcome Measure Development

Other

Development of Patient Reported Outcome Measure

Primary outcomes

  1. Recurrent Urinary Tract Infection Symptom Scale

    Time frame: Baseline (Time 1)

    RUTISS; Total minimum score = 0, total maximum score = 170. Newly designed instrument that can measure the patient experience of recurrent UTI symptoms and pain and/or discomfort; Urinary symptoms sub-scale minimum score = 0, maximum score = 70; urinary pain sub-scale minimum score = 0, maximum score = 100; higher scores indicate higher symptom severity

  2. Recurrent Urinary Tract Infection Symptom Scale

    Time frame: Time 2 (24 hours after baseline)

    RUTISS; Total minimum score = 0, total maximum score = 170. Newly designed instrument that can measure the patient experience of recurrent UTI symptoms and pain and/or discomfort; Urinary symptoms sub-scale minimum score = 0, maximum score = 70; urinary pain sub-scale minimum score = 0, maximum score = 100; higher scores indicate higher symptom severity

  3. Recurrent Urinary Tract Infection Impact Questionnaire

    Time frame: Baseline (Time 1)

    RUTIIQ; Total minimum score = 0, maximum score = 300. Higher scores indicate higher rUTI impact and psychosocial burden. Newly designed instrument that can measure the patient experience of recurrent UTI impact on personal wellbeing, social activities, work and daily activities, sexual activity, and satisfaction with UTI-related medical care; personal wellbeing sub-scale minimum score = 0; maximum score = 40; social wellbeing sub-scale minimum score = 0, maximum score = 50; work/activity interference sub-scale minimum score = 0, maximum score = 70; sexual wellbeing sub-scale minimum score = 0, maximum score = 40; patient satisfaction sub-scale minimum score = 0, maximum score = 100.

    The sexual wellbeing subscale is optional and therefore fewer participants than the total number provided data for analysis.

  4. Recurrent Urinary Tract Infection Impact Questionnaire

    Time frame: Time 2 (24 hours after baseline)

    RUTIIQ; Total minimum score = 0, maximum score = 300. Higher scores indicate higher rUTI impact and psychosocial burden. Newly designed instrument that can measure the patient experience of recurrent UTI impact on personal wellbeing, social activities, work and daily activities, sexual activity, and satisfaction with UTI-related medical care; personal wellbeing sub-scale minimum score = 0; maximum score = 40; social wellbeing sub-scale minimum score = 0, maximum score = 50; work/activity interference sub-scale minimum score = 0, maximum score = 70; sexual wellbeing sub-scale minimum score = 0, maximum score = 40; patient satisfaction sub-scale minimum score = 0, maximum score = 100.

    The sexual wellbeing subscale is optional and therefore fewer participants than the total number provided data for analysis.

Secondary outcomes

  1. Urinary Tract Infection Symptom Assessment

    Time frame: Baseline (Time 1)

    (UTISA) 7 items assessing the severity of UTI symptoms in the past 24 hours; minimum total score = 0; maximum total score = 21. Higher scores indicate higher symptom severity and clinical cut-off for presence of a UTI = 3.

  2. Urinary Tract Infection Symptom Assessment

    Time frame: Time 2 (24 hours after baseline)

    (UTISA) 7 items assessing the severity of UTI symptoms in the past 24 hours; minimum total score = 0; maximum total score = 21. Higher scores indicate higher symptom severity and clinical cut-off for presence of a UTI = 3.

  3. Numerical Pain Rating Scale

    Time frame: Baseline (Time 1)

    Minimum total score = 0, maximum total score = 40. Higher scores indicate higher pain intensity. Scores assess pain intensity in the past 24 hours

  4. Numerical Pain Rating Scale

    Time frame: Time 2 (24 hours after baseline)

    Minimum total score = 0, maximum total score = 40. Higher scores indicate higher pain intensity. Scores assess pain intensity in the past 24 hours

  5. Depression

    Time frame: Baseline (Time 1)

    Patient Health Questionnaire-9; Minimum total score = 0, maximum total score = 27; higher scores indicate higher depression levels.

  6. Depression

    Time frame: Time 2 (24 hours after baseline)

    Patient Health Questionnaire-9; Minimum total score = 0, maximum total score = 27; higher scores indicate higher depression levels.

  7. Anxiety

    Time frame: Baseline (Time 1)

    Generalised Anxiety Disorder - 7; minimum total score = 0, maximum total score = 21. Higher scores indicate higher anxiety severity.

  8. Anxiety

    Time frame: Time 2 (24 hours after baseline)

    Generalised Anxiety Disorder - 7; minimum total score = 0, maximum total score = 21. Higher scores indicate higher anxiety severity.

  9. Loneliness

    Time frame: Baseline (Time 1)

    UCLA Loneliness Scale (V3); minimum total score = 0, maximum total score = 80; Higher scores indicate greater feelings of loneliness/social isolation.

  10. Loneliness

    Time frame: Time 2 (24 hours after baseline)

    UCLA Loneliness Scale (V3); minimum total score = 0, maximum total score = 80; Higher scores indicate greater feelings of loneliness/social isolation.

  11. Work Productivity and Impairment Questionnaire

    Time frame: Baseline (Time 1)

    Measure assessing specific health problems impairing work capacity. Work impairment sub-scale minimum score = 0; maximum work impairment = 100; activity impairment minimum total score = 0, maximum activity impairment = 100. Higher scores indicate greater impairment due to health problems. The 'work impairment' subscale is only applicable to participants who report to be currently in work.

  12. Work Productivity and Impairment Questionnaire

    Time frame: Time 2 (24 hours after baseline)

    Measure assessing specific health problems impairing work capacity. Work impairment sub-scale minimum score = 0; maximum work impairment = 100; activity impairment minimum total score = 0, maximum activity impairment = 100. Higher scores indicate greater impairment due to health problems. The 'work impairment' subscale is only applicable to participants who report to be currently in work.

  13. Sexual Distress

    Time frame: Baseline (Time 1)

    Female Sexual Distress Scale for assessing feelings of sexual distress. Minimum total score = 0, maximum total score = 52. Higher scores indicate greater sexual distress. Scores greater than 10 may indicate atypical/abnormal sexual distress. This scale is optional and therefore fewer participants than the total number provided data for analysis.

  14. Sexual Distress

    Time frame: Time 2 (24 hours after baseline)

    Female Sexual Distress Scale for assessing feelings of sexual distress. Minimum total score = 0, maximum total score = 52. Higher scores indicate greater sexual distress. Scores greater than 10 may indicate atypical/abnormal sexual distress. This scale is optional and therefore fewer participants than the total number provided data for analysis.

  15. Satisfaction With Treatment

    Time frame: Baseline (Time 1)

    Patient Satisfaction Questionnaire - 18: 18 items assessing feelings about current medical care. The score represents the sum of seven different patient satisfaction domain scores (see more here: https://www.rand.org/content/dam/rand/www/external/health/surveys_tools/psq/psq18_scoring.pdf).

    Higher scores indicate greater satisfaction with medical care. Minimum score = 1; maximum score = 35.

  16. Satisfaction With Treatment

    Time frame: Time 2 (24 hours after baseline)

    Patient Satisfaction Questionnaire - 18: 18 items assessing feelings about current medical care. The score represents the sum of seven different patient satisfaction domain scores (see more here: https://www.rand.org/content/dam/rand/www/external/health/surveys_tools/psq/psq18_scoring.pdf).

    Higher scores indicate greater satisfaction with medical care. Minimum score = 1; maximum score = 35.

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Live UTI Free

Registry information

Official study title

Developing a Patient Reported Outcome Measure for Recurrent Urinary Tract Infection

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 21, 2021
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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