Developing a PROM for Recurrent Urinary Tract Infection

Pain, Chronic Clinical Trial

Official title:

Developing a Patient Reported Outcome Measure for Recurrent Urinary Tract Infection

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05086900
• Other study ID #: RUTI01-KF-2021
• Status: Enrolling by invitation
• Start date: May 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: October 2021
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

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, content validity indices, and consensus scores 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 145
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Clinicians:

• 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:

• 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.

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic
• Patient Satisfaction
• Sexual Dysfunction
• Urinary Tract Infections
• Urologic Diseases

Intervention

Other:
• Non-interventional Cross-sectional Patient Reported Outcome Measure Development
Development of Patient Reported Outcome Measure

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	Berkshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Reading	Live UTI Free, University of Buckingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent Urinary Tract Infection Symptom Scale	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	Baseline (Time 1)
Primary	Recurrent Urinary Tract Infection Symptom Scale	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	Time 2 (24 hours after baseline)
Primary	Recurrent Urinary Tract Infection Impact Questionnaire	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 = 40; 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.	Baseline (Time 1)
Primary	Recurrent Urinary Tract Infection Impact Questionnaire	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 = 40; 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.	Time 2 (24 hours after baseline)
Secondary	Urinary Tract Infection Symptom Assessment	(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.	Baseline (Time 1)
Secondary	Urinary Tract Infection Symptom Assessment	(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.	Time 2 (24 hours after baseline)
Secondary	Numerical Pain Rating Scale	Minimum total score = 0, maximum total score = 10. Higher scores indicate higher pain intensity. Scores assess pain intensity in the past 24 hours	Baseline (Time 1)
Secondary	Numerical Pain Rating Scale	Minimum total score = 0, maximum total score = 10. Higher scores indicate higher pain intensity. Scores assess pain intensity in the past 24 hours	Time 2 (24 hours after baseline)
Secondary	Depression	Patient Health Questionnaire-9; Minimum total score = 0, maximum total score = 27; higher scores indicate higher depression levels.	Baseline (Time 1)
Secondary	Depression	Patient Health Questionnaire-9; Minimum total score = 0, maximum total score = 27; higher scores indicate higher depression levels.	Time 2 (24 hours after baseline)
Secondary	Anxiety	Generalised Anxiety Disorder - 7; minimum total score = 0, maximum total score = 21. Higher scores indicate higher anxiety severity.	Baseline (Time 1)
Secondary	Anxiety	Generalised Anxiety Disorder - 7; minimum total score = 0, maximum total score = 21. Higher scores indicate higher anxiety severity.	Time 2 (24 hours after baseline)
Secondary	Loneliness	UCLA Loneliness Scale (V3); minimum total score = 0, maximum total score = 80; Higher scores indicate greater feelings of loneliness/social isolation.	Baseline (Time 1)
Secondary	Loneliness	UCLA Loneliness Scale (V3); minimum total score = 0, maximum total score = 80; Higher scores indicate greater feelings of loneliness/social isolation.	Time 2 (24 hours after baseline)
Secondary	Work Productivity and Impairment Questionnaire	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.	Baseline (Time 1)
Secondary	Work Productivity and Impairment Questionnaire	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.	Time 2 (24 hours after baseline)
Secondary	Sexual Distress	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.	Baseline (Time 1)
Secondary	Sexual Distress	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.	Time 2 (24 hours after baseline)
Secondary	Satisfaction with Treatment	Patient Satisfaction Questionnaire - 18: 18 items assessing feelings about current medical care. Higher scores indicate greater satisfaction with medical care. Minimum total score = 18; maximum total score = 90.	Baseline (Time 1)
Secondary	Satisfaction with Treatment	Patient Satisfaction Questionnaire - 18: 18 items assessing feelings about current medical care. Higher scores indicate greater satisfaction with medical care. Minimum total score = 18; maximum total score = 90.	Time 2 (24 hours after baseline)