Clinical trial NCT05086900: Developing a PROM for Recurrent Urinary Tract Infection
Official title: Developing a Patient Reported Outcome Measure for Recurrent Urinary Tract Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urologic Diseases
Patient Satisfaction
Pain, Chronic
Sexual Dysfunction
Keywords: urinary
UTI
burden
outcome measure
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Live UTI Free
name: University of Buckingham
First posted: 2021-10-21
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the target patient population consists of adults with a minimum of 2 UTIs in 6 months or a minimum of 3 UTIs in 12 months.

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrent Urinary Tract Infection Symptom Scale
timeFrame: Baseline (Time 1)
measure: Recurrent Urinary Tract Infection Symptom Scale
timeFrame: Time 2 (24 hours after baseline)
measure: Recurrent Urinary Tract Infection Impact Questionnaire
timeFrame: Baseline (Time 1)
measure: Recurrent Urinary Tract Infection Impact Questionnaire
timeFrame: Time 2 (24 hours after baseline)
Secondary outcomes:
measure: Urinary Tract Infection Symptom Assessment
timeFrame: Baseline (Time 1)
measure: Urinary Tract Infection Symptom Assessment
timeFrame: Time 2 (24 hours after baseline)
measure: Numerical Pain Rating Scale
timeFrame: Baseline (Time 1)
measure: Numerical Pain Rating Scale
timeFrame: Time 2 (24 hours after baseline)
measure: Depression
timeFrame: Baseline (Time 1)
measure: Depression
timeFrame: Time 2 (24 hours after baseline)
measure: Anxiety
timeFrame: Baseline (Time 1)
measure: Anxiety
timeFrame: Time 2 (24 hours after baseline)
measure: Loneliness
timeFrame: Baseline (Time 1)
measure: Loneliness
timeFrame: Time 2 (24 hours after baseline)
measure: Work Productivity and Impairment Questionnaire
timeFrame: Baseline (Time 1)
measure: Work Productivity and Impairment Questionnaire
timeFrame: Time 2 (24 hours after baseline)
measure: Sexual Distress
timeFrame: Baseline (Time 1)
measure: Sexual Distress
timeFrame: Time 2 (24 hours after baseline)
measure: Satisfaction with Treatment
timeFrame: Baseline (Time 1)
measure: Satisfaction with Treatment
timeFrame: Time 2 (24 hours after baseline)
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Katherine A Finlay, PhD
role: STUDY_DIRECTOR
References: