Developing a Patient Reported Outcome Measure for Recurrent Urinary Tract Infection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Reading
- Enrollment
- 283
- Locations
- 1
- Primary Endpoint
- Recurrent Urinary Tract Infection Symptom Scale
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Current diagnosis of interstitial cystitis.
- •Non-fluent or non-advanced level of English.
- •Current pregnancy.
- •Current use of urinary catheterisation.
Outcomes
Primary Outcomes
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
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
- Depression(Time 2 (24 hours after baseline))
- Urinary Tract Infection Symptom Assessment(Time 2 (24 hours after baseline))
- Loneliness(Time 2 (24 hours after baseline))
- Anxiety(Time 2 (24 hours after baseline))
- Satisfaction with Treatment(Time 2 (24 hours after baseline))
- Work Productivity and Impairment Questionnaire(Time 2 (24 hours after baseline))
- Numerical Pain Rating Scale(Time 2 (24 hours after baseline))
- Sexual Distress(Time 2 (24 hours after baseline))
Investigators
Katherine Finlay
Lecturer in Psychology
University of Reading