An observational study in Urologic Diseases, Patient Satisfaction and Pain, Chronic, sponsored by University of Reading. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by University of Reading · Observational
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).
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.
221 studies on the registry are indexed under Urologic Diseases; 48 are open to participants now.
This study's enrollment of 283 is above the median of 200 across 49 observational studies indexed under Urologic Diseases.
Browse Urologic Diseases studies →University of Reading is the lead sponsor of 150 studies on the registry; 21 are open to participants now.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinicians (Phase III only):
Patients (Phases IV and V):
Exclusion Criteria:
Patients:
Development of Patient Reported Outcome Measure
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 frame: Baseline (Time 1)
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 frame: Time 2 (24 hours after baseline)
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 = 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.
Time frame: Baseline (Time 1)
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 = 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.
Time frame: Time 2 (24 hours after baseline)
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 frame: Baseline (Time 1)
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 frame: Time 2 (24 hours after baseline)
Numerical Pain Rating Scale
Minimum total score = 0, maximum total score = 40. Higher scores indicate higher pain intensity. Scores assess pain intensity in the past 24 hours
Time frame: Baseline (Time 1)
Numerical Pain Rating Scale
Minimum total score = 0, maximum total score = 40. Higher scores indicate higher pain intensity. Scores assess pain intensity in the past 24 hours
Time frame: Time 2 (24 hours after baseline)
Depression
Patient Health Questionnaire-9; Minimum total score = 0, maximum total score = 27; higher scores indicate higher depression levels.
Time frame: Baseline (Time 1)
Depression
Patient Health Questionnaire-9; Minimum total score = 0, maximum total score = 27; higher scores indicate higher depression levels.
Time frame: Time 2 (24 hours after baseline)
Anxiety
Generalised Anxiety Disorder - 7; minimum total score = 0, maximum total score = 21. Higher scores indicate higher anxiety severity.
Time frame: Baseline (Time 1)
Anxiety
Generalised Anxiety Disorder - 7; minimum total score = 0, maximum total score = 21. Higher scores indicate higher anxiety severity.
Time frame: Time 2 (24 hours after baseline)
Loneliness
UCLA Loneliness Scale (V3); minimum total score = 0, maximum total score = 80; Higher scores indicate greater feelings of loneliness/social isolation.
Time frame: Baseline (Time 1)
Loneliness
UCLA Loneliness Scale (V3); minimum total score = 0, maximum total score = 80; Higher scores indicate greater feelings of loneliness/social isolation.
Time frame: Time 2 (24 hours after baseline)
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. The 'work impairment' subscale is only applicable to participants who report to be currently in work.
Time frame: Baseline (Time 1)
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. The 'work impairment' subscale is only applicable to participants who report to be currently in work.
Time frame: Time 2 (24 hours after baseline)
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. This scale is optional and therefore fewer participants than the total number provided data for analysis.
Time frame: Baseline (Time 1)
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. This scale is optional and therefore fewer participants than the total number provided data for analysis.
Time frame: Time 2 (24 hours after baseline)
Satisfaction With Treatment
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.
Time frame: Baseline (Time 1)
Satisfaction With Treatment
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.
Time frame: Time 2 (24 hours after baseline)
| Milestone | Pilot Participants | Expert Clinicians | Cognitive Interview Participants |
|---|---|---|---|
| Started | 240 | 15 | 28 |
| Completed | 106 | 12 | 28 |
| Not completed | 134 | 3 | 0 |
| Withdrew: Lost to follow-up | 69 | 3 | 0 |
| Withdrew: Withdrawal by subject | 19 | 0 | 0 |
| Withdrew: Completed follow-up significantly outside the 24-hour testing window | 46 | 0 | 0 |
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
| score on a scale | Pilot Participants |
|---|---|
| Urinary Symptoms | 23.2 ± 16.9 |
| UTI Pain | 26.2 ± 23.0 |
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
| score on a scale | Pilot Participants |
|---|---|
| Urinary symptoms | 17.3 ± 15.4 |
| UTI pain | 22.8 ± 22.2 |
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.
| score on a scale | Pilot Participants |
|---|---|
| Personal Wellbeing | 26.2 ± 11.1 |
| Social Wellbeing | 23.3 ± 15.9 |
| Work and Activity Interference | 35.8 ± 23.1 |
| Sexual Wellbeing | 36.2 ± 6.3 |
| Patient Satisfaction | 36.6 ± 28.5 |
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.
| score on a scale | Pilot Participants |
|---|---|
| Personal Wellbeing | 21.8 ± 12.9 |
| Social wellbeing | 20.4 ± 15.8 |
| Work and activity interference | 30.9 ± 23.1 |
| Sexual wellbeing | 34.9 ± 7.52 |
| Patient satisfaction | 38.9 ± 27.8 |
(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.
| score on a scale | Pilot Participants |
|---|---|
| Urinary Tract Infection Symptom Assessment | 6.71 ± 4.75 |
(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.
| score on a scale | Pilot Participants |
|---|---|
| Urinary Tract Infection Symptom Assessment | 6.05 ± 4.6 |
Minimum total score = 0, maximum total score = 40. Higher scores indicate higher pain intensity. Scores assess pain intensity in the past 24 hours
| score on a scale | Pilot Participants |
|---|---|
| Numerical Pain Rating Scale | 12.1 ± 10.0 |
Minimum total score = 0, maximum total score = 40. Higher scores indicate higher pain intensity. Scores assess pain intensity in the past 24 hours
| score on a scale | Pilot Participants |
|---|---|
| Numerical Pain Rating Scale | 11.2 ± 10.3 |
Patient Health Questionnaire-9; Minimum total score = 0, maximum total score = 27; higher scores indicate higher depression levels.
| score on a scale | Pilot Participants |
|---|---|
| Depression | 11.5 ± 7.22 |
Patient Health Questionnaire-9; Minimum total score = 0, maximum total score = 27; higher scores indicate higher depression levels.
| score on a scale | Pilot Participants |
|---|---|
| Depression | 10.1 ± 7.11 |
Generalised Anxiety Disorder - 7; minimum total score = 0, maximum total score = 21. Higher scores indicate higher anxiety severity.
| score on a scale | Pilot Participants |
|---|---|
| Anxiety | 9.23 ± 6.21 |
Generalised Anxiety Disorder - 7; minimum total score = 0, maximum total score = 21. Higher scores indicate higher anxiety severity.
| score on a scale | Pilot Participants |
|---|---|
| Anxiety | 9.02 ± 6.11 |
UCLA Loneliness Scale (V3); minimum total score = 0, maximum total score = 80; Higher scores indicate greater feelings of loneliness/social isolation.
| score on a scale | Pilot Participants |
|---|---|
| Loneliness | 48.8 ± 13.9 |
UCLA Loneliness Scale (V3); minimum total score = 0, maximum total score = 80; Higher scores indicate greater feelings of loneliness/social isolation.
| score on a scale | Pilot Participants |
|---|---|
| Loneliness | 47.0 ± 13.4 |
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.
| score on a scale | Pilot Participants |
|---|---|
| Work impairment | 45.0 ± 33.3 |
| Activity impairment | 45.7 ± 29.6 |
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.
| score on a scale | Pilot Participants |
|---|---|
| Work impairment | 37.4 ± 33.3 |
| Activity impairment | 42.6 ± 32.1 |
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.
| score on a scale | Pilot Participants |
|---|---|
| Sexual Distress | 30.3 ± 13.7 |
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.
| score on a scale | Pilot Participants |
|---|---|
| Sexual Distress | 30.8 ± 14.0 |
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.
| score on a scale | Pilot Participants |
|---|---|
| Satisfaction With Treatment | 17.9 ± 5.32 |
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.
| score on a scale | Pilot Participants |
|---|---|
| Satisfaction With Treatment | 17.9 ± 5.73 |
Collected over All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. This is because no intervention was applied and the study simply observed characteristics of symptoms and quality of life when experiencing recurrent urinary tract infection. No intervention was administered. Patient participants were encouraged to seek support from a medical and/or mental health professional to discuss their symptoms and any concerns with physical and/or mental health.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pilot Participants | — | — | — |
Baseline demographic characteristics are reported for all three arms of the study. Arm 1 (Pilot Participants, N=240) comprised adults with recurrent UTI who completed the Phase V psychometric validation pilot and the full battery of pre-specified quantitative outcome measures. Arm 2 (Expert Clinicians, N=15) comprised specialist and general clinicians who participated in a two-round Delphi consensus study to establish content validity of draft RUTISS and RUTIIQ items. Arm 3 (Cognitive Intervie
| Age, Continuous(years) | Pilot Participants | Expert Clinicians | Cognitive Interview Participants | Total |
|---|---|---|---|---|
| Mean | 45.0 ± 17.3 | 46.8 ± 9.24 | 46.8 ± 16.9 | 45.8 ± 16.8 |
| Sex: Female, Male(Participants) | Pilot Participants | Expert Clinicians | Cognitive Interview Participants | Total |
|---|---|---|---|---|
| Female | 235 | 12 | 26 | 273 |
| Male | 5 | 3 | 2 | 10 |
| Race/Ethnicity, Customized(Participants) | Pilot Participants | Expert Clinicians | Cognitive Interview Participants | Total |
|---|---|---|---|---|
| White | 214 | 10 | 25 | 249 |
| Asian | 11 | 4 | 2 | 17 |
| Spanish, Hispanic or Latino American | 6 | 0 | 1 | 7 |
| Mixed Ethnicity | 2 | 0 | 0 | 2 |
| Black or African American | 1 | 0 | 0 | 1 |
| Native Hawaiian or other Pacific Islander | 1 | 0 | 0 | 1 |
| Prefer not to say | 5 | 0 | 0 | 5 |
| Other | 0 | 1 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2021 to primary completion in Sep 2021, 4 months.
Results were first posted in Jun 2026, 4 years 9 months after primary completion.
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