Trial Outcomes & Findings for Developing a PROM for Recurrent Urinary Tract Infection (NCT NCT05086900)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

283 participants

Primary outcome timeframe

Baseline (Time 1)

Results posted on

2026-08-05

Participant Flow

Inclusion Criteria: Clinicians: * 18+ years old * Specialist doctor or nurse in the field of urology or related discipline OR general health doctor or nurse * 2+ years of direct experience treating patients with recurrent UTI Patients: * 18+ years old * 2+ UTIs in 6 months or 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

Participant milestones

Participant milestones
Measure	Pilot Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).	Expert Clinicians Specialist doctors or nurses in urology or a closely related discipline, or general health doctors or nurses, with a minimum of 2 years of direct experience treating patients with recurrent UTI (N=15). This arm participated in a two-round Delphi consensus study to establish content validity of draft RUTISS and RUTIIQ items. The pre-specified quantitative outcome measures were not administered to this arm, as participants were clinicians rather than rUTI patients; data collected consisted of item-level consensus ratings and qualitative feedback only.	Cognitive Interview Participants Adult participants with a diagnosis of recurrent urinary tract infection (N=28). This arm participated in one-to-one cognitive think-aloud interviews evaluating the comprehension, relevance, and acceptability of draft RUTISS and RUTIIQ items. The pre-specified quantitative outcome measures were not administered as standardised scored assessments in this arm, as the PROMs were under development at this phase; data collected consisted of qualitative verbal probes and item-level feedback only.
Overall Study STARTED	240	15	28
Overall Study COMPLETED	106	12	28
Overall Study NOT COMPLETED	134	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Pilot Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).	Expert Clinicians Specialist doctors or nurses in urology or a closely related discipline, or general health doctors or nurses, with a minimum of 2 years of direct experience treating patients with recurrent UTI (N=15). This arm participated in a two-round Delphi consensus study to establish content validity of draft RUTISS and RUTIIQ items. The pre-specified quantitative outcome measures were not administered to this arm, as participants were clinicians rather than rUTI patients; data collected consisted of item-level consensus ratings and qualitative feedback only.
Overall Study Lost to Follow-up	69	3
Overall Study Withdrawal by Subject	19	0
Overall Study completed follow-up significantly outside the 24-hour testing window	46	0

Baseline Characteristics

Developing a PROM for Recurrent Urinary Tract Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pilot Participants n=240 Participants Adult participants with a diagnosis of recurrent urinary tract infection who completed the Phase V psychometric validation pilot. This arm completed the full battery of pre-specified quantitative outcome measures (RUTISS, RUTIIQ, UTISA, NPRS, PHQ-9, GAD-7, UCLA Loneliness Scale, WPAI, FSDS, and Satisfaction with Treatment) at baseline and at 24-hour follow-up. Demographic data (age, sex, race/ethnicity) were collected via self-report at baseline.	Expert Clinicians n=15 Participants Specialist doctors or nurses in urology or a closely related discipline, or general health doctors or nurses, with a minimum of 2 years of direct experience treating patients with recurrent UTI. This arm participated in a two-round Delphi consensus study to establish content validity of draft RUTISS and RUTIIQ items. Demographic data collected at enrolment are reported below. Pre-specified quantitative outcome measures were not administered to this arm, as participants were clinicians rather than rUTI patients.	Cognitive Interview Participants n=28 Participants Adult participants with a diagnosis of recurrent urinary tract infection who participated in one-to-one cognitive think-aloud interviews evaluating the comprehension, relevance, and acceptability of draft RUTISS and RUTIIQ items. Demographic data collected at enrolment are reported below. The pre-specified quantitative outcome measures were not administered as scored assessments in this arm, as the PROMs were under development at this phase; data collected from this arm consisted of qualitative item-level feedback only.	Total n=283 Participants Total of all reporting groups
Age, Continuous	45.0 years STANDARD_DEVIATION 17.3 • n=20 Participants	46.8 years STANDARD_DEVIATION 9.24 • n=20 Participants	46.8 years STANDARD_DEVIATION 16.9 • n=40 Participants	45.8 years STANDARD_DEVIATION 16.8 • n=6 Participants
Sex: Female, Male Female	235 Participants n=20 Participants	12 Participants n=20 Participants	26 Participants n=40 Participants	273 Participants n=6 Participants
Sex: Female, Male Male	5 Participants n=20 Participants	3 Participants n=20 Participants	2 Participants n=40 Participants	10 Participants n=6 Participants
Race/Ethnicity, Customized White	214 Participants n=20 Participants	10 Participants n=20 Participants	25 Participants n=40 Participants	249 Participants n=6 Participants
Race/Ethnicity, Customized Asian	11 Participants n=20 Participants	4 Participants n=20 Participants	2 Participants n=40 Participants	17 Participants n=6 Participants
Race/Ethnicity, Customized Spanish, Hispanic or Latino American	6 Participants n=20 Participants	0 Participants n=20 Participants	1 Participants n=40 Participants	7 Participants n=6 Participants
Race/Ethnicity, Customized Mixed Ethnicity	2 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	2 Participants n=6 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=6 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=6 Participants
Race/Ethnicity, Customized Prefer not to say	5 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	5 Participants n=6 Participants
Race/Ethnicity, Customized Other	0 Participants n=20 Participants	1 Participants n=20 Participants	0 Participants n=40 Participants	1 Participants n=6 Participants

PRIMARY outcome

Timeframe: Baseline (Time 1)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure as a scored assessment, as their study procedures did not include administration of the PROM as a quantitative instrument, instead focusing on qualitative assessment of PROMs in development. Summary statistics are therefore not available for Arms 2 and 3.

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

Outcome measures

Outcome measures
Measure	Pilot Participants n=240 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Recurrent Urinary Tract Infection Symptom Scale Urinary Symptoms	23.2 score on a scale Standard Deviation 16.9
Recurrent Urinary Tract Infection Symptom Scale UTI Pain	26.2 score on a scale Standard Deviation 23.0

PRIMARY outcome

Timeframe: Time 2 (24 hours after baseline)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure as a scored assessment, as their study procedures did not include administration of the PROM as a quantitative instrument, instead focusing on qualitative assessment of PROMs in development. Summary statistics are therefore not available for Arms 2 and 3.

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

Outcome measures

Outcome measures
Measure	Pilot Participants n=106 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Recurrent Urinary Tract Infection Symptom Scale Urinary symptoms	17.3 score on a scale Standard Deviation 15.4
Recurrent Urinary Tract Infection Symptom Scale UTI pain	22.8 score on a scale Standard Deviation 22.2

PRIMARY outcome

Timeframe: Baseline (Time 1)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure as a scored assessment; their procedures focused on qualitative assessment of PROMs in development rather than quantitative administration. Summary statistics are therefore not available for Arms 2 and 3. The sexual wellbeing subscale is optional; fewer participants provided data.

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.

Outcome measures

Outcome measures
Measure	Pilot Participants n=240 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Recurrent Urinary Tract Infection Impact Questionnaire Personal Wellbeing	26.2 score on a scale Standard Deviation 11.1
Recurrent Urinary Tract Infection Impact Questionnaire Social Wellbeing	23.3 score on a scale Standard Deviation 15.9
Recurrent Urinary Tract Infection Impact Questionnaire Work and Activity Interference	35.8 score on a scale Standard Deviation 23.1
Recurrent Urinary Tract Infection Impact Questionnaire Sexual Wellbeing	36.2 score on a scale Standard Deviation 6.3
Recurrent Urinary Tract Infection Impact Questionnaire Patient Satisfaction	36.6 score on a scale Standard Deviation 28.5

PRIMARY outcome

Timeframe: Time 2 (24 hours after baseline)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure as a scored assessment; their procedures focused on qualitative assessment of PROMs in development rather than quantitative administration. Summary statistics are therefore not available for Arms 2 and 3. The sexual wellbeing subscale is optional; fewer participants provided data.

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.

Outcome measures

Outcome measures
Measure	Pilot Participants n=106 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Recurrent Urinary Tract Infection Impact Questionnaire Personal Wellbeing	21.8 score on a scale Standard Deviation 12.9
Recurrent Urinary Tract Infection Impact Questionnaire Social wellbeing	20.4 score on a scale Standard Deviation 15.8
Recurrent Urinary Tract Infection Impact Questionnaire Work and activity interference	30.9 score on a scale Standard Deviation 23.1
Recurrent Urinary Tract Infection Impact Questionnaire Sexual wellbeing	34.9 score on a scale Standard Deviation 7.52
Recurrent Urinary Tract Infection Impact Questionnaire Patient satisfaction	38.9 score on a scale Standard Deviation 27.8

SECONDARY outcome

Timeframe: Baseline (Time 1)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3.

(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.

Outcome measures

Outcome measures
Measure	Pilot Participants n=240 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Urinary Tract Infection Symptom Assessment	6.71 score on a scale Standard Deviation 4.75

SECONDARY outcome

Timeframe: Time 2 (24 hours after baseline)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3.

(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.

Outcome measures

Outcome measures
Measure	Pilot Participants n=106 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Urinary Tract Infection Symptom Assessment	6.05 score on a scale Standard Deviation 4.6

SECONDARY outcome

Timeframe: Baseline (Time 1)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3.

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

Outcome measures

Outcome measures
Measure	Pilot Participants n=240 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Numerical Pain Rating Scale	12.1 score on a scale Standard Deviation 10.0

SECONDARY outcome

Timeframe: Time 2 (24 hours after baseline)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3.

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

Outcome measures

Outcome measures
Measure	Pilot Participants n=106 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Numerical Pain Rating Scale	11.2 score on a scale Standard Deviation 10.3

SECONDARY outcome

Timeframe: Baseline (Time 1)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3.

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

Outcome measures

Outcome measures
Measure	Pilot Participants n=240 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Depression	11.5 score on a scale Standard Deviation 7.22

SECONDARY outcome

Timeframe: Time 2 (24 hours after baseline)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3.

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

Outcome measures

Outcome measures
Measure	Pilot Participants n=106 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Depression	10.1 score on a scale Standard Deviation 7.11

SECONDARY outcome

Timeframe: Baseline (Time 1)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3.

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

Outcome measures

Outcome measures
Measure	Pilot Participants n=240 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Anxiety	9.23 score on a scale Standard Deviation 6.21

SECONDARY outcome

Timeframe: Time 2 (24 hours after baseline)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3.

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

Outcome measures

Outcome measures
Measure	Pilot Participants n=106 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Anxiety	9.02 score on a scale Standard Deviation 6.11

SECONDARY outcome

Timeframe: Baseline (Time 1)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3.

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

Outcome measures

Outcome measures
Measure	Pilot Participants n=240 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Loneliness	48.8 score on a scale Standard Deviation 13.9

SECONDARY outcome

Timeframe: Time 2 (24 hours after baseline)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3.

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

Outcome measures

Outcome measures
Measure	Pilot Participants n=106 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Loneliness	47.0 score on a scale Standard Deviation 13.4

SECONDARY outcome

Timeframe: Baseline (Time 1)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure; their procedures did not include validator instruments. Summary statistics are therefore not available for Arms 2 and 3. Work impairment subscale applies only to those currently in work.

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.

Outcome measures

Outcome measures
Measure	Pilot Participants n=240 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Work Productivity and Impairment Questionnaire Work impairment	45.0 score on a scale Standard Deviation 33.3
Work Productivity and Impairment Questionnaire Activity impairment	45.7 score on a scale Standard Deviation 29.6

SECONDARY outcome

Timeframe: Time 2 (24 hours after baseline)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure; their procedures did not include validator instruments. Summary statistics are therefore not available for Arms 2 and 3. Work impairment subscale applies only to those currently in work.

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.

Outcome measures

Outcome measures
Measure	Pilot Participants n=106 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Work Productivity and Impairment Questionnaire Work impairment	37.4 score on a scale Standard Deviation 33.3
Work Productivity and Impairment Questionnaire Activity impairment	42.6 score on a scale Standard Deviation 32.1

SECONDARY outcome

Timeframe: Baseline (Time 1)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure; their procedures did not include validator instruments. Summary statistics are therefore not available for Arms 2 and 3. This scale is optional; fewer participants provided data.

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.

Outcome measures

Outcome measures
Measure	Pilot Participants n=197 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Sexual Distress	30.3 score on a scale Standard Deviation 13.7

SECONDARY outcome

Timeframe: Time 2 (24 hours after baseline)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure; their procedures did not include validator instruments. Summary statistics are therefore not available for Arms 2 and 3. This scale is optional; fewer participants provided data.

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.

Outcome measures

Outcome measures
Measure	Pilot Participants n=75 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Sexual Distress	30.8 score on a scale Standard Deviation 14.0

SECONDARY outcome

Timeframe: Baseline (Time 1)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3.

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.

Outcome measures

Outcome measures
Measure	Pilot Participants n=240 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Satisfaction With Treatment	17.9 score on a scale Standard Deviation 5.32

SECONDARY outcome

Timeframe: Time 2 (24 hours after baseline)

Population: Administered only to Arm 1 (Pilot Participants) during the Phase V PROM validation pilot, in line with the study design, as a comparator measure for evaluating convergent and discriminant validity of the RUTISS and RUTIIQ. Arms 2 (Expert Clinicians) and 3 (Cognitive Interview Participants) did not complete this measure, as their study procedures did not include administration of validator instruments. Summary statistics are therefore not available for Arms 2 and 3.

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.

Outcome measures

Outcome measures
Measure	Pilot Participants n=106 Participants Adult participants with diagnosis of Recurrent Urinary Tract Infection (N = 240).
Satisfaction With Treatment	17.9 score on a scale Standard Deviation 5.73

Adverse Events

Pilot Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Katherine Finlay, Associate Professor

University of Reading

Phone: 0118 987 5123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place