Developing a PROM for Recurrent Urinary Tract Infection

NCT05086900 | Completed Results

• 1 other identifier: RUTI01-KF-2021
• Study Type: observational
• Target: 283
• Locations: 1 country
• Sites: 1

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).

Conditions

Urologic Diseases; Patient Satisfaction; Pain, Chronic; Sexual Dysfunction

Keywords

urinary; UTI; burden; outcome measure

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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.

  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 2 (24 hours after baseline)

Secondary Outcomes (16)

• Urinary Tract Infection Symptom Assessment

  Baseline (Time 1)

• Urinary Tract Infection Symptom Assessment

  Time 2 (24 hours after baseline)

• Numerical Pain Rating Scale

  Baseline (Time 1)

• Numerical Pain Rating Scale

  Time 2 (24 hours after baseline)

• Depression

  Baseline (Time 1)

Interventions

Non-interventional Cross-sectional Patient Reported Outcome Measure Development OTHER

Development of Patient Reported Outcome Measure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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. 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients:
• Current diagnosis of interstitial cystitis.
• Non-fluent or non-advanced level of English.
• Current pregnancy.
• Current use of urinary catheterisation.

Sponsors & Collaborators

• University of Reading: lead
• Live UTI Free: collaborator

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 7BE, United Kingdom

Location

Related Publications (2)

• Newlands AF, Roberts L, Maxwell K, Kramer M, Price JL, Finlay KA. The Recurrent Urinary Tract Infection Symptom Scale: Development and validation of a patient-reported outcome measure. BJUI Compass. 2023 Jan 17;4(3):285-297. doi: 10.1002/bco2.222. eCollection 2023 May.

  PMID: 37025478 RESULT

• Newlands AF, Roberts L, Maxwell K, Kramer M, Price JL, Finlay KA. Development and psychometric validation of a patient-reported outcome measure of recurrent urinary tract infection impact: the Recurrent UTI Impact Questionnaire. Qual Life Res. 2023 Jun;32(6):1745-1758. doi: 10.1007/s11136-023-03348-7. Epub 2023 Feb 6.

  PMID: 36740638 RESULT

MeSH Terms

Conditions

Urologic Diseases; Patient Satisfaction; Chronic Pain; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases

Results Point of Contact

• Title: Dr Katherine Finlay, Associate Professor
• Organization: University of Reading

katherine.finlay@reading.ac.uk

0118 987 5123

Study Officials

• Katherine A Finlay, PhD

  University of Reading

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Psychology

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: October 21, 2021
• Study Start: May 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 11, 2026
• Results First Posted: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)