Urologic DiseasesNCT05086900
Developing a PROM for Recurrent Urinary Tract Infection
An observational study of Urologic Diseases and Patient Satisfaction, run by University of Reading at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Diseases, Patient Satisfaction, Pain, Chronic
- What is being tested?
- Non-interventional Cross-sectional Patient Reported Outcome Measure Development
- How many people
- 283 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2021to 1 Sep 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients:
- Current diagnosis of interstitial cystitis.
- Non-fluent or non-advanced level of English.
- Current pregnancy.
- Current use of urinary catheterisation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Patient Reported Outcome Measure for Recurrent Urinary Tract Infection
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).
Read the 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 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.
- Being tested
- Non-interventional Cross-sectional Patient Reported Outcome Measure Development
- Keywords
- urinary, UTI, burden, outcome measure
- Medical subject headings
- Urologic Diseases, Patient Satisfaction, Chronic Pain, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional Cross-sectional Patient Reported Outcome Measure DevelopmentOther
Development of Patient Reported Outcome Measure
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Time 2 (24 hours after baseline)
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline (Time 1)
Depression
Patient Health Questionnaire-9; Minimum total score = 0, maximum total score = 27; higher scores indicate higher depression levels.
Measured: 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.
Measured: Baseline (Time 1)
Anxiety
Generalised Anxiety Disorder - 7; minimum total score = 0, maximum total score = 21. Higher scores indicate higher anxiety severity.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Time 2 (24 hours after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 May 2021
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Live UTI Free
- Responsible party
- Principal investigator, Katherine Finlay, University of Reading
- Investigators
- Katherine A Finlay, PhD, Study director, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086900
- Sponsor's protocol ID
- RUTI01-KF-2021
- Status last verified
- Jul 2026
- First submitted
- 17 Aug 2021
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37025478Newlands 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.
PubMed 36740638
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Patient Reported Outcome Measure for Recurrent Urinary Tract Infection
- ClinicalTrials.gov ID
- NCT05086900
- Acronym / sponsor ID
- RUTI01-KF-2021
- Keywords
- urinary, UTI, burden, outcome measure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Live UTI Free
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Posted 11 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
- 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.
Key exclusion criteria (5 listed)
- Current diagnosis of interstitial cystitis.
- Non-fluent or non-advanced level of English.
- Current pregnancy.
- Current use of urinary catheterisation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional Cross-sectional Patient Reported Outcome Measure DevelopmentDevelopment of Patient Reported Outcome Measure | Other | – |
Primary outcome
Recurrent Urinary Tract Infection Symptom Scale
Time frame: Baseline (Time 1)
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 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: Baseline (Time 1)
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.
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.
16 secondary outcomes
Urinary Tract Infection Symptom Assessment
Time frame: Baseline (Time 1)
Urinary Tract Infection Symptom Assessment
Time frame: Time 2 (24 hours after baseline)
Numerical Pain Rating Scale
Time frame: Baseline (Time 1)
Numerical Pain Rating Scale
Time frame: Time 2 (24 hours after baseline)
Depression
Time frame: Baseline (Time 1)
Depression
Time frame: Time 2 (24 hours after baseline)
Anxiety
Time frame: Baseline (Time 1)
Anxiety
Time frame: Time 2 (24 hours after baseline)
Loneliness
Time frame: Baseline (Time 1)
Loneliness
Time frame: Time 2 (24 hours after baseline)
Work Productivity and Impairment Questionnaire
Time frame: Baseline (Time 1)
Work Productivity and Impairment Questionnaire
Time frame: Time 2 (24 hours after baseline)
Sexual Distress
Time frame: Baseline (Time 1)
Sexual Distress
Time frame: Time 2 (24 hours after baseline)
Satisfaction With Treatment
Time frame: Baseline (Time 1)
Satisfaction With Treatment
Time frame: Time 2 (24 hours after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37025478Newlands 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.
- Results publication: PubMed 36740638Newlands 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine A Finlay, PhD study director
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Diseases and Patient Satisfaction, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent Urinary Tract Infection Symptom Scale (time frame: Baseline (Time 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05086900, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.