UrologyNCT07698041
RUTISS-Diary and RUTISS-65 Study
An observational study of Urology and Urological Diseases, run by Katherine Finlay at 2 sites in United Kingdom.
Trial summary
Existing patient-reported outcome measures assess acute urinary tract infection but do not support daily symptom tracking in recurrent UTI (rUTI) or meet the needs of older adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urology, Urological Diseases, Patient Satisfaction
- What is being tested?
- Non-interventional Patient Reported Outcome Measure Development (RUTISS-Diary) and Non-interventional Patient Reported Outcome Measure Development (RUTISS-65)
- How many people
- 200 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 8 Jul 2026to 24 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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.
Who may be able to join
- Participants must be 18 years and older
- All participants must have native/bilingual or advanced fluency in English.
- Access to a computer/mobile device for survey completion.
- Symptoms-led diagnosis: Participants must report that they experience recurrent UTI episodes or symptoms. They must report the minimum of 2 UTIs in 6 months or 3 in 12 months, in line with the rUTI diagnostic criteria (European Association of Urology, 2020).
- Participants must be 65 years and older
- Access to a computer/mobile device for survey completion, paper copy available upon request.
- All participants must have native/bilingual or advanced fluency in English.
- Symptoms-led diagnosis: Participants must report that they experience recurrent UTI episodes or symptoms. They must report the minimum of 2 UTIs in 6 months or 3 in 12 months, in line with the rUTI diagnostic criteria (European Association of Urology, 2020).
Who cannot join
- Participants must not report a current diagnosis of interstitial cystitis (measured in demographics questionnaire).
- Symptoms of cognitive confusion or dementia.
- No active malignancy e.g. bladder or prostate cancer
- Participants must not report beginner or intermediate level fluency in English. Future work will be done to translate the PROMs into alternative languages.
- In addition to the interstitial cystitis exclusion question, participants will also be asked in the demographic questionnaire if they are pregnant or have an indwelling catheter or use intermittent self-catheterisation. Participants who report "yes" to either of these will be excluded from participation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites
University of Reading
Reading, RG6 6ET
Katherine A Finlay, PhD, CPsychol, 0118 378 8523, katherine.finlay@reading.ac.uk
Lydia V Tidmarsh, PhD, 0118 378 8523, l.v.tidmarsh@reading.ac.uk
Royal Berkshire NHS Foundation Trust
Reading
About this study
Official title: Developing and Validating Two New Patient-Reported Outcome Measures of Recurrent Urinary Tract Infection Symptoms: A Symptoms Diary and Adapted Measure for Older Adults
Existing patient-reported outcome measures assess acute urinary tract infection but do not support daily symptom tracking in recurrent UTI (rUTI) or meet the needs of older adults. This single-site study will develop and validate two adapted measures: the RUTISS-Diary for daily symptom monitoring and the RUTISS-65 for reporting symptoms in adults aged 65 years and over. Approximately 200 participants with rUTI will complete the RUTISS-Diary daily for 7 days and again on day 14. Participants aged 65 years and over will also complete the RUTISS-65 on days 1 and 2 to assess its reliability and validity.
Read the detailed description
400 million people globally each year are affected by Urinary Tract Infections (UTIs) (Yang et al., 2022), with annual recurrence ranging from 24-50% (Foxman, 2014). Recurrent UTI (rUTI), defined as at least two UTIs in six months or at least three in one year (Bonkat et al., 2020), negatively affects quality of life (Wagenlehner et al., 2018) and repeat treatment risks antimicrobial resistance (Ormeño et al., 2022). Standard urine culture may present results discrepant with symptoms (Harding et al., 2022), hence the urgent need for quantifiable rUTI Patient Reported Outcome Measures (PROMs). Measures exist for acute infection (e.g. cystitis (Alidjanov et al., 2018) but not rUTI. We recently developed, published and commercially licensed two rUTI PROMs (the Recurrent Urinary Tract Infection Symptom Scale; RUTISS (Newlands et al., 2023) and the Recurrent Urinary Tract Infection Impact Questionnaire; RUTIIQ; Newlands et al., 2023b). However, neither has been adapted for daily symptom tracking or tailored to the needs of older adults. As a result, there is no rapid assessment tool that individuals living with rUTI (or their healthcare professionals) to analyse how rUTI symptoms change daily or to suitably assess adults over 65 years. This study aims to develop, validate and pilot two PROMs: 1) an adaptation of the RUTISS in daily diary format (RUTISS-Diary); and 2) an adapted RUTISS measure adapted for observational reporting of rUTI symptoms in older adults (RUTISS-65).
To inform the items of the RUTISS-Diary and RUTISS-65, extensive multiphase, mixed-methods preparatory work has been completed to ensure the items are informed from both patient and clinician perspectives. Phase 1 comprised of one-to-one interviews conducted with clinical experts working with older adults experiencing recurrent urinary tract infections (inclusive of urology, microbiology and geriatrics, N = 10, completed, UoR ethics ref: 2025-039-KF). This was accompanied by a literature review specific to older adult experiences of rUTI and patient interviews with outpatient members of Live UTI Free (N = 20, completed, UoR ethics ref: 2024-071-KF). Phase 2 consisted of two-rounds of HCP expert panel Delphi-surveys (N = 11) and cognitive interviews with expert patients (N = 25) for refinement of the measures (completed, UoR ethics ref: 2025-039-KF). These first phases are complete, informing the items of the RUTISS-Diary and RUTISS-65. The present study therefore aims to test and validate these measures to ensure they are reliable and are able to detect meaningful change.
- Conditions
- Urology, Urological Diseases, Patient Satisfaction, Pain, Chronic
- Being tested
- Non-interventional Patient Reported Outcome Measure Development (RUTISS-Diary), Non-interventional Patient Reported Outcome Measure Development (RUTISS-65)
- Keywords
- recurrent urinary tract infection, rUTI, outcome measure, PROMs, urinary, UTI, burden, assessment tools
- Medical subject headings
- Urologic Diseases, Patient Satisfaction, Chronic Pain, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional Patient Reported Outcome Measure Development (RUTISS-Diary)Other
RUTISS-Diary
Non-interventional Patient Reported Outcome Measure Development (RUTISS-65)Other
RUTISS-65
| Study group | Role | What they receive |
|---|---|---|
| RUTISS-Diary (Cohort A) | All rUTI patients of any age Receives: Other: Non-interventional Patient Reported Outcome Measure Development (RUTISS-Diary) | |
| RUTISS-65 (Cohort B) | rUTI patients aged 65 years and over Receives: Other: Non-interventional Patient Reported Outcome Measure Development (RUTISS-Diary); Other: Non-interventional Patient Reported Outcome Measure Development (RUTISS-65) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest reliability
Primary outcome measures will include the test-retest reliability and construct validity of the instrument. Test-retest reliability will be assessed by calculating intraclass correlation coefficients (ICCs) for each subscale at each time point.
Measured: RUTISS-Diary: From day 1 to day 7 and day 1 to day 14. RUTISS-65: From day 1 to day 2.
Construct validity
Construct validity will be examined using correlation analyses between the subscales of the study measures and relevant comparative measures.
Measured: RUTISS-Diary: From day 1 to day 7 and day 1 to day 14. RUTISS-65: From day 1 to day 2.
Secondary outcomes (1)
Sensitivity to change
Secondary outcome measures will assess the responsiveness (sensitivity to change) of the RUTISSdiary and RUTISS-65 using both anchor-based and distribution-based approaches, in line with COSMIN recommendations for continuous outcome measures (COSMIN, 2019).
Measured: RUTISS-Diary: From day 1 to day 7 and day 1 to day 14. RUTISS-65: From day 1 to day 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start8 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion24 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for UrologyStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Katherine Finlay
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Berkshire NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Katherine Finlay, University of Reading
- Investigators
- Katherine A Finlay, PhD, CPsychol, Study director, University of ReadingBob Yang, FRCS (UROL), MBBS, BSC (HONS), Principal investigator, Royal Berkshire NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698041
- Sponsor's protocol ID
- 2026-028-KF
- Other IDs
- IRAS ID: 366353
- Status last verified
- Jun 2026
- First submitted
- 6 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential patient records. Anonymous records will be shared only.
Publications
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.
PubMed 36740638Newlands AF, Kramer M, Roberts L, Maxwell K, Price JL, Finlay KA. Confirmatory structural validation and refinement of the Recurrent Urinary Tract Infection Symptom Scale. BJUI Compass. 2023 Oct 4;5(2):240-252. doi: 10.1002/bco2.297. eCollection 2024 Mar.
PubMed 38371201Alidjanov JF, Naber KG, Abdufattaev UA, Pilatz A, Wagenlehner FME. Reevaluation of the Acute Cystitis Symptom Score, a Self-Reporting Questionnaire. Part I. Development, Diagnosis and Differential Diagnosis. Antibiotics (Basel). 2018 Jan 15;7(1):6. doi: 10.3390/antibiotics7010006.
PubMed 30720775Harding C, Mossop H, Homer T, Chadwick T, King W, Carnell S, Lecouturier J, Abouhajar A, Vale L, Watson G, Forbes R, Currer S, Pickard R, Eardley I, Pearce I, Thiruchelvam N, Guerrero K, Walton K, Hussain Z, Lazarowicz H, Ali A. Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial. BMJ. 2022 Mar 9;376:e068229. doi: 10.1136/bmj-2021-0068229.
PubMed 35264408Ormeno MA, Ormeno MJ, Quispe AM, Arias-Linares MA, Linares E, Loza F, Ruiz J, Pons MJ. Recurrence of Urinary Tract Infections due to Escherichia coli and Its Association with Antimicrobial Resistance. Microb Drug Resist. 2022 Feb;28(2):185-190. doi: 10.1089/mdr.2021.0052. Epub 2021 Aug 27.
PubMed 34449257Wagenlehner F, Wullt B, Ballarini S, Zingg D, Naber KG. Social and economic burden of recurrent urinary tract infections and quality of life: a patient web-based study (GESPRIT). Expert Rev Pharmacoecon Outcomes Res. 2018 Feb;18(1):107-117. doi: 10.1080/14737167.2017.1359543. Epub 2017 Jul 31.
PubMed 28737469Foxman B. Urinary tract infection syndromes: occurrence, recurrence, bacteriology, risk factors, and disease burden. Infect Dis Clin North Am. 2014 Mar;28(1):1-13. doi: 10.1016/j.idc.2013.09.003. Epub 2013 Dec 8.
PubMed 24484571Yang X, Chen H, Zheng Y, Qu S, Wang H, Yi F. Disease burden and long-term trends of urinary tract infections: A worldwide report. Front Public Health. 2022 Jul 27;10:888205. doi: 10.3389/fpubh.2022.888205. eCollection 2022.
PubMed 35968451
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Validating Two New Patient-Reported Outcome Measures of Recurrent Urinary Tract Infection Symptoms: A Symptoms Diary and Adapted Measure for Older Adults
- ClinicalTrials.gov ID
- NCT07698041
- Acronym / sponsor ID
- 2026-028-KF
- Conditions
- Urology, Urological Diseases, Patient Satisfaction, Pain, Chronic
- Keywords
- recurrent urinary tract infection, rUTI, outcome measure, PROMs, urinary, UTI, burden, assessment tools
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Katherine FinlayUniversity, hospital or other
- Collaborators
- Royal Berkshire NHS Foundation Trust
- Study start
- 8 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 24 Dec 2027 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Existing patient-reported outcome measures assess acute urinary tract infection but do not support daily symptom tracking in recurrent UTI (rUTI) or meet the needs of older adults. This single-site study will develop and validate two adapted measures: the RUTISS-Diary for daily symptom monitoring and the RUTISS-65 for reporting symptoms in adults aged 65 years and over. Approximately 200 participants with rUTI will complete the RUTISS-Diary daily for 7 days and again on day 14. Participants aged 65 years and over will also complete the RUTISS-65 on days 1 and 2 to assess its reliability and validity.
Detailed description
400 million people globally each year are affected by Urinary Tract Infections (UTIs) (Yang et al., 2022), with annual recurrence ranging from 24-50% (Foxman, 2014). Recurrent UTI (rUTI), defined as at least two UTIs in six months or at least three in one year (Bonkat et al., 2020), negatively affects quality of life (Wagenlehner et al., 2018) and repeat treatment risks antimicrobial resistance (Ormeño et al., 2022). Standard urine culture may present results discrepant with symptoms (Harding et al., 2022), hence the urgent need for quantifiable rUTI Patient Reported Outcome Measures (PROMs). Measures exist for acute infection (e.g. cystitis (Alidjanov et al., 2018) but not rUTI. We recently developed, published and commercially licensed two rUTI PROMs (the Recurrent Urinary Tract Infection Symptom Scale; RUTISS (Newlands et al., 2023) and the Recurrent Urinary Tract Infection Impact Questionnaire; RUTIIQ; Newlands et al., 2023b). However, neither has been adapted for daily symptom tracking or tailored to the needs of older adults. As a result, there is no rapid assessment tool that individuals living with rUTI (or their healthcare professionals) to analyse how rUTI symptoms change daily or to suitably assess adults over 65 years. This study aims to develop, validate and pilot two PROMs: 1) an adaptation of the RUTISS in daily diary format (RUTISS-Diary); and 2) an adapted RUTISS measure adapted for observational reporting of rUTI symptoms in older adults (RUTISS-65).
To inform the items of the RUTISS-Diary and RUTISS-65, extensive multiphase, mixed-methods preparatory work has been completed to ensure the items are informed from both patient and clinician perspectives. Phase 1 comprised of one-to-one interviews conducted with clinical experts working with older adults experiencing recurrent urinary tract infections (inclusive of urology, microbiology and geriatrics, N = 10, completed, UoR ethics ref: 2025-039-KF). This was accompanied by a literature review specific to older adult experiences of rUTI and patient interviews with outpatient members of Live UTI Free (N = 20, completed, UoR ethics ref: 2024-071-KF). Phase 2 consisted of two-rounds of HCP expert panel Delphi-surveys (N = 11) and cognitive interviews with expert patients (N = 25) for refinement of the measures (completed, UoR ethics ref: 2025-039-KF). These first phases are complete, informing the items of the RUTISS-Diary and RUTISS-65. The present study therefore aims to test and validate these measures to ensure they are reliable and are able to detect meaningful change.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RUTISS-Diary (Cohort A) | – | Other: Non-interventional Patient Reported Outcome Measure Development (RUTISS-Diary)All rUTI patients of any age |
| RUTISS-65 (Cohort B) | – | Other: Non-interventional Patient Reported Outcome Measure Development (RUTISS-Diary), Other: Non-interventional Patient Reported Outcome Measure Development (RUTISS-65)rUTI patients aged 65 years and over |
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.
Key inclusion criteria (8 listed)
- Participants must be 18 years and older
- All participants must have native/bilingual or advanced fluency in English.
- Access to a computer/mobile device for survey completion.
- Symptoms-led diagnosis: Participants must report that they experience recurrent UTI episodes or symptoms. They must report the minimum of 2 UTIs in 6 months or 3 in 12 months, in line with the rUTI diagnostic criteria (European Association of Urology, 2020).
- Participants must be 65 years and older
Key exclusion criteria (5 listed)
- Participants must not report a current diagnosis of interstitial cystitis (measured in demographics questionnaire).
- Symptoms of cognitive confusion or dementia.
- No active malignancy e.g. bladder or prostate cancer
- Participants must not report beginner or intermediate level fluency in English. Future work will be done to translate the PROMs into alternative languages.
- In addition to the interstitial cystitis exclusion question, participants will also be asked in the demographic questionnaire if they are pregnant or have an indwelling catheter or use intermittent self-catheterisation. Participants who report "yes" to either of these will be excluded from participation.
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 Patient Reported Outcome Measure Development (RUTISS-Diary)RUTISS-Diary | Other | RUTISS-65 (Cohort B), RUTISS-Diary (Cohort A) |
| Non-interventional Patient Reported Outcome Measure Development (RUTISS-65)RUTISS-65 | Other | RUTISS-65 (Cohort B) |
Primary outcome
Test-retest reliability
Time frame: RUTISS-Diary: From day 1 to day 7 and day 1 to day 14. RUTISS-65: From day 1 to day 2.
Primary outcome measures will include the test-retest reliability and construct validity of the instrument. Test-retest reliability will be assessed by calculating intraclass correlation coefficients (ICCs) for each subscale at each time point.
Construct validity
Time frame: RUTISS-Diary: From day 1 to day 7 and day 1 to day 14. RUTISS-65: From day 1 to day 2.
Construct validity will be examined using correlation analyses between the subscales of the study measures and relevant comparative measures.
1 secondary outcome
Sensitivity to change
Time frame: RUTISS-Diary: From day 1 to day 7 and day 1 to day 14. RUTISS-65: From day 1 to day 2.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: 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.
- Background: PubMed 38371201Newlands AF, Kramer M, Roberts L, Maxwell K, Price JL, Finlay KA. Confirmatory structural validation and refinement of the Recurrent Urinary Tract Infection Symptom Scale. BJUI Compass. 2023 Oct 4;5(2):240-252. doi: 10.1002/bco2.297. eCollection 2024 Mar.
- Background: PubMed 30720775Alidjanov JF, Naber KG, Abdufattaev UA, Pilatz A, Wagenlehner FME. Reevaluation of the Acute Cystitis Symptom Score, a Self-Reporting Questionnaire. Part I. Development, Diagnosis and Differential Diagnosis. Antibiotics (Basel). 2018 Jan 15;7(1):6. doi: 10.3390/antibiotics7010006.
- Background: PubMed 35264408Harding C, Mossop H, Homer T, Chadwick T, King W, Carnell S, Lecouturier J, Abouhajar A, Vale L, Watson G, Forbes R, Currer S, Pickard R, Eardley I, Pearce I, Thiruchelvam N, Guerrero K, Walton K, Hussain Z, Lazarowicz H, Ali A. Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial. BMJ. 2022 Mar 9;376:e068229. doi: 10.1136/bmj-2021-0068229.
- Background: PubMed 34449257Ormeno MA, Ormeno MJ, Quispe AM, Arias-Linares MA, Linares E, Loza F, Ruiz J, Pons MJ. Recurrence of Urinary Tract Infections due to Escherichia coli and Its Association with Antimicrobial Resistance. Microb Drug Resist. 2022 Feb;28(2):185-190. doi: 10.1089/mdr.2021.0052. Epub 2021 Aug 27.
- Background: PubMed 28737469Wagenlehner F, Wullt B, Ballarini S, Zingg D, Naber KG. Social and economic burden of recurrent urinary tract infections and quality of life: a patient web-based study (GESPRIT). Expert Rev Pharmacoecon Outcomes Res. 2018 Feb;18(1):107-117. doi: 10.1080/14737167.2017.1359543. Epub 2017 Jul 31.
- Background: PubMed 24484571Foxman B. Urinary tract infection syndromes: occurrence, recurrence, bacteriology, risk factors, and disease burden. Infect Dis Clin North Am. 2014 Mar;28(1):1-13. doi: 10.1016/j.idc.2013.09.003. Epub 2013 Dec 8.
- Background: PubMed 35968451Yang X, Chen H, Zheng Y, Qu S, Wang H, Yi F. Disease burden and long-term trends of urinary tract infections: A worldwide report. Front Public Health. 2022 Jul 27;10:888205. doi: 10.3389/fpubh.2022.888205. eCollection 2022.
- Individual participant dataSharing planned: No. Confidential patient records. Anonymous records will be shared only.
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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.
Katherine A Finlay, PhD, CPsychol study director
University of Reading
Bob Yang, FRCS (UROL), MBBS, BSC (HONS) principal investigator
Royal Berkshire NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urology and Urological Diseases, run by Katherine Finlay at 2 sites 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 8 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: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine A Finlay, PhD, CPsychol (0118 378 8523, katherine.finlay@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-retest reliability (time frame: RUTISS-Diary: From day 1 to day 7 and day 1 to day 14. RUTISS-65: From day 1 to day 2.). The study lists 2 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 NCT07698041, which also lists 8 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 13 Jul 2026.