UrolithiasisNCT02188108
Validation of the Wisconsin Stone-QOL
A study testing Wisconsin Stone-QOL survey in people with Urolithiasis and Nephrolithiasis, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The overall purpose of this study is to evaluate criterion-related validity of a newly-developed disease-specific instrument to assess the health-related quality of life (HRQOL) of patients who have had kidney stones. Specific aims of this study are: 1. Aim 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis, Nephrolithiasis, Kidney Stones
- What is being tested?
- Wisconsin Stone-QOL survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,299 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Clinical diagnosis of kidney stones, either in the past or currently
- 18 years of age or older
Who cannot join
- Under 18 years of age
- No previous or current diagnosis of kidney stones
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison Department of Urology, School of Medicine & Public Heatlh
Madison, Wisconsin, 53705-2281
About this study
Official title: Validation of the Wisconsin Stone-QOL, a Quality of Life Survey for Kidney Stone Formers
The overall purpose of this study is to evaluate criterion-related validity of a newly-developed disease-specific instrument to assess the health-related quality of life (HRQOL) of patients who have had kidney stones. Specific aims of this study are:
- Aim 1. Evaluate the population/external validity (generalizability) of the Wisconsin Stone-QOL by answering the question, "Is the Wisconsin Stone-QOL useful for assessing the HRQOL of patients who form kidney stones from a broad region of North America?"
- Aim 2. Assess the ability of the Wisconsin Stone-QOL to detect changes within patients related to stone interventions and other disease-specific outcomes by answering the question, "Is the Wisconsin Stone-QOL sensitive to changes in stone-related outcomes within individuals?"
Read the detailed description
The Wisconsin Stone-QOL was developed as the only known HRQOL instrument designed specifically for patients with kidney stones. Its development has been published. Internal and other validity tests on the instrument have been conducted and reported. Further validity testing of the instrument is needed to confirm its broader utility in the context of surgical and medical management of patients with kidney stones.
Upon enrollment at each site, patients will be asked to complete a medical history form and the Wisconsin Stone-QOL. To supplement the information provided in the medical history forms, patients' medical records will be reviewed in order to collect and enter approved data into a spreadsheet. Further patient interventions include completion of the Wisconsin Stone-QOL at 3 months, 12 months, 24 months, and 36 months post-enrollment. These post-enrollment surveys will usually be mailed to patients to the addresses they provide. Alternatively, patients may be provided the surveys at a urology encounter if it falls on or near the intervention time points. At each time point, patients' medical records will also be searched to document any changes in the data entered at enrollment.
- Conditions
- Urolithiasis, Nephrolithiasis, Kidney Stones
- Being tested
- Wisconsin Stone-QOL survey
- Keywords
- quality of life, QOL, urolithiasis, nephrolithiasis, kidney stones, patient-reported outcomes
- Medical subject headings
- Urolithiasis, Nephrolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wisconsin Stone-QOL surveyOther
Patients will complete a health-related quality of life survey at multiple time points at enrollment and at multiple time points thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Survey | Experimental | Wisconsin Stone-QOL survey. Patients with kidney stones or a history thereof will complete a kidney stone-specific health-related survey at enrollment and post-enrollment at 3 months, 12 months, 24 months, and 36 months. Receives: Other: Wisconsin Stone-QOL survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' self-reported health-related quality of life (HRQOL)
Change in HRQOL from baseline to follow-up time points will be assessed
Measured: Enrollment
Secondary outcomes (1)
Patients' self-reported quality of life
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJul 2014
- Primary completion31 May 2022
- Study completion30 Jun 2023
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 UrolithiasisStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,299 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, University of California, San Diego, University of North Carolina, Dartmouth College, The Cleveland Clinic, University of British Columbia, University of Texas, University of California, Davis, University of California, Irvine, University of California, San Francisco, University of Washington, Penn State University, McGill University, University of Pittsburgh, Université de Montréal
- Responsible party
- Sponsor
- Investigators
- Kristina L Penniston, PhD, Principal investigator, University of Wisconsin Department of Urology, School of Medicine & Public HealthStephen Y Nakada, MD, Principal investigator, University of Wisconsin Department of Urology, School of Medicine & Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188108
- Sponsor's protocol ID
- 2014-0062
- Other IDs
- UW QOL, A539998, SMPH\VOLUNTEER STAFF\UROLOGY, Protocol Version 1/19/2018
- Status last verified
- Jun 2023
- First submitted
- 7 Jul 2014
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Penniston KL, Nakada SY. Health related quality of life differs between male and female stone formers. J Urol. 2007 Dec;178(6):2435-40; discussion 2440. doi: 10.1016/j.juro.2007.08.009. Epub 2007 Oct 15.
PubMed 17937947Penniston KL, Nakada SY. Development of an instrument to assess the health related quality of life of kidney stone formers. J Urol. 2013 Mar;189(3):921-30. doi: 10.1016/j.juro.2012.08.247. Epub 2012 Sep 24.
PubMed 23017521Ahmad TR, Tzou DT, Usawachintachit M, Reliford-Titus S, Wu C, Goodman J, Antonelli JA, Viprakasit DP, Averch TD, Sivalingam S, Chew BH, Bird VG, Pais VM Jr, Streeper NM, Sur RL, Nakada SY, Penniston KL, Chi T. Low Income and Nonwhite Race are Strongly Associated with Worse Quality of Life in Patients with Nephrolithiasis. J Urol. 2019 Jul;202(1):119-124. doi: 10.1097/JU.0000000000000233. Epub 2019 Jun 7.
PubMed 30865567Raffin EP, Penniston KL, Antonelli JA, Viprakasit DP, Averch TD, Bird VG, Chew BH, Sivalingam S, Sur RL, Nakada SY, Pais VM Jr. The Effect of Thiazide and Potassium Citrate Use on the Health Related Quality of Life of Patients with Urolithiasis. J Urol. 2018 Dec;200(6):1290-1294. doi: 10.1016/j.juro.2018.06.023. Epub 2018 Jun 18.
PubMed 29913138Stern KL, Gao T, Antonelli JA, Viprakasit DP, Averch TD, Chi T, Chew BH, Bird VG, Pais VM Jr, Streeper NM, Sur RL, Nakada SY, Penniston KL, Sivalingam S. Association of Patient Age and Gender with Kidney Stone Related Quality of Life. J Urol. 2019 Aug;202(2):309-313. doi: 10.1097/JU.0000000000000291. Epub 2019 Jul 8.
PubMed 31026215Atalay HA, Ulker V, Canat L, Ozer M, Can O, Penniston KL. Validation of the Turkish version of the Wisconsin stone-quality of life questionnaire. Turk J Urol. 2018 Mar 16;45(2):118-123. doi: 10.5152/tud.2018.35305. Print 2019 Mar.
PubMed 29799402Penniston KL, Antonelli JA, Viprakasit DP, Averch TD, Sivalingam S, Sur RL, Pais VM Jr, Chew BH, Bird VG, Nakada SY. Validation and Reliability of the Wisconsin Stone Quality of Life Questionnaire. J Urol. 2017 May;197(5):1280-1288. doi: 10.1016/j.juro.2016.11.097. Epub 2016 Nov 23.
PubMed 27889419Streeper NM, Wertheim ML, Nakada SY, Penniston KL. Cystine Stone Formers Have Impaired Health-Related Quality of Life Compared with Noncystine Stone Formers: A Case-Referent Study Piloting the Wisconsin Stone Quality of Life Questionnaire Among Patients with Cystine Stones. J Endourol. 2017 Apr;31(S1):S48-S53. doi: 10.1089/end.2016.0564. Epub 2016 Nov 8.
PubMed 27717296
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Wisconsin Stone-QOL, a Quality of Life Survey for Kidney Stone Formers
- ClinicalTrials.gov ID
- NCT02188108
- Acronym / sponsor ID
- 2014-0062
- Conditions
- Urolithiasis, Nephrolithiasis, Kidney Stones
- Keywords
- quality of life, QOL, urolithiasis, nephrolithiasis, kidney stones, patient-reported outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,299 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- University of Florida, University of California, San Diego, University of North Carolina, Dartmouth College, The Cleveland Clinic, University of British Columbia, University of Texas, University of California, Davis, University of California, Irvine, University of California, San Francisco, University of Washington, Penn State University, McGill University, University of Pittsburgh, Université de Montréal
- Study start
- Jul 2014
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 11 Jul 2014 (estimated)
- 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.
The overall purpose of this study is to evaluate criterion-related validity of a newly-developed disease-specific instrument to assess the health-related quality of life (HRQOL) of patients who have had kidney stones. Specific aims of this study are:
- Aim 1. Evaluate the population/external validity (generalizability) of the Wisconsin Stone-QOL by answering the question, "Is the Wisconsin Stone-QOL useful for assessing the HRQOL of patients who form kidney stones from a broad region of North America?"
- Aim 2. Assess the ability of the Wisconsin Stone-QOL to detect changes within patients related to stone interventions and other disease-specific outcomes by answering the question, "Is the Wisconsin Stone-QOL sensitive to changes in stone-related outcomes within individuals?"
Detailed description
The Wisconsin Stone-QOL was developed as the only known HRQOL instrument designed specifically for patients with kidney stones. Its development has been published. Internal and other validity tests on the instrument have been conducted and reported. Further validity testing of the instrument is needed to confirm its broader utility in the context of surgical and medical management of patients with kidney stones.
Upon enrollment at each site, patients will be asked to complete a medical history form and the Wisconsin Stone-QOL. To supplement the information provided in the medical history forms, patients' medical records will be reviewed in order to collect and enter approved data into a spreadsheet. Further patient interventions include completion of the Wisconsin Stone-QOL at 3 months, 12 months, 24 months, and 36 months post-enrollment. These post-enrollment surveys will usually be mailed to patients to the addresses they provide. Alternatively, patients may be provided the surveys at a urology encounter if it falls on or near the intervention time points. At each time point, patients' medical records will also be searched to document any changes in the data entered at enrollment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survey | Experimental | Other: Wisconsin Stone-QOL surveyWisconsin Stone-QOL survey. Patients with kidney stones or a history thereof will complete a kidney stone-specific health-related survey at enrollment and post-enrollment at 3 months, 12 months, 24 months, and 36 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of kidney stones, either in the past or currently
- 18 years of age or older
Key exclusion criteria (2 listed)
- Under 18 years of age
- No previous or current diagnosis of kidney stones
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 |
|---|---|---|
| Wisconsin Stone-QOL surveyPatients will complete a health-related quality of life survey at multiple time points at enrollment and at multiple time points thereafter. | Other | Survey |
Primary outcome
Patients' self-reported health-related quality of life (HRQOL)
Time frame: Enrollment
Change in HRQOL from baseline to follow-up time points will be assessed
1 secondary outcome
Patients' self-reported quality of life
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Background: PubMed 17937947Penniston KL, Nakada SY. Health related quality of life differs between male and female stone formers. J Urol. 2007 Dec;178(6):2435-40; discussion 2440. doi: 10.1016/j.juro.2007.08.009. Epub 2007 Oct 15.
- Background: PubMed 23017521Penniston KL, Nakada SY. Development of an instrument to assess the health related quality of life of kidney stone formers. J Urol. 2013 Mar;189(3):921-30. doi: 10.1016/j.juro.2012.08.247. Epub 2012 Sep 24.
- Background: PubMed 30865567Ahmad TR, Tzou DT, Usawachintachit M, Reliford-Titus S, Wu C, Goodman J, Antonelli JA, Viprakasit DP, Averch TD, Sivalingam S, Chew BH, Bird VG, Pais VM Jr, Streeper NM, Sur RL, Nakada SY, Penniston KL, Chi T. Low Income and Nonwhite Race are Strongly Associated with Worse Quality of Life in Patients with Nephrolithiasis. J Urol. 2019 Jul;202(1):119-124. doi: 10.1097/JU.0000000000000233. Epub 2019 Jun 7.
- Background: PubMed 29913138Raffin EP, Penniston KL, Antonelli JA, Viprakasit DP, Averch TD, Bird VG, Chew BH, Sivalingam S, Sur RL, Nakada SY, Pais VM Jr. The Effect of Thiazide and Potassium Citrate Use on the Health Related Quality of Life of Patients with Urolithiasis. J Urol. 2018 Dec;200(6):1290-1294. doi: 10.1016/j.juro.2018.06.023. Epub 2018 Jun 18.
- Background: PubMed 31026215Stern KL, Gao T, Antonelli JA, Viprakasit DP, Averch TD, Chi T, Chew BH, Bird VG, Pais VM Jr, Streeper NM, Sur RL, Nakada SY, Penniston KL, Sivalingam S. Association of Patient Age and Gender with Kidney Stone Related Quality of Life. J Urol. 2019 Aug;202(2):309-313. doi: 10.1097/JU.0000000000000291. Epub 2019 Jul 8.
- Background: PubMed 29799402Atalay HA, Ulker V, Canat L, Ozer M, Can O, Penniston KL. Validation of the Turkish version of the Wisconsin stone-quality of life questionnaire. Turk J Urol. 2018 Mar 16;45(2):118-123. doi: 10.5152/tud.2018.35305. Print 2019 Mar.
- Background: PubMed 27889419Penniston KL, Antonelli JA, Viprakasit DP, Averch TD, Sivalingam S, Sur RL, Pais VM Jr, Chew BH, Bird VG, Nakada SY. Validation and Reliability of the Wisconsin Stone Quality of Life Questionnaire. J Urol. 2017 May;197(5):1280-1288. doi: 10.1016/j.juro.2016.11.097. Epub 2016 Nov 23.
- Background: PubMed 27717296Streeper NM, Wertheim ML, Nakada SY, Penniston KL. Cystine Stone Formers Have Impaired Health-Related Quality of Life Compared with Noncystine Stone Formers: A Case-Referent Study Piloting the Wisconsin Stone Quality of Life Questionnaire Among Patients with Cystine Stones. J Endourol. 2017 Apr;31(S1):S48-S53. doi: 10.1089/end.2016.0564. Epub 2016 Nov 8.
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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.
Kristina L Penniston, PhD principal investigator
University of Wisconsin Department of Urology, School of Medicine & Public Health
Stephen Y Nakada, MD principal investigator
University of Wisconsin Department of Urology, School of Medicine & Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wisconsin Stone-QOL survey in people with Urolithiasis and Nephrolithiasis, run by University of Wisconsin, Madison at 1 site in United States.
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 2 inclusion and 2 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 3 Jul 2023. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patients' self-reported health-related quality of life (HRQOL) (time frame: Enrollment). 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 NCT02188108, 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 3 Jul 2023.