Validation of the Wisconsin Stone-QOL
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02188108 |
Recruitment Status :
Recruiting
First Posted : July 11, 2014
Last Update Posted : September 14, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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?"
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urolithiasis Nephrolithiasis Kidney Stones | Other: Wisconsin Stone-QOL survey | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 2000 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Validation of the Wisconsin Stone-QOL, a Quality of Life Survey for Kidney Stone Formers |
Study Start Date : | July 2014 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Survey
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.
|
Other: Wisconsin Stone-QOL survey
Patients will complete a health-related quality of life survey at multiple time points at enrollment and at multiple time points thereafter. |
- 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
- Patients' self-reported quality of life [ Time Frame: 3 months ]
- Patients' self-reported quality of life [ Time Frame: 12 months ]
- Patients' self-reported quality of life [ Time Frame: 24 months ]
- Patients' self-reported quality of life [ Time Frame: 36 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of kidney stones, either in the past or currently
- 18 years of age or older
Exclusion Criteria:
- Under 18 years of age
- No previous or current diagnosis of kidney stones

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188108
Contact: Kristina L Penniston, PhD | 608-265-9797 | penn@urology.wisc.edu |
United States, Wisconsin | |
University of Wisconsin-Madison Department of Urology, School of Medicine & Public Heatlh | Recruiting |
Madison, Wisconsin, United States, 53705-2281 | |
Contact: Kristina L Penniston, PhD 608-265-9797 penn@urology.wisc.edu |
Principal Investigator: | Kristina L Penniston, PhD | University of Wisconsin Department of Urology, School of Medicine & Public Health | |
Principal Investigator: | Stephen Y Nakada, MD | University of Wisconsin Department of Urology, School of Medicine & Public Health |
Responsible Party: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT02188108 |
Other Study ID Numbers: |
2014-0062 UW QOL ( Other Identifier: Study Team ) A539998 ( Other Identifier: UW Madison ) SMPH\VOLUNTEER STAFF\UROLOGY ( Other Identifier: UW Madison ) Protocol Version 1/19/2018 ( Other Identifier: UW Madison ) |
First Posted: | July 11, 2014 Key Record Dates |
Last Update Posted: | September 14, 2020 |
Last Verified: | September 2020 |
quality of life QOL urolithiasis |
nephrolithiasis kidney stones patient-reported outcomes |
Kidney Calculi Nephrolithiasis Urolithiasis Calculi |
Pathological Conditions, Anatomical Kidney Diseases Urologic Diseases Urinary Calculi |