NCT02188108

Brief 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. 1.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?"
  2. 2.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?"

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,299

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

7.9 years

First QC Date

July 7, 2014

Last Update Submit

June 30, 2023

Conditions

UrolithiasisNephrolithiasisKidney Stones

Keywords

quality of lifeQOLurolithiasisnephrolithiasiskidney stonespatient-reported outcomes

Outcome Measures

Primary Outcomes (1)

  • Patients' self-reported health-related quality of life (HRQOL)

    Change in HRQOL from baseline to follow-up time points will be assessed

    Enrollment

Secondary Outcomes (1)

  • Patients' self-reported quality of life

    3 months

Other Outcomes (3)

  • Patients' self-reported quality of life

    12 months

  • Patients' self-reported quality of life

    24 months

  • Patients' self-reported quality of life

    36 months

Study Arms (1)

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.

Other: Wisconsin Stone-QOL survey

Interventions

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.

Survey

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of kidney stones, either in the past or currently
  • years of age or older

You may not qualify if:

  • Under 18 years of age
  • No previous or current diagnosis of kidney stones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Madison Department of Urology, School of Medicine & Public Heatlh

Madison, Wisconsin, 53705-2281, United States

Location

Related Publications (8)

  • 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.

    PMID: 17937947BACKGROUND

  • Penniston 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.

    PMID: 23017521BACKGROUND

  • Ahmad 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.

    PMID: 30865567BACKGROUND

  • Raffin 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.

    PMID: 29913138BACKGROUND

  • Stern 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.

    PMID: 31026215BACKGROUND

  • Atalay 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.

    PMID: 29799402BACKGROUND

  • Penniston 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.

    PMID: 27889419BACKGROUND

  • Streeper 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.

    PMID: 27717296BACKGROUND

MeSH Terms

Conditions

UrolithiasisNephrolithiasisKidney Calculi

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesKidney DiseasesUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 11, 2014

Study Start

July 1, 2014

Primary Completion

May 31, 2022

Study Completion

June 30, 2023

Last Updated

July 3, 2023

Record last verified: 2023-06

Locations

US(1)