Trial document

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Trial Description

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The German linguistic validation of the Wisconsin Stone Quality of Life Questionnaire

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Trial Acronym


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URL of the Trial


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Brief Summary in Lay Language

The recording of symptoms and consequences on daily life from patients with stones in the urinary collecting system plays an important role for the treatment. The "Wisconsin Quality of Life"-Score (WISQOL) is a suitable tool to collect this Information. After validated translation and application this study aims to get this Score available for the German language.

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Brief Summary in Scientific Language

This study aims to establish a validated German version of the "Wisconsin Quality of Life" Score for patients with stones in the urinary collecting system. A first step is a translation from English into German language by two independent professional translators. After the first consensus conference a translation of this established German Version back to English by another two independent translators follows. After a short test on a small number of patients to check for comprehensibility, we want to prove the applicability of this newly translated questionnaire in clinical routine. We will recruit patients planned for stone removal via ureterorenoscopy. After informed consent the patients will complete the German Version of the "Wisconsin Quality of Life" (WISQOL) questionnaire as well as the SF-36 questionnaire both concerning the impact of urolithiasis on every day life. 12 months of recruitment will be succeded by 6 months of follow-up followed by statistical analysis.

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Organizational Data

  •   DRKS00012262
  •   2017/09/22
  •   [---]*
  •   yes
  •   Approved
  •   F-2017-033, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   N20 -  Calculus of kidney and ureter
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Interventions/Observational Groups

  •   Patients sufferning from recurring urolithiasis are supposed to complete "Wisconsin Quality of Life" questionnaire as well as the "SF-36" questionnaire before receiving stone surgery as well as 1,3 and 6 months afterwards.
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  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The target of this study is to proof the German version of the “Wisconsin quality of life score” as a valid instrument for registration of stone related symptoms. Those parameters are obtained at the end of the study by statistical analysis.
Herein we check for internal consistency (Cronbach's Alpha), test-retest-reliability (Intraclass correlation coefficient) and Inter Domain Associations (Spearman's Rho). In addition we will search for convergence validity (Spearman's Rho) of the questions implemented in this questionnaire.

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Secondary Outcome

There are no concomittant risks ermeging from the participance on this study. Therefore, the secondary outcome would be the decision to stop the attendance to this study by the test person.

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Countries of Recruitment

  •   Germany
  •   Switzerland
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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  •   Actual
  •   2018/02/01
  •   100
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Generally, all patients with at least one episode of urinary stones are suitable for the recruitment of this study pupulation. At the time of recruiting before stone removal the patient has to be at least 18 years of age and familiar to the German language.

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Exclusion Criteria

First stone surgery, minor 18 years of age, no familiarity with the German language

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Sources of Monetary or Material Support

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  •   Recruiting ongoing
  •   2019/04/30
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.