Trial document




drksid header

  DRKS00012262

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

German WISQOL

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00012262
  •   2017/09/22
  •   [---]*
  •   yes
  •   Approved
  •   F-2017-033, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   N20 -  Calculus of kidney and ureter
end of 1:N-Block indications
start of 1:N-Block interventions

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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Switzerland
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/02/01
  •   100
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   2019/04/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications


* This entry means the parameter is not applicable or has not been set.