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Clinical Trials/NCT01816724
NCT01816724
Completed
N/A

Spanish (Spain) Validation of a Specific Symptomatic Questionnaire for Patients With Nocturia

Corporacion Parc Tauli1 site in 1 country129 target enrollmentMarch 2013
ConditionsNocturia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Nocturia
Sponsor
Corporacion Parc Tauli
Enrollment
129
Locations
1
Primary Endpoint
score in n-QoL questionnaire
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The objective of this study is to validate the spanish (from Spain) version of the "Nocturia Quality of Life Questionnaire and assess their psychometric properties, using the spanish translation provided by the copyright holder.

Internal consistency (measured by Alpha cronbach coefficient), Reproductibility (measured by Intraclass Correlation Coefficient), Convergent Validity (assessed using other already validate questionnaires such the International Prostate Symptom Score (IPSS), King's Health and Pittsburgh Sleeps Quality Index questionnaires) and Discriminant Validity will be evaluated.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
April 2014
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Corporacion Parc Tauli
Responsible Party
Principal Investigator
Principal Investigator

EDUARDO VICENTE PALACIO

Principal Investigator

Corporacion Parc Tauli

Eligibility Criteria

Inclusion Criteria

  • Men and women
  • Older than 60 years old
  • One or more voidings overnight

Exclusion Criteria

  • Sleep disturbances
  • Psychiatric diseases
  • Surgical procedures during the time of study
  • Introduction of new pharmacological treatments during the time of study
  • Inability to complete the questionnaires

Outcomes

Primary Outcomes

score in n-QoL questionnaire

Time Frame: two determinations in ten days

Secondary Outcomes

  • score in IPSS spanish validated questionnaire(two determinations in ten days (only men))
  • score in Pittsburgh Sleep Quality Index spanish validated questionnaire(two determinations in ten days)
  • score in King's health spanish validated questionnaire(two determinations in ten days)

Study Sites (1)

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