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

May 31, 2017 updated by: EDUARDO VICENTE PALACIO, Corporacion Parc Tauli

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

129

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Universitario Parc Tauli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Men older than 60 years old suffering from nocturia (one or more voidings overnight) without exclusion criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Men with nocturia
Men older than 60 years old suffering from nocturia (one or more voidings overnight) without exclusion criteria
Women with nocturia
Women older than 60 years old suffering from nocturia (one or more voidings overnight) without exclusion criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
score in n-QoL questionnaire
Time Frame: two determinations in ten days
two determinations in ten days

Secondary Outcome Measures

Outcome Measure
Time Frame
score in IPSS spanish validated questionnaire
Time Frame: two determinations in ten days (only men)
two determinations in ten days (only men)
score in Pittsburgh Sleep Quality Index spanish validated questionnaire
Time Frame: two determinations in ten days
two determinations in ten days
score in King's health spanish validated questionnaire
Time Frame: two determinations in ten days
two determinations in ten days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

March 20, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (ESTIMATE)

March 22, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPT/URO/2013/546

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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