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

NCT ID: NCT01816724

Last Updated: 2017-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nocturia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Men with nocturia

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

No interventions assigned to this group

Women with nocturia

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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EDUARDO VICENTE PALACIO

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario Parc Tauli

Sabadell, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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CSPT/URO/2013/546

Identifier Type: -

Identifier Source: org_study_id

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