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

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ClinicalTrials.gov Identifier: NCT01816724
Recruitment Status : Completed
First Posted : March 22, 2013
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
EDUARDO VICENTE PALACIO, Corporacion Parc Tauli

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.


Condition or disease
Nocturia

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Study Type : Observational
Actual Enrollment : 129 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Spanish (Spain) Validation of a Specific Symptomatic Questionnaire for Patients With Nocturia
Study Start Date : March 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : April 2014

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



Primary Outcome Measures :
  1. score in n-QoL questionnaire [ Time Frame: two determinations in ten days ]

Secondary Outcome Measures :
  1. score in IPSS spanish validated questionnaire [ Time Frame: two determinations in ten days (only men) ]
  2. score in Pittsburgh Sleep Quality Index spanish validated questionnaire [ Time Frame: two determinations in ten days ]
  3. score in King's health spanish validated questionnaire [ Time Frame: two determinations in ten days ]


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Ages Eligible for Study:   60 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men older than 60 years old suffering from nocturia (one or more voidings overnight) without exclusion criteria
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816724


Locations
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Spain
Hospital Universitario Parc Tauli
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli

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Responsible Party: EDUARDO VICENTE PALACIO, Principal Investigator, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT01816724     History of Changes
Other Study ID Numbers: CSPT/URO/2013/546
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: May 2017
Keywords provided by EDUARDO VICENTE PALACIO, Corporacion Parc Tauli:
NOCTURIA
SYMPTOMATIC QUESTIONNAIRE
N-QOL
Additional relevant MeSH terms:
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Nocturia
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms