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

Nocturia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816724
• Other study ID #: CSPT/URO/2013/546
• Status: Completed
• Phase: N/A
• First received: March 20, 2013
• Last updated: May 31, 2017
• Start date: March 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2017
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Nocturia

Locations

Country	Name	City	State
Spain	Hospital Universitario Parc Tauli	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	score in n-QoL questionnaire		two determinations in ten days
Secondary	score in IPSS spanish validated questionnaire		two determinations in ten days (only men)
Secondary	score in Pittsburgh Sleep Quality Index spanish validated questionnaire		two determinations in ten days
Secondary	score in King's health spanish validated questionnaire		two determinations in ten days