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CompletedNCT01816724Updated Jun 2, 2017

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

An observational study in Nocturia, sponsored by Corporacion Parc Tauli. Completed at 1 site in Spain. Open to participants aged 60 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-06-02.

Sponsored by Corporacion Parc Tauli · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
129
Ages
60 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nocturia

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Keywords

  • NOCTURIA
  • SYMPTOMATIC QUESTIONNAIRE
  • N-QOL
03

In context

Nocturia

124 studies on the registry are indexed under Nocturia; 24 are open to participants now.

This study's enrollment of 129 is below the median of 275 across 24 observational studies indexed under Nocturia.

Browse Nocturia studies →

Lead sponsor

Corporacion Parc Tauli is the lead sponsor of 163 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 99 Years
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
129 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. score in n-QoL questionnaire

    Time frame: two determinations in ten days

Secondary outcomes

  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

07

Study locations

1 site
  • Hospital Universitario Parc Tauli
    Sabadell, Barcelona 08208, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01816724
Lead sponsor
Corporacion Parc Tauli
Responsible party
EDUARDO VICENTE PALACIO (Principal Investigator, Corporacion Parc Tauli) — Principal investigator
First posted
Mar 22, 2013
Start date
Mar 2013
Primary completion
Feb 2014
Completion
Apr 2014
Last update
Jun 2, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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