NocturiaNCT01816724
Spanish (Spain) Validation of a Specific Symptomatic Questionnaire for Patients With Nocturia
An observational study of Nocturia, run by Corporacion Parc Tauli at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Nocturia
- How many people
- 129 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men older than 60 years old suffering from nocturia (one or more voidings overnight) without exclusion criteria
Who may be able to join
- Men and women
- Older than 60 years old
- One or more voidings overnight
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Nocturia
- Keywords
- NOCTURIA, SYMPTOMATIC QUESTIONNAIRE, N-QOL
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
score in n-QoL questionnaire
Measured: two determinations in ten days
Secondary outcomes (3)
score in IPSS spanish validated questionnaire
Measured: two determinations in ten days (only men)
score in Pittsburgh Sleep Quality Index spanish validated questionnaire
Measured: two determinations in ten days
score in King's health spanish validated questionnaire
Measured: two determinations in ten days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EDUARDO VICENTE PALACIO, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816724
- Sponsor's protocol ID
- CSPT/URO/2013/546
- Status last verified
- May 2017
- First submitted
- 20 Mar 2013
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spanish (Spain) Validation of a Specific Symptomatic Questionnaire for Patients With Nocturia
- ClinicalTrials.gov ID
- NCT01816724
- Acronym / sponsor ID
- CSPT/URO/2013/546
- Conditions
- Nocturia
- Keywords
- NOCTURIA, SYMPTOMATIC QUESTIONNAIRE, N-QOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men older than 60 years old suffering from nocturia (one or more voidings overnight) without exclusion criteria
Key inclusion criteria (3 listed)
- Men and women
- Older than 60 years old
- One or more voidings overnight
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
score in n-QoL questionnaire
Time frame: two determinations in ten days
3 secondary outcomes
score in IPSS spanish validated questionnaire
Time frame: two determinations in ten days (only men)
score in Pittsburgh Sleep Quality Index spanish validated questionnaire
Time frame: two determinations in ten days
score in King's health spanish validated questionnaire
Time frame: two determinations in ten days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nocturia, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score in n-QoL questionnaire (time frame: two determinations in ten days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.