NocturiaTUCSONNCT05404828
TUCSON Study: Tackling Underlying Causes of Sleep Related Nocturia Nocturia
An observational study of Nocturia and Insomnia, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The TUCSON study is a cross-sectional observational monocentric study. In order to provide a clinical helpful assessment for urologists for possible missed causes of nocturia, the aim is to investigate the voiding and sleep pattern through questionnaires and sleep and voiding diaries of patients consulting the urology… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Polysomnography, Questionnaires and Blood and urine sample
- How many people
- 65 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Feb 2022to 30 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be included by their treating physician from either the urology department for complaints of nocturia, the pneumology department for OSAS or the center for integrative medicine for insomnia complaints.
Who may be able to join
- All adult patients >18 years
- Nocturia 2x/night or more
Who cannot join
- current UTI
- SNM during the last year
- Botox during the last year
- working night shifts during the past 2 weeks
- Pregnant or breastfeeding women
- PTNS/SANS during the past 2 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TUCSON Study: Tackling Underlying Causes of Sleep Related Nocturia
The TUCSON study is a cross-sectional observational monocentric study. In order to provide a clinical helpful assessment for urologists for possible missed causes of nocturia, the aim is to investigate the voiding and sleep pattern through questionnaires and sleep and voiding diaries of patients consulting the urology department, sleep clinic and pneumology department. An assessment of the prevalence of missed underlying causes will be made and a subset of patients will be asked to deliver urine samples from every night time and first morning void to further investigate possible differences in urine content between the groups. First of all, with this research the aim to offer an idea about the order of magnitude for missed underlying causes of nocturia. Secondly, to discover a specific sleep and voiding pattern for the different entities of nocturia and thirdly, to offer a useful screening tool for underlying pathology in clinical practice.
Read the detailed description
Study rationale and unmet medical need:
In current urological practice, patients complaining from nocturia are not systematically screened for underlying pathology that could cause their nocturnal voiding complaints. Even though guidelines recommend screening for other factors besides the urological ones, it remains difficult to implement these strategies in daily practice during consultation. Clear cut questionnaires to screen for OSAS or underlying sleep disorders remain cumbersome and it is yet to be investigated if there is a difference in voiding and sleep pattern between the different causal entities of nocturia.
In order to provide a clinical helpful assessment for urologists for possible missed causes of nocturia, we aim to investigate the voiding and sleep pattern through questionnaires and sleep and voiding diaries in patients consulting the urology department, sleep clinic and pneumology department. An assessment of the prevalence of missed underlying causes will be made and a subset of patients will be asked to deliver urine samples from every night time and first morning void to further investigate possible differences in urine content between the groups.
First of all, with this research the aim is to offer an idea about the order of magnitude for missed underlying causes of nocturia. Secondly, to offer a useful screening tool for underlying pathology in clinical practice and thirdly, to discover a specific sleep and voiding pattern for the different entities of nocturia.
Study objectives:
- To gather cross-sectional information about the underlying cause of nocturia in patients consulting a urologist, sleep specialist or pneumologist.
- The collected data will be saved in a protected and pseudonymised database.
- Sleep, urinary symptoms, sleep apnea and quality of life will be assessed through appropriate questionnaires that patients will need to fill in before treatment.
- The tango questionnaire will be compared to the results from the above mentioned questionnaires in order to assess the value of the Tango questionnaire as a complete screening tool for underlying causes of nocturia, even in first line practice.
- A subset of patients will be asked to take urine samples from every night time and first void in the morning during one night, with a fasting blood collection the following morning. For patients undergoing a PSG, the urine collection and blood draw will be collected during that night.
- Patients will be asked to keep a 7 day nighttime only voiding diary, a 7 day sleep diary and a 3 day FVC. Patients undergoing a PSG will be asked to fill in the last day of their sleep and voiding diary during that night.
- Validation of the FUSP (First Uninterrupted Sleep Period) concept, by comparing data from the PSG to the sleep and voiding diaries.
- Information on comorbidities, medical history and medication use will be derived from the electronic patient files.
- Being tested
- Polysomnography, Questionnaires, Blood and urine sample
- Keywords
- Nocturia, Insomnia, Sleep Apnea, Obstructive, Polysomnography
- Medical subject headings
- Nocturia, Sleep Initiation and Maintenance Disorders, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyOther
Polysomnography: WASO, FUSP, TST, TIB, SEF, Global Wake Index, Sleep Latency, AHI
QuestionnairesOther
STOP-BANG, ISI, ESS, PSQI, MTCQ, ICIQ-F/MLUTS, IRLS, TANGO, SF36
Blood and urine sampleOther
Na, K, Creat, Osm, Urea
| Study group | Role | What they receive |
|---|---|---|
| OSAS | All adult patients consulting the pneumology department for possible OSAS with >1x/night nocturia Receives: Other: Polysomnography; Other: Questionnaires; Other: Blood and urine sample | |
| Insomnia | All adult patients consulting the center for integrative medicine for insomnia with >1x/night nocturia Receives: Other: Polysomnography; Other: Questionnaires; Other: Blood and urine sample | |
| Urological | All adult patients consulting the urology department with >1x/night nocturia Receives: Other: Polysomnography; Other: Questionnaires; Other: Blood and urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voiding pattern
Differences in voiding frequency volume charts
Measured: 1 week
Secondary outcomes (2)
Sleep pattern
Differences in sleeping parameters derived from PSG and sleep diaries. The combined measurements will provide information on sleep quality, total sleep time, the number of awakenings etc
Measured: 1 week
Solute excretion
Differences in urinary composition: Na, Urea, Osm, Creat
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start28 Feb 2022
- Primary completion30 Jan 2024
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NocturiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404828
- Sponsor's protocol ID
- BC-10535
- Acronym
- TUCSON
- Status last verified
- Sep 2024
- First submitted
- 19 May 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verbakel I, Boukheir G, Bliwise D, Vogelaers D, Mariman A, Everaert K. Deciphering Sleepless Nights: Nocturia Analyzed Through a CART-Based Predictive Model in Patients With Insomnia. Retrospective Data From the TUCSON Study. Neurourol Urodyn. 2026 Jun 8. doi: 10.1002/nau.70318. Online ahead of print.
PubMed 42257317
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TUCSON Study: Tackling Underlying Causes of Sleep Related Nocturia
- ClinicalTrials.gov ID
- NCT05404828
- Acronym / sponsor ID
- TUCSON / BC-10535
- Keywords
- Nocturia, Insomnia, Sleep Apnea, Obstructive, Polysomnography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 3 Jun 2022 (actual)
- 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 TUCSON study is a cross-sectional observational monocentric study. In order to provide a clinical helpful assessment for urologists for possible missed causes of nocturia, the aim is to investigate the voiding and sleep pattern through questionnaires and sleep and voiding diaries of patients consulting the urology department, sleep clinic and pneumology department. An assessment of the prevalence of missed underlying causes will be made and a subset of patients will be asked to deliver urine samples from every night time and first morning void to further investigate possible differences in urine content between the groups. First of all, with this research the aim to offer an idea about the order of magnitude for missed underlying causes of nocturia. Secondly, to discover a specific sleep and voiding pattern for the different entities of nocturia and thirdly, to offer a useful screening tool for underlying pathology in clinical practice.
Detailed description
Study rationale and unmet medical need:
In current urological practice, patients complaining from nocturia are not systematically screened for underlying pathology that could cause their nocturnal voiding complaints. Even though guidelines recommend screening for other factors besides the urological ones, it remains difficult to implement these strategies in daily practice during consultation. Clear cut questionnaires to screen for OSAS or underlying sleep disorders remain cumbersome and it is yet to be investigated if there is a difference in voiding and sleep pattern between the different causal entities of nocturia.
In order to provide a clinical helpful assessment for urologists for possible missed causes of nocturia, we aim to investigate the voiding and sleep pattern through questionnaires and sleep and voiding diaries in patients consulting the urology department, sleep clinic and pneumology department. An assessment of the prevalence of missed underlying causes will be made and a subset of patients will be asked to deliver urine samples from every night time and first morning void to further investigate possible differences in urine content between the groups.
First of all, with this research the aim is to offer an idea about the order of magnitude for missed underlying causes of nocturia. Secondly, to offer a useful screening tool for underlying pathology in clinical practice and thirdly, to discover a specific sleep and voiding pattern for the different entities of nocturia.
Study objectives:
- To gather cross-sectional information about the underlying cause of nocturia in patients consulting a urologist, sleep specialist or pneumologist.
- The collected data will be saved in a protected and pseudonymised database.
- Sleep, urinary symptoms, sleep apnea and quality of life will be assessed through appropriate questionnaires that patients will need to fill in before treatment.
- The tango questionnaire will be compared to the results from the above mentioned questionnaires in order to assess the value of the Tango questionnaire as a complete screening tool for underlying causes of nocturia, even in first line practice.
- A subset of patients will be asked to take urine samples from every night time and first void in the morning during one night, with a fasting blood collection the following morning. For patients undergoing a PSG, the urine collection and blood draw will be collected during that night.
- Patients will be asked to keep a 7 day nighttime only voiding diary, a 7 day sleep diary and a 3 day FVC. Patients undergoing a PSG will be asked to fill in the last day of their sleep and voiding diary during that night.
- Validation of the FUSP (First Uninterrupted Sleep Period) concept, by comparing data from the PSG to the sleep and voiding diaries.
- Information on comorbidities, medical history and medication use will be derived from the electronic patient files.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OSAS | – | Other: Polysomnography, Other: Questionnaires, Other: Blood and urine sampleAll adult patients consulting the pneumology department for possible OSAS with >1x/night nocturia |
| Insomnia | – | Other: Polysomnography, Other: Questionnaires, Other: Blood and urine sampleAll adult patients consulting the center for integrative medicine for insomnia with >1x/night nocturia |
| Urological | – | Other: Polysomnography, Other: Questionnaires, Other: Blood and urine sampleAll adult patients consulting the urology department with >1x/night nocturia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be included by their treating physician from either the urology department for complaints of nocturia, the pneumology department for OSAS or the center for integrative medicine for insomnia complaints.
Key inclusion criteria (2 listed)
- All adult patients >18 years
- Nocturia 2x/night or more
Key exclusion criteria (6 listed)
- current UTI
- SNM during the last year
- Botox during the last year
- working night shifts during the past 2 weeks
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographyPolysomnography: WASO, FUSP, TST, TIB, SEF, Global Wake Index, Sleep Latency, AHI | Other | Insomnia, OSAS, Urological |
| QuestionnairesSTOP-BANG, ISI, ESS, PSQI, MTCQ, ICIQ-F/MLUTS, IRLS, TANGO, SF36 | Other | Insomnia, OSAS, Urological |
| Blood and urine sampleNa, K, Creat, Osm, Urea | Other | Insomnia, OSAS, Urological |
Primary outcome
Voiding pattern
Time frame: 1 week
Differences in voiding frequency volume charts
2 secondary outcomes
Sleep pattern
Time frame: 1 week
Solute excretion
Time frame: 1 night
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 19 Sep 2024.
- Derived from this study: PubMed 42257317Verbakel I, Boukheir G, Bliwise D, Vogelaers D, Mariman A, Everaert K. Deciphering Sleepless Nights: Nocturia Analyzed Through a CART-Based Predictive Model in Patients With Insomnia. Retrospective Data From the TUCSON Study. Neurourol Urodyn. 2026 Jun 8. doi: 10.1002/nau.70318. Online ahead of print.
- Individual participant dataSharing planned: No
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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 and Insomnia, run by University Hospital, Ghent at 1 site in Belgium.
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 2 inclusion and 6 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 19 Sep 2024. 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 Belgium. 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?
Voiding pattern (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05404828, which also lists 1 linked publication.
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 19 Sep 2024.