TUCSON Study: Tackling Underlying Causes of Sleep Related Nocturia Nocturia
NCT ID: NCT05404828
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
65 participants
OBSERVATIONAL
2022-02-28
2024-01-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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OSAS
All adult patients consulting the pneumology department for possible OSAS with \>1x/night nocturia
Polysomnography
Polysomnography: WASO, FUSP, TST, TIB, SEF, Global Wake Index, Sleep Latency, AHI
Questionnaires
STOP-BANG, ISI, ESS, PSQI, MTCQ, ICIQ-F/MLUTS, IRLS, TANGO, SF36
Blood and urine sample
Na, K, Creat, Osm, Urea
Insomnia
All adult patients consulting the center for integrative medicine for insomnia with \>1x/night nocturia
Polysomnography
Polysomnography: WASO, FUSP, TST, TIB, SEF, Global Wake Index, Sleep Latency, AHI
Questionnaires
STOP-BANG, ISI, ESS, PSQI, MTCQ, ICIQ-F/MLUTS, IRLS, TANGO, SF36
Blood and urine sample
Na, K, Creat, Osm, Urea
Urological
All adult patients consulting the urology department with \>1x/night nocturia
Polysomnography
Polysomnography: WASO, FUSP, TST, TIB, SEF, Global Wake Index, Sleep Latency, AHI
Questionnaires
STOP-BANG, ISI, ESS, PSQI, MTCQ, ICIQ-F/MLUTS, IRLS, TANGO, SF36
Blood and urine sample
Na, K, Creat, Osm, Urea
Interventions
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Polysomnography
Polysomnography: WASO, FUSP, TST, TIB, SEF, Global Wake Index, Sleep Latency, AHI
Questionnaires
STOP-BANG, ISI, ESS, PSQI, MTCQ, ICIQ-F/MLUTS, IRLS, TANGO, SF36
Blood and urine sample
Na, K, Creat, Osm, Urea
Eligibility Criteria
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Inclusion Criteria
* Nocturia 2x/night or more
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University Ghent
OTHER
University Hospital, Ghent
OTHER
Responsible Party
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Locations
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Ghent University Hospital
Ghent, East-Fanders, Belgium
Countries
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Other Identifiers
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BC-10535
Identifier Type: -
Identifier Source: org_study_id
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