Clinical trial NCT05404828: TUCSON Study: Tackling Underlying Causes of Sleep Related Nocturia Nocturia
Official title: TUCSON Study: Tackling Underlying Causes of Sleep Related Nocturia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nocturia
Insomnia
OSA
Keywords: Nocturia
Insomnia
Sleep Apnea, Obstructive
Polysomnography
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2022-06-03
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* All adult patients \>18 years
* Nocturia 2x/night or more

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Voiding pattern
timeFrame: 1 week
Secondary outcomes:
measure: Sleep pattern
timeFrame: 1 week
measure: Solute excretion
timeFrame: 1 night
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: East-Fanders
Study officials:
References: