TUCSON Study: Tackling Underlying Causes Of Sleep Related Nocturia Nocturia

Insomnia Clinical Trial

— TUCSON  

Official title:

TUCSON Study: Tackling Underlying Causes Of Sleep Related Nocturia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05404828
• Other study ID #: BC-10535
• Status: Recruiting
• Start date: February 28, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: University Hospital, Ghent
• Contact: Irina Verbakel, M.D.
• Phone: 003293322276
• Email: irina.verbakel[@]ugent.be
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Nocturia
• OSA
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• 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

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent	East-Fanders

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Voiding pattern	Differences in voiding frequency volume charts	1 week
Secondary	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	1 week
Secondary	Solute excretion	Differences in urinary composition: Na, Urea, Osm, Creat	1 night