TUCSON Study: Tackling Underlying Causes of Sleep Related Nocturia Nocturia (TUCSON)

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; OSA; Nocturia
• Intervention / Treatment: Other: Polysomnography; Other: Questionnaires; Other: Blood and urine sample

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 Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• Belgium
  • East-Fanders
    • Ghent, East-Fanders, Belgium, 9000
      • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OSAS; All adult patients consulting the pneumology department for possible OSAS with >1x/night nocturia	Other: Polysomnography; Polysomnography: WASO, FUSP, TST, TIB, SEF, Global Wake Index, Sleep Latency, AHI; Other: Questionnaires; STOP-BANG, ISI, ESS, PSQI, MTCQ, ICIQ-F/MLUTS, IRLS, TANGO, SF36; Other: 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	Other: Polysomnography; Polysomnography: WASO, FUSP, TST, TIB, SEF, Global Wake Index, Sleep Latency, AHI; Other: Questionnaires; STOP-BANG, ISI, ESS, PSQI, MTCQ, ICIQ-F/MLUTS, IRLS, TANGO, SF36; Other: Blood and urine sample; Na, K, Creat, Osm, Urea
Urological; All adult patients consulting the urology department with >1x/night nocturia	Other: Polysomnography; Polysomnography: WASO, FUSP, TST, TIB, SEF, Global Wake Index, Sleep Latency, AHI; Other: Questionnaires; STOP-BANG, ISI, ESS, PSQI, MTCQ, ICIQ-F/MLUTS, IRLS, TANGO, SF36; Other: Blood and urine sample; Na, K, Creat, Osm, Urea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voiding pattern	Differences in voiding frequency volume charts	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Solute excretion	Differences in urinary composition: Na, Urea, Osm, Creat	1 night

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Polysomnography; Insomnia; Sleep Apnea, Obstructive; Nocturia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Sleep Initiation and Maintenance Disorders; Nocturia
• Other Study ID Numbers: BC-10535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No