TUCSON Study: Tackling Underlying Causes of Sleep Related Nocturia Nocturia

NCT05404828 | Completed DMC

• 1 other identifier: BC-10535
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Nocturia; Insomnia; OSA

Keywords

Nocturia; Insomnia; Sleep Apnea, Obstructive; Polysomnography

Outcome Measures

Primary Outcomes (1)

• Voiding pattern

  Differences in voiding frequency volume charts

  1 week

Secondary Outcomes (2)

• Sleep pattern

  1 week

• Solute excretion

  1 night

Study Arms (3)

OSAS

All adult patients consulting the pneumology department for possible OSAS with \>1x/night nocturia

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

Other: Polysomnography; Other: Questionnaires; Other: Blood and urine sample

Urological

All adult patients consulting the urology department with \>1x/night nocturia

Other: Polysomnography; Other: Questionnaires; Other: Blood and urine sample

Interventions

Polysomnography OTHER

Polysomnography: WASO, FUSP, TST, TIB, SEF, Global Wake Index, Sleep Latency, AHI

Insomnia; OSAS; Urological

Questionnaires OTHER

STOP-BANG, ISI, ESS, PSQI, MTCQ, ICIQ-F/MLUTS, IRLS, TANGO, SF36

Insomnia; OSAS; Urological

Blood and urine sample OTHER

Na, K, Creat, Osm, Urea

Insomnia; OSAS; Urological

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, East-Fanders, 9000, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and urine

MeSH Terms

Conditions

Nocturia; Sleep Initiation and Maintenance Disorders; Sleep Apnea, Obstructive

Interventions

Surveys and Questionnaires; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: June 3, 2022
• Study Start: February 28, 2022
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)