Diuresis, Functional Bladder Capacity and LUTS in CKD and ESRD Patients.

Universitair Ziekenhuis Brussel

Status: Completed

Conditions: Lower Urinary Tract Symptoms; End Stage Renal Disease

Treatments: Diagnostic Test: ICIQ questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT04622215

2018-284

Details and patient eligibility

About

The aim of the study is to evaluate the prevalence of LUTS in patients with moderate to severe (Stage IIIb), severe (Stage IV) CKD and ESRD : Stage V CKD) without renal transplantation (both pre-dialysis and dialysis patients). The study will also investigate the correlation between the diuresis, functional bladder capacity and LUTS in this population.

By means of the obtained results, the investigators hope to be able to predict at which values of diuresis and functional bladder capacity these patients will start to develop LUTS. The investigators will also evaluate the impact of LUTS on the quality of life of these patients.

Full description

Pre-dialysis and peritoneal dialysis (home dialysis) and hemodialysis patients will be asked to fill in a 24h voiding diary the day prior to the control visit or dialysis session, or this can be registered the day of planned 24h urine collection.

All patients will be asked to fill a ICIQ-LUTS questionnaire. The ICIQ-LUTS questionnaire is a validated questionnaire to investigate the presence of LUTS in a non-invasive way: ICIQ-FLUTS(female lower urinary tract symptoms) for female patients and ICIQ-MLUTS(male lower urinary tract symptoms) for male patients.

Following patient data will be registered:

• Age
• Gender
• eGFR(estimated Glomerular Filtration Rate) (CKD-EPD)
• Cause of CKD-ESRD
• In case of dialysis: duration modality (hemodialysis or peritoneal dialysis)
• Antecedents
• Comorbidities
• Medication
• 24h voiding diary
• LUTS questionnaire

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >18years old
• GFR(CKD-Epi) < 45 ml/min and persisting minimal diuresis
• able to read and understand Dutch, French or English

Exclusion criteria

• <18 years old
• eGFR (CKD-EPI) > 45 ml/min
• eGFR (CKD-EPI) < 45 ml/min and > 3 months absent persisting minimal diuresis
• unable to read and understand Dutch, French or English
• renal transplant recipients.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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128 participants in 1 patient group

ICIQ questionnaire

Other group

Treatment:

Diagnostic Test: ICIQ questionnaire