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

End Stage Renal Disease Clinical Trial

Official title:

Diuresis, Functional Bladder Capacity and LUTS (Lower Urinary Tract Symptoms) in CKD (Chronic Kidney Disease) and ESRD (End Stage Renal Disease) Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04622215
• Other study ID #: 2018-284
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: October 2018
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: July 1, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Lower Urinary Tract Symptoms

Intervention

Diagnostic Test:
• ICIQ questionnaire
questionnaire

Locations

Country	Name	City	State
Belgium	Valida	Brussel	Brussels Hoofdstedelijk Gewest
Belgium	universitair ziekenhuis VUB	Jette	Vlaams Brabant
Belgium	AZ Jan Portaels	Vilvoorde	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of LUTS in ESRD by ICIQ questionnaire	A ICIQ male or female LUTS questionnaire will be taken by investigator in all patient who signed IC.	up to 6 month
Secondary	evaluation of bladder capacity in ESRD	Patient will be asked to keep an 24hour voiding diary This consist in keeping a record of the time of voiding and the volume of urine passed in ml each void. This will be measured in milliliter	up to 6 month