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

Not Applicable

Completed

• Conditions: Lower Urinary Tract Symptoms; End Stage Renal Disease
• Interventions: Diagnostic Test: ICIQ questionnaire

• Registration Number: NCT04622215
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief 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.

Detailed 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

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-12-05
• Study Start: 2019-01-01
• Primary Completion: 2019-05-31
• Study Completion: 2019-07-01
• Study First Submitted QC: 2020-11-06
• Study First Posted: 2020-11-09
• Last Update Submitted: 2020-11-12
• Last Update Posted: 2020-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICIQ questionnaire	ICIQ questionnaire	-

Primary Outcome Measures

Name	Time	Method
prevalence of LUTS in ESRD by ICIQ questionnaire	up to 6 month	A ICIQ male or female LUTS questionnaire will be taken by investigator in all patient who signed IC.

Secondary Outcome Measures

Name	Time	Method
evaluation of bladder capacity in ESRD	up to 6 month	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

Trial Locations

Locations (3)

Valida; 🇧🇪 Brussel, Brussels Hoofdstedelijk Gewest, Belgium

universitair ziekenhuis VUB; 🇧🇪 Jette, Vlaams Brabant, Belgium

AZ Jan Portaels; 🇧🇪 Vilvoorde, Vlaams Brabant, Belgium