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

November 12, 2020 updated by: Universitair Ziekenhuis Brussel

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Brussels Hoofdstedelijk Gewest
      • Brussel, Brussels Hoofdstedelijk Gewest, Belgium, 1082
        • Valida
    • Vlaams Brabant
      • Jette, Vlaams Brabant, Belgium, 1090
        • universitair ziekenhuis VUB
      • Vilvoorde, Vlaams Brabant, Belgium, 1800
        • AZ Jan Portaels

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ICIQ questionnaire
Diagnostic test: ICIQ questionnaire
questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of LUTS in ESRD by ICIQ questionnaire
Time Frame: up to 6 month
A ICIQ male or female LUTS questionnaire will be taken by investigator in all patient who signed IC.
up to 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of bladder capacity in ESRD
Time Frame: 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
up to 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: veerle de boe, md, universitair ziekenhuis VUB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

December 5, 2018

First Submitted That Met QC Criteria

November 6, 2020

First Posted (Actual)

November 9, 2020

Study Record Updates

Last Update Posted (Actual)

November 16, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-284

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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