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

NCT ID: NCT04622215

Last Updated: 2020-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-07-01

Brief Summary

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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

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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

Conditions

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Lower Urinary Tract Symptoms End Stage Renal Disease

Keywords

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Lower Urinary Tract Symptoms End Stage Renal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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ICIQ questionnaire

Group Type OTHER

ICIQ questionnaire

Intervention Type DIAGNOSTIC_TEST

questionnaire

Interventions

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ICIQ questionnaire

questionnaire

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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veerle de boe, md

Role: PRINCIPAL_INVESTIGATOR

universitair ziekenhuis VUB

Locations

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Valida

Brussels, Brussels Capital, Belgium

Site Status

universitair ziekenhuis VUB

Jette, Vlaams Brabant, Belgium

Site Status

AZ Jan Portaels

Vilvoorde, Vlaams Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2018-284

Identifier Type: -

Identifier Source: org_study_id