Diuresis, Functional Bladder Capacity and LUTS in CKD and... | NCT04622215

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

NCT04622215

Sponsor

Universitair Ziekenhuis Brussel

Status

Completed

Last Update Posted

Nov 16, 2020Actual

Enrollment

128Actual

Phase

Not Applicable

Conditions

Lower Urinary Tract Symptoms
End Stage Renal Disease

Interventions

ICIQ questionnaire

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

May 31, 2019Actual

Completion Date

Jul 1, 2019Actual

First Submitted Date

Dec 5, 2018

First Submission Date that Met QC Criteria

Nov 6, 2020

First Posted Date

Nov 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2020

Last Update Posted Date

Nov 16, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

128Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ICIQ questionnaire	Other		Diagnostic Test: ICIQ questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ICIQ questionnaire	Diagnostic Test	questionnaire	ICIQ questionnaire

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
veerle de boe, md	universitair ziekenhuis VUB	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Valida		Brussels	Brussels Capital	1082	Belgium
universitair ziekenhuis VUB

Condition Browse Module

MeSH Terms

ID	Term
D059411	Lower Urinary Tract Symptoms
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D051436	Renal Insufficiency, Chronic

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Browse Branches

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