Diuresis, Functional Bladder Capacity and LUTS in CKD and ESRD Patients.
Primary Purpose
Lower Urinary Tract Symptoms, End Stage Renal Disease
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
ICIQ questionnaire
Sponsored by
About this trial
This is an interventional health services research trial for Lower Urinary Tract Symptoms focused on measuring Lower Urinary Tract Symptoms, End Stage Renal Disease
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.
Sites / Locations
- Valida
- universitair ziekenhuis VUB
- AZ Jan Portaels
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ICIQ questionnaire
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04622215
First Posted
December 5, 2018
Last Updated
November 12, 2020
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT04622215
Brief Title
Diuresis, Functional Bladder Capacity and LUTS in CKD and ESRD Patients.
Official Title
Diuresis, Functional Bladder Capacity and LUTS (Lower Urinary Tract Symptoms) in CKD (Chronic Kidney Disease) and ESRD (End Stage Renal Disease) Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms, End Stage Renal Disease
Keywords
Lower Urinary Tract Symptoms, End Stage Renal Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICIQ questionnaire
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
ICIQ questionnaire
Intervention Description
questionnaire
Primary Outcome Measure Information:
Title
prevalence of LUTS in ESRD by ICIQ questionnaire
Description
A ICIQ male or female LUTS questionnaire will be taken by investigator in all patient who signed IC.
Time Frame
up to 6 month
Secondary Outcome Measure Information:
Title
evaluation of bladder capacity in ESRD
Description
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
Time Frame
up to 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
veerle de boe, md
Organizational Affiliation
universitair ziekenhuis VUB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valida
City
Brussel
State/Province
Brussels Hoofdstedelijk Gewest
ZIP/Postal Code
1082
Country
Belgium
Facility Name
universitair ziekenhuis VUB
City
Jette
State/Province
Vlaams Brabant
ZIP/Postal Code
1090
Country
Belgium
Facility Name
AZ Jan Portaels
City
Vilvoorde
State/Province
Vlaams Brabant
ZIP/Postal Code
1800
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Diuresis, Functional Bladder Capacity and LUTS in CKD and ESRD Patients.
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