End Stage Renal Disease Clinical Trial
Official title:
Diuresis, Functional Bladder Capacity and LUTS (Lower Urinary Tract Symptoms) in CKD (Chronic Kidney Disease) and ESRD (End Stage Renal Disease) Patients.
NCT number | NCT04622215 |
Other study ID # | 2018-284 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2019 |
Est. completion date | July 1, 2019 |
Verified date | October 2018 |
Source | Universitair Ziekenhuis Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 128 |
Est. completion date | July 1, 2019 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Valida | Brussel | Brussels Hoofdstedelijk Gewest |
Belgium | universitair ziekenhuis VUB | Jette | Vlaams Brabant |
Belgium | AZ Jan Portaels | Vilvoorde | Vlaams Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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