Clinical trial NCT04622215: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lower Urinary Tract Symptoms
End Stage Renal Disease
Keywords: Lower Urinary Tract Symptoms
End Stage Renal Disease
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

Primary outcomes:
measure: prevalence of LUTS in ESRD by ICIQ questionnaire
timeFrame: up to 6 month
Secondary outcomes:
measure: evaluation of bladder capacity in ESRD
timeFrame: up to 6 month
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Valida
state: Brussels Hoofdstedelijk Gewest
city: Jette
country: Belgium
facility: universitair ziekenhuis VUB
state: Vlaams Brabant
city: Vilvoorde
country: Belgium
facility: AZ Jan Portaels
state: Vlaams Brabant
Study officials:
affiliation: universitair ziekenhuis VUB
name: veerle de boe, md
role: PRINCIPAL_INVESTIGATOR
References: