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

Diuresis, Functional Bladder Capacity and LUTS (Lower Urinary Tract Symptoms) in CKD (Chronic Kidney Disease) and ESRD (End Stage Renal Disease) Patients.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04622215

Enrollment

128

Registered

2020-11-09

Start date

2019-01-01

Completion date

2019-07-01

Last updated

2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Lower Urinary Tract Symptoms

Keywords

Lower Urinary Tract Symptoms, End Stage Renal Disease

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

Interventions

DIAGNOSTIC_TESTICIQ questionnaire

questionnaire

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
prevalence of LUTS in ESRD by ICIQ questionnaire	up to 6 month	A ICIQ male or female LUTS questionnaire will be taken by investigator in all patient who signed IC.

Secondary

Measure	Time frame	Description
evaluation of bladder capacity in ESRD	up to 6 month	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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026