Skip to main content
Clinical Trials/NCT04622215
NCT04622215
Completed
Not Applicable

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

Universitair Ziekenhuis Brussel3 sites in 1 country128 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lower Urinary Tract Symptoms
Sponsor
Universitair Ziekenhuis Brussel
Enrollment
128
Locations
3
Primary Endpoint
prevalence of LUTS in ESRD by ICIQ questionnaire
Status
Completed
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
July 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

prevalence of LUTS in ESRD by ICIQ questionnaire

Time Frame: up to 6 month

A ICIQ male or female LUTS questionnaire will be taken by investigator in all patient who signed IC.

Secondary Outcomes

  • evaluation of bladder capacity in ESRD(up to 6 month)

Study Sites (3)

Loading locations...

Similar Trials