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OpenTrials
Completed

NCT Number: NCT04622215

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

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.

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Key information

Conditions

Lower Urinary Tract Symptoms Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valida, Brussels, Brussels Capital, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ICIQ questionnaire

Diagnostic Test

questionnaire

Primary outcomes

  1. 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

  1. evaluation of bladder capacity in ESRD

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 9, 2020
Registry last updated
Nov 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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