Diuresis, Functional Bladder Capacity and LUTS (Lower Urinary Tract Symptoms) in CKD (Chronic Kidney Disease) and ESRD (End Stage Renal Disease) Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 6
- 主要终点
- prevalence of LUTS in ESRD by ICIQ questionnaire
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18years old
- •GFR(CKD-Epi) < 45 ml/min and persisting minimal diuresis
- •able to read and understand Dutch, French or English
排除标准
- •<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.
结局指标
主要结局
prevalence of LUTS in ESRD by ICIQ questionnaire
时间窗: up to 6 month
A ICIQ male or female LUTS questionnaire will be taken by investigator in all patient who signed IC.
次要结局
- evaluation of bladder capacity in ESRD(up to 6 month)