Functional Urodynamic Changes in Chronic Kidney Disease Patients and Does Insertion of Urinary Catheter Delay the Need for Kidney Dialysis

Assaf Harofeh MC

Status: Unknown

Conditions: Renal Insufficiency, Chronic

Treatments: Device: urinary catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02731209

0308-15-ASF

Details and patient eligibility

About

The aim of the investigators work is to describe the urodynamic results in the CKD (chronic kidney disease) grade 4 patients and to verify observations that urinary catheter may improve kidney function in those patients.

100 patients with CKD grade 4 will do urodynamic examination.

All patients will be randomized into two groups / the intervention group that will be inserted urinary catheter for 2 weeks and the follow up group. Kidney function will be monitored by creatinin values and the investigators will measure the time to dialysis in the two groups.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > 18
• chronic kidney disease grade 4-5 (eGFR (estimated glomerular filtration rate) <30)
• eligible to sign a consent form

Exclusion criteria

• non controlled Diabetes Melitus (HbA1C>10%)
• not controlled HTN (Hypertension)
• cardiovascular event requiring cardiac stenting
• renal hydronephrosis or post void rest > 200CC according to US (Ultrasound)
• acute renal failure
• not eligible for urodynamics for any reason
• constant urinary catheter for any reason

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

catheter insertion for 2 weeks

Experimental group

Description:

50 randomized patients that will do urodynamic urinary examination and will be inserted urinary catheter for 2 weeks

Treatment:

Device: urinary catheter

follow up

No Intervention group

Description:

50 randomized patients that will do urodynamic urinary examination and will be regularly followed by nephrologist