Early (Postoperative Day 3) Versus Standard (Postoperative Day 6) Urethral Catheter Removal After Living Donor Kidney Transplantation: A Prospective Randomized Controlled Trial
(EARLY-KTx)
Early Versus Standard Urethral Catheter Removal After Kidney Transplantation
1 other identifier
interventional
172
1 country
1
Brief Summary
Urinary tract infection is one of the most common complications after kidney transplantation and is associated with increased morbidity, prolonged hospitalization, and impaired graft outcomes. The duration of urethral catheterization is a modifiable risk factor for catheter-associated urinary tract infection. This randomized controlled trial compares early catheter removal on postoperative day 3 with standard catheter removal on postoperative day 6 in living donor kidney transplant recipients. The primary objective is to determine whether early catheter removal reduces 30-day urinary tract infections without increasing urinary complications requiring intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2026
CompletedFirst Submitted
Initial submission to the registry
June 27, 2026
CompletedFirst Posted
Study publicly available on registry
July 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
July 2, 2026
June 1, 2026
1.1 years
June 27, 2026
June 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Thirty-day urinary tract infection
Incidence of symptomatic urinary tract infection or asymptomatic bacteriuria confirmed by urine culture according to predefined study criteria.
30 days after transplantation
Secondary Outcomes (4)
Urinary leak requiring intervention
30 days
Ureteral stenosis requiring intervention
12 months
Acute urinary retention requiring re-catheterization
5 days
Length of hospital stay
From transplantation until hospital discharge (approximately 30 days)
Study Arms (2)
Early Catheter Removal
EXPERIMENTALUrethral catheter removal on postoperative day 3 (72 ± 6 hours).
Standard Catheter Removal
ACTIVE COMPARATORUrethral catheter removal on postoperative day 6 (144 ± 12 hours).
Interventions
Participants randomized to the experimental arm will undergo removal of the indwelling transurethral Foley catheter on postoperative day 3 (72 ± 6 hours) following living donor kidney transplantation. All participants will receive standardized perioperative care, including routine double-J ureteral stent placement, standardized antibiotic prophylaxis, standardized drain management, and identical postoperative monitoring. After catheter removal, participants will be assessed for spontaneous voiding, urinary retention, post-void residual volume, urinary tract infection, and urinary complications according to the study protocol. If clinically indicated, temporary recatheterization will be performed using predefined protocol criteria.
Participants randomized to the control arm will undergo removal of the indwelling transurethral Foley catheter on postoperative day 6 (144 ± 12 hours) following living donor kidney transplantation. All other perioperative and postoperative management will be identical to the experimental arm, including standardized surgical technique, ureteral stent placement, antibiotic prophylaxis, drain management, postoperative monitoring, and follow-up. Outcomes will be assessed using the same predefined protocol and follow-up schedule.
Eligibility Criteria
You may qualify if:
- Age ≥18 years Living donor kidney transplantation Pre-emptive kidney transplantation Preserved urine output Ability to provide written informed consent
You may not qualify if:
- Previous bladder or urethral surgery Complex urinary tract reconstruction Neurogenic bladder Active urinary tract infection at transplantation Pregnancy BMI \<18 or \>40 kg/m² Intraoperative blood loss \>1000 mL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fahim Kananilead
- Rabin Medical Centercollaborator
Study Sites (1)
Gray Faculty of Tel Aviv
Petah Tikva, 4941492, Israel
Related Publications (1)
Zomorrodi A, et al. The best time to remove urinary catheter in kidney transplant patients. Journal of Nephropathology. 2018;7(4):290-294. Bezherano I, Kayler LK. Removal of Foley Catheters on Postoperative Day 1 After Kidney Transplantation. Kidney Medicine. 2022;4(8):100509. Castelo M, et al. Early urinary catheter removal after rectal surgery: systematic review and meta-analysis. BJS Open. 2020;4(4):545-553. European Renal Best Practice Guidelines. Nephrology Dialysis Transplantation. 2015;30(11):1790-1797. CDC Guidelines for Prevention of Catheter-Associated Urinary Tract Infections. 2019. Bezherano I, Kayler LK. Removal of Foley Catheters on Postoperative Day 1 After Kidney Transplantation. Kidney Medicine. 2022;4(8):100509. Zomorrodi A, et al. The best time to remove urinary catheter in kidney transplant patients. Journal of Nephropathology. 2018;7(4):290-294. European Renal Best Practice (ERBP) Guideline on Kidney Donor and Recipient Care. Nephrology Dialysis Transplantation. 2015.
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The intervention cannot be blinded because catheter removal timing is apparent to participants and treating clinicians. Outcome assessment will be performed by investigators blinded to treatment allocation whenever feasible.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD - assistent professor
Study Record Dates
First Submitted
June 27, 2026
First Posted
July 2, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
May 30, 2027
Study Completion (Estimated)
December 30, 2027
Last Updated
July 2, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Beginning 6 months after publication of the primary manuscript.
- Access Criteria
- Access to de-identified individual participant data (IPD) and supporting study documents will be available to qualified researchers who submit a scientifically sound research proposal. Requests must be submitted to the Principal Investigator and approved by the study investigators and Rabin Medical Center in accordance with institutional policies. Approved investigators will receive access to the de-identified dataset, study protocol, statistical analysis plan, and data dictionary after execution of a Data Use Agreement (DUA) and any required ethics approvals. Data will be provided through a secure electronic transfer or institutional data-sharing platform and may be used only for the purposes described in the approved proposal.
De-identified individual participant data (IPD) underlying the results reported in the primary publication, including demographic characteristics, baseline clinical variables, intervention assignment, primary and secondary outcome measures, and the study data dictionary, will be made available to qualified researchers upon reasonable request. Data will be shared only after publication of the primary study results, following approval by the study investigators and Rabin Medical Center, execution of an appropriate data use agreement, and confirmation that the proposed use is scientifically and ethically appropriate. All shared data will be fully de-identified in accordance with applicable privacy regulations and institutional policies.