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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Transplantation; Catheter-Associated Urinary Tract Infections (CAUTIs)
• Intervention / Treatment: Procedure: Early urethral catheter removal; Procedure: Standard urethral catheter removal

Detailed Description

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# Detailed Description

Urinary tract infection (UTI) is among the most frequent complications following kidney transplantation and remains a major source of postoperative morbidity. Catheter-associated urinary tract infections (CAUTIs) account for a substantial proportion of these infections because urethral catheterization is routinely performed after transplantation to protect the ureterovesical anastomosis, ensure continuous bladder drainage, and facilitate monitoring of urine output during the early postoperative period. However, prolonged catheterization increases the risk of bacterial colonization and infection, which may result in symptomatic UTI, pyelonephritis, bacteremia, prolonged hospitalization, increased healthcare costs, and potentially adverse graft outcomes.

The optimal duration of urethral catheterization after kidney transplantation remains uncertain. Current practice varies considerably among transplant centers, with catheter removal occurring anywhere from postoperative day (POD) 1 to POD 7 or later. This variation reflects the lack of high-quality randomized evidence balancing the potential benefits of earlier catheter removal against concerns regarding urinary retention, urinary leak, ureteral complications, and the need for catheter reinsertion.

Several observational studies and small randomized trials have suggested that early catheter removal may substantially reduce the incidence of postoperative urinary tract infections without increasing clinically significant urological complications. Nevertheless, differences in patient populations, surgical techniques, catheter removal protocols, and outcome definitions have limited the generalizability of previous findings. Consequently, no international consensus exists regarding the optimal timing of catheter removal after kidney transplantation.

The EARLY-KTx trial is a prospective, single-center, randomized controlled trial designed to compare early urethral catheter removal with standard catheter removal following living donor kidney transplantation. Eligible participants will be randomly assigned in a 1:1 ratio to undergo catheter removal either on postoperative day 3 (experimental group) or postoperative day 6 (standard care group). The study uses an open-label design because catheter removal timing cannot be concealed from participants or treating clinicians; however, whenever feasible, outcome assessment and data analysis will be performed by investigators blinded to treatment allocation (Prospective Randomized Open-label Blinded Endpoint [PROBE] design).

All participants will undergo standardized kidney transplantation using the institutional surgical technique, including ureteroneocystostomy with routine double-J ureteral stent placement, standardized perioperative antimicrobial prophylaxis, and standardized postoperative care. Both study groups will receive identical perioperative management, differing only in the timing of urethral catheter removal.

The primary objective is to determine whether early catheter removal reduces the incidence of urinary tract infection within 30 days after transplantation without increasing clinically significant urinary complications. The primary efficacy outcome is the incidence of microbiologically confirmed urinary tract infection, including asymptomatic bacteriuria, symptomatic urinary tract infection, complicated urinary tract infection, or transplant pyelonephritis occurring within 30 days after transplantation. The primary safety outcome is the occurrence of urinary complications requiring intervention, including urinary leak, ureteral stenosis, or other complications requiring catheter reinsertion, ureteral stenting, nephrostomy, or surgical intervention.

Secondary outcomes include urinary retention requiring recatheterization, postoperative pain, voiding symptoms, patient satisfaction, length of hospital stay, graft function assessed by serum creatinine, postoperative complications, reoperation, healthcare utilization, and cost-effectiveness. Participants will be followed for 12 months after transplantation to evaluate both early postoperative outcomes and medium-term graft and urological outcomes.

The findings of this trial are expected to provide high-quality evidence regarding the optimal timing of urethral catheter removal after kidney transplantation. If early catheter removal is shown to reduce infectious complications without compromising patient safety, the results may contribute to standardization of postoperative management protocols and improve outcomes for kidney transplant recipients.

• Study Type: Interventional
• Enrollment (Estimated): 172
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petah Tikva, Israel, 4941492
    • Gray Faculty of Tel Aviv

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion

Age ≥18 years Living donor kidney transplantation Pre-emptive kidney transplantation Preserved urine output Ability to provide written informed consent

Exclusion

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Catheter Removal; Urethral catheter removal on postoperative day 3 (72 ± 6 hours).	Procedure: Early urethral catheter removal; 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.; Other Names: Early Foley catheter removal; Postoperative day 3 catheter removal; POD3 catheter removal
Active Comparator: Standard Catheter Removal; Urethral catheter removal on postoperative day 6 (144 ± 12 hours).	Procedure: Standard urethral catheter removal; 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.; Other Names: Standard Foley catheter removal; Postoperative day 6 catheter removal; POD6 catheter removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary leak requiring intervention	Incidence of clinically significant urinary leak occurring within 30 days after transplantation, confirmed by clinical findings and/or imaging, and requiring therapeutic intervention including prolonged catheterization, ureteral stenting, percutaneous nephrostomy, percutaneous drainage, or surgical repair.	30 days
Ureteral stenosis requiring intervention	Incidence of ureteral stenosis diagnosed during the first 12 months after transplantation based on imaging and clinical assessment, requiring intervention such as ureteral stent placement, percutaneous nephrostomy, endourological treatment, or surgical reconstruction.	12 months
Acute urinary retention requiring re-catheterization	Incidence of acute urinary retention following catheter removal requiring temporary urethral catheter reinsertion, defined according to the study protocol by inability to void within the predefined observation period, symptomatic urinary retention, or elevated post-void residual volume requiring intervention.	5 days
Length of hospital stay	Total duration of postoperative hospitalization measured as the number of days from kidney transplantation to discharge from the index hospital admission.	From transplantation until hospital discharge (approximately 30 days)

Collaborators and Investigators

• Sponsor: Fahim Kanani
• Collaborators: Rabin Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: June 27, 2026
• First Submitted That Met QC Criteria: June 27, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 27, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Randomized trial; Kidney transplantation; Urinary tract infection; Foley catheter; Catheter-associated urinary tract infection; Living donor kidney transplantation
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Urinary Tract Infections
• Other Study ID Numbers: RMC-0154-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 6 months after publication of the primary manuscript.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No