Early (Postoperative Day 3) Versus Standard (Postoperative Day 6) Urethral Catheter Removal After Living Donor Kidney Transplantation: A Prospective Randomized Controlled Trial
NCT07681843 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172
Last updated 2026-07-02
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.
Conditions
- Catheter-Associated Urinary Tract Infections (CAUTIs)
- Kidney Transplantation
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
Rabin Medical Center
collaborator OTHER -
Fahim Kanani
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-01
- Primary Completion
- 2027-05-30
- Completion
- 2027-12-30
Countries
- Israel
Study Locations
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