An interventional study of Early urethral catheter removal and Standard urethral catheter removal in Catheter-Associated Urinary Tract Infections (CAUTIs) and Kidney Transplantation, sponsored by Fahim Kanani. Active, not recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Fahim Kanani · Not applicable, Interventional, and Prevention
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.
For ClinicalTrials.gov, the **Detailed Description** should be scientific and comprehensive, but not written like the introduction of a manuscript. It should explain the rationale, study design, intervention, and outcomes in language understandable to both clinicians and the public.
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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.
752 studies on the registry are indexed under Urinary Tract Infections; 127 are open to participants now.
This study's planned enrollment of 172 is above the median of 130 across 523 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →This is the only study on the registry with Fahim Kanani as lead sponsor.
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Exclusion Criteria:
Urethral catheter removal on postoperative day 3 (72 ± 6 hours).
Procedure: Early urethral catheter removal
Urethral catheter removal on postoperative day 6 (144 ± 12 hours).
Procedure: Standard 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.
Also known as: Early Foley catheter removal, Postoperative day 3 catheter removal, POD3 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.
Also known as: Standard Foley catheter removal, Postoperative day 6 catheter removal, POD6 catheter removal
Thirty-day urinary tract infection
Incidence of symptomatic urinary tract infection or asymptomatic bacteriuria confirmed by urine culture according to predefined study criteria.
Time frame: 30 days after transplantation
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From transplantation until hospital discharge (approximately 30 days)
Plan to share: Yes — 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.
Supporting information: Study protocol
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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