To evaluate the effectiveness and safety of Foley balloon catheters compared with non-balloon catheters as nephrostomy tubes after percutaneous nephrolithotomy (PCNL).
Design
Clinical trial with a control group, parallel design, double-blind, randomized, conducted on 200patients. Randomization was performed using block randomization.
Settings and conduct
Patients eligible for percutaneous nephrolithotomy (PCNL) who visit Shahid Modarres Hospital, in Tehran, Iran, from November 2025 to March 2026, will be enrolled if they meet the inclusion criteria. They will be randomly assigned to the intervention group (Foley catheter with balloon) or the control group (non-balloon nephrostomy tube) using blocks of 4. The study will be conducted as double-blind, with patients, surgeons, and data analysts unaware of the intervention type
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients aged 18 to 70 years; presence of renal stones in the upper urinary tract with a diameter greater than 2 cm; eligibility for percutaneous nephrolithotomy (PCNL); and provision of written informed consent.
Exclusion criteria:
Patients with severe bleeding requiring a conventional balloon; patients with a solitary kidney; patients receiving anticoagulant therapy; pregnant patients; and those with active infection or sepsis
Intervention groups
Intervention group: Patients undergoing percutaneous nephrolithotomy (PCNL) with a Foley catheter with balloon (16 French, 5 mL balloon) placed in the upper urinary tract, maintained for 48 hours post-procedure,manufactured by Bard Medical.
Control group: Patients undergoing percutaneous nephrolithotomy (PCNL) with a non-balloon nephrostomy tube (16 French) placed at the surgical site, maintained for 48 hours post-procedure, manufactured by Bard Medical.
Main outcome variables
Blood hemoglobin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250413065309N1
Registration date:2025-11-09, 1404/08/18
Registration timing:registered_while_recruiting
Last update:2025-11-09, 1404/08/18
Update count:0
Registration date
2025-11-09, 1404/08/18
Registrant information
Name
Mostafa Farajpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7729 1971
Email address
mostafa.farajpour.kh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-22, 1404/07/30
Expected recruitment end date
2025-12-21, 1404/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of routine use of Foley catheter balloon as nephrostomy in percutaneous nephrolithotomy patients
Public title
Evaluating the Effect of Balloon Catheters in Reducing Complications of Percutaneous Nephrolithotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of a stone in the upper urinary tract
Stone with a diameter greater than 2 cm
Written informed consent to undergo surgery
Exclusion criteria:
Patients with significant bleeding requiring classical balloon placement.
Single-kidney patients
Patients on anticoagulant therapy
Pregnant patients
infection or sepsis
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomized into two groups (nephrostomy with balloon vs. without balloon) using a computer-generated random sequence created by Randomizer.org and the block randomization method (block size = 4) to ensure balance between groups.
Allocation concealment was achieved using opaque, sealed, and sequentially numbered envelopes prepared by an independent researcher to minimize allocation bias.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blinding was implemented. The primary surgeon was blinded to group allocation, with nephrostomy placement performed by surgical assistants to maintain blinding.
Placebo
Not used
Assignment
Parallel
Other design features
The study used Guy’s Stone Score to standardize stone complexity across groups, ensuring comparability. Nephrostomy tube placement was confirmed using fluoroscopic guidance with contrast injection.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of the Vice Chancellor for Research and Technology, SBMU
Street address
Building No. 2, University Headquarters, Arabi Street, Yemen Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2025-08-17, 1404/05/26
Ethics committee reference number
IR.SBMU.RETECH.REC.1404.384
Health conditions studied
1
Description of health condition studied
Kidney stone
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
Blood hemoglobin level
Timepoint
Measurement of blood hemoglobin level on the day before surgery (baseline), and on days 2 and 7 after surgery.
Method of measurement
Hematology analyzer
Secondary outcomes
1
Description
Transfusion rate
Timepoint
2 days and 7 days after the intervention.
Method of measurement
Review of patients’ medical records and data collection by the researcher using a standardized checklist, verified by the hospital blood bank records.
Intervention groups
1
Description
Intervention group: Placement of a Foley catheter with balloon (16 French, 5 mL balloon) in the upper urinary tract following percutaneous nephrolithotomy (PCNL), maintained for 48 hours post-surgery, manufactured by Bard Medical.
Category
Treatment - Devices
2
Description
Control group: Placement of a non-balloon nephrostomy tube (16 French) at the surgical site following percutaneous nephrolithotomy (PCNL), maintained for 48 hours post-surgery, manufactured by Bard Medical.
Shahid Modarres Hospital, Yadegar-e-Imam Highway, Saadat Abad Intersection, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4090
Email
Mostafa.farajpour.kh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to ethical and institutional constraints, including patient privacy concerns and the absence of a secure data-sharing platform compliant with national regulations, deidentified individual participant data will not be shared at this time.