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IRCT20190624043991N38 IRCT 2026-04-22 Tehran University of Medical Sciences Assessment of using Extra Double J Stents complications in comparison with standard method. Investigation of Urinary Symptoms, Biofilm Formation, and Encrustation in Extra Double J Stents compared to the Standard Method: A clinical trial 2026-09-23 anticipated 80 Recruiting https://irct.ir/trial/89472 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Using the Random Allocation Software, a list of random allocations to two groups is created. This list is organized into small blocks (blocks of 4) to maintain a balance of patients in each group throughout the study. The allocation process is as follows: as soon as each patient enters the study, his or her identification number is matched with the randomization list and the corresponding group is determined. To prevent bias, the person responsible for randomization and recording the data in a sealed envelope is independent of the treatment team. The only informed person is the attending physician responsible for the surgery. Each group includes 40 patients, Blinding description: Patients will be informed about general issues in study groups. Patients who have entered the study after filling out the ethical consent form refer to the nurse. The nurse places a box with two folded papers, one A and the other B, in front of the patient. The patient selects a paper and gives it to the nurse. The nurse records it on the patient's form. Patients are randomly and blindly divided into two groups, A and, by a nurse. 3 kidney stone disease. Intervention 1: Intervention group: In the intervention group, 40 patients will receive a double-loop double-J stent. A double-J stent is a stent with two loops extending outward from the midline of the kidney, designed at the suggestion of the Urology Center of Sina Hospital. Both the distal and proximal loops of this stent are positioned outward from the midline, whereas in standard stents, the proximal loop is positioned outward and the distal loop is positioned inward. Intervention 2: Control group: 40 patients receive standard double-J stents. In standard stents, the proximal loop faces outward and the distal loop faces inward. Yes - There is a plan to make this available What will be shared: Demographic information anonymously When: One year after the results are published To whom: Researchers working in academic and scientific institutes, doctors, hospital surgeons Conditions: Any analysis can be done with the consent of the main reserarcher Where to obtain: Sina Hospital, Urology Research Centet,Head of Urology Research Center:Dr seyed mohammad kazem Aghamir How to obtain: After the review by the main executive and epidemiologist, while maintaining confidentiality, the information of the patients will be provided to the applicant Comments:
public Dr Zahra Navi
Tehran
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8593 shahrzadn951@gmail.com Tehran University of Medical Sciences scientific Dr.Mohammad Kazem Aghamir
Sina Hospital, Imam khomeini st, urology Research Center
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8560 mkaghamir@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) patients who needs treatment with Double J Stents Male sexuality Patients elder than 18 years old 18 years no limit Male Patients with active or systemic infection in urinary tract Patients who suffer from chronic kidney diseases Patients with history of complicated urethra surgery or anatomic abnormality that effect Double J Stents installation N00 Acute nephritic syndrome Prevention Prevention Intervention group: In the intervention group, 40 patients will receive a double-loop double-J stent. A double-J stent is a stent with two loops extending outward from the midline of the kidney, designed at the suggestion of the Urology Center of Sina Hospital. Both the distal and proximal loops of this stent are positioned outward from the midline, whereas in standard stents, the proximal loop is positioned outward and the distal loop is positioned inward. Control group: 40 patients receive standard double-J stents. In standard stents, the proximal loop faces outward and the distal loop faces inward. Urinary tract symptoms (pain, irritation, urinary frequency & urgency). Timepoint: 3 , 7 and 14 days after placement of double J stent. Method of measurement: Ureteral Symptom Stent Questionnaire. Biofilm formation. Timepoint: Days 3, 7, and 14 after placement of the Extra Double G stent. Method of measurement: Urine bacterial culture. Analysis of mineral deposits. Timepoint: Days 3, 7, and 14 after placement of the Extra Double G stent. Method of measurement: FECal grading. Tehran University of Medical Sciences Approved 2025-05-03 Research Ethics committee, sina hospital Room 206, Ethics committee office, second floor, administrative building, sina hospital, imam khomeini street Tehran Tehran Iran (Islamic Republic of)