Investigation of Urinary Symptoms, Biofilm Formation, and Encrustation in Extra Double J Stents compared to the Standard Method: A clinical trial

investigate the incidence of urinary tract symptoms , biofilm formation and encrustation in extra Stent Double j in comparison with standard method.

A total of 80 people will be included in the study, who will be divided into two groups: control and intervention. The clinical trial is single-blind. Randomization will be performed using the balanced block randomization method in four-blocks to allocate to two intervention and two control groups. After the randomization sequence is prepared by the methodologist and using the online site Seal Denvelop, the created sequence will be provided to a technician outside the research team.

This clinical trial will be conducted at Sina Hospital, Urology Research Center, on 80 patients. The first group, the control group, will receive standard double-G stents, and the second group, the intervention group, will receive extra double-j stents.

Inclusion criteria: 40 male patients over 18 years of age who have kidney stones and require placement of a double J stent in the ureter for treatment. Exclusion criteria: Patients with active urinary tract infection or systemic infection at the time of stent placement. Patients with severe chronic kidney disease. Patients with a history of complex ureteral surgeries or severe anatomical abnormalities that may affect stent placement.

The first control group will receive 40 patients with standard double-gauge stents. The second intervention group will receive 40 patients with extra double-gauge stents.

urinary tract symptoms (pain, irritation, urinary frequency & urgency)

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.

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.

Demographic information anonymously

One year after the results are published

Researchers working in academic and scientific institutes, doctors, hospital surgeons

Any analysis can be done with the consent of the main reserarcher

Sina Hospital, Urology Research Centet,Head of Urology Research Center:Dr seyed mohammad kazem Aghamir

After the review by the main executive and epidemiologist, while maintaining confidentiality, the information of the patients will be provided to the applicant