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IRCT20090427001853N20 IRCT 2025-05-13 Urology Research Center, Guilan University of Medical Sciences Comparison of the effectiveness and safety of cranberry with tamsulosin and placebo in improving symptoms associated with ureteral stents. Comparative study of the effectiveness and safety of cranberry with tamsulosin and placebo in improving stent-related symptoms in patients undergoing Double-J ureteral stent placement: a three-group randomized controlled trial 2025-05-15 anticipated 96 Complete https://irct.ir/trial/83147 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with blocks of 6 with a 1:1 ratio (in three groups A, B, and C) using the graphpad.com website and through the sealed envelope online program will be done. To assign the target group to one of the three study groups, the block randomization method with blocks of six will be used. Then, the participants will be allocated to one of the three groups in a 1:1 ratio according to the block randomization protocol (generated by graphpad.com website), in such a way that the researcher cannot predict which group of the intervention the next person will be placed in. In order to conceal the random assignment, the codes generated by the software will be placed in an envelope so that it is not clear which group the next person will be placed in. Concealed random assignment refers to the method used to perform the random sequence on study participants, in such a way that the assigned group is not known before the individual is assigned. In this study, the method of sealed opaque envelopes with a random sequence will be used. Based on the sample size of this study, a number of envelopes are prepared and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the envelopes are glued shut and placed in a box in order. At the start of registration, based on the order in which eligible participants enter the study, one of the envelopes is opened in order and the assigned group of that participant is revealed, Blinding description: Patients and researchers associated with patients are unaware of the patient's exposure. Each patient will be identified with a code that will be placed in an envelope. Researcher responsible for data collection (urology resident) places the patients in one of 3 groups based on random numbers generated in the software and after completing the checklist for them, each patient is identified with a code that is placed in an envelope (B, A or C). Then, the patients are referred to the Urology research center to receive the medicine (without knowing its type). The coating and appearance of all drugs are the same. Tamsulosin and placebo (Contains chickpea flour) are placed in empty cranberry capsules and will be packaged by one of the researchers (other than the researcher responsible for data collection and the researcher distributing the medicine) in one of the B, A, and C envelopes. The researcher distributing the medicine is unaware of the type of contents inside the medicine envelopes. The analyst will also be unaware of the type of grouping of the patients. 3 Condition 1: Urinary tract symptoms due to double-J stent insertion. Condition 2: Urinary tract symptoms due to double-J stent insertion. Condition 3: Urinary tract symptoms due to double-J stent insertion. Condition 4: Urinary tract symptoms due to double-J stent insertion. Condition 5: Urinary tract symptoms due to double-J stent insertion. Intervention 1: Intervention group 1: daily receiving one 500 mg cranberry capsule of Dayan Pharmed Behin Tolid company, from the first day after stent placement until the stent removal. Intervention 2: Intervention group 2: daily receiving one tamsulosin 0.4 mg PORTRAL OPAS for Tasnim Pharmaceutical Company, placed in cranberry-like coatings, from the first day after stent placement until the stent removal. Intervention 3: Control group: Receiving one placebo daily, consisting of empty cranberry capsules filled with chickpea flour, from the first day after stent placement until stent removal. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to the possibility of prolonging the study and publication of the article, researchers will decide regarding the details of sharing the unidentifiable personal data of the participants after the end of the study and publication of the results in the form of an article.
public Fariman Asheghpour
Urology Department, Razi Hospital, Sardar-e-Jangal street
Rasht Iran (Islamic Republic of) 41448-95655 +98 13 3352 5259 farimanasheghpour1371@gmail.com Rasht University of Medical Sciences scientific Reza Shahrokhi Damavand
Urology Department, Razi Hospital, Sardar-e-Jangal street
Rasht Iran (Islamic Republic of) 41448-95655 +98 13 3352 5259 reza_sh_urg@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) age over 18 years Candidate for Double-J Ureteral Stent Placement 18 years no limit Both Insertion of bilateral stents Concurrent urinary tract infection Pregnancy Neurogenic bladder Overactive bladder syndrome History of or current treatment for urinary incontinence Lower urinary tract symptoms (LUTS) related to benign prostatic hyperplasia (BPH) Chronic pelvic pain syndrome Use of anticholinergic, alpha-blockers, and analgesics drugs Major complications after urethroscopy surgery (such as perforation, .....) R30 R30.0 R30.9 R31 R39.8 Pain associated with micturition Dysuria Painful micturition, unspecified Hematuria Other symptoms and signs involving the genitourinary system Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: daily receiving one 500 mg cranberry capsule of Dayan Pharmed Behin Tolid company, from the first day after stent placement until the stent removal Intervention group 2: daily receiving one tamsulosin 0.4 mg PORTRAL OPAS for Tasnim Pharmaceutical Company, placed in cranberry-like coatings, from the first day after stent placement until the stent removal Control group: Receiving one placebo daily, consisting of empty cranberry capsules filled with chickpea flour, from the first day after stent placement until stent removal Dysuria. Timepoint: 3 and 7 days after the start of the intervention and after the end of the intervention. Method of measurement: Ureteral Stent Symptom Questionnaire (USSQ). Hematuria. Timepoint: 3 and 7 days after the start of the intervention and after the end of the intervention. Method of measurement: Ureteral Stent Symptom Questionnaire (USSQ). Frequency. Timepoint: 3 and 7 days after the start of the intervention and after the end of the intervention. Method of measurement: Ureteral Stent Symptom Questionnaire (USSQ). Nocturia. Timepoint: 3 and 7 days after the start of the intervention and after the end of the intervention. Method of measurement: Ureteral Stent Symptom Questionnaire (USSQ). Pain. Timepoint: 3 and 7 days after the start of the intervention and after the end of the intervention. Method of measurement: Ureteral Stent Symptom Questionnaire (USSQ). Sexual dysfunction. Timepoint: 3 and 7 days after the start of the intervention and after the end of the intervention. Method of measurement: Ureteral Stent Symptom Questionnaire (USSQ). Drug side effects. Timepoint: From the start of the intervention to the end of the intervention. Method of measurement: Patient report in person or by phone. Vice chancellor of research and technology Urology Research Center, Guilan University of Medical Sciences Vice chancellor of research and technology Approved 2025-04-09 Ethics committee of Guilan University of Medical Sciences Vice chancellor of research and technology, Siyadati Street, Namjoo Street, Rasht Rasht Guilan Iran (Islamic Republic of)