Comparison of Melatonin, Solifenacin, and Their Combination to Improve Symptoms After Insertion of a Double-J Ureteral Stent in Adults Aged 18 to 60

What this Trial Is About

Researchers are studying patients who have undergone unilateral ureteroscopic lithotripsy with insertion of a unilateral Double-J ureteral stent. The trial aims to compare the effects of oral solifenacin, oral melatonin, and their combination on relieving symptoms related to the ureteral stents, which often cause discomfort, urinary symptoms, pain, sleep problems, and reduced quality of life. This is a phase 2, randomized, assessor-blinded study conducted at a single center. Participants are randomly assigned to one of three groups one receives solifenacin 5 mg once daily, another takes melatonin 3 mg once nightly, and the third group receives both solifenacin 5 mg once daily and melatonin 3 mg once nightly. The treatments start immediately after surgery and hospital discharge and continue for 14 days. The study includes evaluations at postoperative Day 7 and Day 14. During the study, participants will complete questionnaires to assess ureteral stent symptoms, sleep quality, and pain levels. Researchers will record the total symptom scores, pain scores, treatment compliance, use of rescue pain medication, and any side effects. The main measurement is the symptom questionnaire score at Day 7. Participants will be monitored through these assessments over the two-week treatment period to better understand how the medications affect stent-related symptoms and quality of life.

Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms