Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms

Double-J ureteral stents are commonly inserted after ureteroscopy, but they may cause bothersome urinary symptoms, pain, sleep disturbance, and reduced quality of life. This prospective randomized assessor-blinded three-arm clinical trial will compare oral solifenacin, oral melatonin, and their combination for improving ureteral stent-related symptoms in adult patients after unilateral ureteroscopic lithotripsy with insertion of a unilateral Double-J ureteral stent. Participants will be randomized to receive solifenacin 5 mg once daily, melatonin 3 mg once nightly, or combined solifenacin 5 mg once daily plus melatonin 3 mg once nightly for 14 days after surgery. The primary outcome is the total Ureteral Stent Symptom Questionnaire score at postoperative Day 7. Secondary outcomes include total Ureteral Stent Symptom Questionnaire score at Day 14, change in questionnaire score between Day 7 and Day 14, Insomnia Severity Index score, Visual Analogue Scale pain score, adverse events, treatment compliance, and rescue analgesic consumption.

NCT Number	NCT07617922
Lead Sponsor	Beni-Suef University
Conditions	Ureteral Stent-Related Symptoms, Ureteral Calculi, Lower Urinary Tract Symptoms
Enrollment	189 participants
Start Date	2026-05-07
Primary Completion	2027-04 (estimated)
Study Completion	2027-05 (estimated)
Updated on ClinicalTrials.gov	2026-06-02