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Study identifier: NCT07617922 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms

Condition: Ureteral Stent-Related Symptoms · Ureteral Calculi · Lower Urinary Tract Symptoms  ·  Sponsor: Beni-Suef University

PhasePhase 2
Planned participants189
Who can joinAll sexes, 18 Years to 60 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Hany F Badawy, MD  ·  +201149525028  ·  HANYFATHY86@GMAIL.COM

Mahmoud Abdallah, MD  ·  +201211874080  ·  Drhanyfathy86@GMAIL.COM

Always discuss trial participation with your own doctor first.

Locations (1)

Department of Urology- Beni-Suef University HospitalsBanī Suwayf, BeniSuef, EgyptRecruiting

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Source record: clinicaltrials.gov/study/NCT07617922