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Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms

Study acronym: MEL-SOL-STENT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: details revised at 2 of 3 entriesv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07617922
Lead Sponsor Beni-Suef University
Conditions
(from sponsor)		 Ureteral Stent-Related Symptoms, Ureteral Calculi, Lower Urinary Tract Symptoms
Related terms Lower Urinary Tract Symptoms, Ureteral Calculi
Enrollment 189 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov