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โ† Trials
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Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms

RecruitingPhase 2Ages 18 Years - 60 YearsAllBeni-Suef University
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In plain words

What the trial is, and whether it could suit you

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 D

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age 18 to 60 years. 2. Patients undergoing unilateral ureteroscopy or ureteroscopic lithotripsy with insertion of a unilateral Double-J ureteral stent. 3. Ability to understand and complete the study questionnaires. 4. Willingness to participate and provide written informed consent. Exclusion Criteria: 1. Bilateral ureteral stents. 2. Stents inserted for malignant ureteral obstruction or non-stone reconstructive indications. 3. Known hypersensitivity or contraindication to solifenacin or melatonin. 4. History of acute or chronic urinary retention, or evidence of clinically significant bladder outlet obstruction at baseline. 5. History of narrow-angle glaucoma or other contraindications to antimuscarinic therapy, including gastric retention. 6. Significant hepatic impairment. 7. Severe renal impairment if judged clinically relevant to study medication safety. 8. Pre-existing moderate to severe lower urinary tract symptoms unrelated to the stent. 9. Recent use of antimuscarinics, alpha-blockers, or melatonin that may interfere with symptom assessment. 10. Pregnancy or lactation. 11. Inability to complete follow-up.
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What it tests

  • Solifenacin
  • Melatonin
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Where

1 site
Department of Urology- Beni-Suef University Hospitals
Banฤซ Suwayf, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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