Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms

Официальное название

Melatonin Versus Solifenacin Versus Their Combination for Improving Double-J Ureteral Stent-Related Symptoms and Quality of Life: A Prospective Randomized Study

Обзор

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.

Подробное описание

This is a single-center, prospective, randomized, assessor-blinded, parallel-group, three-arm clinical trial conducted at the Department of Urology, Beni-Suef University Hospital, Egypt.

The study will include adult patients aged 18 to 60 years undergoing unilateral ureteroscopic lithotripsy for ureteral stones with postoperative insertion of a unilateral Double-J ureteral stent. Eligible patients who provide written informed consent will be randomized into one of three treatment groups.

Participants in Group A will receive solifenacin 5 mg once daily. Participants in Group B will receive melatonin 3 mg once nightly. Participants in Group C will receive combined solifenacin 5 mg once daily plus melatonin 3 mg once nightly. Study medication will start immediately after surgery and hospital discharge and will continue for 14 days.

Outcome assessors will remain blinded to treatment allocation throughout the study period. Study assessments will be performed at postoperative Day 7 and postoperative Day 14. Ureteral stent-related symptoms and quality of life will be assessed using the Arabic-validated Ureteral Stent Symptom Questionnaire. Sleep-related symptoms will be assessed using the Arabic version of the Insomnia Severity Index. Pain will be assessed using a Visual Analogue Scale. Drug-related adverse events, treatment compliance, and rescue analgesic consumption will also be recorded during follow-up.

The primary endpoint is the difference among the three study groups in total Ureteral Stent Symptom Questionnaire score at postoperative Day 7.

Вмешательства

• Препарат Solifenacin
  Solifenacin 5 mg orally once daily for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.
• Препарат Melatonin
  Melatonin 3 mg orally once nightly for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.

Первичные конечные точки

• Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 7 [Срок оценки: Postoperative Day 7]

Вторичные конечные точки (3)

• Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 14 [Срок оценки: Postoperative Day 14]
• Visual Analogue Scale Pain Score [Срок оценки: Postoperative Day 7 and postoperative Day 14]
• Treatment Compliance [Срок оценки: From postoperative Day 0 to postoperative Day 14]

Критерии участия

Критерии включения

• Age 18 to 60 years.
• Patients undergoing unilateral ureteroscopy or ureteroscopic lithotripsy with insertion of a unilateral Double-J ureteral stent.
• Ability to understand and complete the study questionnaires.
• Willingness to participate and provide written informed consent.

Критерии исключения

• Bilateral ureteral stents.
• Stents inserted for malignant ureteral obstruction or non-stone reconstructive indications.
• Known hypersensitivity or contraindication to solifenacin or melatonin.
• History of acute or chronic urinary retention, or evidence of clinically significant bladder outlet obstruction at baseline.
• History of narrow-angle glaucoma or other contraindications to antimuscarinic therapy, including gastric retention.
• Significant hepatic impairment.
• Severe renal impairment if judged clinically relevant to study medication safety.
• Pre-existing moderate to severe lower urinary tract symptoms unrelated to the stent.
• Recent use of antimuscarinics, alpha-blockers, or melatonin that may interfere with symptom assessment.
• Pregnancy or lactation.
• Inability to complete follow-up.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Department of Urology- Beni-Suef University Hospitals — Banī Suwayf

Идентификаторы

NCT: NCT07617922 · FMBSUREC05052026BadawyMS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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