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Идёт набор NCT07617909

L-Citrulline Versus Tamsulosin for Medical Expulsive Therapy of Distal Ureteral Stones

Фаза II С лечением Distal Ureteral Stone Urolithiasis Ureteral Calculi

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: L-Citrulline, Tamsulosin.
Кому может быть актуально
Состояния в реестре: Distal Ureteral Stone, Urolithiasis, Ureteral Calculi. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

L-Citrulline Versus Tamsulosin for Medical Expulsive Therapy of Distal Ureteral Stones: A Prospective Randomized Study

Обзор

This study will compare L-citrulline and tamsulosin as medical expulsive therapy for adults with single distal ureteral stones. Eligible participants with a single distal ureteral stone measuring 5 to 10 mm will be randomly assigned to receive either oral L-citrulline 750 mg twice daily or oral tamsulosin 0.4 mg once daily. Treatment will continue until documented stone passage or completion of 4 weeks of therapy, whichever occurs first. Participants will be followed weekly for up to 4 weeks. The main outcome is stone expulsion within 4 weeks. The study will also assess time to stone expulsion, pain episodes, analgesic use, need for additional intervention, and adverse events.

Подробное описание

This is a prospective, randomized, controlled trial conducted at the outpatient Urology Clinic, Beni-Suef University Hospital.

The study will include adult patients aged 18 to 60 years with a single distal ureteral stone measuring 5 to 10 mm, normal renal function, and controlled pain. Patients with fever or active urinary tract infection, severe hydronephrosis, solitary kidney, pregnancy, previous ureteric surgery, multiple stones, or an indication for urgent surgical intervention will be excluded.

Eligible participants will be randomized in a 1:1 ratio to one of two treatment groups. The L-citrulline group will receive oral L-citrulline 750 mg twice daily. The tamsulosin group will receive oral tamsulosin 0.4 mg once daily. Treatment will be discontinued upon stone passage or after completion of 4 weeks of therapy, whichever occurs first. Both groups will receive standard supportive care, including analgesics as needed, hydration advice, and use of a stone strainer.

Participants will be evaluated weekly for 4 weeks. Follow-up assessments will include symptom review, pain assessment using the Visual Analog Scale, documentation of pain episodes, analgesic requirements, adverse event monitoring, and imaging assessment using ultrasound with or without KUB, with low-dose computed tomography when clinically needed.

The primary outcome is stone expulsion rate within 4 weeks. Stone expulsion will be confirmed by patient-reported stone passage with stone capture, or by absence of the stone on follow-up imaging. Secondary outcomes include time to stone expulsion, number of pain episodes, analgesic use, need for additional intervention such as ureteroscopy or ureteral stenting, and adverse events.

Вмешательства

  • Препарат L-Citrulline
    Oral L-citrulline 750 mg twice daily will be administered until documented stone passage or completion of 4 weeks of therapy, whichever occurs first.
  • Препарат Tamsulosin
    Oral tamsulosin 0.4 mg once daily will be administered until documented stone passage or completion of 4 weeks of therapy, whichever occurs first.

Первичные конечные точки

  • Stone Expulsion Rate Within 4 Weeks [Срок оценки: Within 4 weeks after randomization]
Вторичные конечные точки (3)
  • Time to Stone Expulsion [Срок оценки: From randomization up to 4 weeks]
  • Number of Pain Episodes [Срок оценки: From randomization up to 4 weeks]
  • Analgesic Use [Срок оценки: From randomization up to 4 weeks]

Критерии участия

Критерии включения

  • Adults aged 18 to 60 years.
  • Single distal ureteral stone.
  • Stone size 5 to 10 mm.
  • Normal renal function.
  • Controlled pain.
  • Willingness to comply with follow-up for 4 weeks.
  • Written informed consent.

Критерии исключения

  • Fever or active urinary tract infection.
  • Severe hydronephrosis.
  • Solitary kidney.
  • Pregnancy.
  • Previous ureteric surgery.
  • Multiple ureteral stones.
  • Indication for urgent surgical intervention.
  • Known hypersensitivity or contraindication to L-citrulline or tamsulosin.
  • 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
Четверное слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Department of Urology- Beni-Suef University Hospitals — Banī Suwayf

Идентификаторы

NCT: NCT07617909 · FMBSUREC05052026BadawyCIT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗