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

What this Trial Is About

Researchers are evaluating the use of L-citrulline compared to tamsulosin as medical treatments to help adults pass single distal ureteral stones measuring 5 to 10 mm. This prospective, randomized, controlled trial focuses on adult patients aged 18 to 60 years with normal kidney function and controlled pain. The study aims to determine which treatment is more effective in expelling the stone within 4 weeks and also examines related factors such as pain episodes, medication use, and the need for additional procedures. Participants are randomly assigned to one of two groups: one group receives oral L-citrulline 750 mg twice daily plus a placebo matching tamsulosin once daily, while the other group receives oral tamsulosin 0.4 mg once daily plus a placebo matching L-citrulline twice daily. Treatment continues until the stone passes or after 4 weeks of therapy, whichever happens first. Both groups receive standard supportive care including pain relief as needed, hydration advice, and the use of a stone strainer. During the 4-week follow-up, participants are evaluated weekly with symptom reviews, pain assessments using a Visual Analog Scale, and monitoring of pain episodes and medication use. Imaging tests such as ultrasound or X-rays are used to confirm stone passage, with low-dose CT scans as needed. The primary outcome is the rate of stone expulsion within 4 weeks, while secondary outcomes include time to stone passage, pain frequency, analgesic use, need for further intervention, and any adverse events. The study is conducted at an outpatient urology clinic and is expected to end in November 2026.

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