L-Citrulline Versus Tamsulosin for Medical Expulsive Therapy of Distal Ureteral Stones
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: L-Citrulline, Tamsulosin.
- Who it may be relevant to
- Registry conditions: Distal Ureteral Stone, Urolithiasis, Ureteral Calculi. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
L-Citrulline Versus Tamsulosin for Medical Expulsive Therapy of Distal Ureteral Stones: A Prospective Randomized Study
Overview
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.
Detailed description
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.
Interventions
- Drug 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. - Drug 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.
Primary outcome measures
- Stone Expulsion Rate Within 4 Weeks [Time frame: Within 4 weeks after randomization]
Secondary outcome measures (3)
- Time to Stone Expulsion [Time frame: From randomization up to 4 weeks]
- Number of Pain Episodes [Time frame: From randomization up to 4 weeks]
- Analgesic Use [Time frame: From randomization up to 4 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Department of Urology- Beni-Suef University Hospitals — Banī Suwayf
Identifiers
NCT: NCT07617909 · FMBSUREC05052026BadawyCIT