L-Citrulline vs Tamsulosin for Helping Distal Ureteral Stones Pass
Official title: L-Citrulline Versus Tamsulosin for Medical Expulsive Therapy of Distal Ureteral Stones: A Prospective Randomized Study
Run by Beni-Suef University · NCT07617909 · Data updated 2026-11-12
This study tests whether L-citrulline helps stones pass from the distal ureter as well as or better than tamsulosin in adults with a single 5–10 mm stone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Beni-Suef University Academic / other |
| Locations | 1 site (Banī Suwayf, Beni Suweif Governorate) |
| Status | Recruiting |
| Started | May 6, 2026 |
| Main results expected | October 2026 |
| Study ends | November 2026 |
| Registry record updated | June 1, 2026 |
| Trial ID | NCT07617909 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–60 with a single distal ureteral stone measuring 5–10 mm and normal kidney function who are able to attend 4 weeks of follow-up.
✕Probably not a fit
Patients with fever, active infection, severe hydronephrosis, solitary kidney, pregnancy, prior ureteric surgery, multiple stones, or urgent surgical needs may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, controlled Phase 2 trial comparing two oral medicines for medical expulsive therapy in adults with a single distal ureteral stone (5–10 mm). Participants are assigned 1:1 to receive either L-citrulline 750 mg twice daily or tamsulosin 0.4 mg once daily for up to 4 weeks or until the stone passes. Weekly follow-ups assess pain, analgesic use, stone passage, need for extra intervention, and adverse events, with imaging used to confirm passage as needed. The study is conducted at the outpatient Urology Clinic of Beni-Suef University Hospital and includes adults 18–60 without infection, severe hydronephrosis, or other exclusion criteria.
Why it matters
Potential benefit: If successful, the trial could identify a non-surgical option that more effectively helps distal ureteral stones pass, potentially reducing pain and the need for procedures.
How similar studies have gone: Previous studies have explored medical expulsive therapy, but this direct head-to-head comparison between L-citrulline and tamsulosin for distal ureteral stones is novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, Beni Suweif Governorate, Egypt Recruiting
Study contacts
- Principal investigator: Hany F Badawy, MD — Faculty of Medicine, Beni-Suef University
- Study coordinator: Hany F Badawy, MD
- Email: Hanyfathy86@gmail.com
- Phone: +201149525028
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.