NCT07617909 L-Citrulline Versus Tamsulosin for Medical Expulsive Therapy of Distal Ureteral Stones
| NCT ID | NCT07617909 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Beni-Suef University |
| Condition | Distal Ureteral Stone |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-05-06 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2026-05-06 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Hany F Badawy, MD
PRINCIPAL INVESTIGATOR
Faculty of Medicine, Beni-Suef University
Frequently Asked Questions
Who can join the NCT07617909 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Distal Ureteral Stone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07617909 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07617909 currently recruiting?
Yes, NCT07617909 is actively recruiting participants. Contact the research team at Hanyfathy86@gmail.com for enrollment information.
Where is the NCT07617909 trial being conducted?
This trial is being conducted at Banī Suwayf, Egypt.
Who is sponsoring the NCT07617909 clinical trial?
NCT07617909 is sponsored by Beni-Suef University. The principal investigator is Hany F Badawy, MD at Faculty of Medicine, Beni-Suef University. The trial plans to enroll 120 participants.