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

NCT07617909 | Recruiting Phase 2

• 1 other identifier: FMBSUREC05052026BadawyCIT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Ureteral Stone; Urolithiasis; Ureteral Calculi

Keywords

L-Citrulline; Medical Expulsive Therapy; Ureteral Stone Passage; Tamsulosin

Outcome Measures

Primary Outcomes (1)

• Stone Expulsion Rate Within 4 Weeks

  Stone expulsion rate will be defined as the proportion of randomized participants with confirmed stone passage within 4 weeks. Stone expulsion will be confirmed by patient-reported stone passage with stone capture, or by absence of the ureteral stone on follow-up imaging.

  Within 4 weeks after randomization

Secondary Outcomes (3)

• Time to Stone Expulsion

  From randomization up to 4 weeks

• Number of Pain Episodes

  From randomization up to 4 weeks

• Analgesic Use

  From randomization up to 4 weeks

Study Arms (2)

L-Citrulline Plus Tamsulosin Placebo

EXPERIMENTAL

Participants will receive oral L-citrulline 750 mg twice daily plus a matched tamsulosin placebo once daily. Treatment will continue until documented stone passage or completion of 4 weeks of therapy, whichever occurs first. Standard supportive care will be provided as needed.

Drug: L-Citrulline

Tamsulosin Plus L-Citrulline Placebo

ACTIVE COMPARATOR

Participants will receive oral tamsulosin 0.4 mg once daily plus a matched L-citrulline placebo twice daily. Treatment will continue until documented stone passage or completion of 4 weeks of therapy, whichever occurs first. Standard supportive care will be provided as needed.

Drug: Tamsulosin

Interventions

L-Citrulline DRUG

Oral L-citrulline 750 mg twice daily will be administered until documented stone passage or completion of 4 weeks of therapy, whichever occurs first.

L-Citrulline Plus Tamsulosin Placebo

Tamsulosin DRUG

Oral tamsulosin 0.4 mg once daily will be administered until documented stone passage or completion of 4 weeks of therapy, whichever occurs first.

Tamsulosin Plus L-Citrulline Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, 02456, Egypt

RECRUITING

MeSH Terms

Conditions

Urolithiasis; Ureteral Calculi

Interventions

Citrulline; Tamsulosin

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Ureterolithiasis; Ureteral Diseases; Urinary Calculi; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Diamino; Amino Acids; Amino Acids, Peptides, and Proteins; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Hany F Badawy, MD

  Faculty of Medicine, Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany F Badawy, MD

CONTACT

+201149525028; Hanyfathy86@gmail.com

Ahmed Gmal, MD

CONTACT

+20 11 18206022; Drhanyfathy86@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will use a double-dummy design. Participants in each group will receive one active treatment and one matched placebo to maintain blinding. Participants, care providers, investigators, and outcomes assessors will remain blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Beni-Suef University

Model Details: Participants with single distal ureteral stones will be randomized in a 1:1 ratio to receive either oral L-citrulline or oral tamsulosin as medical expulsive therapy for up to 4 weeks, or until documented stone passage, whichever occurs first.

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 1, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)