Distal Ureteral StonePhase 2NCT07617909
L-Citrulline Versus Tamsulosin for Medical Expulsive Therapy of Distal Ureteral Stones
A Phase 2 study testing L-Citrulline and Tamsulosin in people with Distal Ureteral Stone and Urolithiasis, run by Beni-Suef University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Distal Ureteral Stone, Urolithiasis, Ureteral Calculi
- What is being tested?
- L-Citrulline and Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 6 May 2026to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Fever or active urinary tract infection.
- Severe hydronephrosis.
- Solitary kidney.
- Pregnancy.
- Previous ureteric surgery.
- Multiple ureteral stones.
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- Indication for urgent surgical intervention.
- Known hypersensitivity or contraindication to L-citrulline or tamsulosin.
- Inability to complete follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, Beni Suweif Governorate, 02456
Hany F Badawy, MD, +201149525028, Hanyfathy86@gmail.com
Mahmoud Abdallah, Md, +20 11 55361979, Mahmoud.abdalla@med.bsu.edu.eg
About this study
Official title: L-Citrulline Versus Tamsulosin for Medical Expulsive Therapy of Distal Ureteral Stones: A Prospective Randomized Study
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.
Read the 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.
- Conditions
- Distal Ureteral Stone, Urolithiasis, Ureteral Calculi
- Being tested
- L-Citrulline, Tamsulosin
- Keywords
- L-Citrulline, Medical Expulsive Therapy, Ureteral Stone Passage, Tamsulosin
- Medical subject headings
- Urolithiasis, Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CitrullineDrug
Oral L-citrulline 750 mg twice daily will be administered until documented stone passage or completion of 4 weeks of therapy, whichever occurs first.
TamsulosinDrug
Oral tamsulosin 0.4 mg once daily will be administered until documented stone passage or completion of 4 weeks of therapy, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 4 weeks after randomization
Secondary outcomes (3)
Time to Stone Expulsion
Time to stone expulsion will be defined as the number of days from randomization to confirmed stone passage. Stone passage will be confirmed by patient-reported stone passage with stone capture, or by absence of the ureteral stone on follow-up imaging.
Measured: From randomization up to 4 weeks
Number of Pain Episodes
The number of renal colic pain episodes reported by each participant during the follow-up period will be recorded and compared between the study groups.
Measured: From randomization up to 4 weeks
Analgesic Use
Analgesic use will be assessed by recording the number of analgesic doses required by each participant during the follow-up period.
Measured: From randomization up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start6 May 2026
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Ureteral StoneStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Fathy Badawy, MD, Beni-Suef University
- Investigators
- Hany F Badawy, MD, Principal investigator, Faculty of Medicine, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617909
- Sponsor's protocol ID
- FMBSUREC05052026BadawyCIT
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study is an investigator-initiated single-center clinical trial and the informed consent does not include a specific plan for external individual-level data sharing. Only aggregated, de-identified study results will be reported. Any future sharing of de-identified individual participant data would require additional approval from the Research Ethics Committee.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-Citrulline Versus Tamsulosin for Medical Expulsive Therapy of Distal Ureteral Stones: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07617909
- Acronym / sponsor ID
- FMBSUREC05052026BadawyCIT
- Conditions
- Distal Ureteral Stone, Urolithiasis, Ureteral Calculi
- Keywords
- L-Citrulline, Medical Expulsive Therapy, Ureteral Stone Passage, Tamsulosin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| L-Citrulline Plus Tamsulosin Placebo | Experimental | Drug: L-CitrullineParticipants 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. |
| Tamsulosin Plus L-Citrulline Placebo | Active comparator | Drug: TamsulosinParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adults aged 18 to 60 years.
- Single distal ureteral stone.
- Stone size 5 to 10 mm.
- Normal renal function.
- Controlled pain.
Key exclusion criteria (9 listed)
- Fever or active urinary tract infection.
- Severe hydronephrosis.
- Solitary kidney.
- Pregnancy.
- Previous ureteric surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-CitrullineOral L-citrulline 750 mg twice daily will be administered until documented stone passage or completion of 4 weeks of therapy, whichever occurs first. | Drug | L-Citrulline Plus Tamsulosin Placebo |
| TamsulosinOral tamsulosin 0.4 mg once daily will be administered until documented stone passage or completion of 4 weeks of therapy, whichever occurs first. | Drug | Tamsulosin Plus L-Citrulline Placebo |
Primary outcome
Stone Expulsion Rate Within 4 Weeks
Time frame: Within 4 weeks after randomization
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study is an investigator-initiated single-center clinical trial and the informed consent does not include a specific plan for external individual-level data sharing. Only aggregated, de-identified study results will be reported. Any future sharing of de-identified individual participant data would require additional approval from the Research Ethics Committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hany F Badawy, MD principal investigator
Faculty of Medicine, Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-Citrulline and Tamsulosin in people with Distal Ureteral Stone and Urolithiasis, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hany F Badawy, MD (+201149525028, Hanyfathy86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone Expulsion Rate Within 4 Weeks (time frame: Within 4 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.