Distal Ureteral Stone, Ureteral Calculi, Urolithiasis
Conditions
Keywords
L-Citrulline, Medical Expulsive Therapy, Ureteral Stone Passage, Tamsulosin
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.
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
DRUGL-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.
DRUGTamsulosin
Oral tamsulosin 0.4 mg once daily will be administered until documented stone passage or completion of 4 weeks of therapy, whichever occurs first.
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone Expulsion Rate Within 4 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Stone Expulsion | From randomization up to 4 weeks | 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. |
| Number of Pain Episodes | From randomization up to 4 weeks | 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. |
| Analgesic Use | From randomization up to 4 weeks | Analgesic use will be assessed by recording the number of analgesic doses required by each participant during the follow-up period. |
Countries
Egypt
Contacts
CONTACTHany F Badawy, MD
CONTACTAhmed Gmal, MD
PRINCIPAL_INVESTIGATORHany F Badawy, MD
Faculty of Medicine, Beni-Suef University
Outcome results
None listed