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

25. maj 2026 opdateret af: Hany Fathy Badawy, MD, Beni-Suef University

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Egypten
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egypten, 02456
        • Rekruttering
        • Department of Urology- Beni-Suef University Hospitals
        • Kontakt:
        • Ledende efterforsker:
          • Hany F Badawy, MD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: L-Citrulline Plus Tamsulosin Placebo
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.
Medicin: L-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.
Aktiv komparator: Tamsulosin Plus L-Citrulline Placebo
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.
Medicin: Tamsulosin
Oral tamsulosin 0.4 mg once daily will be administered until documented stone passage or completion of 4 weeks of therapy, whichever occurs first.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stone Expulsion Rate Within 4 Weeks
Tidsramme: 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.
Within 4 weeks after randomization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Stone Expulsion
Tidsramme: 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.
From randomization up to 4 weeks
Number of Pain Episodes
Tidsramme: 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.
From randomization up to 4 weeks
Analgesic Use
Tidsramme: 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.
From randomization up to 4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beni-Suef University

Efterforskere

  • Ledende efterforsker: Hany F Badawy, MD, Faculty of Medicine, Beni-Suef University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. maj 2026

Primær færdiggørelse (Anslået)

1. oktober 2026

Studieafslutning (Anslået)

1. november 2026

Datoer for studieregistrering

Først indsendt

25. maj 2026

Først indsendt, der opfyldte QC-kriterier

25. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FMBSUREC05052026BadawyCIT

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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