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Extracorporeal Shock Wave Lithotripsy Versus Ureteroscopy for Upper Ureteric Stones

18. August 2026 aktualisiert von: Hanzla Arshad

Comparison of Treatment Efficacy of Extracorporeal Shock Wave Lithotripsy Versus Ureteroscopy in Patients With Upper Ureteric Stones: A Randomized Controlled Trial

Upper ureteric stones can be treated using extracorporeal shock wave lithotripsy or ureteroscopy. Extracorporeal shock wave lithotripsy breaks the stone using shock waves delivered from outside the body, whereas ureteroscopy involves passing a small instrument through the urinary tract to locate and fragment the stone.

This randomized controlled trial compared the effectiveness and safety of these two treatments in adults with a single upper ureteric stone smaller than 10 mm and a stone density of 1000 Hounsfield units or less. Participants were assigned to receive either extracorporeal shock wave lithotripsy or semirigid ureteroscopy. The main outcome was complete stone clearance on non-contrast computed tomography four weeks after completion of the assigned treatment. Pain relief, number of treatment sessions and treatment-related complications were also assessed.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This single-centre, randomized, parallel-group controlled trial was conducted in the Department of Urology, Federal Postgraduate Medical Institute, Shaikh Zayed Hospital, Lahore, Pakistan. The objective was to compare the treatment efficacy and short-term safety of extracorporeal shock wave lithotripsy (ESWL) with semirigid ureteroscopy (URS) in patients presenting with an upper ureteric stone.

A total of 100 participants aged 18-75 years were enrolled. Eligible participants had a single unilateral upper ureteric stone located above the sacroiliac joint. The stone was confirmed on non-contrast computed tomography of the kidneys, ureters and bladder, measured less than 10 mm in maximum diameter and had a density of 1000 Hounsfield units or less. Participants were randomized in a 1:1 ratio by lottery, with 50 participants assigned to each treatment group.

Participants assigned to ESWL were treated using the MODULITH SLX-F2 lithotripter. Shock waves were delivered at a rate of 60-120 shocks per minute, with an energy setting of 1-9 kV and approximately 2500-3000 shocks per session. Each session lasted approximately 30-60 minutes. A maximum of three sessions was permitted, with an interval of at least 48 hours between successive sessions.

Participants assigned to URS underwent semirigid ureteroscopy under general anesthesia using a 6.5-7.5 Fr semirigid ureteroscope. Stones were fragmented using the Swiss LithoClast Master pneumatic lithotripsy system with a 1-1.2 Fr probe. Stone fragments were removed using a Dormia basket or grasping forceps when required. A double-J ureteric stent was inserted in every participant undergoing URS and was subsequently removed according to clinical assessment.

The primary outcome was complete stone clearance, assessed using non-contrast computed tomography four weeks after completion of the assigned treatment. Complete stone clearance was defined as the absence of any residual stone or stone fragment in the ipsilateral kidney or ureter. A participant requiring an additional stone-removal procedure before the four-week assessment was classified as having treatment failure.

Secondary outcomes included the number of ESWL sessions required, pain relief, immediate procedure-related complications and complications occurring during the four-week follow-up period.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Pakistan
      • Lahore, Pakistan, 54810
        • Sheikh Zayed Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Male or female participant aged 18 to 75 years Single unilateral upper ureteric stone located above the sacroiliac joint Stone confirmed by non-contrast computed tomography of the kidneys, ureters and bladder Stone maximum diameter less than 10 mm Stone density of 1000 Hounsfield units or less Written informed consent provided Willing and able to complete the assigned treatment and four-week follow-up

Exclusion Criteria:

  • Solitary functioning kidney Bilateral ureteric stones Active urinary tract infection Deranged renal function Stone maximum diameter of 10 mm or greater Stone density greater than 1000 Hounsfield units Unable or unwilling to complete the assigned treatment or four-week follow-up

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Extracorporeal Shock Wave Lithotripsy
Participants received extracorporeal shock wave lithotripsy using the MODULITH SLX-F2 lithotripter. A maximum of three sessions was permitted, with an interval of at least 48 hours between sessions.
Verfahren: Extracorporeal Shock Wave Lithotripsy
ESWL was performed using the MODULITH SLX-F2 lithotripter at 60-120 shocks per minute, an energy setting of 1-9 kV and approximately 2500-3000 shocks per session. Each session lasted approximately 30-60 minutes. Up to three sessions were permitted, with at least 48 hours between sessions.
Aktiver Komparator: Semirigid Ureteroscopy
Participants underwent semirigid ureteroscopy under general anesthesia with pneumatic stone fragmentation. Stone fragments were removed when required, and a double-J ureteric stent was inserted in all participants.
Verfahren: Semirigid Ureteroscopy
Semirigid ureteroscopy was performed under general anesthesia using a 6.5-7.5 Fr ureteroscope. Stones were fragmented using the Swiss LithoClast Master pneumatic lithotripsy system with a 1-1.2 Fr probe. Fragments were removed using a Dormia basket or grasping forceps when required. A double-J ureteric stent was inserted in every participant and subsequently removed according to clinical assessment.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Complete Stone Clearance
Zeitfenster: 4 weeks after completion of the assigned treatment
Number of participants with complete stone clearance on non-contrast computed tomography of the kidneys, ureters and bladder. Complete stone clearance was defined as the absence of any residual stone or stone fragment in the ipsilateral kidney or ureter. Participants requiring an additional stone-removal procedure before assessment were classified as treatment failures.
4 weeks after completion of the assigned treatment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of ESWL Sessions Required
Zeitfenster: Immediately after completion of the final ESWL treatment session
Number of extracorporeal shock wave lithotripsy sessions received by each participant assigned to the ESWL arm. Participants could receive a maximum of three sessions, with an interval of at least 48 hours between successive sessions.
Immediately after completion of the final ESWL treatment session

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hanzla Arshad

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Dezember 2025

Primärer Abschluss (Tatsächlich)

1. Juni 2026

Studienabschluss (Tatsächlich)

1. Juni 2026

Studienanmeldedaten

Zuerst eingereicht

13. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. August 2026

Zuerst gepostet (Tatsächlich)

19. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • TERC/SC/INT/2025/570
  • Technical and Ethical Review C (Andere Kennung: Shaikh Zayed Federal Postgraduate Medical Institute)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Deidentified individual participant data underlying the results reported in the final publication will be available upon reasonable request. Data will be shared only after approval of a scientifically sound proposal and completion of a data-use agreement. Information that could identify individual participants will not be shared.

IPD-Sharing-Zeitrahmen

Beginning 3 months after publication of the study results and available for 5 years.

IPD-Sharing-Zugriffskriterien

Researchers with a methodologically sound proposal may request access from the principal investigator. Requests must describe the research objectives, proposed analyses and data-security arrangements. Access will require approval by the principal investigator and completion of a data-use agreement. Data may be used only for the analyses specified in the approved proposal.

Art der unterstützenden IPD-Freigabeinformationen

  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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