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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07772635
Extracorporeal Shock Wave Lithotripsy Versus Ureteroscopy for Upper Ureteric Stones
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Lahore, Pakistán, 54810
- Sheikh Zayed Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
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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.
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Comparador activo: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Complete Stone Clearance
Periodo de tiempo: 4 weeks after completion of the assigned treatment
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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.
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4 weeks after completion of the assigned treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of ESWL Sessions Required
Periodo de tiempo: Immediately after completion of the final ESWL treatment session
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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.
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Immediately after completion of the final ESWL treatment session
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades urogenitales masculinas
- Cálculos
- Condiciones Patológicas, Anatómicas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Cálculos urinarios
- Enfermedades ureterales
- Condiciones Patológicas, Signos y Síntomas
- Cálculos ureterales
- Ureterolitiasis
- Urolitiasis
- Terapéutica
- Procedimientos quirúrgicos, operativo
- Procedimientos quirúrgicos ultrasónicos
- Litotripia
Otros números de identificación del estudio
- TERC/SC/INT/2025/570
- Technical and Ethical Review C (Otro identificador: Shaikh Zayed Federal Postgraduate Medical Institute)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
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