Intravesical Aminophylline for Urgent Ureteral Stenting in Acute Calculous Anuria
Intravesical Aminophylline-Assisted Urgent Retrograde Ureteral Stenting for Acute Calculous Anuria: A Prospective Randomized Controlled Trial
Acute calculous anuria is a urological emergency caused by ureteral stone obstruction in a solitary functioning kidney or bilateral ureteral obstruction. Urgent decompression of the upper urinary tract is required to restore urine drainage and prevent further renal impairment.
This prospective randomized double-blind controlled trial will evaluate whether intravesical aminophylline can facilitate urgent retrograde ureteral stenting in adult patients with acute calculous anuria due to ureteral stones. Eligible patients will be randomly assigned to receive either intravesical aminophylline diluted in normal saline or placebo saline before attempted retrograde Double-J ureteral stent placement.
The primary outcome is technical success, defined as successful placement of a Double-J ureteral stent across the obstructing stone without the need for percutaneous nephrostomy. Secondary outcomes include stenting time, intraoperative complications, renal function recovery, postoperative pain, analgesic requirement, and the need for alternative drainage.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This is a prospective, randomized, double-blind, controlled trial conducted at the Department of Urology, Beni-Suef University Hospital.
The study will include adult patients aged 18 years or older presenting with acute calculous anuria due to ureteral stone obstruction in a solitary functioning kidney or bilateral ureteral obstruction. Obstruction will be confirmed by pelvi-abdominal ultrasound and computed tomography of the urinary tract. Eligible patients will have clinical and laboratory evidence of acute renal impairment, including oliguria or anuria and elevated serum creatinine.
After eligibility assessment and informed consent, participants will be randomly allocated in a 1:1 ratio to one of two groups.
Participants in the aminophylline group will receive intravesical instillation of 250 mg aminophylline diluted in normal saline to a total volume of 160 mL. Participants in the control group will receive placebo intravesical instillation using normal saline with the same total volume. The study solution will be prepared by a nurse who is not involved in the operation to maintain blinding of the patient and the operating surgeon.
Under general or spinal anesthesia, the patient will be placed in the lithotomy position. A cystoscope will be introduced and the bladder will be emptied. The assigned intravesical solution will then be instilled into the bladder and retained for 5 minutes before proceeding with retrograde ureteral stenting. Under fluoroscopic guidance, a guidewire will be advanced through the ureteric orifice in an attempt to bypass the obstructing ureteral stone. If successful, a Double-J ureteral stent will be advanced over the guidewire and positioned across the obstruction.
The primary endpoint is technical success of retrograde ureteral stenting, defined as successful placement of the Double-J stent across the obstructing stone without the need for percutaneous nephrostomy. Secondary endpoints include time required for successful stent placement, intraoperative complications, serum creatinine changes at 24, 48, and 72 hours after decompression, postoperative pain score, analgesic requirement, and the need for alternative drainage after failed retrograde stenting.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hany F Badawy, MD
- Número de teléfono: +201149525028
- Correo electrónico: HANYFATHY86@GMAIL.COM
Copia de seguridad de contactos de estudio
- Nombre: Mahmoud Abdallah, MD
- Número de teléfono: +201211874080
- Correo electrónico: Drhanyfathy86@GMAIL.COM
Ubicaciones de estudio
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Beni Suweif Governorate
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Banī Suwayf, Beni Suweif Governorate, Egipto
- Reclutamiento
- Department of Urology- Beni-Suef University Hospitals
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Contacto:
- Hany F Badawy, MD
- Número de teléfono: +201149525028
- Correo electrónico: HANYFATHY86@GMAIL.COM
-
Contacto:
- Mahmoud Abdallah, MD
- Número de teléfono: +201211874080
- Correo electrónico: Drhanyfathy86@GMAIL.COM
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Investigador principal:
- Hany F Badawy, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients aged 18 years or older.
- Diagnosis of acute calculous anuria due to ureteral stone obstruction in a solitary functioning kidney.
- Obstruction confirmed by pelvi-abdominal ultrasound and computed tomography of the urinary tract.
- Clinical and laboratory evidence of acute renal impairment, including oliguria or anuria and serum creatinine >2 mg/dL.
- Ability to provide written informed consent.
Exclusion Criteria:
- Known hypersensitivity to aminophylline, theophylline, or other methylxanthines.
- Evidence of active urinary tract infection or urosepsis.
- Previous history of ureteral stricture or major urinary tract reconstructive surgery.
- Hemodynamic instability requiring immediate life-saving measures before urological intervention.
- Pregnancy.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intravesical Aminophylline
Participants will receive intravesical instillation of 250 mg aminophylline diluted with normal saline to a total volume of 160 mL.
The solution will be retained in the bladder for 5 minutes before attempted urgent retrograde Double-J ureteral stent placement.
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Aminophylline 250 mg diluted with normal saline to a total intravesical instillation volume of 160 mL.
The solution will be retained in the bladder for 5 minutes before urgent retrograde Double-J ureteral stent placement.
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Comparador de placebos: Placebo Saline
Participants will receive intravesical placebo instillation using normal saline to a total volume of 160 mL.
The solution will be retained in the bladder for 5 minutes before attempted urgent retrograde Double-J ureteral stent placement.
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Placebo intravesical instillation using normal saline to a total volume of 160 mL.
The solution will be retained in the bladder for 5 minutes before urgent retrograde Double-J ureteral stent placement.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Technical Success of Retrograde Double-J Ureteral Stent Placement
Periodo de tiempo: During the index urgent retrograde stenting procedure
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Technical success will be defined as successful placement of a Double-J ureteral stent across the obstructing ureteral stone during the initial urgent retrograde stenting procedure without the need for percutaneous nephrostomy.
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During the index urgent retrograde stenting procedure
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Retrograde Stenting Attempt Time
Periodo de tiempo: During the index urgent retrograde stenting procedure
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Time will be measured in minutes from the start of the retrograde stenting attempt after the 5-minute intravesical dwell time until successful final Double-J stent positioning or the decision to stop the retrograde attempt because of technical failure.
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During the index urgent retrograde stenting procedure
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Intraoperative Complication Rate
Periodo de tiempo: During the index urgent retrograde stenting procedure
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Proportion of participants who experience intraoperative procedure-related complications, including ureteral mucosal injury, ureteral perforation, bleeding, guidewire false passage, or other procedure-related adverse events.
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During the index urgent retrograde stenting procedure
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Serum Creatinine Change During the First 72 Hours After Decompression
Periodo de tiempo: Baseline, 24 hours, 48 hours, and 72 hours after decompression
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Serum creatinine will be measured before decompression and at 24, 48, and 72 hours after the procedure to assess early renal function recovery.
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Baseline, 24 hours, 48 hours, and 72 hours after decompression
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Postoperative Pain Score During the First 24 Hours
Periodo de tiempo: Every 4 hours during the first 24 hours postoperatively
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Postoperative pain will be assessed using a 10-point Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Scores will be recorded every 4 hours during the first 24 hours after recovery from anesthesia.
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Every 4 hours during the first 24 hours postoperatively
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hany F Badawy, MD, Beni-Suef University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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 Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Urolitiasis
- Cálculos urinarios
- Insuficiencia renal
- Enfermedades ureterales
- Condiciones Patológicas, Signos y Síntomas
- Ureterolitiasis
- Lesión renal aguda
- Cálculos ureterales
Otros números de identificación del estudio
- FMBSUREC07042026Ahmed
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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