Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg
Safety and Efficacy of Combination of Tamsulosin 0.4 mg Plus Tadalafil 5mg Versus 2.5 mg for Ureteric Stent Related Symptoms
Ureteral stenting is a common urological procedure performed to relieve obstruction and facilitate urinary drainage. Despite its effectiveness, stent-related symptoms (SRS) such as dysuria, frequency, urgency, flank pain, and sexual discomfort negatively affect patient quality of life.
Pharmacological management with alpha-blockers such as Tamsulosin and phosphodiesterase-5 inhibitors (PDE5i) such as Tadalafil has shown promise in reducing SRS. While low-dose Tadalafil (2.5 mg) has not been explored, its comparative effectiveness against the standard 5 mg dose when combined with Tamsulosin remains under-researched. This study aims to evaluate the difference in reduction of SRS between Tamsulosin with Tadalafil in standard and half dosage.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Ureteral stents are commonly used for temporary drainage in various urological procedures. Despite their usefulness, they are frequently associated with bothersome symptoms collectively termed as "stent-related symptoms" (SRS),These symptoms include flank pain, lower urinary tract symptoms (LUTS), hematuria, dysuria, urgency, frequency, and sexual dysfunction.
The exact pathophysiology of SRS is multifactorial, involving local irritation, vesicoureteral reflux, and smooth muscle spasm.
Various pharmacological agents have been studied to alleviate these symptoms, with alpha-blockers and PDE-5 inhibitors showing promising results .
Tamsulosin, a selective al-blocker, reduces bladder neck and distal ureteral smooth muscle tone, alleviating irritative urinary symptoms.
Tadalafil, a PDE-5 inhibitor, has been shown to improve LUTS through its smooth muscle relaxation and increased perfusion effects. While both have been studied individually and in combination, the optimal dose of Tadalafil in combination therapy is yet to be clearly established
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ahmed Amr Mohammed Mounier, MSc
- Número de teléfono: +201111984645
- Correo electrónico: 160022@med.asu.edu.eg
Copia de seguridad de contactos de estudio
- Nombre: Waleed Mousa, Professor
- Número de teléfono: +201067628771
- Correo electrónico: Waleedmousa@med.asu.edu.eg
Ubicaciones de estudio
-
-
Abbasia
-
Cairo, Abbasia, Egipto
- Reclutamiento
- Ain Shams University Hospital
-
Contacto:
- Hisham Arafa, Lecturer
- Número de teléfono: +201001921334
- Correo electrónico: Hishamarafa1988@gmail.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- patients older than 18 years of age, with presence of a double-J (DJ) stent (polyurethane) post endoscopic stone removal.
Exclusion Criteria:
- Patients younger than 18 years of age were excluded.
- Patients with a history of prostate or bladder surgery were excluded.
- Patients with prior lower urinary tract procedures were excluded.
- Patients with cancer were excluded.
- Patients with neurological conditions were excluded.
- Patients with a history of pelvic radiation were excluded.
- Patients with diabetes were excluded.
- Patients with kidney dysfunction (acute or chronic) were excluded.
- Patients with a solitary kidney were excluded.
- Patients with congenital urinary anomalies were excluded.
Patients taking the following medications were excluded:
- α-blockers
- beta-blockers
- calcium channel blockers
- 5-alpha reductase inhibitors
- PDE5 inhibitors
- anticholinergics
- nitrates
- Patients with cardiac issues were excluded.
- Patients with residual stone fragments after surgery were excluded.
- Patients with multiple or bilateral ureteral stones were excluded.
- Patients with long-term or bilateral stents requiring frequent changes were excluded.
- Patients with interstitial cystitis were excluded.
- Patients with chronic cystitis were excluded.
- Patients with prostatitis were excluded.
- Pregnant women were excluded.
- Breastfeeding women were excluded.
- Patients unavailable for follow-up were excluded.
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 |
|---|---|
|
Comparador activo: Group A : (Tamsulosin 0.4 mg + Tadalafil 2.5 mg)
About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 2.5 mg tablets daily for evaluation of relieving stent-related symptoms
|
Evaluation of safety and efficacy of Tamsulosin 0.4 mg plus Tadalafil 2.5 mg versus Tamsulosin 0.4 mg plus Tadalafil 5 mg in relieving stent-related symptoms.
Otros nombres:
|
|
Comparador activo: Group B:(Tamsulosin 0.4 mg + Tadalafil 5 mg)
About 70 patients will receive Tamsulosin 0.4 mg + Tadalafil 5 mg tablets daily for evaluation of relieving stent-related symptoms
|
Evaluation of safety and efficacy of Tamsulosin 0.4 mg plus Tadalafil 2.5 mg versus Tamsulosin 0.4 mg plus Tadalafil 5 mg in relieving stent-related symptoms.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluation of Ureteral Stent Symptoms
Periodo de tiempo: 4 weeks
|
Evaluation of Ureteral Stent Symptoms postoperatively using Questionnaire (USSQ) score after treatment (from 1 to 5) as: 1 is best relief of symptoms but 5 is worsen relief of symptoms
|
4 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Waleed Mousa, Professor, Assistant Professor of Urology Department of Urology Ain Shams 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
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
- Enfermedades ureterales
- Nefrolitiasis
- Condiciones Patológicas, Signos y Síntomas
- Cálculos renales
- Ureterolitiasis
- Compuestos de azufre
- Químicos orgánicos
- Piridina
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Hidrocarburos
- Hidrocarburos, cíclico
- Hidrocarburos, aromáticos
- Amidas
- Indoles
- Derivados de benceno
- Alcaloides de indol
- Bencenosulfonamidas
- Sulfonamidas
- Sulfonas
- Compuestos heterocíclicos, 3 anillos
- Carbolines
- Tadalafilo
- Tamsulosina
Otros números de identificación del estudio
- Ureteric Stent
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .