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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Ahmed Amr Mohammed Mounier, MSc
- Número de telefone: +201111984645
- E-mail: 160022@med.asu.edu.eg
Estude backup de contato
- Nome: Waleed Mousa, Professor
- Número de telefone: +201067628771
- E-mail: Waleedmousa@med.asu.edu.eg
Locais de estudo
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Abbasia
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Cairo, Abbasia, Egito
- Recrutamento
- Ain Shams University Hospital
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Contato:
- Hisham Arafa, Lecturer
- Número de telefone: +201001921334
- E-mail: Hishamarafa1988@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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
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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.
Outros nomes:
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Comparador Ativo: 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
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Evaluation of Ureteral Stent Symptoms
Prazo: 4 weeks
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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
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4 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Waleed Mousa, Professor, Assistant Professor of Urology Department of Urology Ain Shams University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Urogenitais Masculinas
- Cálculos
- Condições Patológicas, Anatômicas
- Doenças renais
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Urolitíase
- Cálculos urinários
- Doenças ureterais
- Nefrolitíase
- Condições Patológicas, Sinais e Sintomas
- Cálculos renais
- Ureterolitíase
- Compostos de enxofre
- Produtos químicos orgânicos
- Piridinas
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Compostos heterocíclicos, 2 anel
- Compostos heterocíclicos, anel fundido
- Hidrocarbonetos
- Hidrocarbonetos, cíclicos
- Hidrocarbonetos, aromáticos
- Amidas
- Indoles
- Derivados de benzeno
- Alcalóides indol
- Benzenésulfonamidas
- Sulfonamidas
- Sulfonas
- Compostos heterocíclicos, 3 anel
- Carbolinas
- Tadalafila
- Tansulosina
Outros números de identificação do estudo
- Ureteric Stent
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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