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Tamsulosin Dose Escalation or Silodosin Switch Before Trial Without Catheter in BPH-Related Acute Urinary Retention

11 de junho de 2026 atualizado por: Hany Fathy Badawy, MD, Beni-Suef University

Tamsulosin 0.4 mg Continuation Versus Dose Escalation to 0.8 mg Versus Switch to Silodosin 8 mg for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia: A Randomized Controlled Trial

This randomized controlled trial will compare three medication strategies before trial without catheter in men with acute urinary retention due to benign prostatic hyperplasia who were already taking tamsulosin 0.4 mg once daily before the retention episode. After urethral catheterization, eligible participants will be randomly assigned to one of three groups for 7 days: continuation of tamsulosin 0.4 mg once daily, escalation to tamsulosin 0.8 mg once daily, or switching to silodosin 8 mg once daily. The urethral catheter will be removed on Day 7, and the ability to void successfully without re-catheterization will be assessed. Follow-up will continue to Day 30, with additional recording of catheter-free status, recurrent urinary retention, urinary flow, post-void residual urine, symptom scores, adverse drug events, catheter-related complications, and the need for later benign prostatic hyperplasia-related surgery.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

Acute urinary retention is a common emergency complication of benign prostatic hyperplasia. Standard management includes immediate bladder decompression by urethral catheterization followed by alpha-blocker therapy before attempting catheter removal. However, the optimal management strategy is unclear in men who develop acute urinary retention despite already receiving standard-dose tamsulosin 0.4 mg once daily.

This trial is designed to evaluate whether continuing tamsulosin 0.4 mg, increasing the dose to tamsulosin 0.8 mg, or switching to silodosin 8 mg provides better clinical outcomes before trial without catheter. Eligible men aged 50 years or older with painful acute urinary retention presumed to be secondary to benign prostatic enlargement or obstruction, and who were already taking tamsulosin 0.4 mg once daily for at least 4 weeks before the retention episode, will be enrolled after successful urethral catheterization and written informed consent.

Participants will be randomized in a 1:1:1 ratio to one of three parallel treatment arms. The assigned medication will be given for 7 days while the urethral catheter remains in place. On Day 7, the catheter will be removed in the outpatient urology clinic. Trial without catheter success will be assessed using a predefined clinical definition based on spontaneous voiding, voided volume, post-void residual urine measured by ultrasound, absence of clinically significant voiding difficulty, and no need for re-catheterization within 24 hours.

Participants will be followed until Day 30 for urinary outcomes and safety assessment. The study will also record adverse drug events and catheter-related complications. Participants who fail the Day-7 trial without catheter will be managed according to standard clinical care, including re-catheterization and possible rescue trial without catheter or further benign prostatic hyperplasia management according to clinical judgment.

Tipo de estudo

Intervencional

Inscrição (Estimado)

378

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Egito
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egito, 02456
        • Recrutamento
        • Department of Urology- Beni-Suef University Hospitals
        • Contato:
        • Investigador principal:
          • Hany F Badawy, MD
        • Investigador principal:
          • Ahmed M Elsherif, MD
        • Investigador principal:
          • Mohamed M Dogha, MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  • Male patients aged 50 years or older.
  • Acute urinary retention requiring urethral catheterization.
  • Presumed acute urinary retention secondary to benign prostatic enlargement or benign prostatic obstruction.
  • Already receiving tamsulosin 0.4 mg once daily for at least 4 weeks before the acute urinary retention episode.
  • Successful urethral catheterization at presentation.
  • Initial catheterized urine volume ≤1000 mL, with a clinical presentation consistent with painful acute urinary retention.
  • Prostate enlargement on ultrasound or clinical assessment consistent with benign prostatic hyperplasia or benign prostatic obstruction.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Known or suspected prostate cancer.
  • Previous prostate surgery.
  • Previous urethral stricture disease or urethral surgery.
  • Neurogenic bladder or known neurological disease affecting voiding.
  • Chronic urinary retention rather than acute painful retention.
  • Acute urinary retention due to non-BPH causes, including clot retention, bladder stone obstruction, acute prostatitis, urethral trauma, or drug-induced retention.
  • Severe urinary tract infection, sepsis, or fever at presentation.
  • Gross hematuria requiring irrigation.
  • Failed urethral catheterization or need for suprapubic catheterization.
  • Current use of silodosin, alfuzosin, doxazosin, terazosin, tadalafil, anticholinergics, beta-3 agonists, or other drugs that may significantly affect voiding.
  • Severe renal impairment requiring urgent intervention.
  • Symptomatic postural hypotension or recurrent syncope.
  • Known hypersensitivity to silodosin.
  • Severe hepatic impairment.
  • Inability to comply with follow-up.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Tamsulosin 0.4 mg Continuation
Participants will continue tamsulosin 0.4 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.
Medicamento: Tamsulosin 0.4 mg
Participants assigned to this intervention will continue tamsulosin 0.4 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.
Experimental: Tamsulosin 0.8 mg Dose Escalation
Participants will receive tamsulosin 0.8 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.
Medicamento: Tamsulosin 0.8 mg
Participants assigned to this intervention will receive tamsulosin 0.8 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.
Experimental: Switch to Silodosin 8 mg
Participants will stop tamsulosin 0.4 mg and switch to silodosin 8 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.
Medicamento: Silodosin 8 mg
Participants assigned to this intervention will stop tamsulosin 0.4 mg and switch to silodosin 8 mg once daily for 7 days during urethral catheterization before Trial Without Catheter at Day 7.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Successful Trial Without Catheter at Day 7
Prazo: Day 7, with assessment continuing for 24 hours after catheter removal
Proportion of participants with successful Trial Without Catheter at Day 7. Success is defined as spontaneous voiding within 6 hours after urethral catheter removal, voided volume ≥100 mL, post-void residual urine <150 mL measured by ultrasound within 10-15 minutes after voiding, no painful bladder distension or clinically significant voiding difficulty requiring immediate re-catheterization, and no need for re-catheterization within 24 hours after catheter removal.
Day 7, with assessment continuing for 24 hours after catheter removal

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Catheter-Free Status at Day 14
Prazo: Day 14
Proportion of participants who are free from an indwelling urinary catheter at Day 14 after randomization, including participants who undergo rescue Trial Without Catheter after initial Day-7 failure.
Day 14
Recurrent Acute Urinary Retention Within 30 Days
Prazo: Up to 30 days
Proportion of participants who develop recurrent acute urinary retention requiring re-catheterization after initially successful Trial Without Catheter.
Up to 30 days
Adverse Drug Events
Prazo: Up to 30 days
Proportion of participants with adverse drug events, including dizziness, postural hypotension, syncope, headache, nasal congestion, abnormal ejaculation, diarrhea, allergic reaction, or other clinically significant drug-related adverse events.
Up to 30 days

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Beni-Suef University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

8 de junho de 2026

Conclusão Primária (Estimado)

1 de maio de 2027

Conclusão do estudo (Estimado)

1 de junho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

11 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de junho de 2026

Primeira postagem (Real)

16 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • TAMS-TWOC-2026

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be shared because the study includes individual-level clinical data related to acute urinary retention, medication exposure, catheterization, follow-up outcomes, and adverse events. Only aggregated, de-identified results will be reported in publications or presentations. Any future sharing of de-identified participant-level data would require additional approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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