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Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Urinary Retention

8 de setembro de 2026 atualizado por: Süleyman Öner, Eskişehir Osmangazi University Medicine Faculty Hospital

Evaluation of the Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Indwelling Catheters Due to Urinary Retention: A Multicenter Study of the Minimally Invasive Urology Society

Benign Prostatic Obstruction (BPO) is a common condition in aging men that can lead to urinary retention, often requiring the use of an indwelling urinary catheter. While laser enucleation of the prostate (such as HoLEP, ThuLEP or ThuFLEP) is a safe and effective surgical treatment, it is not well understood how the length of time a patient spent with a urethral catheter before surgery affects the final surgical outcomes. By analyzing patient data from multiple centers of the Minimally Invasive Urology Society, this study aims to evaluate the impact of preoperative catheterization duration on functional outcomes.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

This study is designed as a prospective, observational, multicenter, cohort study conducted under the academic coordination of the Minimally Invasive Urology Society. The study will analyze data from multiple participating centers across Turkey. All clinical parameters will be standardized and recorded in a secure, electronic environment. Preoperative data include patient demographics, catheter duration and baseline urinary scores. Intraoperative data focus on surgical duration and energy parameters. Postoperative data track recovery, complication rates according to the Clavien-Dindo classifications and functional outcomes like flow rates (Qmax), International Prostate Symptom Score (IPSS), post-void residual volume (PVR) at 3 months.

By integrating data from diverse clinical settings, this multicenter study aims to establish a clearer understanding of the optimal timing of surgery, ultimately improving clinical decision-making for patients with urinary retention.

Tipo de estudo

Observacional

Inscrição (Estimado)

54

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

  • Turquia (Türkiye)
    • Eskişehir
      • Eskişehir, Eskişehir, Turquia (Türkiye), 26040
        • Recrutamento
        • Eskisehir Osmangazi University, Faculty of Medicine, Department of Urology
        • Contato:

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

N/D

Método de amostragem

Amostra Não Probabilística

População do estudo

The study population consists of adult male patients presenting to the urology departments of multiple tertiary care hospitals (university and research centers) across Turkey. These patients are characterized by symptomatic benign prostatic obstruction (BPO) and require surgical intervention. Specifically, the population includes individuals who are managed with an indwelling urinary catheter due to urinary retention while awaiting laser enucleation of the prostate (HoLEP, ThuLEP or ThuFLEP).

Descrição

Inclusion Criteria:

  • Patients undergoing laser enucleation of the prostate, including HoLEP, ThuLEP or ThuFLEP procedures, who have an indwelling urinary catheter due to pre-operative urinary retention.

Exclusion Criteria:

  • Patients with a diagnosis of neurogenic bladder or prostate cancer.

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

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Short-term Catheterization Group
Patients who have been using an indwelling urinary catheter for less than the average of groups prior to the laser enucleation surgery (HoLEP, ThuLEP, ThuFLEP)
Procedimento: Laser Enucleation of the Prostate (HoLEP, ThuLEP, ThuFLEP)
Patients undergo endoscopic laser enucleation of the prostate using either Holmium or Thulium laser platforms, depending on the standard equipment and clinical preference of the participating center. The procedure involves the anatomical enucleation of the prostatic adenoma from the surgical capsule, followed by intravesical morcellation of the enucleated tissue. All surgeries are performed by urologists according to established surgical protocols.
Outros nomes:
  • ThuLEP
  • HoLEP
  • ThuFLEP
  • Holmium Laser Enucleation of the Prostate
  • Thulium Laser Enucleation of the Prostate
  • Laser Prostatectomy
  • Thulium Fiber Laser Enucleation of the Prostate
Long-term Catheterization Group
Patients who have been using an indwelling urinary catheter for more than the average of groups prior to the laser enucleation surgery (HoLEP, ThuLEP, ThuFLEP)
Procedimento: Laser Enucleation of the Prostate (HoLEP, ThuLEP, ThuFLEP)
Patients undergo endoscopic laser enucleation of the prostate using either Holmium or Thulium laser platforms, depending on the standard equipment and clinical preference of the participating center. The procedure involves the anatomical enucleation of the prostatic adenoma from the surgical capsule, followed by intravesical morcellation of the enucleated tissue. All surgeries are performed by urologists according to established surgical protocols.
Outros nomes:
  • ThuLEP
  • HoLEP
  • ThuFLEP
  • Holmium Laser Enucleation of the Prostate
  • Thulium Laser Enucleation of the Prostate
  • Laser Prostatectomy
  • Thulium Fiber Laser Enucleation of the Prostate

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in International Prostate Symptom Score (IPSS)
Prazo: Baseline and 3 months postoperatively

Evaluation of the improvement in urinary functions after laser enucleation of the prostate (HoLEP, ThuLEP, ThuFLEP):

The International Prostate Symptom Score (IPSS) is a validated questionnaire used to assess the severity of urinary symptoms. It consists of 7 questions, each scored from 0 to 5. Total score ranges from 0 to 35. Higher scores indicate more severe urinary symptoms (0-7: mild, 8-19: moderate, 20-35: severe).
Baseline and 3 months postoperatively
Change in Peak Urinary Flow Rate (Qmax)
Prazo: Baseline and 3 months postoperatively.

Evaluation of the improvement in urinary functions after laser enucleation of the prostate (HoLEP, ThuLEP, ThuFLEP):

Peak urinary flow rate is measured in milliliters per second (mL/s) using uroflowmetry to assess the improvement in urinary flow after the surgical procedure.
Baseline and 3 months postoperatively.
Change in Post-Void Residual Volume (PVR)
Prazo: Baseline and 3 months postoperatively.

Evaluation of the improvement in urinary functions after laser enucleation of the prostate (HoLEP, ThuLEP, ThuFLEP):

Post-void residual volume is the amount of urine remaining in the bladder after voiding, measured in milliliters (mL) via transabdominal ultrasound or catheterization.
Baseline and 3 months postoperatively.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Postoperative Complication Rate
Prazo: From the date of surgery up to 3 months postoperatively.

The frequency and severity of surgical complications occurring after laser enucleation of the prostate (HoLEP, ThuLEP, ThuFLEP). Complications will be categorized and graded using the Clavien-Dindo Classification of Surgical Complications. This scale ranges from Grade I (minor deviations from the normal postoperative course) to Grade V (death of the patient). Higher grades indicate a worse outcome (more severe complications).

Grade I: Any deviation from the normal postoperative course without the need for treatment.

Grade II: Complications requiring pharmacological treatment Grade III: Complications requiring surgical, endoscopic, or radiological intervention Grade IV: Life-threatening complications requiring intensive care unit (ICU) management Grade V: Death of the patient.
From the date of surgery up to 3 months postoperatively.

Colaboradores e Investigadores

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

Patrocinador

Eskişehir Osmangazi University Medicine Faculty Hospital

Colaboradores

Cukurova University
Gazi University
Marmara University
Dokuz Eylul University
Ondokuz Mayıs University
Tepecik Training and Research Hospital
Ankara University
Samsun Education and Research Hospital
Erol Olcok Corum Training and Research Hospital
Izmir Metropolitan Municipality Esrefpasa Hospital

Investigadores

  • Cadeira de estudo: Suleyman Oner, MD, Eskisehir Osmangazi University Faculty of Medicine Hospital

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)

4 de fevereiro de 2026

Conclusão Primária (Estimado)

4 de fevereiro de 2028

Conclusão do estudo (Estimado)

4 de fevereiro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

12 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de maio de 2026

Primeira postagem (Real)

22 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de setembro de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • E-25403353-050.04-260029122

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data (IPD) will not be shared due to privacy concerns and data protection regulations, including the Turkish Personal Data Protection Law (KVKK). Only aggregated, de-identified results will be reported in publications and presentations.

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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