跳至主要内容
临床试验/NCT07468084
NCT07468084已完成不适用

Comparative Neurocognitive Outcomes Following Holmium Laser Enucleation and Transurethral Resection of the Prostate: A Prospective Cohort Study

Cengiz Canakci, MD1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2025年7月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
132
试验地点
1
主要终点
changes from cognitive function

研究概览

简要总结

This prospective observational cohort study aims to evaluate postoperative cognitive outcomes in patients undergoing surgical treatment for benign prostatic hyperplasia (BPH). Two commonly used surgical techniques-Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP)-will be compared. Cognitive function will be assessed before surgery and three months after surgery using validated neurocognitive and psychological assessment tools. The primary outcome measure is the change in Montreal Cognitive Assessment (MoCA) score. Secondary outcomes include changes in Mini-Mental State Examination (MMSE), Beck Anxiety Inventory (BAI), and Beck Depression Inventory (BDI) scores. The study aims to determine whether the type of surgical technique independently influences postoperative cognitive function after adjusting for important patient-related factors such as age and educational level.

详细描述

Benign prostatic hyperplasia (BPH) is a common condition among aging men and is one of the most frequent causes of lower urinary tract symptoms. When symptoms become moderate to severe and do not respond adequately to medical therapy, surgical treatment is recommended. Transurethral resection of the prostate (TURP) has long been considered the standard surgical approach for BPH, while Holmium Laser Enucleation of the Prostate (HoLEP) has emerged as an effective minimally invasive alternative with favorable perioperative outcomes.

Although these procedures are widely used and generally considered safe, concerns remain regarding potential postoperative cognitive changes, particularly in elderly surgical populations. Postoperative cognitive dysfunction has been described after various surgical procedures and may affect patient recovery, functional independence, and quality of life. However, limited data are available regarding cognitive outcomes after BPH surgery, and direct comparisons between different surgical techniques remain scarce.

Most previous studies assessing cognitive outcomes after urological surgery have relied on the Mini-Mental State Examination (MMSE), which may have limited sensitivity in detecting mild cognitive impairment. The Montreal Cognitive Assessment (MoCA) is a more sensitive tool that evaluates multiple cognitive domains including executive function, attention, memory, language, and visuospatial ability.

This prospective observational cohort study aims to compare postoperative cognitive trajectories in patients undergoing HoLEP or TURP for symptomatic BPH. Eligible patients will undergo standardized cognitive and psychological assessments before surgery and three months postoperatively. The primary outcome is the change in MoCA score over time. Secondary outcomes include changes in MMSE, Beck Anxiety Inventory (BAI), and Beck Depression Inventory (BDI) scores.

Statistical analyses will evaluate longitudinal changes in cognitive outcomes and investigate whether surgical technique independently influences postoperative cognitive performance after adjustment for potential confounding factors such as age and educational level.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Male
接受健康志愿者

入选标准

  • Male patients aged 55-80 years
  • Symptomatic benign prostatic hyperplasia requiring surgery
  • Prostate volume 50-100 cc
  • Baseline MMSE ≥ 24
  • Ability to complete cognitive tests independently

排除标准

  • Neurodegenerative diseases (Alzheimer's, Parkinson's)
  • History of cerebrovascular accident with deficits
  • Traumatic brain injury
  • Severe psychiatric disorders
  • Alcohol or substance abuse Chronic sedative or antipsychotic use
  • Severe visual or auditory impairment
  • Previous prostate surgery
  • Active malignancy
  • Perioperative complications requiring ICU admission

研究组 & 干预措施

HoLEP

Participants were divided into two cohorts based on the surgical procedure performed for the treatment of benign prostatic hyperplasia (BPH). One cohort included patients undergoing Holmium Laser Enucleation of the Prostate (HoLEP), and the other cohort included patients undergoing Transurethral Resection of the Prostate (TURP). The choice of surgical technique was determined according to clinical indications and institutional practice rather than study participation.

All participants underwent standardized preoperative and postoperative evaluations. Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA) and the Mini-Mental State Examination (MMSE). Psychological status was evaluated using the Beck Anxiety Inventory (BAI) and the Beck Depression Inventory (BDI). Assessments were performed before surgery and repeated three months after surgery to evaluate potential changes in cognitive and psychological outcomes

TURP

Participants were divided into two cohorts based on the surgical procedure performed for the treatment of benign prostatic hyperplasia (BPH). One cohort included patients undergoing Holmium Laser Enucleation of the Prostate (HoLEP), and the other cohort included patients undergoing Transurethral Resection of the Prostate (TURP). The choice of surgical technique was determined according to clinical indications and institutional practice rather than study participation.

All participants underwent standardized preoperative and postoperative evaluations. Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA) and the Mini-Mental State Examination (MMSE). Psychological status was evaluated using the Beck Anxiety Inventory (BAI) and the Beck Depression Inventory (BDI). Assessments were performed before surgery and repeated three months after surgery to evaluate potential changes in cognitive and psychological outcomes

结局指标

主要结局

changes from cognitive function

时间窗: 3 months

The primary objective of this study was to utilize the Montreal Cognitive Assessment three months post-surgery to examine and evaluate cognitive alterations following HoLEP and TURP procedures

次要结局

未报告次要终点

研究者

发起方
Cengiz Canakci, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Cengiz Canakci, MD

Assos. Prof.

Lütfi Kırdar City Hospital

研究点 (1)

Loading locations...

相似试验

Comparative Neurocognitive Outcomes Following... | 临床试验