- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07468084
Comparative Neurocognitive Outcomes Following Prostate Surgery
Comparative Neurocognitive Outcomes Following Holmium Laser Enucleation and Transurethral Resection of the Prostate: A Prospective Cohort Study
Study Overview
Status
Conditions
Detailed Description
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.
The findings of this study may contribute to a better understanding of the neurocognitive safety of modern endoscopic prostate surgery and help clinicians and patients make more informed decisions when selecting the most appropriate surgical treatment for BPH.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Health Science University Kartal Dr. Lütfi Kırdar City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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 |
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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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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changes from cognitive function
Time Frame: 3 months
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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
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3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Canakci002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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