Comparative Neurocognitive Outcomes Following Prostate Surgery

NCT07468084 | Completed

• 1 other identifier: Canakci002
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia; Cognitive Functions

Keywords

Benign Prostatic Hyperplasia; MoCA; HoLEP; TURP

Outcome Measures

Primary Outcomes (1)

• changes from cognitive function

  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

  3 months

Study Arms (2)

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

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgical treatment for symptomatic BPH at a tertiary urology center.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cengiz Canakci, MD: lead

Study Sites (1)

Health Science University Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assos. Prof.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: July 8, 2025
• Primary Completion: December 2, 2025
• Study Completion: March 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)