Benign Prostatic HyperplasiaNCT07468084
Comparative Neurocognitive Outcomes Following Prostate Surgery
An observational study of Benign Prostatic Hyperplasia and Cognitive Functions, run by Cengiz Canakci, MD at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Cognitive Functions
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jul 2025to 1 Mar 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing surgical treatment for symptomatic BPH at a tertiary urology center.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Previous prostate surgery
- Active malignancy
- Perioperative complications requiring ICU admission
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University Kartal Dr. Lütfi Kırdar City Hospital
Istanbul
About this study
Official title: Comparative Neurocognitive Outcomes Following Holmium Laser Enucleation and Transurethral Resection of the Prostate: A Prospective Cohort Study
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.
Read the 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.
- Conditions
- Benign Prostatic Hyperplasia, Cognitive Functions
- Keywords
- Benign Prostatic Hyperplasia, MoCA, HoLEP, TURP
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start8 Jul 2025
- Primary completion2 Dec 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Cengiz Canakci, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cengiz Canakci, MD, Lütfi Kırdar City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468084
- Sponsor's protocol ID
- Canakci002
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Neurocognitive Outcomes Following Holmium Laser Enucleation and Transurethral Resection of the Prostate: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07468084
- Acronym / sponsor ID
- Canakci002
- Conditions
- Benign Prostatic Hyperplasia, Cognitive Functions
- Keywords
- Benign Prostatic Hyperplasia, MoCA, HoLEP, TURP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Cengiz Canakci, MDUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing surgical treatment for symptomatic BPH at a tertiary urology center.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
changes from cognitive function
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia and Cognitive Functions, run by Cengiz Canakci, MD at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes from cognitive function (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.