Benign Prostatic HyperplasiaHoLEP and TURPNCT07663097
Preoperative Anxiety and Surgical Fear in Holmium Laser Enucleation of the Prostate and Transurethral Resection of the Prostate Patients With Benign Prostatic Hyperplasia
An observational study of Benign Prostatic Hyperplasia, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
Benign prostatic hyperplasia (BPH) is a common condition in older men and may cause bothersome lower urinary tract symptoms that can negatively affect quality of life. Surgical treatment with Holmium Laser Enucleation of the Prostate (HoLEP) or Transurethral Resection of the Prostate (TURP) is often recommended when… Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP)
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jun 2026to 8 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients aged 50 years or older with benign prostatic hyperplasia (BPH) who are scheduled to undergo Holmium Laser Enucleation of the Prostate (HoLEP) or Transurethral Resection of the Prostate (TURP) at Hitit University Erol Olcok Training and Research Hospital and who provide written informed consent.
Who may be able to join
- Male patients aged 50 years or older
- Diagnosis of benign prostatic hyperplasia (BPH)
- Scheduled to undergo HoLEP or TURP
- Ability to understand and complete study questionnaires
- Provided written informed consent
Who cannot join
- History of severe psychiatric disorder
- Active psychiatric treatment
- Neurogenic bladder or neurologic voiding dysfunction
- Diagnosis of prostate cancer
- Previous prostate surgery
- Inability to comply with study procedures or follow-up visits
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Effects of Preoperative Anxiety and Surgical Fear on Postoperative Functional Outcomes and Patient Satisfaction in Patients Scheduled for HoLEP and TURP Due to Benign Prostatic Hyperplasia: A Prospective Observational Study
Benign prostatic hyperplasia (BPH) is a common condition in older men and may cause bothersome lower urinary tract symptoms that can negatively affect quality of life. Surgical treatment with Holmium Laser Enucleation of the Prostate (HoLEP) or Transurethral Resection of the Prostate (TURP) is often recommended when medical therapy is insufficient.
This prospective observational study aims to evaluate whether preoperative anxiety, depression, and surgical fear influence postoperative functional outcomes, urinary continence, erectile function, and patient satisfaction in patients undergoing HoLEP or TURP for BPH. Participants will complete validated psychological and functional questionnaires before surgery and during postoperative follow-up visits at 1 and 3 months. The study will also assess changes in psychological status after surgery and compare outcomes between HoLEP and TURP patients.
The findings may help improve preoperative patient counseling and identify patients who could benefit from additional psychological support before surgery.
Read the detailed description
Benign prostatic hyperplasia (BPH) is one of the most common urological conditions affecting aging men and is frequently associated with lower urinary tract symptoms (LUTS) that significantly impair quality of life. Although medical therapy is the first-line treatment for most patients, surgical intervention becomes necessary in cases with severe symptoms, complications, or inadequate response to medication. Transurethral Resection of the Prostate (TURP) has long been considered the standard surgical treatment, while Holmium Laser Enucleation of the Prostate (HoLEP) has emerged as an effective minimally invasive alternative with favorable perioperative and functional outcomes.
Psychological factors such as anxiety, depression, and fear of surgery have been shown to influence recovery, pain perception, treatment satisfaction, and functional outcomes after various surgical procedures. However, the impact of preoperative psychological status on postoperative outcomes in patients undergoing surgery for BPH remains insufficiently investigated.
This prospective, single-center, observational study aims to evaluate the relationship between preoperative anxiety, depression, and surgical fear and postoperative functional outcomes in patients undergoing HoLEP or TURP for BPH. Eighty patients scheduled for surgical treatment of BPH will be enrolled. Patients will be allocated to HoLEP or TURP according to routine clinical practice, surgeon preference, and patient choice. No randomization or study-related intervention will be performed.
Before surgery, participants will complete validated questionnaires assessing lower urinary tract symptoms, erectile function, anxiety, depression, and surgical fear, including the International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 (IIEF-5), State-Trait Anxiety Inventory (STAI), Hospital Anxiety and Depression Scale (HADS), and Surgical Fear Questionnaire (SFQ).
Follow-up assessments will be conducted at postoperative 1 month and 3 months. Functional outcomes, urinary continence, erectile function, psychological status, and patient satisfaction will be evaluated using the same validated instruments. Urinary continence will additionally be assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF).
The primary objective is to determine whether preoperative anxiety levels are associated with postoperative functional improvement, measured by changes in IPSS scores. Secondary objectives include evaluating the relationship between psychological status and postoperative urinary incontinence, erectile function, patient satisfaction, and longitudinal changes in anxiety and depression after surgery. Outcomes will also be compared between patients undergoing HoLEP and TURP.
The results of this study may improve understanding of the role of psychological factors in BPH surgery and contribute to the development of targeted perioperative counseling and psychological support strategies for patients undergoing surgical treatment for BPH.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Holmium Laser Enucleation of the Prostate (HoLEP), Transurethral Resection of the Prostate (TURP)
- Keywords
- BPH, HOLEP, TURP, Preoperative anxiety, surgical fear, depression, Patient satisfaction, lower urinary tract symptoms, urinary incontinence, erectile function
- Medical subject headings
- Prostatic Hyperplasia, Depression, Patient Satisfaction, Lower Urinary Tract Symptoms, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium Laser Enucleation of the Prostate (HoLEP)Procedure or surgery
Standard HoLEP procedure for treatment of benign prostatic hyperplasia.
Transurethral Resection of the Prostate (TURP)Procedure or surgery
Standard TURP procedure for treatment of benign prostatic hyperplasia.
| Study group | Role | What they receive |
|---|---|---|
| HoLEP Group | Patients with benign prostatic hyperplasia undergoing HoLEP surgery. Receives: Procedure: Holmium Laser Enucleation of the Prostate (HoLEP) | |
| TURP Group | Patients with benign prostatic hyperplasia undergoing TURP surgery. Receives: Procedure: Transurethral Resection of the Prostate (TURP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Prostate Symptom Score (IPSS)
Association between preoperative anxiety levels and postoperative functional improvement measured by changes in International Prostate Symptom Score (IPSS). IPSS scores range from 0 to 35, with higher scores indicating more severe lower urinary tract symptoms. Change from baseline to postoperative 3 months will be evaluated.
Measured: Baseline to 3 months after surgery
Secondary outcomes (5)
Change in IIEF-5 Score
Change in International Index of Erectile Function-5 (IIEF-5) score. Scores range from 5 to 25, with higher scores indicating better erectile function.
Measured: Baseline to 3 months after surgery
Urinary Incontinence Assessed by ICIQ-SF
Urinary continence assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF). Scores range from 0 to 21, with higher scores indicating more severe urinary incontinence.
Measured: 1 and 3 months after surgery
Change in HADS Score
Change in Hospital Anxiety and Depression Scale (HADS) score. Total scores range from 0 to 42, with higher scores indicating greater anxiety and depressive symptoms.
Measured: Baseline to 3 months after surgery
Change in STAI Score
Change in State-Trait Anxiety Inventory (STAI) score. Scores range from 20 to 80, with higher scores indicating greater anxiety levels.
Measured: Baseline to 3 months after surgery
Patient Satisfaction Score
Patient satisfaction will be assessed using a visual analog scale ranging from 0 to 10, with higher scores indicating greater satisfaction with surgical outcomes.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start14 Jun 2026 (estimated)
- Primary completion8 Apr 2027 (estimated)
- Study completion8 Jun 2027 (estimated)
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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Serdar CAGLAYAN, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663097
- Sponsor's protocol ID
- 2026-85
- Acronym
- HoLEP and TURP
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this study will not be made publicly available due to privacy and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Preoperative Anxiety and Surgical Fear on Postoperative Functional Outcomes and Patient Satisfaction in Patients Scheduled for HoLEP and TURP Due to Benign Prostatic Hyperplasia: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07663097
- Acronym / sponsor ID
- HoLEP and TURP / 2026-85
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- BPH, HOLEP, TURP, Preoperative anxiety, surgical fear, depression, Patient satisfaction, lower urinary tract symptoms
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 14 Jun 2026 (estimated)
- Primary completion
- 8 Apr 2027 (estimated)
- Study completion
- 8 Jun 2027 (estimated)
- First posted
- 23 Jun 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.
Benign prostatic hyperplasia (BPH) is a common condition in older men and may cause bothersome lower urinary tract symptoms that can negatively affect quality of life. Surgical treatment with Holmium Laser Enucleation of the Prostate (HoLEP) or Transurethral Resection of the Prostate (TURP) is often recommended when medical therapy is insufficient.
This prospective observational study aims to evaluate whether preoperative anxiety, depression, and surgical fear influence postoperative functional outcomes, urinary continence, erectile function, and patient satisfaction in patients undergoing HoLEP or TURP for BPH. Participants will complete validated psychological and functional questionnaires before surgery and during postoperative follow-up visits at 1 and 3 months. The study will also assess changes in psychological status after surgery and compare outcomes between HoLEP and TURP patients.
The findings may help improve preoperative patient counseling and identify patients who could benefit from additional psychological support before surgery.
Detailed description
Benign prostatic hyperplasia (BPH) is one of the most common urological conditions affecting aging men and is frequently associated with lower urinary tract symptoms (LUTS) that significantly impair quality of life. Although medical therapy is the first-line treatment for most patients, surgical intervention becomes necessary in cases with severe symptoms, complications, or inadequate response to medication. Transurethral Resection of the Prostate (TURP) has long been considered the standard surgical treatment, while Holmium Laser Enucleation of the Prostate (HoLEP) has emerged as an effective minimally invasive alternative with favorable perioperative and functional outcomes.
Psychological factors such as anxiety, depression, and fear of surgery have been shown to influence recovery, pain perception, treatment satisfaction, and functional outcomes after various surgical procedures. However, the impact of preoperative psychological status on postoperative outcomes in patients undergoing surgery for BPH remains insufficiently investigated.
This prospective, single-center, observational study aims to evaluate the relationship between preoperative anxiety, depression, and surgical fear and postoperative functional outcomes in patients undergoing HoLEP or TURP for BPH. Eighty patients scheduled for surgical treatment of BPH will be enrolled. Patients will be allocated to HoLEP or TURP according to routine clinical practice, surgeon preference, and patient choice. No randomization or study-related intervention will be performed.
Before surgery, participants will complete validated questionnaires assessing lower urinary tract symptoms, erectile function, anxiety, depression, and surgical fear, including the International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 (IIEF-5), State-Trait Anxiety Inventory (STAI), Hospital Anxiety and Depression Scale (HADS), and Surgical Fear Questionnaire (SFQ).
Follow-up assessments will be conducted at postoperative 1 month and 3 months. Functional outcomes, urinary continence, erectile function, psychological status, and patient satisfaction will be evaluated using the same validated instruments. Urinary continence will additionally be assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF).
The primary objective is to determine whether preoperative anxiety levels are associated with postoperative functional improvement, measured by changes in IPSS scores. Secondary objectives include evaluating the relationship between psychological status and postoperative urinary incontinence, erectile function, patient satisfaction, and longitudinal changes in anxiety and depression after surgery. Outcomes will also be compared between patients undergoing HoLEP and TURP.
The results of this study may improve understanding of the role of psychological factors in BPH surgery and contribute to the development of targeted perioperative counseling and psychological support strategies for patients undergoing surgical treatment for BPH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HoLEP Group | – | Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)Patients with benign prostatic hyperplasia undergoing HoLEP surgery. |
| TURP Group | – | Procedure: Transurethral Resection of the Prostate (TURP)Patients with benign prostatic hyperplasia undergoing TURP surgery. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients aged 50 years or older with benign prostatic hyperplasia (BPH) who are scheduled to undergo Holmium Laser Enucleation of the Prostate (HoLEP) or Transurethral Resection of the Prostate (TURP) at Hitit University Erol Olcok Training and Research Hospital and who provide written informed consent.
Key inclusion criteria (5 listed)
- Male patients aged 50 years or older
- Diagnosis of benign prostatic hyperplasia (BPH)
- Scheduled to undergo HoLEP or TURP
- Ability to understand and complete study questionnaires
- Provided written informed consent
Key exclusion criteria (6 listed)
- History of severe psychiatric disorder
- Active psychiatric treatment
- Neurogenic bladder or neurologic voiding dysfunction
- Diagnosis of prostate cancer
- Previous prostate surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holmium Laser Enucleation of the Prostate (HoLEP)Standard HoLEP procedure for treatment of benign prostatic hyperplasia. | Procedure or surgery | HoLEP Group |
| Transurethral Resection of the Prostate (TURP)Standard TURP procedure for treatment of benign prostatic hyperplasia. | Procedure or surgery | TURP Group |
Primary outcome
Change in International Prostate Symptom Score (IPSS)
Time frame: Baseline to 3 months after surgery
Association between preoperative anxiety levels and postoperative functional improvement measured by changes in International Prostate Symptom Score (IPSS). IPSS scores range from 0 to 35, with higher scores indicating more severe lower urinary tract symptoms. Change from baseline to postoperative 3 months will be evaluated.
5 secondary outcomes
Change in IIEF-5 Score
Time frame: Baseline to 3 months after surgery
Urinary Incontinence Assessed by ICIQ-SF
Time frame: 1 and 3 months after surgery
Change in HADS Score
Time frame: Baseline to 3 months after surgery
Change in STAI Score
Time frame: Baseline to 3 months after surgery
Patient Satisfaction Score
Time frame: 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data collected during this study will not be made publicly available due to privacy and confidentiality considerations.
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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.
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, run by Hitit University 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 6 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: opening soon, as of the sponsor's last update on 26 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Metin Kızgın, Araştırma görevlisi Dr. (+90 507 136 20 45, mtnkizgin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Prostate Symptom Score (IPSS) (time frame: Baseline to 3 months after surgery). 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 26 Jun 2026.