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NCT Number: NCT07663097

Preoperative Anxiety and Surgical Fear in Holmium Laser Enucleation of the Prostate and Transurethral Resection of the Prostate Patients With Benign Prostatic Hyperplasia

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Holmium Laser Enucleation of the Prostate (HoLEP)

Procedure

Standard HoLEP procedure for treatment of benign prostatic hyperplasia.

Transurethral Resection of the Prostate (TURP)

Procedure

Standard TURP procedure for treatment of benign prostatic hyperplasia.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in IIEF-5 Score

    Time frame: Baseline to 3 months after surgery

    Change in International Index of Erectile Function-5 (IIEF-5) score. Scores range from 5 to 25, with higher scores indicating better erectile function.

  2. Urinary Incontinence Assessed by ICIQ-SF

    Time frame: 1 and 3 months after surgery

    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.

  3. Change in HADS Score

    Time frame: Baseline to 3 months after surgery

    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.

  4. Change in STAI Score

    Time frame: Baseline to 3 months after surgery

    Change in State-Trait Anxiety Inventory (STAI) score. Scores range from 20 to 80, with higher scores indicating greater anxiety levels.

  5. Patient Satisfaction Score

    Time frame: 3 months after surgery

    Patient satisfaction will be assessed using a visual analog scale ranging from 0 to 10, with higher scores indicating greater satisfaction with surgical outcomes.

Study contacts

Contact information is provided by the study sponsor or research team.

Metin Kızgın, Araştırma görevlisi Dr.

CONTACT

[email protected]

+90 507 136 20 45

Mustafa Serdar Caglayan

CONTACT

[email protected]

05074311951

Sponsors and collaborators

Lead sponsor

Hitit University

Other

Registry information

Official study 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

Acronym: HoLEP and TURP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 23, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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