- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07663097
Preoperative Anxiety and Surgical Fear in Holmium Laser Enucleation of the Prostate and Transurethral Resection of the Prostate Patients With Benign Prostatic Hyperplasia (HoLEP and TURP)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mustafa Serdar Caglayan
- Phone Number: 05074311951
- Email: serdar.09.09@hotmail.com
Study Contact Backup
- Name: Metin Kızgın, Araştırma görevlisi Dr.
- Phone Number: +90 507 136 20 45
- Email: mtnkizgin@gmail.com
Study Locations
-
-
Çorum
-
Çorum, Çorum, Turkey (Türkiye), 19030
- Hitit university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
HoLEP Group
Patients with benign prostatic hyperplasia undergoing HoLEP surgery.
|
Standard HoLEP procedure for treatment of benign prostatic hyperplasia.
|
|
TURP Group
Patients with benign prostatic hyperplasia undergoing TURP surgery.
|
Standard TURP procedure for treatment of benign prostatic hyperplasia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 IPSS scores following HoLEP or TURP surgery.
|
Baseline to 3 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in IIEF-5 Score
Time Frame: Baseline to 3 months after surgery
|
Baseline to 3 months after surgery
|
|
Urinary Incontinence Assessed by ICIQ-SF
Time Frame: 1 and 3 months after surgery
|
1 and 3 months after surgery
|
|
Change in HADS Score
Time Frame: Baseline to 3 months after surgery
|
Baseline to 3 months after surgery
|
|
Change in STAI Score
Time Frame: Baseline to 3 months after surgery
|
Baseline to 3 months after surgery
|
|
Patient Satisfaction Score
Time Frame: 3 months after surgery
|
3 months after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Urological Manifestations
- Behavioral Symptoms
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Treatment Adherence and Compliance
- Health Behavior
- Urinary Incontinence
- Depression
- Prostatic Hyperplasia
- Lower Urinary Tract Symptoms
- Patient Satisfaction
- Surgical Procedures, Operative
- Urologic Surgical Procedures
- Urogenital Surgical Procedures
- Urologic Surgical Procedures, Male
- Prostatectomy
- Transurethral Resection of Prostate
Other Study ID Numbers
- 2026-85
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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