Hitit university
Çorum, 19030, Turkey (Türkiye)
NCT Number: NCT07663097
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.
Trial opening soon.
Get Notified50 year and older
Male
Observational
Çorum, 19030, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard HoLEP procedure for treatment of benign prostatic hyperplasia.
Standard TURP procedure for treatment of benign prostatic hyperplasia.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Metin Kızgın, Araştırma görevlisi Dr.
CONTACT
Mustafa Serdar Caglayan
CONTACT
Hitit University
Other
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
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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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