- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mustafa Serdar Caglayan
- Numéro de téléphone: 05074311951
- E-mail: serdar.09.09@hotmail.com
Sauvegarde des contacts de l'étude
- Nom: Metin Kızgın, Araştırma görevlisi Dr.
- Numéro de téléphone: +90 507 136 20 45
- E-mail: mtnkizgin@gmail.com
Lieux d'étude
-
-
Çorum
-
Çorum, Çorum, Turquie (Türkiye), 19030
- Hitit University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in International Prostate Symptom Score (IPSS)
Délai: 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.
|
Baseline to 3 months after surgery
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in IIEF-5 Score
Délai: 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.
|
Baseline to 3 months after surgery
|
|
Urinary Incontinence Assessed by ICIQ-SF
Délai: 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.
|
1 and 3 months after surgery
|
|
Change in HADS Score
Délai: 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.
|
Baseline to 3 months after surgery
|
|
Change in STAI Score
Délai: 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.
|
Baseline to 3 months after surgery
|
|
Patient Satisfaction Score
Délai: 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.
|
3 months after surgery
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Maladies génitales, sexe masculin
- Maladies de la prostate
- Maladies urogénitales masculines
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Troubles urinaires
- Manifestations urologiques
- Symptômes comportementaux
- Conditions pathologiques, signes et symptômes
- Comportement
- Signes et symptômes
- Adhésion et conformité au traitement
- Comportement de santé
- Incontinence urinaire
- La dépression
- Hyperplasie prostatique
- Symptômes des voies urinaires inférieures
- Satisfaction des patients
- Procédures chirurgicales, opératoires
- Procédures chirurgicales urologiques
- Procédures chirurgicales urogénitales
- Procédures chirurgicales urologiques, mâle
- Prostatectomie
- Résection transurétrale de la prostate
Autres numéros d'identification d'étude
- 2026-85
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .