NCT07663097

Brief 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 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 Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Jun 2026Jun 2027

Study Start

First participant enrolled

June 14, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2027

Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

June 17, 2026

Last Update Submit

June 23, 2026

Conditions

Keywords

BPHHOLEPTURPPreoperative anxietysurgical feardepressionPatient satisfactionlower urinary tract symptomsurinary incontinenceerectile function

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to 3 months after surgery

Secondary Outcomes (5)

  • Change in IIEF-5 Score

    Baseline to 3 months after surgery

  • Urinary Incontinence Assessed by ICIQ-SF

    1 and 3 months after surgery

  • Change in HADS Score

    Baseline to 3 months after surgery

  • Change in STAI Score

    Baseline to 3 months after surgery

  • Patient Satisfaction Score

    3 months after surgery

Study Arms (2)

HoLEP Group

Patients with benign prostatic hyperplasia undergoing HoLEP surgery.

Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)

TURP Group

Patients with benign prostatic hyperplasia undergoing TURP surgery.

Procedure: Transurethral Resection of the Prostate (TURP)

Interventions

Standard HoLEP procedure for treatment of benign prostatic hyperplasia.

HoLEP Group

Standard TURP procedure for treatment of benign prostatic hyperplasia.

TURP Group

Eligibility Criteria

Age50 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly male participants are eligible because benign prostatic hyperplasia (BPH) occurs in males and both HoLEP and TURP are surgical procedures performed for male patients with BPH.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hitit university

Çorum, Çorum, 19030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic HyperplasiaDepressionPatient SatisfactionLower Urinary Tract SymptomsUrinary Incontinence

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorTreatment Adherence and ComplianceHealth BehaviorUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Metin Kızgın, Araştırma görevlisi Dr.

CONTACT

Mustafa Serdar Caglayan

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Department of Urology

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 23, 2026

Study Start

June 14, 2026

Primary Completion (Estimated)

April 8, 2027

Study Completion (Estimated)

June 8, 2027

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data collected during this study will not be made publicly available due to privacy and confidentiality considerations.

Locations