Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH

The Comparison of Efficacy Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH)

The purpose of this study is to compare of Efficacy and Safety Between Holmium Laser Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH).

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia
• Intervention / Treatment: Procedure: Transurethral resection of the prostate; Procedure: Holmium Laser Enucleation of the Prostate

• Study Type: Interventional
• Enrollment (Actual): 313
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 50 yrs or greater
• International prostatic symptom score >= 12
• Bladder outlet obstruction confirmed by pressure-flow study (BOOI > 20)
• Able to give fully informed consent

Exclusion Criteria:

• Patients with urologic malignancies such as prostate cancer and bladder cancer
• Patients underwent urethral, prostate surgery
• Patients with urethral stricture or bladder diverticulum or bladder neck contracture
• Patients with histories of bacterial prostatitis within 1 year
• seems not to be appropriate to this study by the decision of investigators because of any other reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transurethral resection of the prostate; TURP group	Procedure: Transurethral resection of the prostate; Standard transurethral resection of the prostate using electrocautery loop; Other Names: TURP
Experimental: Holmium Laser Enucleation of Prostate; HoLEP group	Procedure: Holmium Laser Enucleation of the Prostate; HoLEP using 100W Ho:YAG laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Complications	During all study periods
The changes of Quality of Life (QoL) parameters	6 months
The changes of IPSS and QoL parameters	1 month and 3months after operation
The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) parameters	2 weeks and 3 and 6 months after operation
Postoperative hospital stay days and postoperative catheterization days	immediate postoperative period
The changes of the hemoglobin and the serum sodium	0 and 1 day after operation
Operative time and Resected tissue weight	0 day after operation
The changes of ICS male questionnaire (short form) parameters	3 and 6 months after operation
The changes of international index of erectile function (IIEF)-15 parameters	6 months after operation
The changes of Patient perception of treatment benefit questionnaire (PPTB) parameters	3 and 6 months after operation
The changes of voiding frequencies and urgency parameters in Frequency volume chart	3 and 6 months after operation
Ejaculation parameter	6 months after operation

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Kyu-Sung Lee, Ph.D.,M.D., Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 6, 2009
• First Submitted That Met QC Criteria: April 7, 2009
• First Posted (Estimate): April 8, 2009

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 28, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: 2008-10-038