Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia

Intervention / Treatment
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* Procedure: Transurethral resection of the prostate
* Procedure: Holmium Laser Enucleation of the Prostate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Complications |  | During all study periods |