Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH

Samsung Medical Center313 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

313

Conditions

Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia

Interventions

Transurethral resection of the prostatePROCEDURE

Standard transurethral resection of the prostate using electrocautery loop

Holmium Laser Enucleation of the ProstatePROCEDURE

HoLEP using 100W Ho:YAG laser

Eligibility

Sex: MALEMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

The changes of Quality of Life (QoL) parameters

Time frame: 6 months

The changes of IPSS and QoL parameters

Time frame: 1 month and 3months after operation

The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) parameters

Time frame: 2 weeks and 3 and 6 months after operation

Postoperative hospital stay days and postoperative catheterization days

Time frame: immediate postoperative period

The changes of the hemoglobin and the serum sodium

Time frame: 0 and 1 day after operation

Operative time and Resected tissue weight

Time frame: 0 day after operation

The changes of ICS male questionnaire (short form) parameters

Time frame: 3 and 6 months after operation

The changes of international index of erectile function (IIEF)-15 parameters

Time frame: 6 months after operation

The changes of Patient perception of treatment benefit questionnaire (PPTB) parameters

Time frame: 3 and 6 months after operation

The changes of voiding frequencies and urgency parameters in Frequency volume chart

Data from ClinicalTrials.gov

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