Impact of 80 W KTP Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia

Samsung Medical Center86 enrolled

Overview

The purpose of this study is to compared the efficacy of 80W KTP photoselective laser vaporization prostatectomy (PVP) and transurethral resection of the prostate (TURP) in reducing the volume of prostate and relieving the obstruction in men with benign prostatic hyperplasia (BPH) on non-randomized controlled design.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia

Interventions

photoselective vaporization prostatectomy (PVP)PROCEDURE

PVP using 80 W KTP laser with a Greenlight system (GreenLight PVTM, Laserscope®, San Jose, CA)

Transurethral resection of the prostatePROCEDURE

Standard transurethral resection of the prostate using electrocautery loop

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Symptomatic BPH * International Score Prostate Symptom (IPSS) of 13 or greater * prostate volume of 30 to 100 ML * Peak urinary flow rate (Qmax) less than 15 mL/s with a voided volume of \>125 mL and a PVR \<350mL * Able to give fully informed consent Exclusion Criteria: * Subjects with histological diagnosis of prostate cancer * Subjects with history of chronic urinary retention * Subjects with urethral stricture, * Subjects with bladder neck contracture * Subjects with urinary tract infection * Subjects with prostate volume on TRUS of \>100 mL * Subjects with suspected neurogenic bladder dysfunction * Subjects who, in the opinion of investigator, are not likely to complete the study for whatever reason

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

The changes of bladder outlet obstruction index (BOOI)

Time frame: 6months

Secondary Outcomes

The changes of Quality of Life (QoL) parameters

Time frame: 6, 12 months

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

Time frame: 6, 12 months

The changes of detrusor pressure at maximum flow rate (PdetQmax)parameters

Time frame: 6months

The changes of International Prostatic Symptom Scores (IPSS)

Time frame: 6, 12 months

The changes of Schafer obstruction grade parameters

Time frame: 6months

The changes of prostate volume

Time frame: 6, 12 months

postoperative catheterization days

Time frame: immediate postoperative period

Complications

Time frame: During all study periods

The changes of the hemoglobin and the serum sodium and the serum PSA

Time frame: immediate postoperative period

The change of IIEF score

Time frame: 6, 12 months

Data from ClinicalTrials.gov

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