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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00908427

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia	Procedure: photoselective vaporization prostatectomy (PVP) Procedure: Transurethral resection of the prostate	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Impact of 80 Watt KTP Photoselective Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia: 6-Month Results of a Nonrandomized Prospective Trial

Study Start Date :

Jun 1, 2004

Actual Primary Completion Date :

May 1, 2006

Actual Study Completion Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 PVP group	Procedure: photoselective vaporization prostatectomy (PVP) PVP using 80 W KTP laser with a Greenlight system (GreenLight PVTM, Laserscope®, San Jose, CA) Other Names: PVP
Active Comparator: 2 TURP group	Procedure: Transurethral resection of the prostate Standard transurethral resection of the prostate using electrocautery loop Other Names: TURP

Arm

Intervention/Treatment

Active Comparator: 1

PVP group

Procedure: photoselective vaporization prostatectomy (PVP)

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

Other Names:

PVP

Active Comparator: 2

TURP group

Procedure: Transurethral resection of the prostate

Standard transurethral resection of the prostate using electrocautery loop

Other Names:

TURP

Outcome Measures

Primary Outcome Measures

The changes of bladder outlet obstruction index (BOOI) [6months]

Secondary Outcome Measures

The changes of Quality of Life (QoL) parameters [6, 12 months]
The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) [6, 12 months]
The changes of detrusor pressure at maximum flow rate (PdetQmax)parameters [6months]
The changes of International Prostatic Symptom Scores (IPSS) [6, 12 months]
The changes of Schafer obstruction grade parameters [6months]
The changes of prostate volume [6, 12 months]
postoperative catheterization days [immediate postoperative period]
Complications [During all study periods]
The changes of the hemoglobin and the serum sodium and the serum PSA [immediate postoperative period]
The change of IIEF score [6, 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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