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

Not Applicable

Completed

• Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia
• Interventions: Procedure: photoselective vaporization prostatectomy (PVP); Procedure: Transurethral resection of the prostate

• Registration Number: NCT00908427
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2006-05
• Study Completion: 2007-09
• Status Verified: 2009-05
• Study First Submitted: 2009-05-22
• Study First Submitted QC: 2009-05-22
• Last Update Submitted: 2009-05-22
• Study First Posted: 2009-05-25
• Last Update Posted: 2009-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	photoselective vaporization prostatectomy (PVP)	PVP group
2	Transurethral resection of the prostate	TURP group

Primary Outcome Measures

Name	Time	Method
The changes of bladder outlet obstruction index (BOOI)	6months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of