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

NCT ID: NCT00908427

Last Updated: 2009-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-09-30

Brief Summary

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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

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Conditions

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Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

PVP group

Group Type ACTIVE_COMPARATOR

photoselective vaporization prostatectomy (PVP)

Intervention Type PROCEDURE

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

2

TURP group

Group Type ACTIVE_COMPARATOR

Transurethral resection of the prostate

Intervention Type PROCEDURE

Standard transurethral resection of the prostate using electrocautery loop

Interventions

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photoselective vaporization prostatectomy (PVP)

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

Intervention Type PROCEDURE

Transurethral resection of the prostate

Standard transurethral resection of the prostate using electrocautery loop

Intervention Type PROCEDURE

Other Intervention Names

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PVP TURP

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Samsung Medical Center

Principal Investigators

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Sung-Won Lee, Ph.D.,M.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2004-05-09

Identifier Type: -

Identifier Source: org_study_id

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