Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH

NCT ID: NCT00877669

Last Updated: 2019-12-02

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

PHASE2

Total Enrollment

313 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2016-12-31

Brief Summary

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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).

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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transurethral resection of the prostate

TURP group

Group Type ACTIVE_COMPARATOR

Transurethral resection of the prostate

Intervention Type PROCEDURE

Standard transurethral resection of the prostate using electrocautery loop

Holmium Laser Enucleation of Prostate

HoLEP group

Group Type EXPERIMENTAL

Holmium Laser Enucleation of the Prostate

Intervention Type PROCEDURE

HoLEP using 100W Ho:YAG laser

Interventions

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Transurethral resection of the prostate

Standard transurethral resection of the prostate using electrocautery loop

Intervention Type PROCEDURE

Holmium Laser Enucleation of the Prostate

HoLEP using 100W Ho:YAG laser

Intervention Type PROCEDURE

Other Intervention Names

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TURP

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 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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KYU-SUNG LEE

Urology, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyu-Sung 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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2008-10-038

Identifier Type: -

Identifier Source: org_study_id

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