NCT00877669

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
313

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2019

Enrollment Period

7.8 years

First QC Date

April 6, 2009

Last Update Submit

November 28, 2019

Conditions

Lower Urinary Tract SymptomsBenign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation

    6 months

Secondary Outcomes (12)

  • The changes of Quality of Life (QoL) parameters

    6 months

  • The changes of IPSS and QoL parameters

    1 month and 3months after operation

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

    2 weeks and 3 and 6 months after operation

  • Postoperative hospital stay days and postoperative catheterization days

    immediate postoperative period

  • The changes of the hemoglobin and the serum sodium

    0 and 1 day after operation

  • +7 more secondary outcomes

Study Arms (2)

Transurethral resection of the prostate

ACTIVE COMPARATOR

TURP group

Procedure: Transurethral resection of the prostate

Holmium Laser Enucleation of Prostate

EXPERIMENTAL

HoLEP group

Procedure: Holmium Laser Enucleation of the Prostate

Interventions

Transurethral resection of the prostatePROCEDURE

Standard transurethral resection of the prostate using electrocautery loop

Also known as: TURP
Transurethral resection of the prostate
Holmium Laser Enucleation of the ProstatePROCEDURE

HoLEP using 100W Ho:YAG laser

Holmium Laser Enucleation of Prostate

Eligibility Criteria

Age50 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yrs or greater
  • International prostatic symptom score \>= 12
  • Bladder outlet obstruction confirmed by pressure-flow study (BOOI \> 20)
  • Able to give fully informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Lower Urinary Tract SymptomsProstatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsProstatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Kyu-Sung Lee, Ph.D.,M.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Urology, Professor

Study Record Dates

First Submitted

April 6, 2009

First Posted

April 8, 2009

Study Start

October 1, 2008

Primary Completion

July 1, 2016

Study Completion

December 1, 2016

Last Updated

December 2, 2019

Record last verified: 2019-11

Locations

KR(1)