search
Back to results

Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH

Primary Purpose

Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Transurethral resection of the prostate
Holmium Laser Enucleation of the Prostate
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Urinary Tract Symptoms

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Transurethral resection of the prostate

Holmium Laser Enucleation of Prostate

Arm Description

TURP group

HoLEP group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The changes of Quality of Life (QoL) parameters
The changes of IPSS and QoL parameters
The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) parameters
Postoperative hospital stay days and postoperative catheterization days
The changes of the hemoglobin and the serum sodium
Operative time and Resected tissue weight
The changes of ICS male questionnaire (short form) parameters
The changes of international index of erectile function (IIEF)-15 parameters
The changes of Patient perception of treatment benefit questionnaire (PPTB) parameters
The changes of voiding frequencies and urgency parameters in Frequency volume chart
Ejaculation parameter
Complications

Full Information

First Posted
April 6, 2009
Last Updated
November 28, 2019
Sponsor
Samsung Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00877669
Brief Title
Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH
Official Title
The Comparison of Efficacy 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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
313 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transurethral resection of the prostate
Arm Type
Active Comparator
Arm Description
TURP group
Arm Title
Holmium Laser Enucleation of Prostate
Arm Type
Experimental
Arm Description
HoLEP group
Intervention Type
Procedure
Intervention Name(s)
Transurethral resection of the prostate
Other Intervention Name(s)
TURP
Intervention Description
Standard transurethral resection of the prostate using electrocautery loop
Intervention Type
Procedure
Intervention Name(s)
Holmium Laser Enucleation of the Prostate
Intervention Description
HoLEP using 100W Ho:YAG laser
Primary Outcome Measure Information:
Title
The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The changes of Quality of Life (QoL) parameters
Time Frame
6 months
Title
The changes of IPSS and QoL parameters
Time Frame
1 month and 3months after operation
Title
The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) parameters
Time Frame
2 weeks and 3 and 6 months after operation
Title
Postoperative hospital stay days and postoperative catheterization days
Time Frame
immediate postoperative period
Title
The changes of the hemoglobin and the serum sodium
Time Frame
0 and 1 day after operation
Title
Operative time and Resected tissue weight
Time Frame
0 day after operation
Title
The changes of ICS male questionnaire (short form) parameters
Time Frame
3 and 6 months after operation
Title
The changes of international index of erectile function (IIEF)-15 parameters
Time Frame
6 months after operation
Title
The changes of Patient perception of treatment benefit questionnaire (PPTB) parameters
Time Frame
3 and 6 months after operation
Title
The changes of voiding frequencies and urgency parameters in Frequency volume chart
Time Frame
3 and 6 months after operation
Title
Ejaculation parameter
Time Frame
6 months after operation
Title
Complications
Time Frame
During all study periods

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Sung Lee, Ph.D.,M.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH

We'll reach out to this number within 24 hrs