Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00877669
First received: April 6, 2009
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention Phase
Lower Urinary Tract Symptoms
Benign Prostatic Hyperplasia
Procedure: Transurethral resection of the prostate
Procedure: Holmium Laser Enucleation of the Prostate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The changes of Quality of Life (QoL) parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The changes of IPSS and QoL parameters [ Time Frame: 1 month and 3months after operation ] [ Designated as safety issue: No ]
  • The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) parameters [ Time Frame: 2 weeks and 3 and 6 months after operation ] [ Designated as safety issue: No ]
  • Postoperative hospital stay days and postoperative catheterization days [ Time Frame: immediate postoperative period ] [ Designated as safety issue: Yes ]
  • The changes of the hemoglobin and the serum sodium [ Time Frame: 0 and 1 day after operation ] [ Designated as safety issue: Yes ]
  • Operative time and Resected tissue weight [ Time Frame: 0 day after operation ] [ Designated as safety issue: No ]
  • The changes of ICS male questionnaire (short form) parameters [ Time Frame: 3 and 6 months after operation ] [ Designated as safety issue: No ]
  • The changes of international index of erectile function (IIEF)-15 parameters [ Time Frame: 6 months after operation ] [ Designated as safety issue: Yes ]
  • The changes of Patient perception of treatment benefit questionnaire (PPTB) parameters [ Time Frame: 3 and 6 months after operation ] [ Designated as safety issue: No ]
  • The changes of voiding frequencies and urgency parameters in Frequency volume chart [ Time Frame: 3 and 6 months after operation ] [ Designated as safety issue: No ]
  • Ejaculation parameter [ Time Frame: 6 months after operation ] [ Designated as safety issue: Yes ]
  • Complications [ Time Frame: During all study periods ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 116
Study Start Date: October 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Transurethral resection of the prostate
TURP group
Procedure: Transurethral resection of the prostate
Standard transurethral resection of the prostate using electrocautery loop
Other Name: TURP
Experimental: Holmium Laser Enucleation of Prostate
HoLEP group
Procedure: Holmium Laser Enucleation of the Prostate
HoLEP using 100W Ho:YAG laser
Other Name: Holmium Laser Enucleation of the Prostate

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877669

Contacts
Contact: Kyu-Sung Lee, Ph.D, M.D. 82-2-3410-3554 ksleedr@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Kyu-Sung Lee, Ph.D.,M.D.    82-2-3410-3554    ksleedr@skku.edu   
Contact: Deok Hyun Han, M.D.    82-2-3410-3559    deokhyun.han@samsung.com   
Principal Investigator: Kyu-Sung Lee, Ph.d.,M.D.         
Sub-Investigator: Deok Hyun Han, M.D.         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Kyu-Sung Lee, Ph.D.,M.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: KYU-SUNG LEE, Urology, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00877669     History of Changes
Other Study ID Numbers: 2008-10-038
Study First Received: April 6, 2009
Last Updated: January 8, 2014
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Hyperplasia
Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Genital Diseases, Male
Pathologic Processes
Prostatic Diseases
Signs and Symptoms
Urological Manifestations

ClinicalTrials.gov processed this record on October 23, 2014