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Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH

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ClinicalTrials.gov Identifier: NCT00877669
Recruitment Status : Unknown
Verified January 2014 by KYU-SUNG LEE, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : April 8, 2009
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):

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).

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : October 2008
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Holmium
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The changes of Quality of Life (QoL) parameters [ Time Frame: 6 months ]
  2. The changes of IPSS and QoL parameters [ Time Frame: 1 month and 3months after operation ]
  3. The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) parameters [ Time Frame: 2 weeks and 3 and 6 months after operation ]
  4. Postoperative hospital stay days and postoperative catheterization days [ Time Frame: immediate postoperative period ]
  5. The changes of the hemoglobin and the serum sodium [ Time Frame: 0 and 1 day after operation ]
  6. Operative time and Resected tissue weight [ Time Frame: 0 day after operation ]
  7. The changes of ICS male questionnaire (short form) parameters [ Time Frame: 3 and 6 months after operation ]
  8. The changes of international index of erectile function (IIEF)-15 parameters [ Time Frame: 6 months after operation ]
  9. The changes of Patient perception of treatment benefit questionnaire (PPTB) parameters [ Time Frame: 3 and 6 months after operation ]
  10. The changes of voiding frequencies and urgency parameters in Frequency volume chart [ Time Frame: 3 and 6 months after operation ]
  11. Ejaculation parameter [ Time Frame: 6 months after operation ]
  12. Complications [ Time Frame: During all study periods ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: KYU-SUNG LEE, Urology, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00877669     History of Changes
Other Study ID Numbers: 2008-10-038
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: January 2014

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