Efficacy Study of 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) - Full Text View

Sponsored by:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00877669

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 II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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)

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 Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator TURP group	Procedure: Transurethral resection of the prostate Standard transurethral resection of the prostate using electrocautery loop
2: Active Comparator HoLEP group	Procedure: Holmium Laser Enucleation of the Prostate HoLEP using 100W Ho:YAG laser

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

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:	Samsung Medical Center ( Kyu-Sung Lee/Professor )
Study ID Numbers:	2008-10-038
Study First Received:	April 6, 2009
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00877669 History of Changes
Health Authority:	South Korea: Institutional Review Board

Study placed in the following topic categories:

Hyperplasia
Prostatic Diseases
Prostatic Hyperplasia
Neoplasm Metastasis
Genital Diseases, Male

Additional relevant MeSH terms:

Hyperplasia
Pathologic Processes
Prostatic Diseases
Prostatic Hyperplasia
Genital Diseases, Male

ClinicalTrials.gov processed this record on May 07, 2009