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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transurethral resection of the prostate | Active Comparator | TURP group |
|
| Holmium Laser Enucleation of Prostate | Experimental | HoLEP group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transurethral resection of the prostate | Procedure | Standard transurethral resection of the prostate using electrocautery loop |
|
| Measure | Description | Time Frame |
|---|---|---|
| The changes of International Prostatic Symptom Scores (IPSS) from baseline to 6 months after operation | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyu-Sung Lee, Ph.D.,M.D. | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011469 | Prostatic Diseases |
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| ID | Term |
|---|---|
| D020728 | Transurethral Resection of Prostate |
| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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|
| Holmium Laser Enucleation of the Prostate | Procedure | HoLEP using 100W Ho:YAG laser |
|
| 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 |
| Operative time and Resected tissue weight | 0 day after operation |
| The changes of ICS male questionnaire (short form) parameters | 3 and 6 months after operation |
| The changes of international index of erectile function (IIEF)-15 parameters | 6 months after operation |
| The changes of Patient perception of treatment benefit questionnaire (PPTB) parameters | 3 and 6 months after operation |
| The changes of voiding frequencies and urgency parameters in Frequency volume chart | 3 and 6 months after operation |
| Ejaculation parameter | 6 months after operation |
| Complications | During all study periods |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D013514 | Surgical Procedures, Operative |