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The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporization of the Prostate) compared to TUR-P in high risk patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KTP laser | Experimental | device |
|
| TUR-P | Active Comparator | device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KTP laser | Procedure |
|
| |
| TUR-P |
| Measure | Description | Time Frame |
|---|---|---|
| Re-bleeding rate requiring hospitalization | two months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| IPSS (International Prostate Symptom Score) | symptom score | 0, 3, 6 and 12 months |
| DAN-PSS (Danish Prostate Symptom Score) | 0, 3, 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | 00029 | Finland |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Procedure |
device |
|
| Maximum flow rate (Qmax) | 0, 3, 6 and 12 months |
| Residual urine | 0, 3, 6 and 12 months |
| Length of catheterization | Participants will be followed for the duration of hospital stay, an expected maximum of one week |
| Length of hospital stay | Participants will be followed for the duration of hospital stay, an expected maximum of one week |
| Perioperative bleeding | Time of operation |
| IIEF (International Index of Erectile Function) questionnaire | 0,12 months |
| TRUS (transrectal ultrasound) | 0, 12 months |
| D052801 |
| Male Urogenital Diseases |