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The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporisation of the Prostate) compared to open prostatectomy when treating benign prostatic hyperplasia (BPH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KTP Green Light Prostatectomy | Experimental | Device |
|
| Open prostatectomy | Active Comparator | Surgical procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KTP Green Light Prostatectomy | Procedure |
| ||
| Green Light |
| Measure | Description | Time Frame |
|---|---|---|
| IPSS (International Prostate Symptom Score) | symptom score | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| DAN-PSS (Danish Prostate Symptom Score) | symptom score | 0, 3, 6 and 12 months |
| Maximum flow rate (Qmax) | 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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| Device |
|
| Open prostatectomy | Procedure |
|
| 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 two weeks |
| Length of hospital stay | Participants will be followed for the duration of hospital stay, an expected maximum of two weeks |
| Perioperative bleeding | Time of operation |
| IIEF (International Index of Erectile Function questionnaire) | 0,12 months |
| Prostate volume measured with TRUS (transrectal ultrasound) | 0, 12 moths |
| Rate of unscheduled hospital contacts | 12 months |
| IPSS (International Prostate Symptom Score) | 0, 3 and 6 months |
| D052801 |
| Male Urogenital Diseases |