Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators hypothesize that Plasmakinetic Enucleation of the Prostate (PkEP) might yield functional results comparable to OP but with lower perioperative morbidity, and have equivalent long-term efficacy with OP for large prostates. The first objective was to demonstrate the non-inferiority of PKEP compared to OP concerning Qmax at one year postoperatively.
To explore the long-term efficacy, we compared the efficacy, safety, and morbidity of PkEP with those of OP in BPH patients with prostate glands larger than 100 g over a follow-up period of 6 years.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PkEP | Active Comparator |
| |
| OP | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PkEP | Procedure |
| ||
| OP |
| Measure | Description | Time Frame |
|---|---|---|
| Qmax at one year postoperatively | 1 year postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Qmax at other time points after surgery | 1, 3, 6, 24, 36, 48, 60 and 72 months postoperatively | |
| resected adenoma weight | right after the operation | |
| operation time |
Not provided
Inclusion Criteria:
•Qmax < 12 mL/s, IPSS >19
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuzhou General Hospital | Fuzhou | Fujian | 350015 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24502959 | Derived | Chen S, Zhu L, Cai J, Zheng Z, Ge R, Wu M, Deng Z, Zhou H, Yang S, Wu W, Liao L, Tan J. Plasmakinetic enucleation of the prostate compared with open prostatectomy for prostates larger than 100 grams: a randomized noninferiority controlled trial with long-term results at 6 years. Eur Urol. 2014 Aug;66(2):284-91. doi: 10.1016/j.eururo.2014.01.010. Epub 2014 Jan 24. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| during the operation |
| blood loss | perioperatively and on the first postoperative day |
| postoperative International Prostate Symptom Score | 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively |
| duration of catheterization | after the operation |
| length of postoperative hospital stay | after the operation |
| QOL | 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively |
| PVR | 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively |
| D052801 |
| Male Urogenital Diseases |