NCT01952912

Plasmakinetic Enucleation of the Prostate and Open Prostatectomy to Treat Large Prostates

Comparison of Plasmakinetic Enucleation of the Prostate With Open Prostatectomy for the Treatment of Benign Prostatic Hypertrophy Patients With Large Prostate

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Fuzhou General Hospital · Academic / Other
• Sex: Male
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Benign Prostate Hyperplasia

Interventions

Type	Name	Description
PROCEDURE	PkEP
PROCEDURE	OP

Timeline

• Start date: 2004-01-01
• Primary completion: 2007-06-01
• Completion: 2013-06-01
• First posted: 2013-09-30
• Last updated: 2013-09-30

Locations

1 site across 1 country: China