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

900 Hospital of the People's Liberation Army Joint Logistic Support Force

Status

Completed

Conditions

Benign Prostate Hyperplasia

Treatments

Procedure: OP

Procedure: PkEP

Study type

Interventional

Funder types

Other

Identifiers

NCT01952912

PKEP-OP

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

Male

Ages

50 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

•Qmax < 12 mL/s, IPSS >19
- Age between 50 and 70 years
- Prostate volume larger than 100 mL, as determined by TRUS post-void residual urine volume greater than 50 ml medical therapy failure.

Exclusion criteria

•severe pulmonary disease or heart disease, coagulopathy, neurogenic bladder, bladder calculus, bladder cancer, prostate cancer, urethral stricture and previous prostate or urethral surgery