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

Not Applicable

Completed

• Conditions: Benign Prostate Hyperplasia
• Interventions: Procedure: OP; Procedure: PkEP

• Registration Number: NCT01952912
• Lead Sponsor: Fuzhou General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2003-12
• Study Start: 2004-01
• Primary Completion: 2007-06
• Study Completion: 2013-06
• Study First Submitted: 2013-09-25
• Study First Submitted QC: 2013-09-27
• Last Update Submitted: 2013-09-27
• Study First Posted: 2013-09-30
• Last Update Posted: 2013-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OP	OP	-
PkEP	PkEP	-

Primary Outcome Measures

Name	Time	Method
Qmax at one year postoperatively	1 year postoperatively

Secondary Outcome Measures

Name	Time	Method
resected adenoma weight	right after the operation
PVR	1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively
Qmax at other time points after surgery	1, 3, 6, 24, 36, 48, 60 and 72 months postoperatively
blood loss	perioperatively and on the first postoperative day
duration of catheterization	after the operation
length of postoperative hospital stay	after the operation
operation time	during the operation
postoperative International Prostate Symptom Score	1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively
QOL	1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively

Trial Locations

Locations (1)

Fuzhou General Hospital; 🇨🇳 Fuzhou, Fujian, China