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

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostate Hyperplasia
• Intervention / Treatment: Procedure: PkEP; Procedure: OP

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350015
      • Fuzhou General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: PkEP	Procedure: PkEP
ACTIVE_COMPARATOR: OP	Procedure: OP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Qmax at one year postoperatively	1 year postoperatively

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fuzhou General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (ACTUAL): June 1, 2007
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: September 25, 2013
• First Submitted That Met QC Criteria: September 27, 2013
• First Posted (ESTIMATE): September 30, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): September 30, 2013
• Last Update Submitted That Met QC Criteria: September 27, 2013
• Last Verified: December 1, 2003

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: PKEP-OP