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
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 25, 2013
CompletedFirst Posted
Study publicly available on registry
September 30, 2013
CompletedSeptember 30, 2013
December 1, 2003
3.4 years
September 25, 2013
September 27, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Qmax at one year postoperatively
1 year postoperatively
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (2)
PkEP
ACTIVE COMPARATOROP
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- severe pulmonary disease or heart disease, coagulopathy, neurogenic bladder, bladder calculus, bladder cancer, prostate cancer, urethral stricture and previous prostate or urethral surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuzhou General Hospital
Fuzhou, Fujian, 350015, China
Related Publications (1)
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.
PMID: 24502959DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2013
First Posted
September 30, 2013
Study Start
January 1, 2004
Primary Completion
June 1, 2007
Study Completion
June 1, 2013
Last Updated
September 30, 2013
Record last verified: 2003-12