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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01952912

Enrollment

160

Registered

2013-09-30

Start date

2004-01-31

Completion date

2013-06-30

Last updated

2013-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostate Hyperplasia

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.

Interventions

PROCEDUREPkEP

PROCEDUREOP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

50 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Qmax at one year postoperatively	1 year postoperatively

Secondary

Measure	Time frame
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
Qmax at other time points after surgery	1, 3, 6, 24, 36, 48, 60 and 72 months postoperatively
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
duration of catheterization	after the operation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026