Skip to main content
OpenTrials
Completed

NCT Number: NCT01952912

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Benign Prostate Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fuzhou General Hospital

Fuzhou, Fujian, 350015, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PkEP

Procedure

OP

Procedure

Primary outcomes

  1. Qmax at one year postoperatively

    Time frame: 1 year postoperatively

Secondary outcomes

  1. Qmax at other time points after surgery

    Time frame: 1, 3, 6, 24, 36, 48, 60 and 72 months postoperatively

  2. resected adenoma weight

    Time frame: right after the operation

  3. operation time

    Time frame: during the operation

  4. blood loss

    Time frame: perioperatively and on the first postoperative day

  5. postoperative International Prostate Symptom Score

    Time frame: 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively

  6. duration of catheterization

    Time frame: after the operation

  7. length of postoperative hospital stay

    Time frame: after the operation

  8. QOL

    Time frame: 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively

  9. PVR

    Time frame: 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively

Sponsors and collaborators

Lead sponsor

Fuzhou General Hospital

Other

Registry information

Official study title

Comparison of Plasmakinetic Enucleation of the Prostate With Open Prostatectomy for the Treatment of Benign Prostatic Hypertrophy Patients With Large Prostate

Important dates

Study start
2004
Primary completion
2007
Study completion
2013
First posted
Sep 30, 2013
Registry last updated
Sep 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.