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

Benign Prostate Hyperplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952912
• Other study ID #: PKEP-OP
• Status: Completed
• Phase: N/A
• First received: September 25, 2013
• Last updated: September 27, 2013
• Start date: January 2004
• Est. completion date: June 2013

Study information

• Verified date: December 2003
• Source: Fuzhou General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 2013
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostate Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Procedure:
• PkEP

• OP

Locations

Country	Name	City	State
China	Fuzhou General Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fuzhou General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qmax at one year postoperatively		1 year postoperatively	No
Secondary	Qmax at other time points after surgery		1, 3, 6, 24, 36, 48, 60 and 72 months postoperatively	No
Secondary	resected adenoma weight		right after the operation	No
Secondary	operation time		during the operation	No
Secondary	blood loss		perioperatively and on the first postoperative day	Yes
Secondary	postoperative International Prostate Symptom Score		1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively	No
Secondary	duration of catheterization		after the operation	Yes
Secondary	length of postoperative hospital stay		after the operation	Yes
Secondary	QOL		1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively	No
Secondary	PVR		1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively	No