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

Primary Purpose

Benign Prostate Hyperplasia

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

PkEP

About this trial

This is an interventional treatment trial for Benign Prostate Hyperplasia

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Fuzhou General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

PkEP

Arm Description

Outcomes

Primary Outcome Measures

Qmax at one year postoperatively

Secondary Outcome Measures

Qmax at other time points after surgery

resected adenoma weight

operation time

blood loss

postoperative International Prostate Symptom Score

duration of catheterization

length of postoperative hospital stay

QOL

PVR

Full Information

NCT ID

NCT01952912

First Posted

September 25, 2013

Last Updated

September 27, 2013

Sponsor

Fuzhou General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01952912

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2003

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

June 2007 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fuzhou General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostate Hyperplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PkEP

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

PkEP

Intervention Type

Procedure

Intervention Name(s)

Primary Outcome Measure Information:

Title

Qmax at one year postoperatively

Time Frame

1 year postoperatively

Secondary Outcome Measure Information:

Title

Qmax at other time points after surgery

Time Frame

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

Title

resected adenoma weight

Time Frame

right after the operation

Title

operation time

Time Frame

during the operation

Title

blood loss

Time Frame

perioperatively and on the first postoperative day

Title

postoperative International Prostate Symptom Score

Time Frame

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

Title

duration of catheterization

Time Frame

after the operation

Title

length of postoperative hospital stay

Time Frame

after the operation

Title

QOL

Time Frame

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

Title

PVR

Time Frame

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Fuzhou General Hospital

City

Fuzhou

State/Province

Fujian

ZIP/Postal Code

350015

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

24502959

Citation

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.

Results Reference

derived

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

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