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Plasmakinetic Enucleation of the Prostate to Treat Benign Prostatic Hypertrophy Patients With Large Prostate

Primary Purpose

BPH With Large Prostate

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PkEP
B-TURP
Sponsored by
Fuzhou General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BPH With Large Prostate focused on measuring benign prostatic hypertrophy, bipolar transurethral resection of the prostate, plasmakinetic enucleation of the prostate

Eligibility Criteria

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

Inclusion Criteria:

  • Qmax < 10 mL/s, IPSS >19
  • Age between 50 and 70 years
  • Prostate volume between 70 and 200 mL, as determined by TRUS, and medical therapy failure.

Exclusion Criteria:

  • Patients with neurogenic bladder
  • Urethral stricture
  • Bladder tumor
  • Prostate cancer and previous prostate bladder neck
  • Urethral surgery
  • PSA>4ng/ml, or receiving prostate biopsy within 3 months

Sites / Locations

  • Fuzhou General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PkEP

B-TURP

Arm Description

Patients in this group undergo PkEP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK).

Patients in this group undergo B-TURP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK).

Outcomes

Primary Outcome Measures

time of catheterization
At the end of both procedures, a 22F three-way Folley catheter was inserted and continuous bladder irrigation was performed. Irrigation was discontinued when the catheter drainage became clear, and the catheter was removed 6 h later.Two experienced urologists who were unaware of the surgical modality used decided bladder irrigation and catheter removal for all cases.

Secondary Outcome Measures

Operation time
resected adenoma weight as a measure of treatment efficacy
changes in serum haemoglobin as a measure of one of the complications
postoperative International Prostate Symptom Score as a measure of treatment efficacy and durability
postoperative Qmax as a masure of treatment efficacy and durability
re-operation rate as a measure of durability

Full Information

First Posted
July 4, 2012
Last Updated
July 7, 2012
Sponsor
Fuzhou General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01637701
Brief Title
Plasmakinetic Enucleation of the Prostate to Treat Benign Prostatic Hypertrophy Patients With Large Prostate
Official Title
Comparison of Pasmakinetic Enucleation of the Prostate With Bipolar Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hypertrophy Patients With Large Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2011 (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 goal of this study is to compare the perioperative and postoperative characters of plasmakinetic enucleation of the prostate(PkEP) with bipolar TURP(B-TURP) for BPH patients with large prostate.
Detailed Description
Despite the availability of numerous minimally invasive alternatives, monopolar transurethral resection of the prostate (TURP) remains the most frequently performed operation for benign prostatic hypertrophy (BPH) with small to moderate size prostates. Nevertheless, TURP for large prostates is associated with various complications and unsatisfactory long-term results. B-TURP and PkEP have both been proved to have more favorable postoperative outcomes than monopolar TURP. But whether B-TURP or PkEP is better remain controversial. We aim to compare the perioperative and postoperative characters of PkEP with B-TURP for BPH patients with large prostate. Moreover, we evaluate the long-term results of both approaches.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPH With Large Prostate
Keywords
benign prostatic hypertrophy, bipolar transurethral resection of the prostate, plasmakinetic enucleation of the prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PkEP
Arm Type
Active Comparator
Arm Description
Patients in this group undergo PkEP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK).
Arm Title
B-TURP
Arm Type
Active Comparator
Arm Description
Patients in this group undergo B-TURP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK).
Intervention Type
Procedure
Intervention Name(s)
PkEP
Intervention Description
Plasmakinetic enucleation of the prostate
Intervention Type
Procedure
Intervention Name(s)
B-TURP
Intervention Description
Bipolar transurethral resection of the prostate
Primary Outcome Measure Information:
Title
time of catheterization
Description
At the end of both procedures, a 22F three-way Folley catheter was inserted and continuous bladder irrigation was performed. Irrigation was discontinued when the catheter drainage became clear, and the catheter was removed 6 h later.Two experienced urologists who were unaware of the surgical modality used decided bladder irrigation and catheter removal for all cases.
Secondary Outcome Measure Information:
Title
Operation time
Title
resected adenoma weight as a measure of treatment efficacy
Title
changes in serum haemoglobin as a measure of one of the complications
Title
postoperative International Prostate Symptom Score as a measure of treatment efficacy and durability
Time Frame
5 years
Title
postoperative Qmax as a masure of treatment efficacy and durability
Time Frame
5 years
Title
re-operation rate as a measure of durability
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Qmax < 10 mL/s, IPSS >19 Age between 50 and 70 years Prostate volume between 70 and 200 mL, as determined by TRUS, and medical therapy failure. Exclusion Criteria: Patients with neurogenic bladder Urethral stricture Bladder tumor Prostate cancer and previous prostate bladder neck Urethral surgery PSA>4ng/ml, or receiving prostate biopsy within 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianming Tan, M.D. & Ph.D.
Organizational Affiliation
Fuzhou General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Fuzhou General Hospital
City
Fuzhou
State/Province
Fujian
Country
China

12. IPD Sharing Statement

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Plasmakinetic Enucleation of the Prostate to Treat Benign Prostatic Hypertrophy Patients With Large Prostate

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