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

NCT ID: NCT01637701

Last Updated: 2012-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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BPH With Large Prostate

Keywords

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benign prostatic hypertrophy bipolar transurethral resection of the prostate plasmakinetic enucleation of the prostate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PkEP

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

Group Type ACTIVE_COMPARATOR

PkEP

Intervention Type PROCEDURE

Plasmakinetic enucleation of the prostate

B-TURP

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

Group Type ACTIVE_COMPARATOR

B-TURP

Intervention Type PROCEDURE

Bipolar transurethral resection of the prostate

Interventions

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PkEP

Plasmakinetic enucleation of the prostate

Intervention Type PROCEDURE

B-TURP

Bipolar transurethral resection of the prostate

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Fuzhou General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianming Tan, M.D. & Ph.D.

Role: STUDY_DIRECTOR

Fuzhou General Hospital

Locations

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Fuzhou General Hospital

Fuzhou, Fujian, China

Site Status

Countries

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China

Other Identifiers

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PkEP-TURP-2004

Identifier Type: -

Identifier Source: org_study_id