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

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

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.

Study Overview

• Status: Completed
• Conditions: BPH With Large Prostate
• Intervention / Treatment: Procedure: PkEP; Procedure: B-TURP

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Fuzhou General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PkEP; Patients in this group undergo PkEP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK).	Procedure: PkEP; Plasmakinetic enucleation of the prostate
Active Comparator: B-TURP; Patients in this group undergo B-TURP using the Gyrus plasmakinetic tissue management system (Gyrus Medical Ltd,Bucks,UK).	Procedure: B-TURP; Bipolar transurethral resection of the prostate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
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

Outcome Measure	Time Frame
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	5 years
postoperative Qmax as a masure of treatment efficacy and durability	5 years
re-operation rate as a measure of durability	5 years

Collaborators and Investigators

• Sponsor: Fuzhou General Hospital
• Investigators: Study Director: Jianming Tan, M.D. & Ph.D., Fuzhou General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: July 4, 2012
• First Submitted That Met QC Criteria: July 7, 2012
• First Posted (Estimate): July 11, 2012

Study Record Updates

• Last Update Posted (Estimate): July 11, 2012
• Last Update Submitted That Met QC Criteria: July 7, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: benign prostatic hypertrophy; bipolar transurethral resection of the prostate; plasmakinetic enucleation of the prostate
• Additional Relevant MeSH Terms: Prostatic Diseases; Pathological Conditions, Anatomical; Prostatic Hyperplasia; Hypertrophy
• Other Study ID Numbers: PkEP-TURP-2004