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

Not Applicable

Completed

• Conditions: BPH With Large Prostate
• Interventions: Procedure: B-TURP; Procedure: PkEP

• Registration Number: NCT01637701
• Lead Sponsor: Fuzhou General Hospital

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.

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2006-12
• Study Completion: 2011-12
• Status Verified: 2012-07
• Study First Submitted: 2012-07-04
• Study First Submitted QC: 2012-07-07
• Last Update Submitted: 2012-07-07
• Study First Posted: 2012-07-11
• Last Update Posted: 2012-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
changes in serum haemoglobin as a measure of one of the complications
Operation time
resected adenoma weight as a measure of treatment efficacy
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

Trial Locations

Locations (1)

Fuzhou General Hospital; 🇨🇳 Fuzhou, Fujian, China