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

Study Overview
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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.

Official Title
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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

Conditions
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BPH With Large Prostate

Intervention / Treatment
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* Procedure: PkEP
* Procedure: B-TURP


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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benign prostatic hypertrophy, bipolar transurethral resection of the prostate, plasmakinetic enucleation of the prostate