Impact of 80 W KTP Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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The purpose of this study is to compared the efficacy of 80W KTP photoselective laser vaporization prostatectomy (PVP) and transurethral resection of the prostate (TURP) in reducing the volume of prostate and relieving the obstruction in men with benign prostatic hyperplasia (BPH) on non-randomized controlled design.

Official Title
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Impact of 80 Watt KTP Photoselective Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia: 6-Month Results of a Nonrandomized Prospective Trial

Conditions
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Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia

Intervention / Treatment
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* Procedure: photoselective vaporization prostatectomy (PVP)
* Procedure: Transurethral resection of the prostate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic BPH International Score Prostate Symptom (IPSS) of 13 or greater prostate volume of 30 to 100 ML Peak urinary flow rate (Qmax) less than 15 mL/s with a voided volume of >125 mL and a PVR <350mL Able to give fully informed consent Exclusion Criteria: Subjects with histological diagnosis of prostate cancer Subjects with history of chronic urinary retention Subjects with urethral stricture, Subjects with bladder neck contracture Subjects with urinary tract infection Subjects with prostate volume on TRUS of >100 mL Subjects with suspected neurogenic bladder dysfunction Subjects who, in the opinion of investigator, are not likely to complete the study for whatever reason

Ages Eligible for Study
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Minimum Age: 50 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>PVP group | Procedure: photoselective vaporization prostatectomy (PVP)<br>* PVP using 80 W KTP laser with a Greenlight system (GreenLight PVTM, Laserscope®, San Jose, CA)<br>* Other names: PVP;|
| Active Comparator: 2<br>TURP group | Procedure: Transurethral resection of the prostate<br>* Standard transurethral resection of the prostate using electrocautery loop<br>* Other names: TURP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of bladder outlet obstruction index (BOOI) |  | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of Quality of Life (QoL) parameters |  | 6, 12 months | 
| The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR) |  | 6, 12 months | 
| The changes of detrusor pressure at maximum flow rate (PdetQmax)parameters |  | 6months | 
| The changes of International Prostatic Symptom Scores (IPSS) |  | 6, 12 months | 
| The changes of Schafer obstruction grade parameters |  | 6months | 
| The changes of prostate volume |  | 6, 12 months | 
| postoperative catheterization days |  | immediate postoperative period | 
| Complications |  | During all study periods | 
| The changes of the hemoglobin and the serum sodium and the serum PSA |  | immediate postoperative period | 
| The change of IIEF score |  | 6, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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benign prostatic hyperplasia, KTP laser, transurethral resection of prostate, urinary bladder neck obstruction