Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH

Study Overview
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Brief Summary
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Twenty (20) subjects presenting with a hyperplasia enlarged prostate and candidates for surgery will undergo a single treatment for ablation of the prostate using the study device.Follow up visits are scheduled for the day of release from the hospital and at 1 and 3 months post procedure. The primary objective of this study is to explore Vaporization efficacy and safety when treating PBH (Benign prostatic hyperplasia ) with the contact side firing fiber with recommended settings.

Official Title
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Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH

Conditions
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Treatment of Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: Lumenis Pulse P120H and Xpeeda side firing fiber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject will be older than 18 years of age Subject was diagnosed with enlarged prostate of ≥ 30 gr volume Subject is a candidate for surgery treatment Subject is willing and has signed the Informed Consent Form AUA score ≥ 12 Qmax <15 mL/s Exclusion Criteria: Need to perform concomitant procedure, other than prostate vaporization PVR > 300mL Current Urine retention and Pdet <40 cm H20 Documented or suspected prostate cancer and / or bladder cancer Neurogenic bladder disorder / neurogenic voiding dysfunction Urethral strictures Previous prostatic, bladder neck, or urethral surgery Known history of spinal cord injury Urogenital trauma Bladder neck stricture Evidence of urinary tract infection History of chronic prostatitis

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ablation of the prostate<br>ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser | Device: Lumenis Pulse P120H and Xpeeda side firing fiber<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ablation time | Calculating the lasing time to ablate the prostate as an indication for treatment efficiency. | change from the beginning of the procedure to the end of the procedure. | 
| Ablation rate | Ablation rate calculated as: Prostate volume measured using baseline and 3 months post treatment TRUS (Trans Rectal Ultrasound) / procedure time as an indication for treatment efficiency. | change from baseline prostate volume at 3 month follow up | 
| efficiency of the laser to ablate the prostate | Ablation efficacy calculated as: Prostate volume measured using baseline and post treatment (3 month) TRUS / energy invested during the procedure. | change from baseline prostate volume at 3 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clavien scaled Complications | Complications will be evaluated according to Clavien scale. Modified Clavien Grading: Grade 1,Grade 2,Grade 3,Grade 3a,Grade 3b,Grade 4,Grade 4a, Grade 4b, Grade 5. | during the procedure, 48 hours post procedure, 1 month and 3 month following the procedure. | 
| Intraoperative complications | to evaluate laser operation malfunction including Capsule perforation or Conversion to TURP (Transurethral Resection of the Prostate) to maintain hemostasis or complete the procedure. | during the procedure | 
| the need for blood transfusion | the need for blood transfusion as an indication of blood loss . | during the procedure as compared to baseline. | 
| Urinary test | analyzing known complication urinary system related including: Urinary Retention ,Hematuria, Dysuria ,Infection,Urge incontinence,Stress incontinence. | Baseline, up to 24 hours post procedure, 3 month post procedure | 
| Erectile Dysfunction | Erectile Dysfunction test using international score. | 3 month following the procedure as compared to baseline | 
| Readmission for secondary operation | to evaluate the need for additional intervention based on blood and urine tests and subjective questionnaires, as an indicator of procedure efficiency. | up to 3 month post procedure | 
| American Urological Association score | questionnaires that helps categorize urinary symptoms and asses the effect of symptoms on everyday life and their interference with daily activities as an indication of procedure efficiency . | Baseline,1 month, 3 month | 
| Blood analysis | PSA blood test is evaluated to asses the efficiency of the procedure. | Baseline , 1 month , 3 month | 
| urinary function | PVR [ml] functional test is evaluated to asses the efficiency of the procedure. | Baseline , 1 month , 3 month | 
| hemoglobin test | pre and post-operative hemoglobin blood test as an indication of blood loss. | Baseline ,immediately following the procedure | 
| hematocrit test | hematocrit blood test as an indication of blood loss. | Baseline ,immediately following the procedure | 
| International Prostate Symptom Score Quality of Life subjective questionnaire | questionnaire that asses the effect of symptoms on everyday life and their interference with daily activities. | Baseline,1 month , 3 month | 
| urinary function | QMax [mL/s] is evaluated to asses the efficiency of the procedure. | Baseline , 1 month , 3 month |