Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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This is a Phase 4, prospective, open-label, randomized study of Greenlight XPS Laser versus BiVAP Saline Vaporization of the prostate in men with symptomatic Benign Prostatic Hyperplasia (BPH). The study consists of a screening phase, treatment, followed by follow-up visits at 1 week, 4 weeks, 3 months, 6 months, and 12 months.

Official Title
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An Open-Label Randomized Phase 4 Study of Greenlight XPS Laser Versus BiVAP Saline Vaporization of the Prostate in Men With Symptomatic Benign Prostatic Hyperplasia

Conditions
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Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
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* Device: Greenlight XPS Laser
* Device: BiVAP Saline Vaporization of the prostate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male over the age of 18 years present with symptomatic/ obstructive symptoms secondary to PBH requiring surgical intervention subjects must read, understand and sign the Informed Consent AUA ≥ 15 Qmax < 15mL/sec Stopped BPH medication. Alpha blockers 15 days 5-α-reductase 3 months Prostate volume ≥ 30g Exclusion Criteria: PVR > 300ml Current urine retention Previous surgical or invasive treatments (TURP, TUMT, TUNA) PSA ≥ 4 (must have negative biopsy within last 12 months) Neurogenic bladder Obstruction due to urethral stricture Any disorder or condition of the subject that the investigator believes will counter indicate their inclusion in the study

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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Accepts Healthy Volunteers

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: Greenlight XPS Laser<br>Greenlight XPS Laser of the prostate | Device: Greenlight XPS Laser<br>* Treatment of BPH with Greenlight XPS laser<br>|
| Active Comparator: BiVAP Saline Vaporization<br>BiVAP Saline Vaporization of the prostate | Device: BiVAP Saline Vaporization of the prostate<br>* treatment of BPH with BiVAP Saline Vaporization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in American Urological Association Symptom Score | The American Urological Association Symptom Score range is 0-35 with 35 being the most severe urinary symptoms | Baseline and 12 months | 
| Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax) | maximum urinary flow rate was measures using uroflow device | baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to 12 Months in Post Void Residual Volume | post void residual was measured using a bladder scan device | baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enlarged prostate