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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2016-10-10

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.

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Detailed Description

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Conditions

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Benign Prostatic Hyperplasia (BPH)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Greenlight XPS Laser

Greenlight XPS Laser of the prostate

Group Type ACTIVE_COMPARATOR

Greenlight XPS Laser

Intervention Type DEVICE

Treatment of BPH with Greenlight XPS laser

BiVAP Saline Vaporization

BiVAP Saline Vaporization of the prostate

Group Type ACTIVE_COMPARATOR

BiVAP Saline Vaporization of the prostate

Intervention Type DEVICE

treatment of BPH with BiVAP Saline Vaporization

Interventions

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Greenlight XPS Laser

Treatment of BPH with Greenlight XPS laser

Intervention Type DEVICE

BiVAP Saline Vaporization of the prostate

treatment of BPH with BiVAP Saline Vaporization

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes