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Completed

NCT Number: NCT01500057

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

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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Key information

Conditions

Benign Prostatic Hyperplasia (BPH) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Brooklyn Urology Research Group

Brooklyn, New York, 11215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Greenlight XPS Laser

Device

Treatment of BPH with Greenlight XPS laser

BiVAP Saline Vaporization of the prostate

Device

treatment of BPH with BiVAP Saline Vaporization

Primary outcomes

  1. Change From Baseline in American Urological Association Symptom Score

    Time frame: Baseline and 12 months

    The American Urological Association Symptom Score range is 0-35 with 35 being the most severe urinary symptoms

  2. Change From Baseline to 12 Months in Maximum Urinary Flow Rate (Qmax)

    Time frame: baseline and 12 months

    maximum urinary flow rate was measures using uroflow device

Secondary outcomes

  1. Change From Baseline to 12 Months in Post Void Residual Volume

    Time frame: baseline and 12 months

    post void residual was measured using a bladder scan device

Sponsors and collaborators

Lead sponsor

Brooklyn Urology Research Group

Other

Collaborators

  • American Medical Systems
  • Richard Wolf Medical Instruments Corporation (RWMIC)

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Dec 26, 2011
Registry last updated
May 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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