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OpenTrials
Completed

NCT Number: NCT02683980

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

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 BPH (Benign prostatic hyperplasia) with the contact side firing fiber with recommended settings.

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Key information

Conditions

Treatment of Benign Prostatic Hyperplasia

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

New York Methodist Hospital

New York, 11215, United States

Who can participate

Healthy volunteers accepted: No

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

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 > 300 mL
  • 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

Treatment and study plan

Lumenis Pulse P120H and Xpeeda side firing fiber

Device

Primary outcomes

  1. Ablation Time

    Time frame: Intraprocedural (procedure time is typically 1 to 3 hours)

    Calculate the lasing time (in minutes) to ablate the prostate as an indication for treatment efficiency.

  2. Ablation Rate

    Time frame: Baseline and 3-month follow-up visit

    Ablation rate is the change in prostate volume measured by trans-rectal ultrasound divided by the procedure time.

    Ablation rate= (baseline prostate volume - 3-Month prostate volume in mL) / Procedure time in minutes

  3. Efficiency of the Laser to Ablate the Prostate

    Time frame: Baseline and 3-month follow-up visit

    Ablation efficiency is the change in prostate volume, as measured by trans-urethral ultrasound, between baseline and the 3-month follow-up visit divided by energy.

    Efficiency = (Baseline prostate volume in mL - prostate volume at the 3-month follow-up visit) / energy in J

  4. Safety: Intraoperative Complications

    Time frame: Intraoperative (procedure time is typically 1 to 3 hours)

    Number and type of intraoperative complications

  5. Safety: Perioperative Complications

    Time frame: Post-procedure through 3 months

    Number of Re-Catheterizations and number of Readmissions were evaluated within this Outcome Measure. Erectile Dysfunction is reported separately. Other complications with reporting of Level of Severity (mild, moderate, or severe) are listed as part of this Outcome Measure. These other complications were Bleeding, Dysuria, Hematuria, Urgency, Urinary Incontinence, Urinary Retention, Frequency, and Nocturia

Secondary outcomes

  1. Erectile Dysfunction

    Time frame: Baseline and 3-month follow-up visit

    Sum score of International Index of Erectile Function (IIEF-5) questionnaire which measures erectile function, orgasmic function, sexual desire, and satisfaction. Each question is ranked 1-5 with a total sum score of 5 (severe erectile dysfunction) to 25 (normal function).

  2. Visibility During Procedure

    Time frame: Intraprocedural (procedure time is typically 1 to 3 hours)

    Rating on a scale of 1 (Poor) to 5 (Excellent) of the visibility during the procedure

  3. Number of Fibers Used During Procedure

    Time frame: Intraprocedural (procedure time is typically 1 to 3 hours)

    Number of fibers used during the BPH procedure

  4. Catheterization Time

    Time frame: Postoperatively through study completion up to 3 months

    Number of days catheter was in place post-ablation of the prostate

  5. Hospital Stay Duration

    Time frame: Procedure through discharge from hospital (typically 1 day, but measured through end of study up to 3 months)

    Number of days in hospital

  6. International Prostate Symptom Score Quality of Life

    Time frame: Baseline, 1-month and 3-month follow-up visits

    The International Prostate Symptom Score (IPSS) is an eight-question written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the lower urinary tract symptoms of benign prostatic hyperplasia (BPH). The Quality of Life question has a scale of 0-6, with 0=delighted and 6=terrible.

  7. Qmax Uroflow

    Time frame: Baseline, 1-month and 3-month follow-up visits

    The maximum urine flow rate (Qmax) is a measure of the quantity of urine excreted in a specified period of time, expressed in cubic centimeters/second (cc/sec).

  8. PVR (Post-void Residual)

    Time frame: Baseline, 1-month and 3-month follow-up visits

    Volume of urine remaining in the bladder after voiding, measured via ultrasound

  9. PSA (Prostate-specific Antigen)

    Time frame: Baseline and 3-month follow-up visit

    Prostate-specific antigen, or PSA, is a protein produced by cells of the prostate gland. Prostate cancer can cause elevated PSA levels.

  10. Americal Urological Association (AUA) Symptom Index

    Time frame: Baseline, 1-month and 3-month follow-up visits

    The American Urological Association (AUA) Symptom Index assesses the severity of lower urinary tract symptoms in men, particularly related to benign prostatic hyperplasia. The AUA Symptom Score ranges from 0 to 35, with higher scores indicating more severe urinary symptoms related to benign prostatic hyperplasia (BPH).

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

  • Lumenis Be Ltd.

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2016
Registry last updated
Nov 25, 2025

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.