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.

Study Overview

• Status: Completed
• Conditions: Treatment of Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: Lumenis Pulse P120H and Xpeeda side firing fiber

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 11215
      • New York Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ablation of the prostate; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ablation Time	Calculate the lasing time (in minutes) to ablate the prostate as an indication for treatment efficiency.	Intraprocedural (procedure time is typically 1 to 3 hours)
Ablation Rate	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	Baseline and 3-month follow-up visit
Efficiency of the Laser to Ablate the Prostate	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	Baseline and 3-month follow-up visit
Safety: Intraoperative Complications	Number and type of intraoperative complications	Intraoperative (procedure time is typically 1 to 3 hours)
Safety: Perioperative Complications	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	Post-procedure through 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erectile Dysfunction	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).	Baseline and 3-month follow-up visit
Visibility During Procedure	Rating on a scale of 1 (Poor) to 5 (Excellent) of the visibility during the procedure	Intraprocedural (procedure time is typically 1 to 3 hours)
Number of Fibers Used During Procedure	Number of fibers used during the BPH procedure	Intraprocedural (procedure time is typically 1 to 3 hours)
Catheterization Time	Number of days catheter was in place post-ablation of the prostate	Postoperatively through study completion up to 3 months
Hospital Stay Duration	Number of days in hospital	Procedure through discharge from hospital (typically 1 day, but measured through end of study up to 3 months)
International Prostate Symptom Score Quality of Life	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.	Baseline, 1-month and 3-month follow-up visits
Qmax Uroflow	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).	Baseline, 1-month and 3-month follow-up visits
PVR (Post-void Residual)	Volume of urine remaining in the bladder after voiding, measured via ultrasound	Baseline, 1-month and 3-month follow-up visits
PSA (Prostate-specific Antigen)	Prostate-specific antigen, or PSA, is a protein produced by cells of the prostate gland. Prostate cancer can cause elevated PSA levels.	Baseline and 3-month follow-up visit
Americal Urological Association (AUA) Symptom Index	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).	Baseline, 1-month and 3-month follow-up visits

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Collaborators: Lumenis Be Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: January 31, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimated): February 17, 2016

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: LUM-SBU-VP-15-02