Trial Outcomes & Findings for Ablation Efficacy of Contact Side Firing Fiber in Predefined Settings for Treating BPH (NCT NCT02683980)

NCT ID: NCT02683980

Last Updated: 2025-11-25

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Intraprocedural (procedure time is typically 1 to 3 hours)
• Results posted on: 2025-11-25

Participant Flow

Participant milestones

Measure	Ablation of the Prostate ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Ablation of the Prostate n=20 Participants ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
Age, Continuous	70.7 years STANDARD_DEVIATION 7.4 • n=20 Participants
Sex: Female, Male Female	0 Participants n=20 Participants
Sex: Female, Male Male	20 Participants n=20 Participants
Region of Enrollment United States	20 participants n=20 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Ablation of the Prostate n=20 Participants ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
Ablation Time	36.0 Minutes Standard Deviation 19.3

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Ablation of the Prostate n=20 Participants ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
Ablation Rate	0.4 mL/minutes Standard Deviation 0.2

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Ablation of the Prostate n=20 Participants ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
Efficiency of the Laser to Ablate the Prostate	9.4 mL/Joules Standard Deviation 6.9

PRIMARY outcome

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

Number and type of intraoperative complications

Outcome measures

Measure	Ablation of the Prostate n=20 Participants ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
Safety: Intraoperative Complications Conversion to Transurethral resection procedure (TURP) to complete procedure	1 number of events
Safety: Intraoperative Complications Conversion to TURP to maintain hemostasis	0 number of events
Safety: Intraoperative Complications Capsule perforation	0 number of events
Safety: Intraoperative Complications Bleeding - occurred several times but could be controlled	3 number of events
Safety: Intraoperative Complications Blood transfusion	0 number of events

PRIMARY outcome

Timeframe: Post-procedure through 3 months

Population: All patients were assessed post-procedurally through the 3-month follow-up visit for number of Re-Catheterizations, Readmissions and other complications including Bleeding, Dysuria, Hematuria, Urgency, Urinary Incontinence, Urinary Retention, Frequency, and Nocturia.

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

Outcome measures

Measure	Ablation of the Prostate n=28 Specific intraoperative complications ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
Safety: Perioperative Complications Recatheterization	2 Events
Safety: Perioperative Complications Readmission	0 Events
Safety: Perioperative Complications Peri-procedure Urinary Retention (mild)	1 Events
Safety: Perioperative Complications Urinary retention (mild) at 1 month post procedure	1 Events
Safety: Perioperative Complications Urinary retention (moderate) at 1 month post procedure	1 Events
Safety: Perioperative Complications Peri-procedure Urgency (mild)	1 Events
Safety: Perioperative Complications Urgency (mild) at 1 month	5 Events
Safety: Perioperative Complications Urgency (mild) at 3 months	1 Events
Safety: Perioperative Complications Urinary Incontinence (mild) at 1 month	1 Events
Safety: Perioperative Complications Dysuria (mild) at 1 month	2 Events
Safety: Perioperative Complications Dysuria (mild) at 3 months	1 Events
Safety: Perioperative Complications Peri-procedure Hematuria (mild)	2 Events
Safety: Perioperative Complications Hematuria (mild) at 3 months post procedure	1 Events
Safety: Perioperative Complications Bleeding (mild) at hospital discharge	1 Events
Safety: Perioperative Complications Bleeding (mild) at 1 month post procedure	1 Events
Safety: Perioperative Complications Frequency (mild) 1 month post procedure	3 Events
Safety: Perioperative Complications Frequency (mild) 3 months post procedure	2 Events
Safety: Perioperative Complications Nocturia (mild) 1 month post procedure	1 Events
Safety: Perioperative Complications Nocturia (mild) 3 months post procedure	1 Events

SECONDARY outcome

Timeframe: Baseline and 3-month follow-up visit

Population: 19 participants had evaluable data at baseline, and 16 participants had evaluable data from the 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).

Outcome measures

Measure	Ablation of the Prostate n=19 Participants ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
Erectile Dysfunction Baseline	6.1 score on a scale Standard Deviation 4.9
Erectile Dysfunction 3-Month Follow-up	8.9 score on a scale Standard Deviation 8.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Ablation of the Prostate n=20 Participants ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
Visibility During Procedure Poor	0 Participants
Visibility During Procedure Fair	0 Participants
Visibility During Procedure Good	4 Participants
Visibility During Procedure Very Good	7 Participants
Visibility During Procedure Excellent	9 Participants

SECONDARY outcome

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

Number of fibers used during the BPH procedure

Outcome measures

Measure	Ablation of the Prostate n=20 Participants ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
Number of Fibers Used During Procedure 1 fiber used	17 Participants
Number of Fibers Used During Procedure 2 fibers used	3 Participants
Number of Fibers Used During Procedure 3 fibers used	0 Participants

SECONDARY outcome

Timeframe: Postoperatively through study completion up to 3 months

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

Outcome measures

Measure	Ablation of the Prostate n=20 Participants ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
Catheterization Time 4 to 7 days	3 Participants
Catheterization Time 8 to 15 days	16 Participants
Catheterization Time Not provided	1 Participants

SECONDARY outcome

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

Number of days in hospital

Outcome measures

Measure	Ablation of the Prostate n=20 Participants ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
Hospital Stay Duration 1 day	20 Participants
Hospital Stay Duration >1 day	0 Participants

SECONDARY outcome

Timeframe: Baseline, 1-month and 3-month follow-up visits

Population: 20 participants, 17 participants, and 18 participants had evaluable data at baseline, 1-month, and 3-month follow-up visits, respectively.

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.

Outcome measures

Measure	Ablation of the Prostate n=20 Participants ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
International Prostate Symptom Score Quality of Life Baseline	3.4 score on a scale Standard Deviation 1.2
International Prostate Symptom Score Quality of Life 1-Month Follow-up	2.6 score on a scale Standard Deviation 2.2
International Prostate Symptom Score Quality of Life 3-Month Follow-up	1.9 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: Baseline, 1-month and 3-month follow-up visits

Population: 20 participants had evaluable data at baseline. 17 participants and 19 participants had evaluable data from the 1-month and 3-month follow-up visits, respectively.

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).

Outcome measures

Measure	Ablation of the Prostate n=20 Participants ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
Qmax Uroflow Baseline	7.3 cc/sec Standard Deviation 3.9
Qmax Uroflow 1-month follow-up visit	12.8 cc/sec Standard Deviation 6.6
Qmax Uroflow 3-month follow-up visit	9.4 cc/sec Standard Deviation 5.0

SECONDARY outcome

Timeframe: Baseline, 1-month and 3-month follow-up visits

Population: 20 participants had evaluable data at baseline and the 1-month follow-up visit. 19 participants had evaluable data at the 3-month follow-up visit.

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

Outcome measures

Measure	Ablation of the Prostate n=20 Participants ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
PVR (Post-void Residual) Baseline	63.0 mL Standard Deviation 60.5
PVR (Post-void Residual) 1-month follow-up visit	44.9 mL Standard Deviation 31.8
PVR (Post-void Residual) 3-month follow-up visit	55.9 mL Standard Deviation 40.8

SECONDARY outcome

Timeframe: Baseline and 3-month follow-up visit

Population: 15 participants and 19 participants had evaluable data at the baseline and 3-month interval, respectively.

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

Outcome measures

Measure	Ablation of the Prostate n=19 Participants ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
PSA (Prostate-specific Antigen) Baseline	2.1 ng/mL Standard Deviation 1.5
PSA (Prostate-specific Antigen) 3-month follow-up visit	2.1 ng/mL Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline, 1-month and 3-month follow-up visits

Population: 20, 17, and 20 participants had evaluable data at baseline, 1-month and 3-month follow-up visits, respectively.

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).

Outcome measures

Measure	Ablation of the Prostate n=20 Participants ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
Americal Urological Association (AUA) Symptom Index Baseline	18.4 score on a scale Standard Deviation 4.3
Americal Urological Association (AUA) Symptom Index 1-month follow-up visit	13.8 score on a scale Standard Deviation 9.5
Americal Urological Association (AUA) Symptom Index 3-month follow-up visit	10.5 score on a scale Standard Deviation 7.4

Adverse Events

Ablation of the Prostate

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ablation of the Prostate n=20 participants at risk ablation of the prostate will be performed using the study device: Lumenis Pulse P120H Holmium Laser Lumenis Pulse P120H and Xpeeda side firing fiber
Renal and urinary disorders Urgency	30.0% 6/20 • Number of events 7 • 3 months
Renal and urinary disorders Urinary Incontinence	5.0% 1/20 • Number of events 1 • 3 months
Renal and urinary disorders Dysuria	15.0% 3/20 • Number of events 3 • 3 months
Renal and urinary disorders Hematuria	15.0% 3/20 • Number of events 3 • 3 months
Renal and urinary disorders Bleeding	5.0% 1/20 • Number of events 1 • 3 months
Renal and urinary disorders Other	5.0% 1/20 • Number of events 1 • 3 months

Additional Information

Clinical Program Manager

Boston Scientific

Phone: 612-322-1189

Email: teri.bird@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place