Trial Outcomes & Findings for MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH) (NCT NCT03131544)

Results Overview

The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

From baseline to 2 months

Results posted on

2024-04-25

Participant Flow

All the procedures were performed between May 2017 and May 2018. All procedures were performed at a free-standing magnetic resonance imaging (MRI) center, and pre-procedure and post-procedure visits were completed in an outpatient office.

Participant milestones

Participant milestones
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FLA for BPH Active Treatment n=10 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
Age, Categorical <=18 years	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=10 Participants
Age, Categorical >=65 years	2 Participants n=10 Participants
Age, Continuous	60.3 years STANDARD_DEVIATION 6.2 • n=10 Participants
Sex: Female, Male Female	0 Participants n=10 Participants
Sex: Female, Male Male	10 Participants n=10 Participants
Region of Enrollment United States	10 participants n=10 Participants
Prostate volume	69.3 cubic centimeters (cc) STANDARD_DEVIATION 31.0 • n=10 Participants
International Prostate Symptom Score (IPSS)	26.3 points STANDARD_DEVIATION 4.96 • n=10 Participants
International Prostate Symptom Score (IPSS) Quality of Life (QoL)	5.1 points STANDARD_DEVIATION 0.83 • n=10 Participants
Benign Prostatic Hyperplasia (BPH) Impact Index	9.7 points STANDARD_DEVIATION 1.9 • n=10 Participants
Sexual Health Inventory For Men (SHIM)	20 points STANDARD_DEVIATION 6.0 • n=10 Participants

PRIMARY outcome

Timeframe: From baseline to 2 months

The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).

Outcome measures

Outcome measures
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n=10 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
International Prostate Symptom Score (IPSS) Change	-17.5 units on a scale Standard Deviation 4.3

PRIMARY outcome

Timeframe: From baseline to 2 months

The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")

Outcome measures

Outcome measures
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n=10 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change	-3.4 units on a scale Standard Deviation 0.8

PRIMARY outcome

Timeframe: From baseline to 2 months

This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)

Outcome measures

Outcome measures
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n=10 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
BPH Impact Index Change	-6.9 units on a scale Standard Deviation 2.1

PRIMARY outcome

Timeframe: From baseline to 2 months

This survey rates erectile function from 0 (no function) to 25 (full function)

Outcome measures

Outcome measures
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n=10 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
Sexual Health Inventory of Men (SHIM) Score Change	1.9 score on a scale Standard Deviation 2.7

PRIMARY outcome

Timeframe: Continuous until completion of the study at 2 years

Population: Two patients experienced urinary tract infections, two patients developed retrograde ejaculation, and one patient had urinary retention after foley catheter removal, requiring catheter replacement and maintenance for 1 week. All adverse events were considered mild using the Society of Interventional Radiology Adverse Events Classification System.

We asked patients to self-report adverse events.

Outcome measures

Outcome measures
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n=10 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
Number of Adverse Events	4 Participants

PRIMARY outcome

Timeframe: From baseline to 4 months

The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).

Outcome measures

Outcome measures
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n=10 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
International Prostate Symptom Score (IPSS) Change	-18.4 units on a scale Standard Deviation 4.2

PRIMARY outcome

Timeframe: From baseline to 4 months

The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")

Outcome measures

Outcome measures
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n=10 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change	-3.1 units on a scale Standard Deviation 1.0

PRIMARY outcome

Timeframe: From baseline to 4 months

This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)

Outcome measures

Outcome measures
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n=10 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
BPH Impact Index Change	-7.4 units on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: From baseline to 4 months

This survey rates erectile function from 0 (no function) to 25 (full function)

Outcome measures

Outcome measures
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n=10 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
Sexual Health Inventory of Men (SHIM) Score Change	1.1 units on a scale Standard Deviation 3.1

PRIMARY outcome

Timeframe: From baseline to 6 months

The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).

Outcome measures

Outcome measures
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n=10 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
International Prostate Symptom Score (IPSS) Change	-17.5 units on a scale Standard Deviation 4.1

PRIMARY outcome

Timeframe: From baseline to 6 months

The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")

Outcome measures

Outcome measures
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n=10 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change	-3.2 units on a scale Standard Deviation 1.2

PRIMARY outcome

Timeframe: From baseline to 6 months

This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)

Outcome measures

Outcome measures
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n=10 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
BPH Impact Index Change	-6.7 units on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: From baseline to 6 months

This survey rates erectile function from 0 (no function) to 25 (full function)

Outcome measures

Outcome measures
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n=10 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
Sexual Health Inventory of Men (SHIM) Score Change	0.8 units on a scale Standard Deviation 3.3

PRIMARY outcome

Timeframe: From baseline to 24 months

The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).

Outcome measures

Outcome measures
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n=9 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
International Prostate Symptom Score (IPSS) Change	-20.1 units on a scale Standard Deviation 5.8

PRIMARY outcome

Timeframe: From baseline to 24 months

The IPSS QoL question asks patients to rate how they would feel if they were to spend the rest of their lives with their urinary condition just the way it is now, from 0 ("delighted") to 6 ("terrible")

Outcome measures

Outcome measures
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n=9 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change	-3.7 units on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: From baseline to 24 months

This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)

Outcome measures

Outcome measures
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n=9 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
BPH Impact Index Change	-7.7 units on a scale Standard Deviation 2.0

PRIMARY outcome

Timeframe: From baseline to 24 months

This survey rates erectile function from 0 (no function) to 25 (full function)

Outcome measures

Outcome measures
Measure	Focal Laser Ablation (FLA) for BPH Active Treatment n=9 Participants MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
Sexual Health Inventory of Men (SHIM) Score Change	2.8 units on a scale Standard Deviation 3.3

Adverse Events

FLA for BPH Active Treatment

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	FLA for BPH Active Treatment n=10 participants at risk MRI Guided Transrectal Periuretheral Transitional Zone Ablation: Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
Renal and urinary disorders Urinary tract infection (UTI)	20.0% 2/10 • Number of events 2 • 2 years The patients were instructed to self-report their adverse events to us.
Reproductive system and breast disorders Retrograde ejaculation	20.0% 2/10 • Number of events 2 • 2 years The patients were instructed to self-report their adverse events to us.
Renal and urinary disorders Urinary retention	10.0% 1/10 • Number of events 1 • 2 years The patients were instructed to self-report their adverse events to us.

Additional Information

Dr. Ara Karamanian, Medical Director of the Prostate Program

Prostate Laser Center, PLLC

Phone: (713) 904-4014

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place