MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)

Over 100,000 BPH procedures are performed annually in the US. The purpose of this study is to evaluate the effectiveness of performing MRI guided transrectal laser ablation using a 980 nm laser (VisualaseTM by Medtronic, Inc., a Minnesota, U.S.A. company) to treat benign prostatic hypertrophy (BPH). The laser system will be used to necrotize urological soft tissue within the prostate under MRI guidance. This will be a single center, single arm prospective trial with an anticipated enrollment of 10 men. Patients who elect this treatment option and choose to be part of the study will be enrolled consecutively.

Study Overview

• Status: Unknown
• Conditions: BPH; Urinary Frequency/Urgency; Prostate Hyperplasia
• Intervention / Treatment: Device: MRI Guided Transrectal Periuretheral Transitional Zone Ablation

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Prostate Laser Center, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Diagnosis of lower urinary track symptoms (LUTS).
2. Prostate volume of 40 - 200 cc.
3. Men ≥ 45 years old.
4. IPSS ≥ 15.
5. BPH Impact Index ≥ 5.

Exclusion Criteria:

1. History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, or findings suggestive of likely underlying prostate cancer.
2. Need to catheterize to relieve obstruction.
3. Daily use of incontinence materials/padding.
4. Neurogenic or hypotonic bladder, Parkinson's Disease, or a history of uncontrolled diabetes.
5. Prior interventional or surgical treatment of BPH.
6. Penile prosthesis.
7. Artificial urinary sphincter or collagen bladder injection.
8. Urethral stricture.
9. Bleeding disorder/coagulopathy.
10. Inability to refrain from blood thinners in the peri-procedural period.
11. Inability or chooses not to provide informed consent.
12. Any serious medical condition which would make proceeding to treatment unsafe.
13. Significant contraindication to MRI or gadolinium contrast.
14. Hip replacement.
15. Lack of a rectum.
16. Life expectancy of less than two years.
17. Unable or unwilling to complete all required questionnaires and follow-up assessments.

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: FLA for BPH Active Treatment	Device: MRI Guided Transrectal Periuretheral Transitional Zone Ablation; Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.; Other Names: Visualase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
International Prostate Symptom Score (IPSS) Change	Time Frame: Baseline, 2 months, 4 months, 6 months and 24 months
International Prostate Symptom Score Quality of Life Question Change	Time Frame: Baseline, 2 months, 4 months, 6 months and 24 months
BPH Impact Index Change	Time Frame: Baseline, 2 months, 4 months, 6 months and 24 months
Sexual Health Inventory of Men (SHIM) Score Change	Time Frame: Baseline, 2 months, 4 months, 6 months and 24 months
Number and severity of adverse events	Continuous until completion of the study at 2 years

Collaborators and Investigators

• Sponsor: Prostate Laser Center, PLLC
• Collaborators: Medtronic, Inc., a Minnesota, U.S.A. company

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2017
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: April 16, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Actual): June 29, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: MRI; Lower Urinary Tract Symptoms; Prostate; BPH; Nocturia; Benign Prostatic Hypertrophy; Incomplete bladder emptying
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Pathological Conditions, Anatomical; Prostatic Hyperplasia; Hyperplasia; Hypertrophy
• Other Study ID Numbers: Prostate Laser Center BPH 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No