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

Primary Purpose

BPH, Prostate Hyperplasia, Urinary Frequency/Urgency

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI Guided Transrectal Periuretheral Transitional Zone Ablation
Sponsored by
Prostate Laser Center, PLLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BPH focused on measuring BPH, Benign Prostatic Hypertrophy, MRI, Prostate, Lower Urinary Tract Symptoms, Nocturia, Incomplete bladder emptying

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Prostate Laser Center, PLLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FLA for BPH Active Treatment

Arm Description

Outcomes

Primary Outcome Measures

International Prostate Symptom Score (IPSS) Change
International Prostate Symptom Score Quality of Life Question Change
BPH Impact Index Change
Sexual Health Inventory of Men (SHIM) Score Change
Number and severity of adverse events

Secondary Outcome Measures

Full Information

First Posted
April 16, 2017
Last Updated
June 27, 2018
Sponsor
Prostate Laser Center, PLLC
Collaborators
Medtronic, Inc., a Minnesota, U.S.A. company
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1. Study Identification

Unique Protocol Identification Number
NCT03131544
Brief Title
MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)
Official Title
MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 17, 2017 (Actual)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prostate Laser Center, PLLC
Collaborators
Medtronic, Inc., a Minnesota, U.S.A. company

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPH, Prostate Hyperplasia, Urinary Frequency/Urgency
Keywords
BPH, Benign Prostatic Hypertrophy, MRI, Prostate, Lower Urinary Tract Symptoms, Nocturia, Incomplete bladder emptying

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FLA for BPH Active Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MRI Guided Transrectal Periuretheral Transitional Zone Ablation
Other Intervention Name(s)
Visualase
Intervention Description
Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
Primary Outcome Measure Information:
Title
International Prostate Symptom Score (IPSS) Change
Time Frame
Time Frame: Baseline, 2 months, 4 months, 6 months and 24 months
Title
International Prostate Symptom Score Quality of Life Question Change
Time Frame
Time Frame: Baseline, 2 months, 4 months, 6 months and 24 months
Title
BPH Impact Index Change
Time Frame
Time Frame: Baseline, 2 months, 4 months, 6 months and 24 months
Title
Sexual Health Inventory of Men (SHIM) Score Change
Time Frame
Time Frame: Baseline, 2 months, 4 months, 6 months and 24 months
Title
Number and severity of adverse events
Time Frame
Continuous until completion of the study at 2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of lower urinary track symptoms (LUTS). Prostate volume of 40 - 200 cc. Men ≥ 45 years old. IPSS ≥ 15. BPH Impact Index ≥ 5. Exclusion Criteria: History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, or findings suggestive of likely underlying prostate cancer. Need to catheterize to relieve obstruction. Daily use of incontinence materials/padding. Neurogenic or hypotonic bladder, Parkinson's Disease, or a history of uncontrolled diabetes. Prior interventional or surgical treatment of BPH. Penile prosthesis. Artificial urinary sphincter or collagen bladder injection. Urethral stricture. Bleeding disorder/coagulopathy. Inability to refrain from blood thinners in the peri-procedural period. Inability or chooses not to provide informed consent. Any serious medical condition which would make proceeding to treatment unsafe. Significant contraindication to MRI or gadolinium contrast. Hip replacement. Lack of a rectum. Life expectancy of less than two years. Unable or unwilling to complete all required questionnaires and follow-up assessments.
Facility Information:
Facility Name
Prostate Laser Center, PLLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.ProstateLaserCenter.com/
Description
Related Info

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

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