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

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ClinicalTrials.gov Identifier: NCT03131544
Recruitment Status : Active, not recruiting
First Posted : April 27, 2017
Last Update Posted : June 29, 2018
Sponsor:
Collaborator:
Medtronic, Inc., a Minnesota, U.S.A. company
Information provided by (Responsible Party):
Prostate Laser Center, PLLC

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.

Condition or disease Intervention/treatment Phase
BPH Prostate Hyperplasia Urinary Frequency/Urgency Device: MRI Guided Transrectal Periuretheral Transitional Zone Ablation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : May 2020

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 Name: Visualase




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


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131544


Locations
United States, Texas
Prostate Laser Center, PLLC
Houston, Texas, United States, 77030
Sponsors and Collaborators
Prostate Laser Center, PLLC
Medtronic, Inc., a Minnesota, U.S.A. company

Additional Information:
Responsible Party: Prostate Laser Center, PLLC
ClinicalTrials.gov Identifier: NCT03131544     History of Changes
Other Study ID Numbers: Prostate Laser Center BPH 01
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Prostate Laser Center, PLLC:
BPH
Benign Prostatic Hypertrophy
MRI
Prostate
Lower Urinary Tract Symptoms
Nocturia
Incomplete bladder emptying

Additional relevant MeSH terms:
Hyperplasia
Hypertrophy
Prostatic Hyperplasia
Pathologic Processes
Pathological Conditions, Anatomical
Prostatic Diseases
Genital Diseases, Male