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Completed

NCT Number: NCT03131544

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.

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Key information

Conditions

BPH Genital Diseases Genital Diseases, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Nocturia Pathological Conditions, Signs and Symptoms Prostate Hyperplasia Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urinary Frequency/Urgency Urogenital Diseases Urological Manifestations

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Prostate Laser Center, PLLC

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI Guided Transrectal Periuretheral Transitional Zone Ablation

Device

Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.

Other names: Visualase

Primary outcomes

  1. International Prostate Symptom Score (IPSS) Change

    Time frame: From baseline to 2 months

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

  2. International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change

    Time frame: 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")

  3. BPH Impact Index Change

    Time frame: From baseline to 2 months

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

  4. Sexual Health Inventory of Men (SHIM) Score Change

    Time frame: From baseline to 2 months

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

  5. Number of Adverse Events

    Time frame: Continuous until completion of the study at 2 years

    We asked patients to self-report adverse events.

  6. International Prostate Symptom Score (IPSS) Change

    Time frame: From baseline to 4 months

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

  7. International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change

    Time frame: 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")

  8. BPH Impact Index Change

    Time frame: From baseline to 4 months

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

  9. Sexual Health Inventory of Men (SHIM) Score Change

    Time frame: From baseline to 4 months

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

  10. International Prostate Symptom Score (IPSS) Change

    Time frame: From baseline to 6 months

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

  11. International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change

    Time frame: 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")

  12. BPH Impact Index Change

    Time frame: From baseline to 6 months

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

  13. Sexual Health Inventory of Men (SHIM) Score Change

    Time frame: From baseline to 6 months

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

  14. International Prostate Symptom Score (IPSS) Change

    Time frame: From baseline to 24 months

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

  15. International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change

    Time frame: 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")

  16. BPH Impact Index Change

    Time frame: From baseline to 24 months

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

  17. Sexual Health Inventory of Men (SHIM) Score Change

    Time frame: From baseline to 24 months

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

Sponsors and collaborators

Lead sponsor

Prostate Laser Center, PLLC

Industry

Collaborators

  • Medtronic

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Apr 27, 2017
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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