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

Prostate Laser Center, PLLC

Status: Completed

Conditions: Prostate Hyperplasia; BPH; Urinary Frequency/Urgency

Treatments: Device: MRI Guided Transrectal Periuretheral Transitional Zone Ablation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03131544

Prostate Laser Center BPH 01

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 45+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

FLA for BPH Active Treatment

Experimental group

Treatment:

Device: MRI Guided Transrectal Periuretheral Transitional Zone Ablation