MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Orthopedic, Hematology, Urology |
| Therapuetic Areas: | Hematology, Nephrology / Urology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 7/1/2018 |
| Start Date: | April 17, 2017 |
| End Date: | May 2020 |
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.
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.
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.
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