Clinical trial NCT03131544: 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
Overall status: COMPLETED
Phase: NA
Conditions: BPH
Prostate Hyperplasia
Urinary Frequency/Urgency
Keywords: BPH
Benign Prostatic Hypertrophy
MRI
Prostate
Lower Urinary Tract Symptoms
Nocturia
Incomplete bladder emptying
Lead sponsor: Prostate Laser Center, PLLC
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2017-04-27
Enrollment: 10
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: International Prostate Symptom Score (IPSS) Change
timeFrame: From baseline to 2 months
measure: International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
timeFrame: From baseline to 2 months
measure: BPH Impact Index Change
timeFrame: From baseline to 2 months
measure: Sexual Health Inventory of Men (SHIM) Score Change
timeFrame: From baseline to 2 months
measure: Number of Adverse Events
timeFrame: Continuous until completion of the study at 2 years
measure: International Prostate Symptom Score (IPSS) Change
timeFrame: From baseline to 4 months
measure: International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
timeFrame: From baseline to 4 months
measure: BPH Impact Index Change
timeFrame: From baseline to 4 months
measure: Sexual Health Inventory of Men (SHIM) Score Change
timeFrame: From baseline to 4 months
measure: International Prostate Symptom Score (IPSS) Change
timeFrame: From baseline to 6 months
measure: International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
timeFrame: From baseline to 6 months
measure: BPH Impact Index Change
timeFrame: From baseline to 6 months
measure: Sexual Health Inventory of Men (SHIM) Score Change
timeFrame: From baseline to 6 months
measure: International Prostate Symptom Score (IPSS) Change
timeFrame: From baseline to 24 months
measure: International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change
timeFrame: From baseline to 24 months
measure: BPH Impact Index Change
timeFrame: From baseline to 24 months
measure: Sexual Health Inventory of Men (SHIM) Score Change
timeFrame: From baseline to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Prostate Laser Center, PLLC
state: Texas
Study officials:
References: