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

Not Applicable

Completed

• Conditions: BPH; Urinary Frequency/Urgency; Prostate Hyperplasia
• Interventions: Device: MRI Guided Transrectal Periuretheral Transitional Zone Ablation

• Registration Number: NCT03131544
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-16
• Study Start: 2017-04-17
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-27
• Primary Completion: 2018-10-15
• Study Completion: 2020-05-15
• Results First Submitted: 2024-01-29
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-01
• Last Update Submitted: 2024-04-01
• Results First Posted: 2024-04-25
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FLA for BPH Active Treatment	MRI Guided Transrectal Periuretheral Transitional Zone Ablation	-

Primary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (IPSS) Change	From baseline to 24 months	The IPSS survey rates lower urinary tract symptom severity from 0 (none) to 35 (severe).
International Prostate Symptom Score (IPSS) Quality of Life (QoL) Question Change	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")
Sexual Health Inventory of Men (SHIM) Score Change	From baseline to 24 months	This survey rates erectile function from 0 (no function) to 25 (full function)
BPH Impact Index Change	From baseline to 24 months	This is another survey which rates lower urinary tract symptoms from 0 (none) to 13 (severe)
Number of Adverse Events	Continuous until completion of the study at 2 years	We asked patients to self-report adverse events.

Trial Locations

Locations (1)

Prostate Laser Center, PLLC; 🇺🇸 Houston, Texas, United States