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MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH) | Clinical Trials | Clareo Health

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

NCT03131544•Prostate Laser Center, PLLC

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

Age

45 - No limit years

Sex

MALE

Healthy Volunteers

Yes

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.
+7 more criteria

Locations (1)

Prostate Laser Center, PLLC

Houston, Texas, United States

Key Dates

Start Date

April 17, 2017

Primary Completion Date

October 15, 2018

Completion Date

May 15, 2020

Last Updated

April 25, 2024

Enrollment

ACTUAL participants

Conditions

BPHProstate HyperplasiaUrinary Frequency/Urgency

Interventions

MRI Guided Transrectal Periuretheral Transitional Zone Ablation

DEVICE

Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia

NCT07016620

Benign Prostatic Hyperplasia (BPH)

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RECRUITING

Intradetrusor Onabotulinumtoxin A (Botox) at the Time of Transurethral Resection of the Prostate or Transurethral Waterjet Ablation of the Prostate for Mixed Lower Urinary Tract Symptoms

NCT07377929

Benign Prostatic Hypertrophy (BPH)Lower Urinary Track Symptoms

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 25, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia

Intradetrusor Onabotulinumtoxin A (Botox) at the Time of Transurethral Resection of the Prostate or Transurethral Waterjet Ablation of the Prostate for Mixed Lower Urinary Tract Symptoms

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