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COMPLETEDNA

Prostatic Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia (BPH)

Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)

NCT02026908•Northwestern University

Summary

This is an open-labeled, non-randomized feasibility study to evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH).

Detailed Description

This pilot study will be a single center, open labeled, non-randomized feasibility study to evaluate the initial safety of PAE for the treatment of symptomatic bladder outlet obstruction. 50 adult male subjects will be enrolled in this study. If eligible patients will undergo the prostate artery embolization procedure in the Interventional Radiology department. An angiogram of the prostate arteries will be done. Small beads called Embospheres will be injected into the prostate artery to slow blood flow to the prostate in the hope of providing relief with minimal side effects and complications, for lower urinary tract symptoms caused by BPH. After the procedure the patient will be followed at 4 weeks, 12 weeks, 6 months, 12 months post procedure and then annually for up to 4 years.

Eligibility

Age

45 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment.
•Ability to understand and the willingness to sign a written informed consent
•Prostate volumes 40 - 200 gm. May include 30-39 gm if the subject has a long history of ineffective response to combination medical treatments (alpha-blocker and a 5-alpha reductase inhibitor) for at least 6 months
•Men ≥ 45 years of age
•IPSS symptom score \> 13 and IPSS bother score \> 2
•Peak flow rate Qmax≤ 12 with voided volume ≥125 cc

Exclusion Criteria

•History of prostate or bladder cancer, pelvic radiation, untreated bladder stones,
•On alpha-blockers within the past 2 weeks unless on a stable dose of medication, with a stable urination pattern for 2 weeks prior to enrollment, and the willingness to stay on the same dose for the duration of the study, or until stopping criteria is met at the 12 month f/u visit, and or/part of a trial without catheter (TWOC) and patient is currently in Acute Urinary Retention (AUR)
•On 5-alpha reductase inhibitors within the past 6 months unless on a stable dose of medication with a stable urination pattern for 30 days prior to enrollment and the willingness to stay on the same dose for the duration of the study or until stopping criteria is met at the 12 month f/u visit .
•On phenylephrine, pseudoephedrine, imipramine, an anticholinergic or cholinergic medication within the past 2 weeks unless on a stable dose of medication with a stable urination pattern for 2 weeks prior to enrollment and the willingness to stay on the same dose for the duration of the study or until stopping criteria is met at the 12 month f/u visit .
•On estrogen, androgen, any drug producing androgen suppression, or anabolic steroids within the past 4 months unless on stable dose of medication for 30 days prior to enrollment and the willingness to stay on the same dose for the duration of the study.
•Daily use of a pad or device for incontinence required.
•Urethral strictures, renal insufficiency (i.e. creatinine \> 1.8)
•Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function.
•Neurogenic bladder, Hypotonic Bladder
•Prior treatment for urinary incontinence
+19 more criteria

Locations (1)

Northwestern Memorial Hospital

Chicago, Illinois, United States

Key Dates

Start Date

January 1, 2014

Primary Completion Date

March 27, 2023

Completion Date

March 27, 2023

Last Updated

November 18, 2024

Enrollment

ACTUAL participants

Conditions

Benign Prostatic Hyperplasia (BPH)

Interventions

Prostate Artery Embolization

DEVICE

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RECRUITINGNA

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COMPLETEDNA

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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: November 18, 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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Prostatic Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia (BPH)

Inclusion Criteria

Exclusion Criteria

Laser Ablation a Salvage Treatment for Obstructive Benign Prostatic Hyperplasia

Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging

Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER)

Prognostic Factor in the Patients With Benign Prostatic Hyperplasia Who Undergo Holmium Laser Enucleation of the Prostate

Study of Median Lobe Prostatic UroLift Procedure