Prostate Embolization for Massive Benign Prostatic Hypertrophy (BPH)

Stopped early · Phase 1/Phase 2

Conditions studied: Benign Prostatic Hypertrophy, Lower Urinary Tract Symptoms

In brief

This is a prospective, open label single center feasibility study to demonstrate basic safety and effectiveness of prostate artery embolization for the treatment of symptomatic benign prostatic Hyperplasia (BPH) in a small series of patients with large (≥90 grams) glands.

Key facts

Study ID

NCT02676544

Run by

Rhode Island Hospital

People needed

9

Starts

2015-12-01

Expected to finish

2021-06-30

Last updated by the study team

2021-07-08

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patients selected for this study must meet all of the following criteria:
• Age ≥ 50 years
• Lower urinary tract symptoms secondary to BPH as defined by:
• IPSS Symptom Index ≥ 12
• Maximum Uroflow rate (Qmax) of ≤ 12cc per sec
• Prostate of ≥ 90 gm as determined by MRI or transrectal ultrasound of the prostate (TRUS)

You may not qualify if…

• Patients meeting any of the following criteria will be excluded from the study.
• Age less than 50 years
• Prostate cancer
• Bladder cancer
• Severe, life-threatening allergy to iodinated contrast
• Bilateral internal iliac artery occlusion
• Causes of obstruction other than BPH such as stricture disease
• Neurogenic bladder or other causes of bladder atonia
• Post void residual greater than 250 cc
• Any contraindication to embolization, including
• Patients intolerant to occlusion procedures
• Vascular anatomy or blood flow that precludes catheter placement or embolic agent injection
• Presence or likely onset of vasospasm
• Presence or likely onset of hemorrhage
• Presence of severe atheromatous disease
• Presence of feeding arteries smaller than distal branches from which they emerge
• Presence of collateral vessel pathways potentially endangering normal territories during embolization
• History of any illness or surgery that might confound the results of the study, which produces symptoms that might be confused with those of the disease process under consideration, or which poses additional risk to the patient.
• Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
• Confirmed or suspected bladder cancer
• Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease
• Previous pelvic irradiation or radical pelvic surgery
• Recent (within 3 months) cystolithiasis
• History or presence of urethral strictures, bladder neck contracture, potentially confounding bladder pathology, or (within 5 years) prostatitis
• Active urinary tract infection

Where it is running

• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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