Analysis of Prostatic Arterial Embolization for Benign Prostatic Hyperplasia Using Embosphere Microspheres

NCT02679430 | Withdrawn DMC

• 1 other identifier: 12/12/VA02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators hypothesis that arterial embolization of men with symptomatic BPH, analogous to uterine fibroid embolization for women, is safe and effective.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• International Prostate Symptom Score (IPSS)

  The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). The questions refer to the following urinary symptoms: Questions Symptom 1. Incomplete emptying 2. Frequency 3. Intermittency 4. Urgency 5. Weak Stream 6. Straining 7. Nocturia Question eight refers to the patient's perceived quality of life.

  12 months

Study Arms (1)

Prostate Arterial Embolization

OTHER

Intervention: Patients will undergo prostatic artery embolization. The purpose of this study is to demonstrate the safety and efficacy of the device, Embosphere Microspheres, in prostatic arterial embolization (PAE). PAE, is now an accepted form of treatment for BPH outside of the United States, however few studies have been performed demonstrating safety and efficacy in the US. Embosphere Microsphere is a device that may be used to reduce blood flow to targeted organs. With this research, we would like to show that Embosphere Microsphere may be used for patients with benign hyperplasia of prostate (BPH to reduce blood flow to the prostate gland. This current study is designed to understand the rate of improved BPH symptoms.

Device: Prostate Arterial Embolization

Interventions

Prostate Arterial Embolization DEVICE

The purpose of this study is to demonstrate the safety and efficacy of the device, Embosphere Microspheres, in prostatic arterial embolization (PAE). PAE, is now an accepted form of treatment for BPH outside of the United States, however few studies have been performed demonstrating safety and efficacy in the US. Embosphere Microsphere is a device that may be used to reduce blood flow to targeted organs. With this research, we would like to show that Embosphere Microsphere may be used for patients with benign hyperplasia of prostate (BPH to reduce blood flow to the prostate gland. This current study is designed to understand the rate of improved BPH symptoms.

Prostate Arterial Embolization

Eligibility Criteria

• Age: 35 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males with the clinical diagnosis of BPH.
• IPSS \>18 with symptoms that are refractory to medical treatment with combination therapy (alpha-blocker + 5-alpha-reductase-inhibitor (5-ARI), as tolerated by the patient) for a minimum of six months.
• Candidates for Transurethral resection of the prostate (TURP), open prostatectomy, Transurethral Needle Ablation (TUNA), or other procedures such as thermal ablation.
• Patients are candidates for above procedures, however comorbid conditions present a prohibitive surgical risk.

You may not qualify if:

• Urethral strictures, bladder neck contracture, or other potentially confounding bladder pathology.
• Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes, etc.
• Uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression
• Severe allergy to iodine contrast and unable to be pre-medicated.
• Allergy to gelatin containing products.
• Patient is on anticoagulation or anti-platelet treatment and cannot halt medication for 5 days prior to PAE.
• Patient is unable to have a MRI/MRA performed.
• Magnetic Resonance Angiogram (MRA) reveals severe aorto-iliac atherosclerotic disease prohibiting intervention.
• Compromised renal function determined as serum creatinine level \> 1.8 mg/dl, or upper-tract disease.
• Prior diagnosis of any pelvic malignancy including prostate cancer.
• Have received prior radiation to the pelvis for any condition.
• Have had prior pelvic surgery or non-medical BPH treatment.

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sergei Sobolevsky, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Administration Director

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: February 10, 2016
• Study Start: May 1, 2013
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: December 4, 2023

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)