Prostate Artery Embolization for Symptomatic Benign Prostatic Hyperplasia

NCT02822924 | Completed

• 1 other identifier: VIR-13-05
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to evaluate the clinical effectiveness and safety of PAE in treating patients with BPH.

Conditions

Benign Prostate Hyperplasia

Outcome Measures

Primary Outcomes (1)

• successful procedure

  Procedure success defined as technically successful selective prostatic arterial catheterization and embolization

  within 1 hour after PAE procedure

Secondary Outcomes (1)

• Incidence of procedure related complication

  6-8 hours after treatment until 1 month time

Study Arms (1)

Prostate artery embolization treatment

OTHER

Prostatic artery embolization (PAE) as a new treatment technology is a potentially promising, minimally invasive alternative procedure for BPH, which has been shown to be safe and effective in both animal models and clinical trials.

Procedure: Prostate artery embolization (PAE)

Interventions

Prostate artery embolization (PAE) PROCEDURE

Right femoral arterial puncture is performed under local anesthesia. The blood supply to the prostate is mapped by angiography of the iliac vessels and the prostate arteries. Microcatheters are used for super-selective catheterization of the right and left inferior vesicle arteries. Embolization is performed with a microcatheter to deliver microspheres of 300 micron diameter. The microsphere mixture is slowly injected under fluoroscopic guidance. The endpoint of embolization is flow stasis in the prostatic vessels with prostatic gland opacification, without reflux of the mixture to undesired arteries.

Prostate artery embolization treatment

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 50 and 80 years old.
• Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) ≥13, despite medical treatment with alpha-blockers for at least 6 months, or
• Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) ≥13, for whom medication is contraindicated, not tolerated or refused, or
• Patients with history of acute retention of urine with or without previous treatment with Alpha-blockers.
• Patients with QOL score ≥3.
• Patients with Urine flow rate \< 15ml/second or acute urinary retention.
• Patients with evidence of prostatic enlargement determined by digital rectal examination or ultrasonography (USG), with a prostate size of not less than 40 grams.

You may not qualify if:

• Active urinary tract infection
• Biopsy proven prostate or bladder cancer, or any recent cancer within 5 years other than basal or squamous cell skin cancer
• Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (e.g. multiple sclerosis, Parkinson's disease, spinal cord injuries, etc)
• Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
• Prostate size \<40 grams on CT or MRI
• Previous non-medical BPH treatment, including surgery, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate
• Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis.
• Unable to have MRI imaging (e.g. metal implant including pacemaker, replacement joint, etc)
• Cardiac condition including congestive heart failure or arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease or known immunosuppression which required hospitalization within the previous 6 months
• Baseline serum creatinine level \> 160 umol/L
• Known upper tract renal disease
• Cystolithiasis or chronic hematuria within 3 months prior to study treatment
• Active prostatitis
• Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease
• History of pelvic irradiation or radical pelvic surgery

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Study Officials

• Simon Yu, Profesor

  Chinese University of Hong Kong

  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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 6, 2016
• Study Start: October 7, 2013
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)