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Prostate Artery Embolization for Symptomatic Benign Prostatic Hyperplasia

Primary Purpose

Benign Prostate Hyperplasia

Status

Completed

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

Prostate artery embolization (PAE)

About this trial

This is an interventional treatment trial for Benign Prostate Hyperplasia

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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
Coagulation disturbances not normalized by medical treatment
Known major iliac arterial occlusive disease
Allergy to iodinated contrast agents
Hypersensitivity to gelatin products

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Prostate artery embolization treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

successful procedure

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

Secondary Outcome Measures

Incidence of procedure related complication

Complication after treatment procedure will be recorded. Major adverse events, which included ischemic, infectious, or puncture site complications, pain will be recorded and evaluated. Further imaging or laboratory studies are conducted when a complication was suspected.

Full Information

NCT ID

NCT02822924

First Posted

June 28, 2016

Last Updated

October 20, 2022

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT02822924

Brief Title

Prostate Artery Embolization for Symptomatic Benign Prostatic Hyperplasia

Official Title

Prostate Artery Embolization for Symptomatic Benign Prostatic Hyperplasia

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

October 7, 2013 (Actual)

Primary Completion Date

March 10, 2021 (Actual)

Study Completion Date

March 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

Benign prostatic hyperplasia (BPH), non-malignant enlargement of the prostate, is a common condition among elderly men with a prevalence increasing with age. When sufficiently large, the hyperplastic nodules compress the urethral canal to cause obstruction of the urethra and interfere the normal flow of urine, leading to symptoms of urinary hesitancy, frequent urination, increased risk of urinary tract infections and urinary retention. While medication is often prescribed as the first treatment option, it often does not adequately restore normal urine flow. Many patients being treated with medication may not achieve sustained improvement in symptoms, or they may stop taking the medication because of side effects, therefore other forms of treatments may be necessary. Although surgery with transurethral resection of prostate (TURP) is a benchmark for BPH treatment, it involves insertion of an endoscope is inserted through the penis, and removal of the prostate piece by piece. While considered a safe technique with a mortality rate below 0.25%, it is not without adverse events. The most frequent complications are ejaculatory disorders (up to 80%), early urinary incontinence (30 to 40%), acute urinary retention caused by blood clots (2 to 5%), sexual impotence (up to 5%), and the need for blood transfusions (0.4 to 7%). Patients who have undergone TURP require surgical retreatment for lower urinary tract symptoms in 3 to 14.5% of cases. Others include infection and urethral stricture. Therefore TURP is only recommended for complicated or severe BPH due to its adverse effects. Prostatic artery embolization (PAE) is a potentially promising, minimally invasive alternative procedure for BPH. Results from early studies showed that PAE might be a safe and effective treatment for BPH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostate Hyperplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prostate artery embolization treatment

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Prostate artery embolization (PAE)

Intervention Description

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.

Primary Outcome Measure Information:

Title

successful procedure

Description

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

Time Frame

within 1 hour after PAE procedure

Secondary Outcome Measure Information:

Title

Incidence of procedure related complication

Description

Time Frame

6-8 hours after treatment until 1 month time

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 Coagulation disturbances not normalized by medical treatment Known major iliac arterial occlusive disease Allergy to iodinated contrast agents Hypersensitivity to gelatin products

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Simon Yu, Profesor

Organizational Affiliation

Chinese University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Hong Kong

Country

Hong Kong

12. IPD Sharing Statement

Plan to Share IPD

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Prostate Artery Embolization for Symptomatic Benign Prostatic Hyperplasia

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