Prostatic Artery Embolization (PAE) for Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) Using Bead Block Microspheres

NCT ID: NCT03052049

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-06
• Study Completion Date: 2022-09-26

Brief 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. 30 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 Bead Block microspheres 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, and 12 months post procedure.

Conditions

Benign Prostatic Hyperplasia (BPH)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prostate Artery Embolization

There is only one arm of this study where patients receive Prostate Artery Embolization

Group Type: EXPERIMENTAL

Prostate Artery Embolization

Intervention Type: DEVICE

The PAE procedure will be completed on all enrolled patients in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Bead Block microspheres to slow/block blood flow to the prostate.

Interventions

Prostate Artery Embolization

The PAE procedure will be completed on all enrolled patients in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Bead Block microspheres to slow/block blood flow to the prostate.

Intervention Type: DEVICE

Other Intervention Names

The interventional type is a procedure

Eligibility Criteria

Inclusion Criteria

• Diagnosis of LUTS secondary to BPH refractory to/contraindicated for medical treatment. Patients with indwelling foley catheters will be treated with culture directed antibiotics one time for 5-7 days. The catheter will be removed so urodynamic testing and cystoscopy can be completed as part of the screening visit. It will be replaced when testing is completed.
• 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 ≥ 18 and IPSS bother score ≥ 3
• Peak flow rate Qmax≤ 12 with voided volume ≥125 cc
• For men 45-59 years old: Prostate Specific Antigen) PSA < 2.5 (or) PSA 2.5-20 with a documented negative biopsy within previous 12 months.
• For men >60: PSA < 4 (or) PSA 4-20 with a documented negative biopsy within previous 12 months.

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 if criteria are met at the 1 year follow up 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 if criteria are met at the 1 year follow up 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 if criteria are met at the 1 year follow up 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 or if criteria are met at the 1 year follow up visit
• Daily use of a pad or device for incontinence required.
• Current urethral strictures/Bladder neck contracture (BNC) (past urethral strictures which have been treated successfully > 6 months prior are eligible)
• 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
• Penile prosthesis.
• Artificial urinary sphincter.
• Documented bacterial prostatitis within the past year.
• Active urinary tract infection (UTI) unless in case of regular catheter dependence and thought to represent colonization.
• History of chronic prostatitis within the last 1 year
• Known bleeding disorders (e.g. VWD)
• Prior prostate procedures (e.g. Transurethral Microwave Therapy (TUMT), Transurethral Needle Ablation of the Prostate (TUNA), Water-induced Thermotherapy (WIT), Transurethral Resection of the Prostate (TURP), Photoselective Vaporization of the Prostate (PVP)
• Prior treatment for overactive bladder (e.g. intravesical botox)
• Enrolled in another treatment trial for any disease within the past 30 days
• Declines or unable to provide informed consent
• Condition precluding catheter-based intervention (ie occluded vessel, severe atheromatous disease)
• Any serious medical condition likely to impede successful completion of the study, such as certain mental disorders, uncontrolled diabetes, cardiac arrhythmias, cardiac disease including congestive heart failure, significant respiratory disease, or known immunosuppression.
• A history of rectal malignancy
• Prior surgical prostate intervention
• Interest in future fertility
• Allergy to iodinated contrast agents not responsive to steroid premedication regimen
• Contraindication to conscious sedation

• Minimum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

BTG International Inc.

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Riad Salem

Professor of Radiology, Medicine and Surgery; Chief, Vascular and Interventional Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Riad Salem, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Matthias Hofer, MD

Role: STUDY_CHAIR

Northwestern University

Bartley Thornburg, MD

Role: STUDY_CHAIR

Northwestern University

Kush Desai, MD

Role: STUDY_CHAIR

Northwestern University

Ahsun Riaz, MD

Role: STUDY_CHAIR

Northwestern University

Samdeep Mouli, MD

Role: STUDY_CHAIR

Northwestern University

Locations

Northwestern

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STU 00204385

Identifier Type: -

Identifier Source: org_study_id