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

NCT03052049 | Completed Results DMC FDA Device

• 1 other identifier: STU 00204385
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Benign Prostatic Hyperplasia (BPH)

Keywords

Prostate Artery Embolization

Outcome Measures

Primary Outcomes (1)

• Number of Reported Treatment-related Adverse Events (AE) as Assessed by NCI CTCAE Grading Scale .

  The number of graded adverse events was recorded to evaluate safety. They were graded using the following scale at 1, 3, 6, and 12 months post procedure: Mild (grade 1): the event causes discomfort without disruption of normal daily activities Moderate (grade 2): the event causes discomfort that affects normal daily activities Severe (grade 3): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status Life-threatening (grade 4): the patient was at risk of death at the time of the event Fatal (grade 5): the event caused death.

  1 year

Secondary Outcomes (4)

• Change in International Prostate Symptom Score (IPSS)

  Baseline, 1, 3, 6, 12 months post procedure

• Change in Quality of Life (QOL) Bother Score

  Baseline, 1, 3, 6, 12 months post procedure

• Change in Benign Prostatic Hyperplasia (BPH) Impact Index Score

  Baseline, 1, 3, 6, 12 months post procedure

• Change in Peak Urine Flow (Qmax)

  Baseline, 1, 3, 6, and 12 months post procedure

Study Arms (1)

Prostate Artery Embolization

EXPERIMENTAL

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

Device: Prostate Artery Embolization

Interventions

Prostate Artery Embolization 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.

Also known as: The interventional type is a procedure

Prostate Artery Embolization

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• BTG International Inc.: collaborator

Study Sites (1)

Northwestern

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

We were funded for 30 procedures and anticipated 30 patients. 2 of the patients needed a second procedure, resulting in 28 patients enrolled. Also, during COVID, there were patients that did not come for Qmax testing.

Results Point of Contact

• Title: Jennifer Karp RN
• Organization: Northwestern Medical Group

jkarp@nm.org

312-926-5289

Study Officials

• Riad Salem, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Matthias Hofer, MD

  Northwestern University

  STUDY CHAIR

• Bartley Thornburg, MD

  Northwestern University

  STUDY CHAIR

• Kush Desai, MD

  Northwestern University

  STUDY CHAIR

• Ahsun Riaz, MD

  Northwestern University

  STUDY CHAIR

• Samdeep Mouli, MD

  Northwestern University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 14, 2017
• Study Start: September 6, 2017
• Primary Completion: September 26, 2022
• Study Completion: September 26, 2022
• Last Updated: October 10, 2023
• Results First Posted: April 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)