Prostatic Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia (BPH)

NCT02026908 | Completed Results DMC

• 2 other identifiers: STU 00081296IDE G130133
• Study Type: interventional
• Target: 45
• 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; PAE; Benign Prostatic Hyperplasia; BPH; Lower Urinary Tract Symptoms; LUTS

Outcome Measures

Primary Outcomes (1)

• The Primary Objective is to Evaluate the Safety of Prostate Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) Attributed to Benign Prostatic Hyperplasia (BPH).

  The number and the severity of adverse events will be recorded to evaluate safety. Events will be reported by subjects and the severity of events will be graded using the following scale: 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

  5 years

Secondary Outcomes (4)

• Change in International Prostate Symptom Score (IPSS)

  baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years

• Change in Quality of Life (QOL) Bother Question

  baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years

• Change in Benign Prostatic Hyperplasia (BPH) Impact Index

  baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years

• Change in Qmax (Peak and Total Void Volume at Each Follow-up Visit)

  baseline, 4 weeks, 12 weeks, 6 months, 12 months, 2 years, 3 years, 4 years, 5 years

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

Procedure completed in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Embosphere microspheres to slow/block blood flow to the prostate.

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.
• 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 \> 13 and IPSS bother score \> 2
• Peak flow rate Qmax≤ 12 with voided volume ≥125 cc

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 until stopping criteria is met at the 12 month f/u 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 until stopping criteria is met at the 12 month f/u 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 until stopping criteria is met at the 12 month f/u 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.
• Daily use of a pad or device for incontinence required.
• Urethral strictures, 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Salem R, Hairston J, Hohlastos E, Riaz A, Kallini J, Gabr A, Ali R, Jenkins K, Karp J, Desai K, Thornburg B, Casalino D, Miller F, Hofer M, Hamoui N, Mouli S. Prostate Artery Embolization for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Results From a Prospective FDA-Approved Investigational Device Exemption Study. Urology. 2018 Oct;120:205-210. doi: 10.1016/j.urology.2018.07.012. Epub 2018 Jul 20.

  PMID: 30036614 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Since the pandemic started in 2020, annual visits were mostly preformed by completion of the IPSS questionnaire only, very few in person annual visits were completed.

Results Point of Contact

• Title: Samdeep Mouli MD
• Organization: Northwestern University/Northwestern Memorial Hospital

s-mouli@northwestern.edu

312-926-5200

Study Officials

• Riad Salem, MD MBA

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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, Section of Vascular and Interventional Radiology Director, Interventional Oncology Vice-Chairman, Image-Guided Therapy Department of Radiology Northwestern University

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: January 3, 2014
• Study Start: January 1, 2014
• Primary Completion: March 27, 2023
• Study Completion: March 27, 2023
• Last Updated: November 18, 2024
• Results First Posted: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)