Prostatic Artery Embolization for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)

NCT04563221 | Withdrawn FDA Device

• 1 other identifier: 51982
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, prospective, investigational study to evaluate the safety and efficacy of prostatic artery embolization (PAE) for the treatment of moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Embolization will be performed with LC Bead LUMI particles using a balloon occlusion microcatheter or standard microcatheter.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Keywords

Benign prostatic hyperplasia (BPH); Prostatic artery embolization (PAE); Lower urinary tract symptoms (LUTS); Prostate artery embolization

Outcome Measures

Primary Outcomes (2)

• Number of patients with treatment related adverse events assessed by CTCAE v4.0.

  12 months post PAE

• Mean change from baseline in symptom score using the IPSS scale at 6 months

  Baseline and 6 months post PAE

Secondary Outcomes (4)

• Mean change from baseline in Qmax (maximum urinary flow)

  Baseline, 6 months and 12 months post PAE

• Mean change from baseline in PVR (post void residual)

  Baseline, 6 months and 12 months post PAE

• Mean change from baseline in prostate volume

  Baseline, 6 months and 12 months post PAE

• Mean change from baseline in IPSS to measure long-terms subjective outcome

  Baseline, 12 and 24 months post PAE

Study Arms (2)

Balloon occlusion microcatheter

EXPERIMENTAL

Participants will undergo the PAE procedure using LC Bead LUMI delivered through a balloon occlusion microcatheter.

Device: Prostatic artery embolization

Standard microcatheter

EXPERIMENTAL

Participants will undergo the PAE procedure using LC Bead LUMI delivered through a standard microcatheter.

Device: Prostatic artery embolization

Interventions

Prostatic artery embolization DEVICE

Prostatic artery embolization is performed using LC Bead LUMI, which is the investigational device. The particles are administered to the prostatic arteries using either a balloon occlusion or standard microcatheter. Follow-up is performed at 1 month, 6 months, 12 months, and 24 months after intervention.

Balloon occlusion microcatheter; Standard microcatheter

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 45 years and ≤ 85 years old
• Prostate volume ≥ 40 mL and ≤ 300 mL
• Diagnosis of BPH with moderate to severe lower urinary tract symptoms (LUTS)
• Refractory or intolerant to medical management
• Ineligibility for or refusal of surgical management
• No evidence of prostate cancer

You may not qualify if:

• History of pelvic cancer
• Neurogenic bladder disorder
• Bladder diverticula greater than 5 cm or bladder stones
• Acute urinary retention with Foley catheter dependence
• Active urinary tract infection, interstitial cystitis, or prostatitis within the last 3 months
• Prior surgical prostate intervention
• Active participation in another clinical trial

Sponsors & Collaborators

• Andrew Picel: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

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

Study Officials

• Andrew Picel, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: September 20, 2020
• First Posted: September 24, 2020
• Study Start: May 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)