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

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Prostatic Artery Embolization (PAE) Using LC Bead LUMI for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04563221
• Other study ID #: 51982
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: September 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Device:
• Prostatic artery embolization
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.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Andrew Picel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with treatment related adverse events assessed by CTCAE v4.0.		12 months post PAE
Primary	Mean change from baseline in symptom score using the IPSS scale at 6 months		Baseline and 6 months post PAE
Secondary	Mean change from baseline in Qmax (maximum urinary flow)		Baseline, 6 months and 12 months post PAE
Secondary	Mean change from baseline in PVR (post void residual)		Baseline, 6 months and 12 months post PAE
Secondary	Mean change from baseline in prostate volume		Baseline, 6 months and 12 months post PAE
Secondary	Mean change from baseline in IPSS to measure long-terms subjective outcome		Baseline, 12 and 24 months post PAE