Benign Prostatic Hyperplasia Clinical Trial
Official title:
Prostatic Artery Embolization (PAE) Using LC Bead LUMI for the Treatment of Symptomatic Benign Prostatic Hyperplasia (BPH)
NCT number | NCT04563221 |
Other study ID # | 51982 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2022 |
Est. completion date | December 1, 2024 |
Verified date | September 2021 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Andrew Picel |
United States,
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 |
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