Prostatic Hyperplasia Clinical Trial
Official title:
Prostate Artery Embolization Safety and Efficacy: A Pilot Study
NCT number | NCT02592473 |
Other study ID # | 18236 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2015 |
Est. completion date | November 2021 |
The purpose of this project is to evaluate the safety, efficacy, and feasibility of performing prostatic artery embolization (PAE) using endovascular techniques and particle embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
Status | Recruiting |
Enrollment | 50 |
Est. completion date | November 2021 |
Est. primary completion date | November 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 45 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients between ages 45-80 years - Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hypertrophy for a minimum of 6 months - IPSS score at initial evaluation should be greater than 7, and uroflowmetry (Qmax) of <12mL/s (milliliters per second) . - All prostate volumes will be at least 40gm and no more than 400gm based on DRE, TRUS, or cross sectional imaging Exclusion Criteria: - Patients with urinary tract infections (> 2/year), prostatitis, or interstitial cystitis - Cases of biopsy proven prostate cancer or urethral cancer. - Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy within 2 months of study. - Patients who are classified as New York Heart Association Class III (Moderate), or higher. - Patients with history of prior pelvic irradiation. - Hypersensitivity reactions to contrast material not manageable with prophylaxis. - Patients with serum creatinine values >1.7mg/dl or glomerular filtration rates less than 50. |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia Health Systems | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | Siemens Medical Solutions |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | QMax (peak urinary flow rate) assessment | 12 months | |
Primary | Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures | 2 weeks | ||
Primary | Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | QMax assessment | 24 months | |
Primary | Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures | 24 months | ||
Primary | Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | IPSS (International Prostate Symptom Score) | 12 months | |
Primary | Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | IPSS | 24 months | |
Primary | Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | QoL(quality of life question) | 12 months | |
Primary | Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | QoL | 24 months | |
Primary | Clinical improvement in Lower Urinary Tract Symptoms (LUTS) | QMax | 24 months | |
Secondary | Urine flow rate as measured by QMax | 1 month | ||
Secondary | Urine flow rate as measured by QMax | 24 months | ||
Secondary | Post-void residual measured in ml/cc | 1 month | ||
Secondary | Post-void residual measured in ml/cc | 24 months | ||
Secondary | UCLA-PCI-SF (University of California, Los Angeles Prostate Cancer Index Short Form) score | 1 month | ||
Secondary | UCLA-PCI-SF score | 24 months |
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