The purpose of the study is to evaluate improvement in symptoms related to benign prostatic hyperplasia (BPH) in men treated with prostate artery embolization (PAE) using Embosphere Microspheres.
The study will evaluate improvement in symptoms associated with benign prostatic hyperplasia (BPH) in men with prostates larger than 90 grams treated with prostate artery embolization (PAE). Symptoms will be assessed utilizing the International Prostate Symptom Score (IPSS) to evaluate change from baseline at 12 months post PAE.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Improvement of Symptoms Associated With Benign Prostatic Hyperplasia (BPH) as Assessed by the International Prostate Symptom Score (IPSS)
The outcome measure was the International Prostate Symptom Score (IPSS). The IPSS is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). A higher score means a worse outcome.
Time frame: 12 months
Change From Baseline in Prostate Size, as Determined by MRI
Prostate size was determined by measuring the prostate with magnetic resonance imaging (MRI) and calculating length x width x height x pi/6.
Time frame: Baseline and 12 months
Change From Baseline in Peak Urine Flow Rate (Qmax) Determined by Urodynamic Testing
Peak urine flow rate (Qmax) is the greatest volumetric flow rate of urine during urination, measured as the quantity of urine excreted in a specified period of time (per second or per minute). Qmax has become a primary objective parameter of treatment outcomes for various surgical and medical therapies for BPH. Unlike other prominent parameters of treatment outcome, Qmax responds minimally to placebo, making it an objective tool when evaluating a patient's response to therapy.
Time frame: 12 Months
Change From Baseline in Post Void Residual Volume (PVR) as Determined by Urodynamic Testing
Post void residual is a measurement of the amount of urine left in the bladder after voiding. It has traditionally been used to evaluate efficacy of treatment efforts. A positive response to treatment is associated with decreased PVR volumes.
Time frame: 12 Months
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Change From Baseline in Detrusor Muscle Pressure (Pdet) as Determined by Urodynamic Testing
Detrusor muscle pressure (Pdet) is important when evaluating how strong the detrusor force must be to initiate urine flow in bladder outlet obstruction. Lower Pdet values are associated with a positive response to treatment.
Time frame: 12 Months
Change From Baseline in Erectile Function as Determined by the International Index of Erectile Function (IIEF)
The outcome measure was the International Index of Erectile Function (IIEF). The 15 question IIEF Questionnaire is a validated, multi-dimensional, self-administered investigation found to be useful in the clinical assessment of erectile dysfunction and treatment. It is examines the four main domains of male sexual function: erectile function, orgasmic function, sexual desire, and intercourse satisfaction. The answer to each question is given a score between 0 and 5 for a total score of 0-75 (higher score = less dysfunction). Higher scores mean better outcome.
Time frame: 12 Months
Change From Baseline in Serum Prostate Specific Antigen (PSA)
Serum prostate specific antigen (PSA) trends over time, may help to improve the specificity of PSA testing in men with BPH. A strong correlation has been demonstrated between prostate volume and serum PSA levels.
Time frame: Baseline and12 Months
Prostate Artery Embolization (PSA) Related Adverse Events
Number of occurrences of adverse events with some relationship to the study procedure or study device. An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject and does not necessarily have to have a causal relationship with the treatment. In order to capture the most potentially relevant safety information during the study, AEs were assessed at each visit. AEs occurring during the clinical trial and the protocol-defined 12-month follow-up period were reported.
Time frame: 12 Months
Overall Adverse Events
All adverse events will be assessed for severity, relationship to study treatment, subsequent treatment required, and outcome
Time frame: 12 Months