APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.
Study Type
OBSERVATIONAL
Enrollment
500
Subject's data will be collected from patients that are undergoing care using the Optilume drug-coated catheter system.
Florida Urology Partners
Tampa, Florida, United States
Kearney Urology Center
Kearney, Nebraska, United States
The Urology Center, P.C.
Omaha, Nebraska, United States
Sheldon Freedman, Ltd
Las Vegas, Nevada, United States
The primary efficacy endpoint is the average IPSS change from baseline to 12 months.
The primary efficacy endpoint is the average IPSS change from baseline to 12 months. The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. It is not a reliable diagnostic tool for lower urinary tract symptoms (LUTS) suggestive of BPH, but can be used to quantitatively measure LUTS after a diagnosis is made.
Time frame: Baseline to 12 months
The primary safety endpoint is the freedom from treatment-related adverse SAEs.
The primary safety endpoint is the freedom from treatment-related adverse SAEs.
Time frame: Baseline to 12 months
Frequency and severity of treatment-related AEs
Adverse events will be collected and assessed for relatedness to the device and the procedure as well as for severity. The Clavien-Dindo severity grading scale is a commonly used criteria in the urology community.
Time frame: From baseline to through study completion, an average of 2 years.
Change in IPSS over time
The IPSS tool is the most commonly reported symptom score for obstructive urinary symptoms secondary to BPH. Average IPSS scores, absolute change from baseline, and percent change from baseline will be reported at each follow-up timepoint. The International Prostate Symptom Score (IPSS) can be utilized to measure the severity of lower urinary tract symptoms. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. It is not a reliable diagnostic tool for lower urinary tract symptoms (LUTS) suggestive of BPH, but can be used to quantitatively measure LUTS after a diagnosis is made.
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Northwell Health - Smith Institute of Urology
Syosset, New York, United States
Good Samaritan Hospital
Corvallis, Oregon, United States
Midtown Urology
Austin, Texas, United States
Potomac Urology
Woodridge, Virginia, United States
Time frame: From baseline to through study completion, an average of 2 years.
Change in Qmax (mL per second) over time
Uroflowmetry represents an objective measure of relief of obstruction. Average peak urinary flow rate (Qmax) and change from baseline will be reported at each follow-up timepoint. Uroflowmetry assesses flow pattern, flow curve shape, maximum urinary flow (Qmax), voided volume (VV), voiding time (VT), PVR volume (PVR). A minimum of 150ml is required to provide an accurate assessment in men
Time frame: From baseline to through study completion, an average of 2 years.
Change in PVR over time
Residual urine in the bladder due to incomplete emptying is an important clinical consideration in subjects with obstructive BPH. Average PVR and change from baseline will be reported at each follow-up timepoint. Post-void residual volume (PVR) is the amount of urine retained in the bladder after a voluntary void and functions as a diagnostic tool. A PVR can be used to assess many disease processes, including but not limited to neurogenic bladder, cauda equina syndrome, urinary outlet obstruction, mechanical obstruction, medication-induced urinary retention, postoperative urinary retention, and urinary tract infections. The PVR may be determined through urinary catheterization, a portable dedicated bladder scanner, or a formal ultrasound examination.
Time frame: From baseline to through study completion, an average of 2 years.
Freedom from repeat intervention (time-to-event)
The proportion of subjects free from repeat surgical or endoscopic intervention for BPH will be reported over time utilizing the Kaplan-Meier method.
Time frame: From baseline to through study completion, an average of 2 years.