OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH
NCT Number: NCT06560476
Acronym: APEX
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Benign Prostatic Hyperplasia
Interventions: OTHER: Data collection
Sponsor: Urotronic Inc.
Sex: MALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 500
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-30
Completion Date: 2027-03-30
Locations: Adult & Pediatric Uroology, PC, Omaha, Nebraska, 68144, United States

Summary:
APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.

Primary Outcome Measures: 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., 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., Baseline to 12 months
Secondary Outcome Measures: 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., 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., 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, 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., 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., From baseline to through study completion, an average of 2 years.