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

OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH

Benign Prostatic Hyperplasia

Data collection

A Prospective Multi-site Registry of Real-world Experience With the OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH

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.

The primary safety endpoint is the freedom from treatment-related adverse SAEs.

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.

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.

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

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.

The proportion of subjects free from repeat surgical or endoscopic intervention for BPH
will be reported over time utilizing the Kaplan-Meier method.

This is the data collection study arm. There is no other arm in the study.

OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?