OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH
ConditionBenign Prostatic Hyperplasia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
AgeNot listed
SponsorUrotronic Inc.
About this trial
APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Unwilling to abstain from sexual intercourse or use a condom for 30 days post-procedure and utilize a highly effective contraceptive for at least 12 months post-procedure
Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate
Confirmed or suspected malignancy of prostate or bladder.
Active urinary tract infection (UTI)
Trial population
Men experiencing symptomatic BPH that are seeking the Optilume drug coated catheter system.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Data collection
Other interventionSubject's data will be collected from patients that are undergoing care using the Optilume drug-coated catheter system.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Study Arm1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 monthsSecondary outcomes
1
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.2
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.
Time frame
From baseline to through study completion, an average of 2 years.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov