An observational study in Benign Prostatic Hyperplasia, sponsored by Urotronic Inc.. Active, not recruiting at 8 sites in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Urotronic Inc. · Observational
APEX is a prospective multi-site registry of real-world experience with the Optilume™ BPH Catheter System for treatment of men experiencing symptomatic BPH.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 500 is above the median of 250 across 177 observational studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Urotronic Inc. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Men experiencing symptomatic BPH that are seeking the Optilume drug coated catheter system.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Patients treated with the Optilume BPH Catheter System in accordance with the Instructions for Use (IFU).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is the data collection study arm. There is no other arm in the study.
Other: Data collection
Subject's data will be collected from patients that are undergoing care using the Optilume drug-coated catheter system.
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.
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.
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Mar 2027, 36 months after the start.
Of 74 observational studies under Prostatic Hyperplasia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 50. This study's planned 36 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Urotronic Inc.