Clinical trial NCT06560476: OPtilume™ BPH Catheter SystEm for Treatment of Men eXperiencing Symptomatic BPH
Official title: 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
Overall status: RECRUITING
Conditions: Benign Prostatic Hyperplasia
Keywords: BPH
Drug Coated Balloon
DCB
Prostate
LUTS
Optilume
Lead sponsor: Urotronic Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-19
Enrollment: 500
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men experiencing symptomatic BPH that are seeking the Optilume drug coated catheter system.

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Patients treated with the Optilume BPH Catheter System in accordance with the Instructions for Use (IFU).

Exclusion Criteria:

1. 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
2. Presence of an artificial urinary sphincter, penile prosthesis, or stent(s) in the urethra or prostate
3. Confirmed or suspected malignancy of prostate or bladder.
4. Active urinary tract infection (UTI)
5. Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System

Primary outcomes:
measure: The primary efficacy endpoint is the average IPSS change from baseline to 12 months.
timeFrame: Baseline to 12 months
measure: The primary safety endpoint is the freedom from treatment-related adverse SAEs.
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Frequency and severity of treatment-related AEs
timeFrame: From baseline to through study completion, an average of 2 years.
measure: Change in IPSS over time
timeFrame: From baseline to through study completion, an average of 2 years.
measure: Change in Qmax (mL per second) over time
timeFrame: From baseline to through study completion, an average of 2 years.
measure: Change in PVR over time
timeFrame: From baseline to through study completion, an average of 2 years.
measure: Freedom from repeat intervention (time-to-event)
timeFrame: From baseline to through study completion, an average of 2 years.
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Golden State Urology
state: California
city: Tampa
country: United States
facility: Florida Urology Partners
state: Florida
city: Kearney
country: United States
facility: Kearney Urology Center
state: Nebraska
city: Omaha
country: United States
facility: Adult & Pediatric Urology, PC
state: Nebraska
city: Las Vegas
country: United States
facility: Sheldon Freedman, Ltd
state: Nevada
city: Syosset
country: United States
facility: Northwell Health - Smith Institute of Urology
state: New York
city: Corvallis
country: United States
facility: Good Samaritan Hospital
state: Oregon
city: Woodridge
country: United States
facility: Potomac Urology
state: Virginia
Study officials:
References: