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

NCT06560476 | Recruiting

• 1 other identifier: PR1326
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 9

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

BPH; Drug Coated Balloon; DCB; Prostate; LUTS; Optilume

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Frequency and severity of treatment-related AEs

  From baseline to through study completion, an average of 2 years.

• Change in IPSS over time

  From baseline to through study completion, an average of 2 years.

• Change in Qmax (mL per second) over time

  From baseline to through study completion, an average of 2 years.

• Change in PVR over time

  From baseline to through study completion, an average of 2 years.

• Freedom from repeat intervention (time-to-event)

  From baseline to through study completion, an average of 2 years.

Study Arms (1)

Study Arm

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

Other: Data collection

Interventions

Data collection OTHER

Subject's data will be collected from patients that are undergoing care using the Optilume drug-coated catheter system.

Study Arm

Eligibility Criteria

• Gender Eligibility Details: Must be a male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men experiencing symptomatic BPH that are seeking the Optilume drug coated catheter system.

You may qualify if:

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

You may not qualify if:

• 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)
• Anatomy (e.g., presence of false passage or size of meatus) is not suitable for treatment with the Optilume BPH Catheter System

Sponsors & Collaborators

• Urotronic Inc.: lead

Study Sites (9)

Golden State Urology

Sacramento, California, 95823, United States

WITHDRAWN

Florida Urology Partners

Tampa, Florida, 33615, United States

RECRUITING

Kearney Urology Center

Kearney, Nebraska, 68847, United States

RECRUITING

The Urology Center, P.C.

Omaha, Nebraska, 68144, United States

COMPLETED

Sheldon Freedman, Ltd

Las Vegas, Nevada, 89144, United States

RECRUITING

Northwell Health - Smith Institute of Urology

Syosset, New York, 11791, United States

RECRUITING

Good Samaritan Hospital

Corvallis, Oregon, 97330, United States

COMPLETED

Midtown Urology

Austin, Texas, 78705, United States

RECRUITING

Potomac Urology

Woodridge, Virginia, 22191, United States

COMPLETED

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Kaitlyn Palm

CONTACT

6128160068; kpalm@laborie.com

Reem Ennenga

CONTACT

61274741836; rennenga@laborie.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: August 19, 2024
• Study Start: March 30, 2024
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)