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

Purpose

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

Condition

  • Benign Prostatic Hyperplasia

Eligibility

Eligible Ages
All ages
Eligible Sex
Male
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Case-Control
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Study Arm 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.

Recruiting Locations

Florida Urology Partners
Tampa 4174757, Florida 4155751 33615
Contact:
Jodi Mummert
813-431-4913
jodi@gulfcoast.com

Kearney Urology Center
Kearney 5071348, Nebraska 5073708 68847
Contact:
Garrett Pohlman, MD
303-249-7570
garrettpohlmanmd@prostatehealthpodcast.com

Sheldon Freedman, Ltd
Las Vegas 5506956, Nevada 5509151 89144
Contact:
Omar Darwish
702-732-0282
omardarwish@freedmanurology.com

Northwell Health - Smith Institute of Urology
Syosset 5140402, New York 5128638 11791
Contact:
Jennifer Polo
5167603980
jpolo1@northwell.edu

Midtown Urology
Austin 4671654, Texas 4736286 78705
Contact:
Andrew Barger
5124517935
apbarger@cimplify.net

Potomac Urology
Woodridge 4794585, Virginia 6254928 22191
Contact:
Morgan Gray
mgray@potomacurology.com

More Details

NCT ID
NCT06560476
Status
Recruiting
Sponsor
Urotronic Inc.

Study Contact

Kaitlyn Palm
6128160068
kpalm@laborie.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center