CompletedPhase 2

Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter

Dominican Republic, Panama80 participantsStarted 2017-12-19

Plain-language summary

A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years. The objective of the study is to evaluate the safety and efficacy of the Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH.

Who can participate

Age range

50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male subject \> 50 years of age who has moderate-to-severe LUTS (IPSS score of ≥ 13) and is a candidate for interventional therapy
. LUTS felt to be secondary to an enlarged prostate (henceforth termed LUTS/BPH)
. Peak urinary flow rate (Qmax) ≥ 5 mL/sec and ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml
. Post-void residual (PVR) ≤ 250 ml
. Prostate volume 20 - 80 gm as determined by TRUS
. Prostatic urethra length is 35 - 55 mm as determined by TRUS
. Able to complete the study protocol in the opinion of the investigator

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Therapeutic Responder at 3 Months

Timeframe: 90 days

Major Device/Procedure Related Complications

Timeframe: 90 days

Trial details

NCT IDNCT03423979

SponsorUrotronic Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-06-04

Results submitted2023-05-10

View on ClinicalTrials.gov More Benign Prostatic Hyperplasia trials