Expert discusses the promise of emerging MISTs for BPH

In recent years, the treatment landscape for benign prostatic hyperplasia (BPH) has rapidly evolved with the rise of minimally invasive surgical therapies (MISTs). These innovative options not only offer greater convenience for patients, but also place a strong emphasis on preserving sexual function and enhancing overall quality of life. As the number of available MISTs continues to grow, treatment plans are becoming increasingly tailored to meet each patient’s unique needs.

James C. Ulchaker, MD

In a conversation with Urology Times®, James C. Ulchaker, MD, shared his insights on the current range of BPH therapies, with a particular focus on the investigational Butterfly Prostatic Retraction Device—a novel addition to the expanding lineup of MISTs.

The Butterfly device is currently under investigation in a prospective pivotal trial (NCT05341661) in men with lower urinary tract symptoms secondary to BPH.¹ The study has completed enrollment at 245 patients. Those included in the study have been randomly assigned 2:1 to receive the Butterfly device or a sham comparator. The primary endpoints for the study are at 3 months and 12-months, culminating in December 2025.

Dr. Ulchaker is an emeritus urologist with the Cleveland Clinic and the Chief Medical Officer for Butterfly Medical.

What is a current unmet need in the BPH space?

TURP, standing for transurethral resection of the prostate, has been the gold standard for my whole career. There have been other minimally invasive treatments that, for various reasons, have come and gone. The Butterfly device, because of its unique shape that fits the prostatic urethra, may be a great future option. It is still an investigational device at this time, and is not being sold yet in the United States.

What is the design of this technology?

The lumen of theprostate is actually not a cylinder; it is in the shape of a trapezoid, which is how the Butterfly device is designed. It has spines up top, and then it opens like a butterfly and pushes the lateral lobes of the prostate to the side, thus opening up the channel within the prostate. This is to improve the retraction of the lateral lobes in a manner that, again, fits the size and shape of the prostate. The device comes in multiple different sizes as well, so it's not one-size-fits-all.

This is to help patients. As our population is aging in the country, there's more and more men that will need to have some type of treatment over the course of their lifetime. This is not a quantity of life issue; this is a quality-of-life issue. If we're able to help men achieve better qualities of life by emptying better, by going less frequently, and being able to do this without taking additional long-term medications, what a big advantage for patients.

What is needed to encourage broader adoption of some of these newer therapies in practice?

We need to make sure that our primary care doctors are aware of some of these new minimally invasive treatments that are available. In the vast majority of men who get treated for their lower urinary tract symptoms, the treatment does not come from the urologist. The treatment comes from their primary care physician. So, to start, we need to educate those individuals.

Then, when patients do eventually see a urologist, we need to make sure the urologist, as well, is aware of various minimally invasive treatment options that are available. Sometimes other treatments, which are more invasive, may be more than what a patient needs for their quality of life.

Is there anything else you wanted to add?

This is being designed and developed for the betterment of men, to achieve better voiding in a much more minimally invasive fashion, and to improve the quality of their life. This is unique in the fact that this device can be placed without burning, without cutting, and without piercing the prostate. It has many distinct advantages different than what's already out on the market. And lastly, once again, unlike other products, this actually fits the shape of the prostate.

REFERENCE

1. Butterfly pivotal study. ClinicalTrials.gov. Last updated January 15, 2025. Accessed May 19, 2025. https://clinicaltrials.gov/study/NCT05341661