UroLift Pros and Cons

[Dr. Aditya Bagrodia]
...As we start talking about the relevant patient characteristics, symptom characteristics, and anatomical considerations, perhaps it would be useful, Claus, if you could give a comprehensive list of options that are available, as you see it.

[Dr. Claus Roehrborn]
...Those treatments nowadays are grouped into minimally invasive (done as an outpatient or an ambulatory surgery center) versus the surgeries that require full anesthesia (done in a hospital setting usually and require more or less an overnight stay).

...You can also group these treatments by if they remove tissue or if they do not remove tissue. I'll give you an example. A TURP classically removes tissue. It's an ablative procedure and it's invasive and it requires hospitalization at least for a day. Non-ablative would be a UroLift. You place the UroLift devices and you push the tissue to the side but no tissue is ultimately removed. So ablative versus non-ablative is another way of differentiating it.

There would be a differentiating between treatments that consist of permanent placement of items, such as a UroLift, and there's a whole slew coming down the pipe, the Zenflow device, the Butterfly device, the Medeon device, all of which are experiencing trials in the United States right now and may or may not be approved by the FDA. Versus treatments that don't use devices that are implanted permanently.

And then there's the categorization by devices that work by laser energy versus electrocautery energy versus other energies. For example the Rezum procedure uses steam, just hot water heated by radio frequency energy, and then is injected and as the steam gives off the energy it destroys the tissue. So the energy source is another question. And to add to that, there is the Aquablation treatment that doesn't use any heat per se--neither electrical generated heat nor laser generated heat nor steam--but it uses basically saline at room temperature with a very intense water pick system to destroy prostate tissue.

You can already see how complex it is, how you can group these treatments by energy source, by ablative or non-ablative, by implant versus non-implant. Then comes the question: are these treatments all suitable for all sizes and shapes? But if you look through the list, minimally invasive devices currently approved and recommended in the United States would be the UroLift device, which is an implant, and the Rezum treatment, which is a steam-based heat treatment that partially ablates tissue. Then amongst the surgical treatments there would be monopolar/bipolar TURP, the PVP, the GreenLight or KTP or 532nm laser ablation of the prostate. Then there would be a host of enucleation techniques and, as you know, enucleation now can be done with the traditional way, the holmium laser enucleation which is called HoLEP, the thulium laser which is called ThuLEP, but people do it with the green-light laser as well and it's called KTP laser enucleation, or even do it with a bipolar resectoscope device and just get into the enucleation plane.

Then we have the treatments for the very large prostates that go beyond the HoLEP or ThuLEP, the robotic or open or robotic-assisted laparoscopic enucleation of the prostate as alternatives for the very large prostates.

[Dr. Aditya Bagrodia]
Okay, fantastic. If I may, for smaller glands of course there's going to be some considerations and perhaps I would ask for you to speak a little bit about transurethral incision of the prostate and even a little bit more broadly on options that are going to be prioritized when preservation of antegrade ejaculation is a priority.

[Dr. Claus Roehrborn]
It used to be said that ejaculation has to do a lot with the bladder neck and every time you mess with the bladder neck you get anejaculation or retrograde ejaculation. And then there is a school of thought that says the antegrade ejaculation hinges on the apical tissue that is right in front of the verumontanum. Currently, most people think that it's just the apical tissue that preserves the ejaculation. Now, just in our meeting this morning I raised this question because it is known that the incision of the bladder neck actually causes 30 to 50% retrograde ejaculation even if you don't come close to the verumontanum. So I'm old school there. I think the bladder neck must play a role in it, perhaps not the only role.

When patients come and they are really, really interested in ejaculation function, fortunately we have excellent studies that use the MSHQ ejaculation questionnaire and they with absolute 100% certainty guide you. The UroLift treatment has no impairment of ejaculation. Period--in no patient that is reported. The Rezum treatment has maybe in 5% maybe in a little bit more but not more than 10% of patients ejaculation impairment. For the incision of the bladder neck either at the six o'clock or four and eight o'clock, up to 30 or 50% of patients have retrograde ejaculation. The Aquablation, due to the fact that the water jet is stopped just shy of the apical tissue, has an ejaculation preservation that is surprisingly high, 95%. So the vast majority of Aquablation treatments enjoy normal ejaculation if you turn this device on so that, with the so-called butterfly cut, this hood of tissue in front of the verumontanum is preserved.

If a man comes in and says ejaculation trumps, then I'll look at him and say, "Okay, let me check your prostate size." If the prostate size is 30, 40, 50g I say, "Let's try a UroLift." If it's a really small prostate I say, "You can try a UroLift. We can also try an incision and I'm not carrying it all the way to the veru. We can see how that works." If it's a larger prostate I say, "Well, let's do the Aquablation treatment because that will give you the best chances of preserving antegrade ejaculation."

Now, full stop. There's a lot of surgeons who claim they can preserve ejaculation to 70, 80, 90% even doing a TURP, doing a GreenLight laser, doing a HoLEP, as long as they preserve this hood of tissue in front of the verumontanum. Well, the problem is that that doesn't seem to be easy to duplicate by others, A. B, the very principle of the HoLEP operation is to make an incision in the mucosa at the apical tissue, so that tissue by definition has to go as part of the package. So I'm really unclear on that. And most of these studies are single center, single investigator. So I'm less enthusiastic about this idea of leaving a little tissue behind close to the verumontanum and I secondarily don't believe you achieve the same efficacy necessarily. So, ejaculation preservation. UroLift tops. Rezum second for the smaller glands. Aquablation for the larger glands. And then comes all this artistry and the individual people who can do it, presumably, with good success, even when they do a standard TURP.