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Ashish Kamat: Hello, everybody, and welcome to UroToday's Center of Excellence. I'm Ashish Kamat, professor of urologic oncology at MD Anderson Cancer Center in Houston, Texas. And it's a distinct pleasure to welcome to the forum Professor Christian Gratzke and Laura Wiemer. Thank you both for joining us today. Really excited to hear what you have to share with us about your latest publication on the app‑based randomized trial, the treatment of LUTS and generally in the field overall. So, Laura, if I could ask you a little bit about the background and the development, and then Christian, feel free to jump in.

Laura Wiemer: Yeah. So we came up with the idea of developing this digital therapeutic because we felt that what is actually written in the guidelines is very hard to give to the patient in real life. There are all these lifestyle changes that we suggest them to do and changing their behavior, as well as it makes sense to do bladder training or pelvic‑floor training.

And all this information that we should give them on the background of the disease, what's actually causing it, what kind of therapy there is, how it is connected to nutrition and everything, it's just a lot really to give to a patient. And I guess it's everywhere the same. We're all lacking time to really talk to the patient in depth about these things.

So we thought, what happens a lot of times is that we end up giving those patients medication in the first place without a lot of explanation. And we thought, what we could do to make this better?

And then we thought, well, it's a good format to put it in a digital therapy because you can actually put all these components in there where you have all these conservative therapies. And you could do it over a longer time span, so you actually have longer follow‑up with the patients and maybe better compliance, because you can also motivate patients in a better way to really keep on doing it.

And yeah, and they can also track it. So maybe they want to fill out a motivation diary or just a symptom diary, and they can actually see that they are improving or not. So it's easier for the patient to see as well.

And it could also benefit doctors, because you will have an analysis of what's going on to really—maybe just the diary to get a better understanding of the patient's symptoms, but maybe also if the patient is really doing his therapy. Is he really participating? You can see all that. So it's maybe also better for patient‑doctor conversations, to see what's going on. So that was the thought about it, about creating this therapy. And then we came together with a lot of experts in different fields to see what we could do and put it all together.

Ashish Kamat: All right. Thanks. Christian, if you could go a little bit into some of the nuances and the details for us.

Christian Gratzke: So we came in. Laura was kind enough to invite us as investigators for this trial. Laura is a urologist that was trained in Berlin, and then went on to develop this app. So the credit goes all to her. We just came in then to really do this trial.

And there were two centers. We were one of them. The basic idea was to do this randomized trial, which is the strength of the trial, and to look at two groups—one using the app and one just staying on their previous medication or their standard therapy, I should say.

So we then randomized over 200 patients. And the primary outcome was the IPSS, the symptom score. We had an overactive‑bladder score as well as quality of life. That's what we wanted to know. We saw and we observed that there was a significant difference in the IPSS change when patients used the app versus the control group. There was a significant improvement in overactive‑bladder symptoms and also quality of life.

So all the outcomes, primary and secondary, were fulfilled. It was also nice to see that the secondary outcome, as far as the side effects go, there were very few side effects, if any, and the ones that we had were non‑related to the app—like a broken finger or a motorcycle accident. So basically, this study showed that if you use an app for 12 weeks, which is a relatively short time frame, it helps you to improve the symptoms in a fashion that is almost equivalent to using tamsulosin, which is the standard treatment worldwide.

So the strength certainly is that we randomized those patients. We have a couple of limitations as well. It's a short time frame—it's only three months. But I think if a doctor uses that for three months and the patient gets better, then that's a plus, instead of using medications right away. So you have an algorithm where you use this as a first treatment and then go to medications as a second.

All the guidelines recommend this. However, very few people actually do this. We don't have any objective measurements because that was an app‑based, online, observational trial. So we don't know about post‑void residual volume. We don't know about any other objective measurements—flow rate, for example. But if you look at, for example, the MTOPS trial, one of the trials in BPH history, more than 80 % of the outcomes in five‑year follow‑up were based on symptoms. So we believe that that is a relevant and valid endpoint. That's, in short, what we did.

Ashish Kamat: Yeah, no, absolutely. I think that's a very important point, because, again, using app‑based or feedback‑based behavioral modifications is something that we've seen explode across medicine and human oncology. For example, side effects from chemo or post‑surgery rehabilitation after radical cystectomy—for example, we have an AI‑based app that we use for this.

So I think it's very important that you look at this the way you are, in some ways, as the first step and to do what the guidelines recommend. Could you share with us a little bit, Laura, the specifics—like the technology behind it—and how you think this might be applicable to, say, different countries? Is it language‑agnostic? Those kinds of things.

Laura Wiemer: All right. So unfortunately, so far, it's only available in Germany. It is here a part of a program supported by the government, where health insurances actually pay for digital therapies if they are able to prove in randomized trials that they have value for the patients and also have very high data‑security standards. So far, it's only available in Germany, but we hope it will be available in other countries and as well in other languages.

It works like this. So patients go into the app. They are getting asked health questions—medical anamnesis. So then the program adjusts to what the patient is actually saying.

So, for example, one part of the program is physiotherapy. So depending on what it's saying—how fit they are—they're starting at a lower level and it starts easier. Or if they say, OK, I'm quite all right, then it will adjust and it will start with a higher difficulty level, and so adjust a bit on what the patient's actually saying.

And then the program itself—it's developed like this. It's over this course of 12 weeks. The different kinds of programs will raise their difficulty over time. And so, for example, pelvic‑floor training: in the beginning you just have to hold for a few seconds and then it will get longer. But also, you can always say, OK, that was too hard for me, so next time it will be a bit easier. So it's just like this.

And then there is also a part for bladder training. So every week, you will have a new challenge that you actually have to fulfill. And it starts with just getting to know your bladder volume, or just feel your bladder and see, do you really have to go? And so—especially for patients with urgency—they are getting motivated not to go every time there's the sensation to go, and to hold it for longer.

And then there's mental therapy—so relaxation exercises. Also, there's an “urgency killer,” I guess I would say that in English. So when you have these urgencies right away, you have a shortcut to different kinds of programs. You can do a little pelvic‑floor training, or you can do a little mindfulness training, or just have a game to get your mind off of it for the urgency.

Then there's the diary, which I told you about before—so a micturition diary, but also a symptom diary. And then there's a lot of knowledge. So every week, you get a new topic, and every day you get little snippets of information about this topic. And also, you can track your nutrition. And depending on if it's needed—if you want to lose weight—you can also track this with it and get explanations about this.

So, yeah, that's what the therapy is designed like. And also, as I told you before, there are these therapy records which you could share with your doctor. So you can actually maybe use it as a diagnostic tool as well.

Ashish Kamat: It sounds like a really good innovative app development. And we'd love to see if you have a little demonstration, and we could link it to this interview if you could share it with UroToday later on, if it's possible at all. We could chat about this forever—I mean, this is such an exciting topic. But in the interest of time, let me wrap it up and give you both a chance for take‑home messages or closing thoughts you want to leave the audience. And Christian, I'll start with you, and then we'll give the lady the last word.

Christian Gratzke: Very much, Ashish. I personally strongly believe, as a urologist, by recommending physiotherapy, for example, for ladies all the time—and it works; everyone knows it works—why wouldn't it work in men? And combining this with other modules, like Laura explained before, this could be a very wise first step.

We're not announcing the fact that this should be an option for all the LUTS patients, because if you have severe symptoms, this won't work. You need medications or surgery, and that's for sure. But trying this, for us as urologists, is certainly worthwhile. And we all know that it should, in theory, work. And now, we actually showed that it does work with this app.

There's one limitation I didn't mention yet, of course. There is a selection bias because this was only meant for app users and patients who actually owned a smartphone. However, this is usually the case in the Western world, where we did this trial. There might be a certain tiredness of apps coming up—I'm sure this is very similar in the US. But if patients are getting motivated to do this to get better and improve, and you know that many patients don't want to use drugs, then that's a perfect first step for their treatment.

Ashish Kamat: Motivation is absolutely key, right? And that's why some of the apps that we have for language learning, they make it a game.

Christian Gratzke: Yeah.

Ashish Kamat: That's very important. Hopefully, the broken‑finger side effect was not because of too much app pressing.

Laura Wiemer: Yeah. I hope this app will help lots of patients. And I think for me, one of the main results of this study was actually that we could really improve quality of life. So as Christian said, it's not for every patient, of course. If you have a major obstruction, that might not solve this or won't solve it. But I think for lots of patients—especially with overactive‑bladder symptoms and early‑stage symptoms—it is a really good step to actually just do something yourself and just not depend on medication.

It could also be an add‑on to medication. It doesn't mean that you have to use it on its own, but you can give it to the patient and just enable them to do something for themselves. And I think it's very, very important that we actually focus on lifestyle changes and modifications of behavior because that is what will be bringing the patient back again and making them unsatisfied with the whole situation.

So I think it's a very important topic. It's still a taboo topic—talking about lower urinary‑tract symptoms—for lots of men, and I hope we can break this taboo and just talk about it and offer our patients a good opportunity to do something themselves. Yeah. So I think that's what I would like to see with this, and I hope this helps a bit.

Ashish Kamat: Absolutely. Very important point. I think empowering patients to be partners in their own health care is absolutely key. And I want to congratulate both of you for this effort—for developing it, for doing it in a trialed manner, and for your publication. And thank you both for spending your time with us today. Thanks.

Christian Gratzke: Thanks so much.