"After 6 months, about 77% of this group have more than 50% improvement on their main symptom," says John Heesakkers, MD, PhD.
In this video, John Heesakers, MD, PhD, highlights findings from the study, “Pivotal Study of a Novel Wirelessly Powered, Patient Tailored Programmed, Tibial Neurostimulator for the Treatment of Patients with Overactive Bladder,” which was presented at the 2023 Annual American Urological Association conference held in Chicago, Illinois. Heesakkers is the head of urology at the Maastricht UMC in the Netherlands.
So we started with the primitive implant a long time ago. And finally, the company BlueWind took up that challenge and said, 'okay, we can develop also a tibial implant, more modern, smaller, without battery, and far better than the old one that we used'. That was very appealing for us, and they approached us and asked whether we could do that implant or whether we could do a study on that. That's how we started first an efficacy study about 5 to 6 years ago, in order to find out whether it's possible, but also whether it's safe. We looked at the results, and we were surprisingly happy with the results because we noticed that it worked very well. And then finally, the study that I presented today or the results I present today of the study started in 2019, which took 150 patients with an implantable stimulator at the tibial nerve and looked at results and also at safety.
That's what I presented today. Well, between it was a joint venture, but also an adventure of many centers in many countries. And we were also happily surprised by the results and also that is really sick. So that's more or less the history of how it is developing and also the position that we have now.
In this study, we looked at these 151 patients actually, and we looked at 6 months what the results were on the main symptom that they had, which was incontinence with an urgency effect. So people have the urge to go to the toilet, and they cannot reach that in time; then they are incontinent. That's the most severe group mainly. In this group, patients had, on average, 4.8 [urge urinary incontinence] UUI per day. And after 6 months, about 77% of this group have more than 50% improvement on their main symptom, which is very high, because it's more than 2/3 that we find in other studies. So that was good.
Then we also looked at the group that had severe incontinence, because there's also a gradation in it. The severe group also went very well. After 12 months, results were even better. They have more patients that benefited from the therapy. We can explain that to some extent, because we think that if you train the nerves and the nervous system by stimulation, that the system knows how to correct itself, and that the effect will be better after some time. That's what we also saw in this study. If we looked at the adverse events, we didn't have serious adverse events. The adverse events were minor. They were only related to the operation that we did, which was a small incision. And of course, you have some wound problems, quite often some pain problems sometimes. That was only about 10%, and another 5% had only some procedural problems, meaning that if you put the stimulator on, they think it's painful in the beginning, and finally, they adjust to it, and then the pain is gone, too. So that was about it. So it means that we had quite an effective implant in a group of patients that were suffering from bad symptoms with OAB, in a very safe situation, and a procedure that is quite simple to learn.