Mechanotherapy device shows efficacy for stress urinary incontinence

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"Our outcomes showed 71% of patients achieved dry or near dry results in 6 to 12 weeks," says Nissrine Nakib, MD.

In this interview, Nissrine Nakib, MD, and Lydia Zeller discuss the recent Therapeutic Advances in Urology study “Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women,” which evaluated Pelvital’s Flyte intra-vaginal device.1 Nakib is associate professor, medical director and vice chair of urology at the University of Minneosta, Minneapolis, and Zeller is CEO of Pelvital.

What was the background for this research?

Nissrine Nakib, MD

Nissrine Nakib, MD

Nakib: This was a product from Norway, and they actually did a clinical study over there where they had about 60 people. [These were] patients who were referred to the Arctic University of Norway for surgery. They'd already gone through pelvic floor muscle training and had failed. So they were all set up for surgery. And so they ended up trying Flyte, and 82% of them achieved continence. And at 2 years, 77% were still having success and none underwent surgery, which is very compelling. When the product was introduced to us, we thought, why limit it to patients potentially with mild or moderate incontinence, which is what the Norway patients had. Let's see if we can maybe bring in all comers with different severities of incontinence and go from there. That's what pushed us to do this trial—to have more patients, and see if we can get the same results by pushing the boundaries.

Lydia Zeller

Lydia Zeller

Zeller: As Dr. Nakib said, the Norway study did not include the highest severity patients as measured by grams of leakage. It included mild and moderate. They had long-standing SUI, so the average duration of symptoms in the Norway study was over 9 years. And as Dr. Nakib said, because they had tried so many things, including pelvic floor muscle training under PT guidance, and had not resolved their incontinence; they'd been referred to surgery, but the Norway study didn't include that really high grams of leakage category that Dr. Nakib is referring to.

What were some of the notable findings? Were any of them surprising to you and your coauthors?

Nakib: The fact that this helped patients with severe incontinence was huge.

Zeller: Leakage of 70 g in 24 hours or above was considered severe, but we included women with over 500 g of leakage.

Nakib: We had about 119 patients in our study. It was multicenter, double blinded; we randomized our patients. As I mentioned, we had the patients with the highest severity. Our outcomes showed 71% of patients achieved dry or near dry results in 6 to 12 weeks. 91% of our patients were responders at all, which was great. And we've shown that over a 2-year follow-up, they've maintained this improvement. I think the biggest thing, again, was that, traditionally, we would think of the severe patients as maybe not a great option for some of the more conservative measures, but this really showed it to be a great first-line option for these patients, regardless of the severity.

What is important to clinicians to know about Flyte if they’re thinking about incorporating it into their practice?

Nakib: I would really emphasize that this is a very unique product in terms of the mechanotherapy. It's not a Kegel trainer. It's not electrical stimulation. The mechanotherapy is really unique to this product and that's been shown in multiple studies to help with tissue repair, and neuromuscular memory, which is, I think, one of the reasons why you get maintained results even when people stop using it. The other thing is that it's a really exciting alternative option to pelvic floor physical therapy, to slings, to periurethral bulkings. And even though it's FDA cleared for stress urinary incontinence, 40% of our patients have mixed incontinence too. I think it's a great product.

[Regarding contraindications], if somebody has an allergy to silicone, they shouldn't use it. This is an intravaginal device, so if they find placing a tampon a little uncomfortable, then this is probably not ideal for them.

What is the take-home message for the practicing urologist?

Nakib: I would say that [Flyte] works. That's the biggest thing that we can say here. It works. It's a great first-line option. It is convenient, it is simple. Patients found it very easy to stick with, so we had great compliance. Five minutes a day at home for a total of 6 to 12 weeks; it's really hard to beat something like that. There really isn't anything on the market like that. I think patients love the convenience of being able to do it at home, which is a private setting. They don't have to go anywhere for it.

Zeller: The difference is the mechanism of action. That's what makes the device unique. The 2 main things are the tissue repair and the creation of neuromuscular memory.

Is there anything you would like to add?

Nakib: Our targets here are urologists, but I would really love for us to be encouraging our primary care providers and our OB/GYNs to be using this because very often, by the time that the patients reach us, they're fed up, and they just want something fixed right now. And so if we can leverage this as a way to rehabilitate the pelvic floor, for example, after childbirth, that would be huge, to have it be a first-line thing that primary care providers could prescribe to patients, just like they would maybe refer them to pelvic floor physical therapy before they refer them to us for more invasive treatment.

Zeller: I would just add that it is increasingly covered by insurance. About 80% of our units are with a clinician prescription and paid by insurance. So that is an additional benefit.

Nakib: Yes, because a lot of these products that they might buy online are not going to be covered. That really adds to the validity of the medical device.

Zeller: The other thing I would add to what Dr. Nakib said, is this is a huge opportunity to treat this upstream in primary care, in OB/GYN, and just encouraging clinicians to screen for urinary incontinence and then treat.

Nakib: Urinary incontinence, unfortunately, is an embarrassing subject for people to talk about. People categorize it at the same level as sexual abuse in terms of embarrassment to talk about it. The onus should be on the physicians or the primary care providers to be asking those questions, because invariably, the answer is going to be yes.

Reference

1. Nakib N, Sutherland S, Hallman K, Mianulli M, Boulware DR. Randomized trial of mechanotherapy for the treatment of stress urinary incontinence in women. Ther Adv Urol. 2024:16:17562872241228023. doi:10.1177/17562872241228023

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