Emmanuel Chartier-Kastler, MD, shares initial data on UroActive System in women with SUI

In this video, Emmanuel Chartier-Kastler, MD, PhD, shares the background and key findings from the study, “First in woman implantation of the new artificial urinary sphincter Uroactive (Uromems): Preliminary data at 12 months post-activation follow-up of the first patient.” These data were presented at the Society of Urodynamics, Female Pelvic Medicine, & Urogenital Recontruction (SUFU) 2025 Winter Meeting in Rancho Mirage, California.

Chartier-Kastler is a professor of urology and chairman of the department at Hôpital Pitié Salpétrière at Sorbonne Université in Paris, France.

Video Transcript:

Could you describe the background/rationale of this study?

Artificial urinary sphincter is part of the armamentarium for the treatment of stress urinary incontinence in women who suffer sphincter deficiency. The legacy device, AMS 800 from Boston Scientific, past AMS, [has been] used [for] more than 35 years, at least in France, because it's marketed and leveled for that. We, at least in my department, but also in routine practice in France and some countries in Europe implant it in women who are suffering severe incontinence and who are bothered by incontinence when they walk, when they stand up, or when they suffer some irritable urgency. This device, AMS 800 is a very good device, as there is a need for pump in the major labia and there is a fixed pressure with the pressure regulating balloon.

The new device we are presenting at this SUFU meeting, [is] an electronic one. The male study has been done, the pilot study. We did also the pilot study in women. I will present the first woman with more than 1-year follow-up with this electronic device, including a cuff, exactly as with the legacy device. The control of the pressure and the control of the voiding phase is made through a control unit which is placed at the abdominal level, subcutaneously. The patient will be able to void using a patient remote control to open the curve, which will spontaneously open when they push on the button, and the system will close by itself when the time of voiding phase is finished. This is exactly the same device as we use for the pilot study in men, but in women, the main challenge is that the cuff has to be implanted around the bladder neck. The bladder neck dissection is a challenging dissection in some patients who suffered past surgeries. We are used to do it since a long time, because we used a previous device. When you know how to dissect bladder necks, the implantation of this device is not easy, but it's quite easy to learn and to do and the patient is able to become quickly dry, not wearing a pad anymore.

What were the key findings?

I will present the result of the first woman who has been implanted with this new device, I would say it's worldwide, the first patient who has been implanted with an electronic device which has been activated and followed at least 1 year. This patient, she was suffering tremendous incontinence, with 4 pads per day and 125 grams of leaks at the 1-hour pad test, which is a way to evaluate the severity of incontinence. After implantation, which went well without any injury of the bladder neck or the bladder or the vagina, she has been activated at 6 weeks. After activation, she started to be dry and not to leak anymore, so she doesn't wear any more pads.

Now, at 1 year, the 1-hour pad test has been done again, as it's part of the protocol, and she suffered 4 g of incontinence on this test, opposed to 125 g at the beginning. She's voiding using the patient remote control. She is able to use a specific programming of the system, where at night she pushes on the lying down button. It means that at night, she reduced the pressure inside the system to protect the urethra. When she wakes up in the morning, she starts again to use daytime pressure to be fully dry in everyday activities.

This transcript was AI generated and edited by human editors for clarity.