FDA approves new devices for bladder and bowel control conditions

August 6, 2020

InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering sacral neuromodulation therapy.

The FDA has approved the InterStim Micro neurostimulator and InterStim SureScan MRI leads for the treatment of patients with bladder and bowl control conditions, according to Medtronic plc, the manufacturer of the devices.1

InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering sacral neuromodulation (SNM) therapy. SNM sends “electrical impulses to the sacral nerves located in the lower back to improve bladder and bowel control. Unlike oral medications that target the muscular component of bladder control, SNM offers control of symptoms through direct modulation of the nerve activity, normalizing the communication between the bladder and the brain,” Medtronic explained in a press release.

InterStim SureScan MRI leads enable full-body 1.5 and 3 Tesla MRI-conditional scans. They are used in conjunction with the InterStim Micro and the recharge-free InterStim II.

“I’m excited about the new InterStim technology because it will allow so many more patients to be able to pursue SNM therapy and get back to living life their way,” Steve Siegel, MD, urologist at the Centers for Female Urology and Continence Care at Minnesota Urology, stated in the Medtronic release. “The new technology by Medtronic allows me and my patients a choice between a rechargeable or a recharge-free system to best suit their lifestyle, and assures them they can have an MRI. Medtronic has left no box unchecked.”

In its press release, Medtronic listed several items it suggests make the InterStim Micro a promising option for urologists, including that at 2.8 cm3 it is half the size of the other available rechargeable SNM device on the market, it allows flexibility on the frequency and method of charging the device, and it can fully recharge in under 1 hour.

Long-term SNM results

Five-year follow-up data from a prospective, multicenter study were previously published showing the efficacy and QoL benefits of SNM in patients with bothersome symptoms of overactive bladder, including urinary urge incontinence and/or urgency-frequency. Successful treatment was defined as a “urinary urge incontinence or urgency-frequency response of 50% or greater improvement in average leaks or voids per day, or return to normal voiding, defined as fewer than 8 voids per day.”2 The investigators measured QoL using the International Consultation on Incontinence Modular Questionnaire (ICIQ-OABqol).

Overall, 272 patients had the device implanted. The average age was 57 years and 91% of patients were women. Among the 202 patients with urinary urge incontinence, the mean number of leaks per day at baseline was 3.1. Among the 189 patients with urgency-frequency, the mean number of voids per day at baseline was 12.6.

Modified completers analysis showed a 5-year therapeutic success rate of 67% and completers analysis showed a success rate of 82% . The mean reduction from baseline among patients with urinary urge incontinence was 2 leaks per day, and the mean reduction from baseline among patients with urgency-frequency was 5.4 voids per day.

There was a significant improvement in QoL in all ICIQ-OABqol measures (P <.0001). All 272 patients were evaluable for safety. The most frequently occurring adverse events related to the device were an undesirable change in stimulation (22%), implant site pain (15%), and therapeutic product ineffectiveness (13%).

The InterStim™ Micro neurostimulator is now available for immediate order in the United States. The first patient implant in the United States was performed at the Cleveland Clinic.

"Effective long-term bladder and bowel control is needed for almost 55 million adultsin the United States who often experience regular accidents and/or frequency issues that are associated with overactive bladder and fecal incontinence,” Sandip Vasavada, MD, professor at the Glickman Urological and Kidney Institute and section head Female Pelvic Medicine and Reconstructive Surgery, Cleveland Clinic, stated in a press release.3 “A new FDA-approved option for these patients is a step forward.”

References

1. Medtronic Expands Leadership in Treating Bladder and Bowel Control Conditions with Two New FDA-Approved Products: InterStim™ Micro Neurostimulator and InterStim™ SureScan™ MRI Leads. Published August 3, 2020. https://bit.ly/2PsC1d7. Accessed August 6, 2020.

2. Siegel S, Noblett K, Mangel J, et al. Five-Year follow-up results of a prospective, multicenter study of patients with overactive bladder treated with sacral neuromodulation. J Urol. 2018;199(1):229-236. doi: 10.1016/j.juro.2017.07.010

3. Medtronic Announces Comprehensive U.S. Launch of New InterStim™ Micro Neurostimulator. Published August 5, 2020. https://bit.ly/3fzkPgG. Accessed August 6, 2020.