Fridley, Minn.-based Medtronic’s Elite study of the rechargeable InterStim Micro SNS (sacral neurostimulation) system includes all SNS indications for symptoms of overactive bladder, including urinary urge incontinence (UUI) and urinary frequency (UF), along with non-obstructive urinary retention (NOUR) and fecal incontinence (FI).
The neurostimulator sends electrical impulses to the sacral nerves in the lower back to improve bladder and bowel control. The therapy offers control of symptoms through direct modulation of nerve activity to normalize communication between the bladder and the brain.
Elite is set to enroll 160 subjects across 40 sites in the U.S., Europe, Australia and Canada to evaluate endpoints such as patient-reported outcomes, disease-specific quality of life and symptom diaries. Patients will be followed for two years, according to a news release.
Medtronic also noted that the study of the InterStim Micro SNS is the first rechargeable SNS study to include fecal incontinence.
InterStim Micro is the world’s smallest rechargeable SNS device, registering about 50% smaller than the market’s other such system, according to Medtronic. A patient has control over how often they want to charge the device, which can be as infrequently as once per month, and it can charge from zero to 100% in less than one hour.
“We designed Elite to include all four indications, and it’s also the first study of a rechargeable device to include fecal incontinence,” Medtronic VP & GM of the pelvic health & gastric therapies business Brooke Story said in the release. “This reinforces our 25-year leadership in the SNS market.
“Elite will provide additional evidence to our existing irrefutable clinical data that InterStim Micro offers patients freedom from conditions that take over their lives, especially for the millions who suffer from fecal incontinence, or from both OAB and FI, and have no other treatment options available to them.”
FDA approved the sacral neuromodulation therapy in August, and it received a CE Mark in January.