Stimguard LLC will begin enrollment for a head-to-head study of its Chronic Affarent Nerve Stimulator (CAN-stim) against Medtronic plc's gold standard Interstim device in treatment of urgency urinary incontinence from over active bladder (OAB) not controlled by medication, following FDA approval of the trial with an investigational device exemption (IDE). Privately held Stimguard's device can be implanted in a physician's office with ultrasound guidance, avoiding a surgical procedure and general anesthesia required for the sacral device.
"The Stimguard device is a chronic implant that is [placed] outpatient in a doctor's office, but does not require coming back repetitively for treatments," Laura Tyler Perryman, co-founder and CEO of parent company, Stimwave Technologies Inc., told BioWorld MedTech. "It lasts for 10 years, and other products either last for just months or require surgery and replacement. Compared to Interstim, the CAN-stim device does not require surgery and does not require replacement of a battery unit like Interstim every three to five years. Eliminating the battery eliminates the risks associated with placing a lithium-ion battery in your body."
CAN-stim vs. Interstim
Unlike Dublin-based Medtronic's Interstim, Stimguard's device can be percutaneously placed to effect the afferent micturition, or neural urinary pathway at the tibial nerve, during an office visit. The minimally invasive neurostimulation device is attached to an external transmitter and activated wirelessly. By comparison, Medtronic's device system, considered the standard of care in OAB for decades, is made up of a sacral lead and battery unit which often needs to be replaced within five years, and is implanted during a fluoroscopy-guided operation.
Pompano Beach, Fla.-based Stimguard's device is intended to provide similar results with a more accessible and potentially less costly treatment.
"An electrode implanted at the tibial nerve in an office setting with the potential to provide the same outcomes as sacral neuromodulation will be a game-changing option for urgency urinary incontinence associated with OAB," said Kenneth Peters, an incontinence expert and consultant for Stimguard. "Stimguard's technology has the potential to provide similar outcomes as sacral nerve stimulation in an office-based procedure, which could drastically reduce the cost of care while allowing more patients to be treated, improving accessibility to a non-drug treatment option for many patients with OAB."
Less obvious device
Perryman added that CAN-stim also may provide a more appealing option to patients who are both put off by a general anesthesia operation and the size of the Interstim system.
"This approach is preferable to patients because it is office-based and you are awake while the device is implanted at the targeted nerve under local anesthesia," Perryman said. "The Interstim device requires surgery and general anesthesia, which is worrisome for many patients. Additionally, most OAB suffers are women, and the last thing women want is some battery device that is bulky and can show in their bathing suit or other warm weather clothing in their buttocks." Clinicians also avoid a time-consuming surgical procedure with Stimguard, she said.
Stimguard will begin enrollment this month for its study intended to determine the effectiveness of its device's delivery of pulsed electrical energy to tibial nerves in impacting bladder function. Tibial nerves signal sacral nerves targeted in standard care. Trial enrollment for a planned 168 patients will last 12 months and include 20 U.S. sites. Patients will be evaluated at three months after implantation for episodes of incontinence in comparison to Interstim.
"The primary efficacy endpoint is defined as an equal to or greater than 50 percent reduction in number of urgency related incontinence episodes at three months post-implant of the CAN-stim system compared to SNS Interstim system therapy," said Perryman. "The number of urgency incontinent episodes per day is taken as an average of two three-day consecutive bladder diaries, with at least 24 hours between when the first diary ends and the second diary begins."
Secondary endpoints and observational endpoints during the study will look at comparison of the two systems in reducing the severity of urinary urgency defined by the Indevus Urgency Severity Scale, differences according to the Urinary Incontinence Quality of Life Scale, and comparison of incontinence episodes tallied daily in patients' voiding diaries. Patients' data indicating "moderately" or "markedly improved" results will be calculated using the Global Response Assessment tool, and patients receiving Interstim or CAN-stim will be asked to complete the Overactive Bladder Questionnaire Short Form. Adverse events for either group also will be compared. Trial results are expected to be used toward FDA clearance and submission to CMS.
Stimguard's CAN-stim device will be compared to Interstim as it is considered the standard treatment for OAB. "Interstim has been used for 20 years and does more than $600 million a year in sales, meaning it is the most well-established stimulation therapy for OAB," said Perryman.
"Allergan did a head-to-head study with Interstim for their Botox therapy as well, so it is already established as a standard of care. For a new therapy that is much less invasive and longer lasting, it seemed prudent to establish that the efficacy is the same as Interstim."
According to the Urology Care Foundation, about 33 million people in the U.S. deal with OAB. This amounts to about 30 percent of American men and 40 percent of women, however, the number is thought to actually be higher since patients may be embarrassed to discuss symptoms with their doctors or unware treatment options exist.
Earlier this year, Axonics Modulation Technologies Inc., of Irvine, Calif., also set its sights on Medtronic's top billing in the OAB space. Axionics r-SNM device is a rechargeable sacral stimulation device that can be implanted for about 15 years compared to Interstim's five years, and can be tracked and modified by a physician. The r-SNM device also is about 60 percent smaller than Interstim, according to the company. Axionics' r-SNM device is approved in Australia, Canada and Europe for urinary and fecal incontinence, OAB in Australia, and received FDA IDE pivotal trial (ARTISAN-SNM) November 2017, with approval anticipated in 2019. Interstim was approved to treat OAB in 1997. (See BioWorld MedTech, Jan. 18, 2018.)