Specialist commentator comments
Comments on this technology were invited from clinical experts working in the field. The comments received are individual opinions and do not represent NICE's view.
All of the specialist commentators were experienced with sacral neuromodulation (SNM) therapy and 2 out of 7 had used the Axonics SNM system before.
Most of the specialist commentators agreed that the rechargeable battery is the technology's main innovation. One commentator thought the technology was novel whereas another said it was a novel concept only because of its rechargeability and small implant size. Five specialists thought it was a minor variation on current standard care, because the underlying SNM technology and implantation procedure are similar to non-rechargeable SNM devices. Five commentators identified the InterStim system as an alternative technology with a similar function to Axonics; all of whom described InterStim as non-rechargeable. Three of the commentators added that it had a larger implant size. Apart from the InterStim system, no other competing device was identified by the specialists.
Most of the commentators thought the longer battery life would provide the largest benefit to patients, and that using the new technology would lead to fewer revision surgeries. One commentator said the technology could be thought of as less invasive because of this. The same commentator, along with 1 other, did not believe it would lead to improved clinical outcomes overall. The smaller implant size was mentioned by 2 commentators who thought this improvement would reduce the risk of device-related pain, as well as improve comfort, although this was said to be speculative.
The constant-current stimulation supplied by the technology was mentioned by 1 commentator who said it implies the same level of stimulation is received, regardless of changes in tissue properties or healing. They added that this could potentially reduce the number of reprogramming visits and the risk of loss of efficacy.
Two commentators thought that younger patients in particular would benefit from the device, because the duration of lifetime SNM therapy would be longer compared with older patients. Another commentator thought that older patients could benefit from the easy-to-use and compact patient equipment, adding that it could reduce complexity for these patients and help improve their understanding of therapy. One of the commentators believed that people with a low BMI would benefit most from the technology because of its smaller implant size. Other commentators did not specify a particular group, but thought that all people having SNM for overactive bladder or voiding dysfunction could benefit from the device.
Fewer revision operations, as well as fewer outpatient follow‑up visits and inpatient visits for implant site pain, were identified as potential system benefits. Three commentators thought the technology would replace current practice, whereas 4 thought it would be an addition to standard care, offered to people depending on the patient's individual preference. One commentator said the technology would cost less than current standard care, whereas 4 thought it would be cost saving in the long term if the battery lasts as long as the company claims it does. The remaining commentators thought it would cost the same as current practice.
All commentators agreed that there would be no need for facility or infrastructure changes to adopt this technology. Product-specific training for clinicians implanting the device and support staff was identified by most commentators, but was thought to be minimal because the implant procedure is comparable to existing SNM devices. One commentator said that the programming is slightly different but not difficult. One commentator thought that continence nurse specialists may have additional training on teaching patients how to recharge the device. None of the commentators were aware of any safety concerns or regulatory issues.
Most commentators said that Axonics was not yet widely available in the NHS, but were not aware of any potential barriers to adoption. According to 1 commentator, patients have found the technology easy to master and the remote control simple to use. According to another, patients are happy with the system and have no issues recharging the device. Another commentator thought the sleek and compact design is more appealing for patients. Dexterity and motivation to recharge the battery weekly were practical issues identified by some of the commentators. One commentator thought that the percutaneous nerve evaluation kit would not be widely used by urologists during the trial phase (basic evaluation), because evidence suggests tined lead testing (advanced evaluation) is more effective. One commentator noted that the technology's MRI compatibility was better than the existing SNM device, which is compatible with MRI scans of 1.5 Tesla only (both the Axonics and the Medtronic systems are only compatible with head scans, but the Axonics system allows for more powerful machines, up to 3 Tesla). The need for long-term follow‑up data was identified by 4 of the commentators. Real-world evidence around device longevity, comparative studies evaluating the time to revision surgery compared with non-chargeable devices, as well as the long-term effects of using a recharging system next to the body were also mentioned.