Study design, materials and methods
Following IRB approval, patients were recruited prior to implantation and will be recruited over a 2-year period. All patients undergoing initial placement or revision of a Medtronics® SNM implant were prospectively included and consented. Participants were excluded if imprisoned, experienced cognitive decline, or expressed no memory of device counseling. Each patient was interviewed using a guided, standardized survey of qualitative questions to collect demographic information, treatment history, technological literacy, and factors informing decision. Patients rated their perceived comfort level with technology on the scale of not at all comfortable, relatively comfortable, or very comfortable. Quantitative data was collected regarding patient concerns for device features by prompting for responses along a significance scale of 1 (no concerns) to 5 (extreme concerns), with 1-2 indicating low concern and 4-5 indicating high concern.
Results
In our ongoing recruitment, data on 36 patients have been collected (30 non-rechargeable, 6 rechargeable). Non-rechargeable device patients had an age range of 21-82 (average 59.2, median 61) while rechargeable device patients had an age range of 31-70 (average 46.4, median 48.5). Preliminary data show that all rechargeable device patients consider battery life to surgical replacement as a high-concern factor. They were more likely to consider “device size” a high-concern factor and “number of accessories” a low-concern factor. Non-rechargeable device patients were more likely to site “regular recharging” (90%) and “interval between recharge sessions” (56%) as high-concern and least likely to site concern for “device size”. 19 of 30 non-rechargeable device patients (63%) report the deciding factor was their preference for a device that did not require recharging. Those opting for rechargeable devices sited most significant considerations being device longevity (5 of 6) and ability to self-monitor device battery. When rating comfortability with technology, 53% of non-rechargeable device patients chose “relatively comfortable” and 43% chose “very comfortable”. Five of six participants opting for rechargeable devices indicated “very comfortable” with technology while just one selected “relatively comfortable”. Amongst the 11 participants undergoing replacement procedures, 2 selected rechargeable devices and 2 indicated transitioning from prior rechargeable device to a non-rechargeable device due to user burden. Others in this group preferenced limited device maintenance due to simplicity of previous devices or management of concurrent comorbidities.
Interpretation of results
The preference by 83% of patients for non-rechargeable devices with over half indicating primary consideration of charging responsibility suggests patients are most concerned by device maintenance. In contrast, the rechargeable device is a more popular option among those who express primary consideration of device lifespan until surgical replacement and a preference for direct device management, often younger participants. Self-perception of capacity to use technology may be an important consideration when counseling patients given correlation with technologic comfortability and device selection. Reported priorities by patients receiving a replacement Interstim device indicates this population most strongly considers device maintenance when making a selection.