Implantable tibial neurostimulation (iTNM) is a recent addition to our minimally-invasive treatment armamentarium for urgency urinary incontinence (UUI). The aim of this study was to assess the stimulation programming patterns during the first 12 months (mo) of the OASIS Study.

The OASIS Study is a prospective, multi-center, single arm, open-label pivotal clinical trial evaluating both efficacy and safety of BlueWind Medical’s iTNM, the Revi device.  As an “OAB WET” or UUI study, enrolled subjects experienced an average of 4.8 UUI episodes per day as noted on 7-day voiding diaries (VD).

Subfascial implantation of the Revi device occurred under local anesthesia; test stimulation of the tibial nerve was completed intraoperatively. After initial healing, the device was activated, and participants performed stimulation treatments at home for 30-minutes twice daily.

Treatment settings were programmed by Field Clinical Specialists (FCSs) using the Clinician Programmer, following a pre-defined algorithm (Figure 1), with consideration of symptom relief captured by VDs and participant feedback. Throughout follow-up, Treatment Program 1 (P1) was adjusted based on VD responses and stimulation sensation. While two treatment settings can be programmed at a given visit, this initial analysis considers programming in P1. 

Customizable treatment settings include Frequency (f), Pulse Width (PW), Amplitude (A), and Polarity (P).  For this initial analysis, only f and PW were considered. Frequency (f) is thought to impact treatment efficacy and sensation, while PW changes compensate for differences in device-to-nerve distance. Twelve-month data was analyzed using descriptive statistics.

A total of 151 UUI patients underwent Revi System implantation. 

Based on the Revi programming algorithm (Figure 1), 84.8% (128/151) of participants were activated at 14 Hz and 81.5% (123/151) with PW of up to 400 µsec (Figure 2). The distribution of f and PW shifted over time, with most changes occurring in the first 3 months (Figure 2).

Reprogramming was performed less often for participants that were considered ‘Responders’ (≥50% decrease in UUI episodes as compared to baseline). Among ‘Responders’ at 1mo, the majority (54.4%; 49/90) did not have f or PW adjustments to their P1; in comparison to 88.9% (48/54) of ‘Non-Responders’ with P1 changes performed at the 1mo visit. 

For those completing 12mo of follow-up (n=139), 66.2% (92/139) had P1 modifications ≤ 2 times. Participants with ≤ 2 P1 modifications were mostly ‘Responders’ at 12mo, with a high responder rate of 93.5% (86/92).  Among participants with ≥3 P1 changes leading up to the 12mo visit (n=47), 59.6% (28/47) were ‘Responders’ at 12mo, which was an improvement from the 44.7% (21/47) responder rate noted at 1mo within this same group.

One year after iTNM with the Revi system, changes to f and PW occurred < 2 times in most patients to maintain or improve efficacy. While most participants did not require frequent programming changes, use of the programming algorithm allowed the FCS flexibility to change parameters based on the individual’s sensation and efficacy. This resulted in individualized customizable programs that varied across a range of frequencies and pulse widths. In the future, it will be helpful to understand how programming patterns change or stabilize with long-term use.

iTNM has emerged as an effective intervention for UUI, with the BlueWind Revi System demonstrating excellent treatment durability, a favorable safety profile, and very high patient satisfaction.1,2 The ability to customize program settings enhances treatment success and subsequent responder rates.  Such individualized programming flexibility serves as an important component for device selection in patients interested in iTNM treatment options.  Longer-term follow-up will be important to understand how programming patterns change or stabilize over time.

Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, et al. A Prospective Study to Assess the Effectiveness and Safety of the BlueWind System in the Treatment of Patients Diagnosed with Urge Urinary Incontinence. Neurourol Urodyn. 2024; 43: 1491-1503. doi:10.1002/nau.25477
Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, et al. Two-Year Efficacy and Safety Outcomes of the Pivotal OASIS Study Using the Revi System for Treatment of Urgency Urinary Incontinence. Journal of Urology. 2025 Mar 1;213(3):323–32. https://doi.org/10.1097/JU.0000000000004328