iTNM may provide comparable safety, efficacy to SNM for OAB, UUI

Findings from a recent meta-analysis suggest that implantable tibial neuromodulation (iTNM) systems may provide comparable safety and efficacy to sacral neuromodulation (SNM) in the treatment of patients with overactive bladder (OAB) and urge urinary incontinence (UUI).¹

There was a similar rate of device-related AEs between both arms.

The data were published in Advances in Therapy.

“Recent data suggest that when patients can interact with their device and adjust treatment times and settings, it may lead to a more personalized and durable therapy,” said lead author Cindy L. Amundsen, MD, a urogynecologist at Duke University in Durham, North Carolina, in a news release on the findings.² “As new guidelines support earlier use of implantable neuromodulation, this personalized approach may help avoid the long-term use of drug therapy that often leads to patient dissatisfaction by offering an alternate effective and satisfying treatment experience.”

For the analysis, the investigators assessed 20 studies that met the criteria for inclusion. In total, this included 1416 patients who received SNM and 350 who received iTNM. No head-to-head or placebo-controlled studies were identified; analyses were conducted using single-arm results.

Data showed a similar weighted average UUI responder rate between the 2 cohorts. Specifically, the UUI responder rate was 71.8% among those who received SNM and 71.3% among those who received iTNM. The weighted average decrease in UUI episodes per day was 3.5 for SNM and 3.0 for iTNM.

A similar trend was noted regarding weighted average of OAB responder rates between the 2 groups. The OAB responder rate was 73.9% among those who received SNM and 79.4% among patients who received iTNM.

The authors wrote, “Notably, this comparable efficacy was seen without the use of a trial phase of neuromodulation in the iTNM studies vs SNM studies.”¹

The early clinical impact of each therapy was also comparable. Among those who received SNM, at least a 50% reduction in UUI episodes was noted in 76.8% of patients at 3 months and 67.9% of patients at 6 months, based on weighted averages. Similarly, in the iTNM studies, at least a 50% decrease in UUI episodes was observed in 69.0% of patients at 3 months and 74.4% of patients at 6 months.

Regarding quality-of-life measures, the average increase in HRQoL scores was 35.1 among patients who underwent SNM and 34.5 among patients who underwent iTNM. Further, 74.9% of patients in the SNM arm and 88.5% of patients in iTNM arm achieved a patient global impression of improvement (PGI-I) score of “better” or above. Therapy satisfaction was also reported among 75.5% of patients who received SNM and 95% of patients who received iTNM.

Rates of permanent explant, surgical revision, and lead migration were lower among patients treated with iTNM. The weighted average ranged between 0 to 1.7% in iTNM studies, compared with 5.6% to 26.8% in SNM studies.

There was a similar rate of device-related adverse events (AEs) between both arms. Device-related serious AEs were reported in 3.3% of patients treated with SNM and 0.3% of patients treated with iTNM, based on weighted averages. Device- and procedure-related AEs occurred in 12.7% and 11.6% of patients who received SNM and 9.6% and 10.6% of patients who received iTNM, respectively.

“This meta-analysis of 1766 patients in 20 clinical studies conducted in patients with OAB showed similar clinical benefits of iTNM and SNM for the treatment of OAB, with similar results in the percentage of patients with ≥ 50% reduction in UUI episodes and OAB symptoms, overall reduction in number of UUI episodes, and improvements in QoL measures,” the authors concluded.¹ “Current results suggest that iTNM may also have lower surgical re-intervention rates; however, additional follow-up time is needed to confirm if this trend will continue."

References

1. Amundsen CL, Sutherland SE, Kielb SJ, Dmochowski RR. Sacral and implantable tibial neuromodulation for the management of overactive bladder: A systematic review and meta-analysis. Adv Ther. 2024. doi:10.1007/s12325-024-03019-0

2. New research from BlueWind Medical shows implantable tibial neuromodulation (iTNM), such as the Revi System, as effective alternative to sacral neuromodulation (SNM) for overactive bladder and urge urinary incontinence. News release. BlueWind Medical, Ltd. October 31, 2024. Accessed November 4, 2024. https://bluewindmedical.com/resource-type/press/