USA: In a pivotal two-year study, the eCoin implantable tibial nerve stimulation (ITNS) system was validated as a safe and effective treatment for urgency urinary incontinence, a challenging condition affecting millions worldwide. This innovative therapy, designed to address overactive bladder symptoms, has shown remarkable consistency in both safety and efficacy, offering new hope for patients who have not found relief through traditional methods.
The findings, published in the Urology Journal, support it as an excellent treatment option for refractory patients.
Urgency urinary incontinence, characterized by a sudden and intense urge to urinate, is a common yet distressing condition that can significantly impact daily life. For patients who do not respond to conventional treatments such as medications or behavioral therapies, implantable tibial nerve stimulation presents a promising alternative. Therefore, Vincent Lucente, Hamilton Court Professional Center, Allentown, PA, and colleagues aimed to assess the ongoing effectiveness and safety of the eCoin ITNS for treating urgency urinary incontinence in patients with overactive bladder, the initial one-year pivotal study was extended to two years. The ITNS is a new and recently FDA-approved treatment option.
For this purpose, the researchers conducted a prospective, multicenter, single-arm trial involving 137 subjects with refractory urgency urinary incontinence to evaluate the effectiveness of eCoin ITNS therapy. Data collection included a 3-day voiding diary, an overactive bladder questionnaire, the Patient Global Impression of Improvement, and a custom Likert scale assessing subject satisfaction.
The primary efficacy measure was the proportion of subjects achieving at least a 50% reduction from baseline in the number of urgency urinary incontinence episodes. The primary safety measure focused on device-related adverse events.
The study revealed the following findings:
Sevent-two subjects completed the 96-week evaluation.
78% experienced at least a 50% reduction in urgency urinary incontinence episodes; 48% experienced at least a 75% reduction, and 22% were dry on a 3-day diary.
Subjects reported a decrease from baseline in their urgency urinary incontinence episodes/day of 2.61 and 2.97 at 48 weeks and 96 weeks, respectively.
91.3% did not require additional medications for overactive bladder.
No serious or unanticipated adverse events were reported in this extension phase.
The results of the two-year pivotal study highlight the sustained effectiveness and safety of the eCoin ITNS.
"This innovative, minimally-invasive device provides a long-lasting solution for the symptoms of urgency urinary incontinence, enhancing patient quality of life while reducing compliance burdens through its automatic therapy delivery," the researchers wrote.
In conclusion, the two-year analysis of the eCoin ITNS system confirms its efficacy and safety, establishing it as a promising treatment for urgency urinary incontinence and potentially setting a new standard in managing this prevalent condition.
About eCoin ITNS System
The eCoin Implantable Tibial Nerve Stimulator system, designed to treat urgency urinary incontinence, is a coin-sized neurostimulator implanted just below the skin in the lower leg through a minimally invasive outpatient procedure using local anesthesia. It is the first subcutaneous tibial nerve stimulator to receive recent approval from the Food and Drug Administration.
Reference:
Lucente, V., Giusto, L., & MacDiarmid, S. (2024). Two-Year Pivotal Study Analysis of the Safety and Efficacy of Implantable Tibial Nerve Stimulation with eCoin® for Urgency Urinary Incontinence. Urology. https://doi.org/10.1016/j.urology.2024.07.046