BACKGROUND

Overactive bladder (OAB) remains a highly prevalent, costly, debilitating and refractory condition despite efficacious third line therapies that often penetrate poorly, suffer from inconsistent delivery and frequently burdensome for patients which contribute to compromised compliance.^1,2 A leadless tibial nerve stimulator (LTNS) might provide an efficacious, reproducible, convenient and appealing treatment option requiring minimal maintenance.³ The coin-sized neurostimulator (eCoin®) is subcutaneously implanted using only local anaesthetic and delivers a forgiving dome-like stimulation from the cathode center to the anode rim (Figure 1). The procedure can be performed in the office setting utilizing minimal resources with no imaging nor interrogation of the device required (Figure 2). Roughly 4-weeks after the implantation procedure, the eCoin is activated and automatically delivers intermittent low-duty 30-minute tibial stimulation sessions every few days with no patient involvement.

OBJECTIVES

To demonstrate the technique for eCoin placement for the treatment of OAB with Urinary Urge Incontinence (UUI).

MATERIALS

Video obtained during an eCoin implant using eCoin procedure sterile kit, local anaesthetic, eCoin implant template, eCoin blunt dissection tool and eCoin device.

RESULTS

A total of 133 patients across 15 sites were implanted with the eCoin device in a clinical trial. The mean implant time from incision to closure was 19.8 (SD 14.3) minutes. Only 12.8% of patients reported mild to moderate wound healing issues with 2.3% explanted due to infection. 1 serious adverse event occurred with an incision site infection managed with removal at a hospital with no long-term sequela.  At 36-weeks 73% (95% CI, 64.16, 80.59) of patients reported a reduction of their UUI episodes by at least 50% and 30% (95% CI, 22.33, 39.30) were dry with no screening test performed prior to implant. The mean change in UUI episodes collected from a 3-day diary compared to baseline was -2.73 (-3.24, -2.22) (p<0.001).

CONCLUSION

We demonstrate a brief procedure to implant a subcutaneous LTNS performed with minimal resources using just local anaesthetic offering a benign safety profile. Unlike current neurostimulators surgically implanted with a pulse generator and separate lead wire this novel LTNS eliminates many inherent barriers with neuromodulation given its distinct form factor that is well tolerated by patients, highly reproducible by even a novice provider and minimizes compliance issues.^4,5 This automatic therapy with an average battery life of 3-years will potentially better penetrate the undertreated OAB population not well managed with current burdensome or undesirable options often compromised by poor adherence, immodesty or invasiveness.

REFERENCES

1. Stewart WF, Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003;20(6):327-336.
2. Moskowitz D, Adelstein SA, Lucioni A, Lee UJ, Kobashi KC. Use of third line therapy for overactive bladder in a practice with multiple subspecialty providers—are we doing enough? J Urol. 2018;199(3):779-784.
3. Tipton WA, de Riese WTW, de Riese CS. Review of new implantable tibial nerve stimulators in comparison to established third-line treatment modalities for non-neurogenic overactive bladder. Urol Pract. Published online 2020:1.
4. Farrell SM, Green A, Aziz T. The use of neuromodulation for symptom management. Brain Sci. 2019;9(9). doi:10.3390/brainsci9090232
5. MacDiarmid S, Staskin DR, Lucente V, et al. Feasibility of a Fully Implanted, Nickel Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence. J Urol. 2019: 201 (3): 967-972.

Figure 1. eCoin Overview.  (A) The eCoin is implanted subcutaneously in a 20-minute office or outpatient procedure under local anesthetic. (B) The eCoin has a forgiving dome-like field. Medical Illustration by Justin A. Klein, CMI.

Figure 2. eCoin implant procedure. (A) Procedure to mark incision and implant location. (B) Creation of pocket using custom tool. (C) Insertion of eCoin. (D) Complete subcutaneous implantation. Medical Illustration by Justin A. Klein, CMI