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Implantable nerve stimulator safely improves symptoms in refractory urgency urinary incontinence

Stephen Padilla
06 May 2019

A recent study has shown the safety and effectiveness of an implantable neuromodulation device for the treatment of urgency urinary incontinence associated with overactive bladder syndrome. The device significantly reduces symptoms without any significant safety concerns.

“We performed a clinical feasibility trial to evaluate the safety and efficacy of a fully implanted, primary battery powered, nickel-sized and -shaped neuromodulation device called the eCoin for tibial nerve stimulation to treat refractory urgency urinary incontinence,” researchers said.

A total of 46 patients (mean age, 63.4 years; 98 percent female) were included. After 3 months of treatment, a relative median reduction of 71 percent in episodes of urgency urinary incontinence (4.2 vs 1.7 daily episodes at 3 months; p=0.001) was reported. Thirty-two of 46 patients (69.6 percent) had a decrease of 50 percent in reported episodes of urgency urinary incontinence at 3 months, with >20 percent dry at 3 and 6 months. [J Urol 2019;201:967-972]

Scores in Incontinence Quality of Life improved by an average of 25.9 percent, with 33 of 46 patients (72 percent) showing improvement in their symptoms. Of note, there was a single serious adverse event secondary to wound care that resolved with intravenous antibiotics.

“The implantable neuromodulation device was a safe and effective treatment of urgency urinary incontinence associated with overactive bladder syndrome with a significant reduction or resolution of symptoms and no significant safety concerns,” researchers said.

In an earlier study, van Breda and colleagues investigated the safety and performance of an implantable system for tibial nerve stimulation (BlueWind Medical, Herzliya, Israel) for overactive bladder symptoms and found it to be “safe and easy to implant with good clinical results.” [J Urol 2017;198:205-210]

The battery-free stimulation device was implanted in two males and 13 females (mean age, 54 years; range, 19–72 years). A significant change was observed in 24-hour frequency from a mean of 1.18 to 2.0 times per day (p=0.002) at 3 months of follow-up.

Significant changes were also seen in the number of severe urinary urgency episodes from 6.5 to 2.0 times per day (p=0.002), the number of severe incontinence episodes from 2.8 to 0.3 episodes per day (p=0.017), urinary loss per day from 243 to 39 gm (p=0.038) and improvement in quality of life.

Three patients received prolonged antibiotic treatment and three received pain medication for 1 week after implantation. One patient had the device explanted due to pain and swelling suspicious for infection, but there was no bacterial infection seen in tissue cultures. [J Urol 2017;198:205-210]

In the current prospective, single-arm, open-label study performed at multiple sites in the US ad New Zealand, MacDiarmid and his team included patients with refractory urgency urinary incontinence. The device was implanted in the lower leg over the tibial nerve and activated after 4 weeks.

 Researchers collected bladder diary data and validated quality of life instruments at 3 and 6 months after activation and compared these to baseline values.

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