Review of New Implantable Tibial Nerve Stimulators in Comparison to Established Third Line Treatment Modalities for Nonneurogenic Overactive Bladder

Tipton, William; Riese, Werner de; Riese, Cornelia S. de

doi:10.1097/upj.0000000000000128

Cited by 4 publications

(3 citation statements)

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“…While new technologies are being developed to treat OAB syndrome, we would like to focus on novel small implanted devices that stimulate the tibial nerve, providing physicians and patients with more treatment options when conservative measures fail to relieve symptoms [ 54 ]. This study will summarize different implant types and their efficacy and safety.…”

Section: Posterior Tibial Nerve Stimulation Classificationsmentioning

confidence: 99%

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Posterior Tibial Nerve Stimulation for Overactive Bladder: Mechanism, Classification, and Management Outlines

Al-Danakh

Safi

Alradhi

et al. 2022

Parkinson's Disease

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Purpose of the Review. Posterior tibial nerve stimulation (PTNS) techniques have dramatically grown after approval to manage overactive bladder (OAB). The present review will focus on the most current data on PTNS types (percutaneous, transcutaneous, and implant) and their mechanism of action, safety, efficacy, advantages, drawbacks, limitation, and clinical applications. Recent Findings. The present review described the recent studies that addressed the tibial nerve stimulation role in OAB management. BlueWind RENOVA system, Bioness StimRouter, and eCoin are examples of emerging technologies that have evolved from interval sessions (percutaneous PTNS and transcutaneous PTNS) to continuous stimulation (implants). These can be efficiently managed at home by patients with minimum burden on the health system and fewer visits, especially in the COVID-19 pandemic. Summary. Our review shows that the tibial nerve stimulation advancements in OAB treatment have been rapidly increasing over the recent years. It is minimally invasive and effective, similar to sacral nerve stimulation (SNM), but less aggressive. Implantable PTNS has been promised in terms of efficacy, safety, and high acceptance rate. However, evidence is still limited to short-term trials, and tolerability, method, and drawbacks remain challenges.

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Section: Posterior Tibial Nerve Stimulation Classificationsmentioning

confidence: 99%

“…The primary advantage of this technology is that it allows patients to receive treatment overnight, but electrode migration could be a significant issue [ 65 ]. Currently, a study is being undertaken to compare StimGuard CAN-stim against Medtronic InterStim [ 35 , 54 , 56 , 57 , 63 ].…”

Section: Posterior Tibial Nerve Stimulation Classificationsmentioning

confidence: 99%

Posterior Tibial Nerve Stimulation for Overactive Bladder: Mechanism, Classification, and Management Outlines

Al-Danakh

Safi

Alradhi

et al. 2022

Parkinson's Disease

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“…The maintenance-free, fully implantable eCoin device has unique attributes compared to current OAB treatments, including delivery with a brief procedure using only local anesthetic and reliance on minimal resources. 18,19 Other potential benefits include automated compliance and less precision of placement compared to both SNM surgery and chronic PTNS sessions with possible elimination of intermittent onabotulinumtoxinA intradetrusor injections. 20 Thus, the aim of this study was to assess the efficacy and safety of eCoin for treatment of OAB with UUI, which might better manage these patients given the distinct features of this novel form factor.…”

mentioning

confidence: 99%

Pivotal Study of Leadless Tibial Nerve Stimulation with eCoin® for Urgency Urinary Incontinence: An Open-Label, Single Arm Trial

et al. 2021

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Purpose: A novel leadless tibial nerve stimulator provides a primary batterypowered, coin-sized, minimally invasive option to deliver automatic low-duty cycle stimulation for overactive bladder syndrome therapy. A pivotal trial was conducted to evaluate the safety and efficacy of this investigational device, eCoinÒ, for treating refractory urgency urinary incontinence. Materials and Methods: This was a prospective, open-label, single arm trial carried out at 15 U.S. medical centers involving 137 subjects with refractory urgency urinary incontinence. After implantation in the lower leg above the fascia over the tibial nerve, eCoin delivered automated stimulation sessions for the duration of the study. The primary efficacy measure was the proportion of subjects who achieved a 50% or greater reduction from baseline in urgency urinary incontinence episodes after 48 weeks of therapy. The primary safety measure was device-related adverse events at the same time point. Results: Of 137 subjects enrolled, 133 were implanted with eCoin, and 132 were included in the intention-to-treat population. Of those 132 subjects, 98% were female, meanAESD age was 63.9AE10.9 years, and baseline daily urgency urinary incontinence episodes were 4.3AE3.1. The primary efficacy analysis showed 68% (95% CI: 60%e76%) of subjects experienced at least a 50% reduction in urgency urinary incontinence episodes at 48 weeks post-activation; 16% of implanted subjects experienced device-related events through 52 weeks post-implantation. Conclusions: eCoin demonstrated clinical benefit for treating overactive bladder syndrome with automatic delivery of an intermittent low-duty cycle and implanted with a minimally invasive, brief procedure.

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Experimental Therapies and Research Needs for Urinary Incontinence in Women

Kowalik

Malik

2022

Female Urinary Incontinence

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Review of New Implantable Tibial Nerve Stimulators in Comparison to Established Third Line Treatment Modalities for Nonneurogenic Overactive Bladder

Cited by 4 publications

References 0 publications

Posterior Tibial Nerve Stimulation for Overactive Bladder: Mechanism, Classification, and Management Outlines

Posterior Tibial Nerve Stimulation for Overactive Bladder: Mechanism, Classification, and Management Outlines

Pivotal Study of Leadless Tibial Nerve Stimulation with eCoin® for Urgency Urinary Incontinence: An Open-Label, Single Arm Trial

Experimental Therapies and Research Needs for Urinary Incontinence in Women

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