3-Year Followup of a New Implantable Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome

Dorsthorst, Manon J. te; Digesu, G. Alessandro; Tailor, Visha; Gore, Michelle; Kerrebroeck, Ph.E.V. Van; Breda, Jetske van; Elneil, Sohier; Heesakkers, John

doi:10.1097/ju.0000000000001024

Cited by 20 publications

(14 citation statements)

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“…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%

“…One major adverse event associated with the technique happened, prompting the device's explanation. Three-year results show that, after 36 months following system activation, about 75% of patients are still responders in those who stayed in an extended study [ 57 ]. The closed-loop nature of the BlueWind RENOVA technology is an advantage.…”

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%

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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“…Another study with different implantable stimulator reported its clinical effects on OAB urgency and urinary incontinence observed from 3-month and 6-month follow-ups 64 . Recently, in their 3-year follow-up study, Dorsthorst et al confirmed both the safety (without any technical failures) and clinical efficacy of this treatment for the improvement of patient quality of life 65 . Therefore, if an implantable stimulator is helpful in treatment of OAB patients, new stimulation protocols for an implantable stimulator need to be developed by taking into consideration the duration of the prolonged post-stimulation inhibitory effect in individual patients.…”

Section: Discussionmentioning

confidence: 88%

The long-lasting post-stimulation inhibitory effects of bladder activity induced by posterior tibial nerve stimulation in unanesthetized rats

Park

Lee

Kim

et al. 2020

Sci Rep

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Tibial nerve stimulation (TNS) is one of the neuromodulation methods used to treat an overactive bladder (OAB). However, the treatment mechanism is not accurately understood owing to significant differences in the results obtained from animal and clinical studies. Thus, this study was aimed to confirm the response of bladder activity to the different stimulation frequencies and to observe the duration of prolonged post-stimulation inhibitory effects following TNS. This study used unanesthetized rats to provide a closer approximation of the clinical setting and evaluated the changes in bladder activity in response to 30 min of TNS at different frequencies. Moreover, we observed the long-term changes of post-stimulation inhibitory effects. Our results showed that bladder response was immediately inhibited after 30 min of 10 Hz TNS, whereas it was excited at 50 Hz TNS. We also used the implantable stimulator to observe a change in duration of the prolonged post-stimulation inhibitory effects of the TNS and found large discrepancies in the time that the inhibitory effect lasted after stimulation between individual animals. This study provides important evidence that can be used to understand the neurophysiological mechanisms underlying the bladder inhibitory response induced by TNS as well as the long-lasting prolonged post-stimulation effect.

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“…Recently, a pilot study con rmed the e cacy and improvement in quality of life on the longer term follow up (3-year) of a new tibial nerve implant. [11] In the future, a larger trial should con rm other theoretical bene ts regarding home based tibial nerve stimulation by an implant. This study should con rm the bene cial concept of implant driven tibial nerve stimulation, being 1) closer stimulation to the tibial nerve,…”

Section: Discussionmentioning

confidence: 99%

Urgent-SQ Implant: Safety and Efficacy, 18 Years After First Implantation.

Dorsthorst¹,

Janssen²,

Martens³

et al. 2020

Preprint

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Background: To evaluate the long term follow up in terms of safety and usability of the Urgent-SQ system (implantable tibial nerve stimulator) based on 1 year, 9 year follow up and novel results 18 years after first implantation in 2002.Materials & Methods: Since 2002, eight patients were implanted with the Urgent-SQ system. Seven patients were included in previous follow up studies, 1 patient had loss of efficacy before 1 year of follow up. During this study all patients who were included in the previous follow-up studies (n=7) were contacted to be interviewed regarding efficacy, usability and safety. Results: Five out of seven patients were available for assessment, mean age 72 years ± 8 (range 65-82). Two patients were considered lost to follow up. None of the interviewed patients reported safety issues, new adverse events or discomfort. One of the patients was able to visit the hospital for efficacy. However, treatment could not be performed due to deficiency of the external or internal component. All patients did not perform self-stimulation anymore due to external stimulator deficiency (n=2) or loss of effect (n=3). Conclusion: 18 year follow up of the Urgent-SQ implant demonstrates a high safety profile. However efficacy after 18 years is lacking in 60% whereas in 40% the therapy cannot be applied because the external stimulator is deficient. This most likely depicts the end of the lifecycle of the device.

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3-Year Followup of a New Implantable Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome

Cited by 20 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

The long-lasting post-stimulation inhibitory effects of bladder activity induced by posterior tibial nerve stimulation in unanesthetized rats

Urgent-SQ Implant: Safety and Efficacy, 18 Years After First Implantation.

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