A novel leadless, miniature implantable Tibial Nerve Neuromodulation System for the management of overactive bladder complaints

Heesakkers, John; Digesu, G. Alessandro; Breda, Jetske van; Kerrebroeck, Philip Van; Elneil, Sohier

doi:10.1002/nau.23401

Cited by 41 publications

(34 citation statements)

References 27 publications

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“…[21][22][23] The RENOVA iStim system (Bluewind Medical Ltd, Herzliya, Israel) showed a clinical success rate of 71% after 6 months based on a reduction in the number of leaks and/or voids and reduction in the number of episodes with a degree of urgency. 22 The eCOIN (Valencia Technologies Corp, Valencia, CA) showed similar success rates, 71% relative median reduction in the number of urgency urinary incontinence episodes after 12 weeks of treatment. 23 Longterm safety and efficacy outcomes are yet unknown.…”

Section: Discussionmentioning

confidence: 99%

Long‐term real‐life adherence of percutaneous tibial nerve stimulation in over 400 patients

Dorsthorst

Heesakkers

Balken

2019

Neurourology and Urodynamics

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Background: Percutaneous tibial nerve stimulation (PTNS) is used as a treatment to reduce the complaints of overactive bladder (OAB). Although it is rewarding therapy patients need maintenance treatment to preserve the beneficial effect. Aim: This real-life retrospective study was performed to assess the feasibility of PTNS adherence. Materials & Methods: All patients who underwent PTNS were retrospectively included. We analyzed the following: indication, kind of treatments (pharmacologic and third-line therapy) before and after PTNS treatment, time and reason for quitting therapy. Statistical analysis was done by performing competitive-risk analysis and Kaplan-Meier curves. Patients were categorized into four groups. Group 1: all patients; group 2: all patients on maintenance PTNS therapy (continuing after 12 weeks); group 3: patients on maintenance PTNS therapy excluding the following: (a) patients with initial good response who seized treatment due to death, (b) patient who successfully switched to transcutaneous stimulation, (c) patients who were cured of their OAB symptoms, or (d) patients who relocated; and group 4: group 3 but excluding those who stopped treatment because of nonmedical reasons (physical strain, inconveniencies associated with visiting the hospital).Results: Four-hundred two patients (70% female) with a median age of 70 years underwent PTNS. Underlying treatment indications were: OAB-wet (54%) and OAB-dry (29%). The median follow-up (FU) of group 1 was 4 months. Fiftyseven percent (N = 228) of the patients received maintenance PTNS therapy. Median FU in group 4 was 46 months (range, 3-111 months). Over 40% of the maintenance patients stopped PTNS because of logistic reasons and physical strain during an FU time of 6 years. Conclusion: The real-world data described here with is in line with earlier published work in terms of the success rate of OAB treatment. However, over 40% quit their therapy due to nonmedical reasons.This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

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Section: Discussionmentioning

confidence: 99%

Long‐term real‐life adherence of percutaneous tibial nerve stimulation in over 400 patients

Dorsthorst

Heesakkers

Balken

2019

Neurourology and Urodynamics

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“…Complications included pain and infection at implantation site requiring oral analgesia and oral antibiotics. Heesakkers et al (2018) [35] evaluated the same device over a 6-month period in a prospective study in 36 participants with OAB. The device was used six times a week for 30-min duration for 3 months or three times a week for 6 months.…”

Section: Implantable Devicesmentioning

confidence: 99%

Posterior tibial nerve stimulation for overactive bladder—techniques and efficacy

et al. 2019

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The ideal treatment for overactive bladder is still elusive. In those where medication fails to improve symptoms options include invasive treatments such as botulinum toxin-A, sacral neural stimulation or posterior tibial nerve stimulation. Scientific professional society guidelines advise percutaneous posterior tibial nerve stimulation as a third line treatment option only after multidisciplinary team review as well as failure of both conservative and pharmacological management. The aim of this article is to review all techniques for tibial nerve stimulation and their efficacy.

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“…A 6-month study evaluated the implant in 36 patients 39 . A total of 71% of patients experienced clinical success (>50% reduction) at 6 months.…”

Section: Neuromodulationmentioning

confidence: 99%

Recent advances in managing overactive bladder

et al. 2020

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Overactive bladder syndrome (OAB) is defined as urinary urgency, usually accompanied by frequency and nocturia, with or without urgency incontinence, in the absence of urinary tract infection or other obvious pathology. In this review, we focus on recent advances in the management of OAB. We examine the evidence on the effect of anticholinergic load on OAB patients. Advances in medical treatment include a new beta-3 agonist, vibegron, which is thought to have fewer drug interactions than mirabegron. Treatment of genitourinary syndrome of the menopause with oestrogens and ospemifene have also shown promise for OAB. Botulinum toxin has been shown to be an effective treatment option. We discuss the new implantable neuromodulators that are on the market as well as selective bladder denervation and laser technology.

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A novel leadless, miniature implantable Tibial Nerve Neuromodulation System for the management of overactive bladder complaints

Abstract: The performance and safety of the BlueWind RENOVA™ implantable tibial nerve neuromodulator for OAB was tested. Our preliminary results demonstrate that the system has a low risk safety profile and may be considered an effective treatment option for OAB management.

Cited by 41 publications

References 27 publications

Long‐term real‐life adherence of percutaneous tibial nerve stimulation in over 400 patients

Long‐term real‐life adherence of percutaneous tibial nerve stimulation in over 400 patients

Posterior tibial nerve stimulation for overactive bladder—techniques and efficacy

Recent advances in managing overactive bladder

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