Feasibility of a Fully Implanted, Nickel Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence

MacDiarmid, Scott; Lucente, Vincent; Kaaki, Bilal; English, Sharon; Gilling, Peter; Meffan, Patrick; Clark, Matthew; Sand, Peter K.; Sen, Subhro K.

doi:10.1016/j.juro.2018.10.017

Cited by 40 publications

(34 citation statements)

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“…The first few pilot studies have recently been published with promising results. [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.…”

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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“…In development and currently undergoing feasibility trials is the battery-powered eCoin™ (Valencia Technologies Corp., CA, USA) implant as well as the StimRouter™ (Bioness, CA, USA) implant. Initial results are promising with further studies anticipated [11].…”

Section: Implantable Devicesmentioning

confidence: 95%

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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“…However, with PTNS, patient compliance is a challenge since patients have to present weekly for in-office treatment, and it takes on an average more than 6 weeks for the patients to start experiencing improvement. Recently, MacDiarmid S et al demonstrated the feasibility of an implantable nickel-sized tibial nerve stimulator in the treatment of OAB with a 71% reduction in the episodes of UUI, 70% response rate (more than 50% decrease in reported episodes of UUI) and 72% improvement in quality of life [43].…”

Section: Plos Onementioning

confidence: 99%

Medium-term outcomes of sacral neuromodulation in patients with refractory overactive bladder: A retrospective single-institution study

Kaaki

Gupta²

2020

PLoS ONE

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Background Sacral neuromodulation (SNM) is a minimally invasive fully reversible therapy that was approved in 1997 for overactive bladder syndrome (OAB) refractory to behavior modification and pharmacotherapy. Despite being in use for over two decades, the data on medium to long-term safety and efficacy of SNM in OAB is limited. We investigated the medium-term efficacy and safety of SNM along with the predictive factors for its success in patients with refractory OAB. Methods A retrospective consecutive case series of 66 patients undergoing SNM for refractory OAB between July 2009 and July 2018. All patients underwent a test period followed by permanent implantation, if there was > = 50% improvement in any symptom. The primary outcome was "success" defined as > = 50% improvement in any clinical parameter based on the subjective assessment of patient's response. The secondary outcomes were number of pads used in 24 hours, post-operative complications and re-operation rates. Results 66 females with an average age of 62.7 years were included. 55/66 patients (83.3%) had a successful test phase and underwent permanent implantation. After a median follow-up of 32 months, SNM was successful in 41/55 (74.5%) patients. Mean number of pads used in 24 hours decreased significantly from 3.5 preoperatively to 1.2 at last follow-up (p<0.001). 8/55 (14.5%) patients reported complications of pain, lead migration, wound dehiscence and device malfunction. 10/55 (18.2%) patients underwent revision surgeries after a median duration of 21.9 months. Device was explanted in 15/55 (27.3%) patients after a median duration of 24 months. No significant predictor for success was identified.

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Feasibility of a Fully Implanted, Nickel Sized and Shaped Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome with Urgency Urinary Incontinence

Cited by 40 publications

References 0 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

Medium-term outcomes of sacral neuromodulation in patients with refractory overactive bladder: A retrospective single-institution study

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