New Technologies and Applications in Sacral Neuromodulation: An Update.
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ABSTRACT:
SUBMITTER: De Wachter S
PROVIDER: S-EPMC7004424 | biostudies-literature | 2020 Feb
REPOSITORIES: biostudies-literature
Publications
New Technologies and Applications in Sacral Neuromodulation: An Update.
De Wachter Stefan S Knowles Charles H CH Elterman Dean S DS Kennelly Michael J MJ Lehur Paul A PA Matzel Klaus E KE Engelberg Stefan S Van Kerrebroeck Philip E V PEV
Advances in therapy 20191224 2
Recently rechargeable devices have been introduced for sacral neuromodulation (SNM) with conditional safety for full-body magnetic resonance imaging (MRI). Currently a recharge-free SNM device represents the standard implant; however, it is only approved for MRI head scans. As further new technologies with broader MRI capabilities are emerging, the advantages as well as disadvantages of both rechargeable versus recharge-free devices will be briefly discussed in this commentary from the perspecti ...[more]
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Project description: Not available
| S-EPMC5534324 | biostudies-literature
Project description:This study tested the hypothesis that sacral neuromodulation, i.e., electrical stimulation of afferent axons in sacral spinal root, can block pudendal afferent inhibition of the micturition reflex. In ?-chloralose-anesthetized cats, pudendal nerve stimulation (PNS) at 3-5 Hz was used to inhibit bladder reflex activity while the sacral S1 or S2 dorsal root was stimulated at 15-30 Hz to mimic sacral neuromodulation and to block the bladder inhibition induced by PNS. The intensity threshold (T) for PNS or S1/S2 dorsal root stimulation (DRS) to induce muscle twitch of anal sphincter or toe was determined. PNS at 1.5-2T intensity inhibited the micturition reflex by significantly ( P < 0.01) increasing bladder capacity to 150-170% of control capacity. S1 DRS alone at 1-1.5T intensity did not inhibit bladder activity but completely blocked PNS inhibition and restored bladder capacity to control level. At higher intensity (1.5-2T), S1 DRS alone inhibited the micturition reflex and significantly increased bladder capacity to 135.8?±?6.6% of control capacity. However, the same higher intensity S1 DRS applied simultaneously with PNS, suppressed PNS inhibition and significantly ( P < 0.01) reduced bladder capacity to 126.8 ± 9.7% of control capacity. S2 DRS at both low (1T) and high (1.5-2T) intensity failed to significantly reduce PNS inhibition. PNS and S1 DRS did not change the amplitude and duration of micturition reflex contractions, but S2 DRS at 1.5-2T intensity doubled the duration of the contractions and increased bladder capacity. These results are important for understanding the mechanisms underlying sacral neuromodulation of nonobstructive urinary retention in Fowler's syndrome.
| S-EPMC5866366 | biostudies-other
Project description:We present the rationale for and design of a randomized, open-label, active-control trial comparing the effectiveness of 200 units of onabotulinum toxin A (Botox A®) versus sacral neuromodulation (InterStim®) therapy for refractory urgency urinary incontinence (UUI). The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment (ROSETTA) trial compares changes in urgency urinary incontinence episodes over 6 months, as well as other lower urinary tract symptoms, adverse events and cost effectiveness in women receiving these two therapies. Eligible participants had previously attempted treatment with at least 2 medications and behavioral therapy. We discuss the importance of evaluating two very different interventions, the challenges related to recruitment, ethical considerations for two treatments with significantly different costs, follow-up assessments and cost effectiveness. The ROSETTA trial will provide information to healthcare providers regarding the technical attributes of these interventions as well as the efficacy and safety of these two interventions on other lower urinary tract and pelvic floor symptoms. Enrollment began in March, 2012 with anticipated end to recruitment in mid 2014.
| S-EPMC3989885 | biostudies-literature
Project description:About 30% of patients suffering from a major depressive disorder do not respond sufficiently to established pharmacological, psychotherapeutic, or somatic treatments. Advances in technology and emerging knowledge about the dysfunctional brain circuits underlying depression have led to the development of different neuromodulation techniques. The aim of the present review is to give an update on noninvasive techniques, such as electroconvulsive therapy (ECT), magnetic seizure therapy (MST), transcranial magnetic stimulation (TMS), and invasive techniques requiring brain surgery, such as vagus nerve stimulation (VNS) and deep brain stimulation (DBS). First, the clinical relevance for therapy-resistant depression, including the current level of evidence, are presented. Neuroethics is concerned with the ethical, legal and social policy implications of neuroscience. A second focus of the review is the application of fundamental ethical principles, such as patient autonomy, patient well-being and justice to neuromodulation therapies. Due to reduced availability and lacking long-term efficacy data, most patients with treatment-resistant depression face a trial-and-error approach to therapeutics. This contravenes the ethical criteria of patient autonomy and justice. In order to raise the level of evidence, financial support of long-term studies, including large samples and randomized control trials, are necessary.
| S-EPMC4754006 | biostudies-literature
Project description:Sacral neuromodulation (SNM) has emerged as a treatment option for faecal incontinence (FI). However, its objective effect on symptoms and anorectal function is inconsistently described. This study aimed to systematically review the impact of SNM on clinical symptoms and gastrointestinal physiology in patients with FI, including factors that may predict treatment outcome.An electronic search of MEDLINE (1946-2014)/EMBASE database was performed in accordance with PRISMA guidelines. Articles that reported the relevant outcome measures following SNM were included. Clinical outcomes evaluated included: frequency of FI episodes, FI severity score and success rates. Its impact on anorectal and gastrointestinal physiology was also evaluated.Of 554 citations identified, data were extracted from 81 eligible studies. Meta-analysis of the data was precluded due to lack of a comparison group in most studies. After permanent SNM, 'perfect' continence was noted in 13-88% of patients. Most studies reported a reduction in weekly FI episodes (median difference of the mean -7.0 (range: -24.8 to -2.7)) and Wexner scores (median difference of the mean -9 (-14.9 to -6)). A trend towards improved resting and squeeze anal pressures and a reduction in rectal sensory volumes were noted. Studies failed to identify any consistent impact on other physiological parameters or clinicophysiological factors associated with success.SNM improves clinical symptoms and reduces number of incontinence episodes and severity scores in patients with FI, in part by improving anorectal physiological function. However, intervention studies with standardized outcome measures and physiological techniques are required to robustly assess the physiological impact of SNM.
| S-EPMC5054906 | biostudies-other
Project description:IntroductionThe massive spread of COVID-19 affected many aspects of medical and surgical services. Many patients with sacral neuromodulation (SNM) devices needed integrated follow-up and close communication regarding the programming of the device. In this study, we aimed to explore the effect of COVID-19 lockdown on patients with SNM devices.Materials and methodsThis was a multicenter study designed and conducted in four centers performing SNM (Toronto Western Hospital, Toronto, Canada; King Abdulaziz University Hospital, Jeddah, Saudi Arabia; Al-Amiri Hospital, Kuwait City, Kuwait; and Austin and Western Health, University of Melbourne, Australia). An online questionnaire was created through Google Forms and circulated among patients with SNM devices in all four mentioned centers. The questionnaire was sent to patients during the forced lockdown period in each country.ResultsA total of 162 responses were received by September 2020. Data showed that most patients had their device implanted before the lockdown period (92.5%, 150/162). Most patients did not experience any contact difficulties (91.9%, 149/162). When patients were requested for their preference of programming, 89.5% (145/162) preferred remote programming. Correlation analysis did not show any significant relation between patient diagnosis and COVID-19-related difficulties or preferences.ConclusionThe difficulties with access to care experienced during the pandemic and the patient's expressed willingness to participate in virtual care should provide impetus for manufacturers of SNM devices to move forward with developing remote programming capabilities.
| S-EPMC8770041 | biostudies-literature
Project description:ImportanceWomen with refractory urgency urinary incontinence are treated with sacral neuromodulation and onabotulinumtoxinA with limited comparative information.ObjectiveTo assess whether onabotulinumtoxinA is superior to sacral neuromodulation in controlling refractory episodes of urgency urinary incontinence.Design, setting, and participantsMulticenter open-label randomized trial (February 2012-January 2015) at 9 US medical centers involving 381 women with refractory urgency urinary incontinence.InterventionsCystoscopic intradetrusor injection of 200 U of onabotulinumtoxinA (n = 192) or sacral neuromodulation (n = 189).Main outcomes and measuresPrimary outcome, change from baseline mean number of daily urgency urinary incontinence episodes over 6 months, was measured with monthly 3-day diaries. Secondary outcomes included change from baseline in urinary symptom scores in the Overactive Bladder Questionnaire Short Form (SF); range, 0-100, higher scores indicating worse symptoms; Overactive Bladder Satisfaction questionnaire; range, 0-100; includes 5 subscales, higher scores indicating better satisfaction; and adverse events.ResultsOf the 364 women (mean [SD] age, 63.0 [11.6] years) in the intention-to-treat population, 190 women in the onabotulinumtoxinA group had a greater reduction in 6-month mean number of episodes of urgency incontinence per day than did the 174 in the sacral neuromodulation group (-3.9 vs -3.3 episodes per day; mean difference, 0.63; 95% CI, 0.13 to 1.14; P = .01). Participants treated with onabotulinumtoxinA showed greater improvement in the Overactive Bladder Questionnaire SF for symptom bother (-46.7 vs -38.6; mean difference, 8.1; 95% CI, 3.0 to 13.3; P = .002); treatment satisfaction (67.7 vs 59.8; mean difference, 7.8; 95% CI, 1.6 to 14.1; P = .01) and treatment endorsement (78.1 vs 67.6; mean difference; 10.4, 95% CI, 4.3 to 16.5; P < .001) than treatment with sacral neuromodulation. There were no differences in convenience (67.6 vs 70.2; mean difference, -2.5; 95% CI, -8.1 to 3.0; P = .36), adverse effects (88.4 vs 85.1; mean difference, 3.3; 95% CI, -1.9 to 8.5; P = .22), and treatment preference (92.% vs 89%; risk difference, -3%; 95% CI, -16% to 10%; P = .49). Urinary tract infections were more frequent in the onabotulinumtoxinA group (35% vs 11%; risk difference, -23%; 95% CI, -33% to -13%; P < .001). The need for self-catheterization was 8% and 2% at 1 and 6 months in the onabotulinumtoxinA group. Neuromodulation device revisions and removals occurred in 3%.Conclusions and relevanceAmong women with refractory urgency urinary incontinence, treatment with onabotulinumtoxinA compared with sacral neuromodulation resulted in a small daily improvement in episodes that although statistically significant is of uncertain clinical importance. In addition, it resulted in a higher risk of urinary tract infections and need for transient self-catheterizations.
| S-EPMC5399419 | biostudies-literature
Project description:BACKGROUND:For patients over the age of 70?years, sacral neuromodulation (SNM) is often not considered a potential therapeutic option. We therefore report on our results from performing SNM in elderly patients ?70?years. METHODS:Between 01/09 and 12/18, a total of 95 patients with refractory overactive bladder (OAB) or chronic non-obstructive urinary retention underwent SNM testing at our department. In the overall sample, 20 patients were aged 70?years or older (21%, group B), and 75 patients were under 70?years old (79%, group A). The mean follow-up period was 50.2?±?36.2?months. Pre-, peri- and postoperative parameters were compared between the two groups. Statistical analysis was carried out with SPSS 25.0 (p?<?0.05). RESULTS:The mean patient age was 53?±?16 (17-76) years. The indications for SNM testing were OAB and retention in 51 and 49% of patients, respectively. A total of 56 patients (59%) [8 patients (40%) in group B, 48 patients (64%) in group A] had more than 50% improvement in the context of the test (stage 1), such that a permanent neuromodulator (stage 2) was implanted. A total of 14 patients, all under 70?years old except for one older female, needed to undergo revision due to defects or infection. Overall, the success rate was 58.3% for OAB and 59.6% for urinary retention. The success rates and complications in our patient group were independent of age and geriatric assessment. CONCLUSION:SNM can also be successfully implemented in older patients.
| S-EPMC7227205 | biostudies-literature
Project description:Introduction and hypothesisIntradetrusor onabotulinumtoxinA (BTX) and sacral neuromodulation (SNM) are effective treatments for refractory urgency urinary incontinence/overactive bladder (UUI/OAB). BTX carries a risk of urinary tract infection (UTI), which is concerning for the development of multidrug resistant (MDR) UTI. We hypothesized that BTX might carry a higher risk of UTI and MDR UTI compared with SNM and that UTI and MDR UTI risk might increase after repeat BTX injection.MethodsThis retrospective cohort study included women undergoing BTX or SNM for refractory UUI/OAB in 2012-2016. UTI and MDR UTI were assessed up to 1 year post-treatment or until repeat treatment and compared between initial BTX and SNM and between repeat BTX injections. Univariate analyses included Chi-squared and Fisher's exact tests and generalized linear models (GLM) with logit link function. Multivariate analyses used GLM to assess the best predictor variables for any UTI.ResultsOne hundred and one patients were included (28 BTX, 73 SNM). Rates of UTI (39.3% [95% CI 21.5, 59.4] BTX vs 37.0% [95% CI 26.0, 49.1] SNM) were similar in the two groups at all time intervals. One MDR UTI occurred after SNM. Risk of UTI did not increase with repeat BTX (11 out of 28 [39.3%], 6 out of 17 [35.3%], and 4 out of 7 [57.1%] after 1, 2, and ≥ 3 treatments respectively; p = 0.62). Multivariate analysis found that history of recurrent UTI (OR 2.5, 95%CI 0.98-6.39) and prolapse repair (OR 4.6, 95%CI 1.23-17.07) had increased odds of UTI.ConclusionsRates of UTI were similar in patients undergoing BTX and SNM. MDR UTI was rare. Patients with prior prolapse repair or recurrent UTI may be at a higher risk of UTI after either procedure.
| S-EPMC6980323 | biostudies-literature
Project description:BackgroundUp to 7.5% of tined-lead removals in patients having sacral neuromodulation (SNM) therapy are associated with a lead breakage. It is still unclear what adverse effects can be caused by unretrieved fragments. The aim of our study was to describe the lead removal technique we have been using for the last 2 years in our centre.MethodsWe retrospectively enrolled patients who had lead removal between January 2018 and January 2020 using our standardized technique. The novelty of the technique is in the use of the straight stylet, which is available in the quadripolar tined-lead kit. The stylet gives the electrode greater stiffness, reducing interactions with surrounding tissues and probability of damage or breakage during removal.ResultsIn 59 patients (42 women, mean age 57.2 years [range 40-79 years]) the lead was removed using our standardized technique. In 44 of 59 patients, the tined-lead was removed within 2 months from the SNM-test, due to lack of beneficial effects. In 15 patients the electrode was removed because of failure of definitive implantation. Meantime from definitive implantable pulse generator (IPG) implantation to lead removal was 67.9 months. We recorded only 1 case of lead-breakage during removal: a female patient with a non-tined lead fixed on sacral bone, placed 18 years previously using an open technique.ConclusionsLead breakage during removal is not uncommon and adverse effects of retained fragments may occur. Our technique has been safely used for the last 2 years in our centre, with no episodes of lead breakage or retained fragments, except for one non-tined electrode.
| S-EPMC8289802 | biostudies-literature