Sacral Neuromodulation Research Articles

Intrathecal baclofen obviating the need for bladder stimulator use in a patient with secondary dystonia: illustrative case.

Children with cerebral palsy often have neurogenic bladders. Bladder function is further affected by complex medical management and multifactorial disease processes, leading to worsened function and poorer quality of life. Intrathecal baclofen (ITB) therapy has been used to treat hypertonia and spasticity, but implications in neurogenic bladder management have not been well described. A 20-year-old female with a history of cerebral palsy and neurogenic bladder treated with sacral neuromodulation underwent ITB therapy and subsequently experienced improvement in bladder control, obviating the need for bladder stimulator use. ITB improves hypertonia and can effectively obviate the need for neurostimulation to treat neurogenic bladder in patients with cerebral palsy. Further research is necessary to discern mechanisms. https://thejns.org/doi/10.3171/CASE24364.

Is Our Limited Understanding of the Effects of Nerve Stimulation Resulting in Poor Outcomes and the Need for Better "Rescue Programming" in SNM and PTNS, and Lost Opportunities for New Sites of Stimulation? ICI-RS 2024.

Sacral neuromodulation (SNM) and percutaneous tibial nerve stimulation (PTNS) are strongly recommended by international guidelines bodies for complex lower urinary tract dysfunctions. However, treatment failure and the need for rescue programming still represent a significant need for long-term follow-up. This review aimed to describe current strategies and future directions in patients undergoing such therapies. This is a consensus report of a Think Tank discussed at the Annual Meeting of the International Consultation on Incontinence - Research Society (ICI-RS), June 6-8, 2024 (Bristol, UK): "Is our limited understanding of the effects of nerve stimulation resulting in poor outcomes and the need for better 'rescue programming' in SNM and PTNS, and lost opportunities for new sites of stimulation?" Rescue programming is important from two different perspectives: to improve patient outcomes and to enhance device longevity (for implantable devices). Standard SNM parameters have remained unchanged since its inception for the treatment of OAB, nonobstructive urinary retention, and voiding dysfunction. SNM rescue programming includes intermittent stimulation (cycling on), increased frequency and changes in pulse width (PW). The effect of PW setting on SNM outcomes remains unclear. Monopolar configurations stimulate more motor nerve fibers at lower stimulation voltage; hence, this could be an option in patients who failed bipolar stimulation in the long term. Unfortunately, there is little evidence for rescue programming for PTNS. However, the development of implantable devices for intermittent stimulation of the tibial nerve may increase long-term adherence to therapy and increase interest in alternative programming. There has been recent promising neurostimulation targeting the pudendal nerve (PNS), especially in BPS/IC. More recently, preliminary data addressed the benefits of high-frequency bilateral pudendal nerve block for DESD and adaptive PNS on both urgency and stress UI in women. The exploration of rescue programming and new stimulation sites remains underutilized, and there are opportunities that could potentially expand the therapeutic applications of nerve stimulation. By broadening the range of target sites, clinicians may be able to tailor treatments according to individual patient needs and underlying conditions, thereby improving overall outcomes. However, further studies are still needed to increase the level of evidence, potentially allowing for an individualized treatment both in patients who are candidates for electrostimulation and in those who have already received surgical implants but seek a better outcome.

Fowler’s syndrome—Patient led phenotyping of 265 patients

Aims:To better understand Fowler’s syndrome from a patient perspective. Methods:The survey was created by the Fowler’s syndrome UK charity(FSUK, registered charity number 1196903), and advertised to patients with a diagnosis of Fowler’s syndrome via social media from December 2021 to March 2022. Results:Of 265 participants, 187 (70%) were aged between 15–30 years. Patients self-reported Fowler’s syndrome. Medical notes were not obtained. However, 195 (74%) were diagnosed by either urethral sphincter EMG or urethral pressure profile suggesting a representative sample, with few differences in those not reporting those investigations. 183 (69%) experienced complete urinary retention. Over 75% reported pain in either their bladder, urethra or pelvis. 224 (84%) used catheters to manage symptoms and 80% were taking opiates for pain. Sacral neuromodulation was offered to 75% of patients and found useful by 27% of these patients. Urethral sphincter or detrusor botulinum toxin, pain management, or physiotherapy were offered to between 32%–61% of patients and found beneficial in less than a third of those undertaking them. Over 50% rated impact on life overall as ‘severe’. Over 80% required help with ADLs on their worst day. 200 (75%) reported being told that their symptoms were due to anxiety, “imaginary” or “all in their head”. Conclusions:This is the largest cross-sectional study of women with Fowler’s syndrome. Fowler’s syndrome severely affected quality of life in >50%. Current management options available were recorded as beneficial in fewer than a third of participants. The majority of participants felt unsupported by medical professionals.

Is it Possible to Regenerate the Underactive Detrusor? Part 2 Electrical Stimulation Therapies, Treatment of Bladder Outlet Obstruction, Constipation, and Pelvic Floor Disorders ICI-RS 2024.

Detrusor muscle weakness is commonly noted on urodynamics in patients with refractory voiding difficulty. No clinical therapy has been proven to augment the strength of a detrusor contraction. This subject was discussed at a think-tank at the International Consultation on Incontinence-Research Society (ICI-RS) held in Bristol, June 2024. The discussions of the think-tank are being published in two parts. This second part discusses the role of electrical stimulation therapies, treatment of bladder outlet obstruction, constipation, and pelvic floor disorders, in the enhancement of strength of a detrusor contraction. Electrical stimulation therapies, specifically sacral neuromodulation, have long been used in the salvage of patients with refractory nonobstructive voiding dysfunction. Clinical improvements can be noted in men following bladder outlet resistance reduction surgery especially, though not limited to those with demonstrable obstruction. Some patients may also show improvement with pelvic floor relaxation therapies and constipation care. However, there is a lack of high-quality urodynamic data to demonstrate an improvement in the strength of a detrusor contraction with these therapies. The think-tank recommends standards for future clinical studies examining treatments aimed at improving an underactive detrusor. Studies need to examine whether clinical improvement following treatment of patients with an underactive detrusor is associated with improvement in strength of the detrusor contraction. New therapeutic options should apply specified standards for assessing and reporting the impact on detrusor contraction.

Sacral neuromodulation for Organophosphate-induced delayed neuropathy neurogenic lower urinary tract dysfunction: a case report

BackgroundOrganophosphate-Induced Delayed Neuropathy (OPIDN) is a rare neurological disorder triggered by exposure to organophosphorus compounds. These compounds exert their neurotoxic effects by impacting the nervous system, leading to systemic manifestations. Urinary system symptoms are infrequently observed in clinical settings. Currently, effective therapeutic interventions for OPIDN-related urinary symptoms are lacking. Sacral nerve modulation therapy, an FDA-approved approach for managing lower urinary tract symptoms, presents as a promising option. Herein, we present a case of OPIDN-induced lower urinary tract obstruction successfully treated with sacral nerve modulation therapy, resulting in substantial symptom relief.Case reportA 27-year-old male patient presented with severe bilateral hydronephrosis, attributed to low bladder compliance and accompanied by a fever persisting for 6 days. The patient’s medical history revealed accidental ingestion of organophosphate pesticide (Dimethoate) with no concomitant underlying diseases. In consideration of the potential for OPIDN, surgical intervention in the form of sacral neuromodulation (phase I) was undertaken. Subsequent evaluation one month post-surgery revealed notable improvements in both bladder compliance and bilateral hydronephrosis, necessitating sacral neuromodulation (phase II). Presently, following a 5-month follow-up period, the patient remains asymptomatic and in favorable health.ConclusionThis patient achieved long-term relief using sacral neuromodulation.

Impact of Antibiotic Choice at the Time of Sacral Neuromodulation Implantation on Rates of Surgical Site Infection.

To evaluate the efficacy of specific antibiotic regimens in preventing infection following sacral neuromodulation. This is a retrospective cohort study utilizing the Premier Healthcare Database. Patients who underwent sacral neuromodulation placement between January 2016 and March 2020. The patients were grouped by those who received dual antibiotic therapy per 2019 AUA guidelines (Gram positive + broad Gram negative coverage), first- or second-generation cephalosporins or any other regimen. Comparison between groups was performed using Kruskal-Wallis and χ2 tests for continuous and categorical variables, respectively. Inverse probability of treatment weighted (IPTW) analysis was used to estimate the average treatment effect of AUA guidelines regimens versus the use the first- or second-generation cephalosporins alone. The sample included 14 179 patients, with 2211 patients receiving prophylaxis that followed the AUA guideline recommendations. There was no significant difference in surgical site infection rates within 3 months (p = 0.28) or within 12 months (p = 0.53) between the groups. On IPTW, the probability of an infection at 3 months was lower with the AUA guideline regimens compared to those who received first- or second-generation cephalosporins alone, but this difference was not statistically significant (OR = 0.73, 95% CI: [0.43, 1.24]). In the absence of allergies to cephalosporins or penicillin, first- or second-generation cephalosporins alone may be a sufficient preoperative antibiotic regimen for prevention of infection at the time of sacral neuromodulation. Not applicable due to being a database study.

Indwelling Urological Device Biofilm Composition and Characteristics in the Presence and Absence of Infection

ObjectiveTo characterize microbial biofilms associated with different device types used in the urological field including ureteral stents, sacral neuromodulation (SNM) devices, penile prostheses, and artificial urinary sphincters (AUS). Materials and MethodsData from four studies, each reporting biofilm composition of a particular device type, were pooled and included for inter-device analysis. Studies recruited adults scheduled for ureteral stent, SNM, IPP, or AUS removal/revision. Device (n=115) biofilms and controls were analyzed with multi-omics approaches, and compositions were compared across device types and clinical factors. ResultsMicrobiota present on each device type was distinct from that of perineal, rectal, or urine flora (p<0.01). Biofilm microbial counts (p<0.001) and diversity (p=0.024) differed by device type. Ureteral stents had greater microbial counts than other device types (p<0.001). Staphylococcus, Pseudomonas, Lactobacillus, Ureaplasma were commonly detected across devices. Device biofilms harbored a greater proportion of Proteobacteria phylum, and the rectal, perineal, and urine flora harbored a greater proportion of Firmicutes. Unique microbe-metabolite interaction networks were identified in presence and absence of infection. Antibiotic resistance genes including sul2 (sulfonamide resistance) and rpoB (rifampin resistance) were detected in biofilms across device types. Biofilm reconstitution in vitro differed by device type from which strains were isolated. ConclusionsUreteral stents, sacral neuromodulation devices, penile prostheses, and artificial urinary sphincters harbored unique microbial and metabolite profiles that differed from those of skin, urine, and rectal flora. The findings of this study set the groundwork for investigation of novel strategies to reduce device-associated infection risk within and outside urology. Data availability statementData are available from corresponding author upon reasonable request.

235 - A ten year analysis of women with voiding dysfunction (VD) treated with Sacral Neuromodulation (SNM): Time for a paradigm change?

235 - A ten year analysis of women with voiding dysfunction (VD) treated with Sacral Neuromodulation (SNM): Time for a paradigm change?

Analgesic efficacy of sacral neuromodulation for chronic pelvic cancer pain

Background: Neuromodulation has provided promising results in chronic pain management. Sacral neurostimulation (SNS) is a neuromodulatory technique, where the sacral nerve roots are electrically stimulated. Objective: Evaluate the efficacy of the trial phase to control severe cancer pain in pelvic organs. Design: Pilot study. Methods: Chronic pelvic cancer pain patients were managed with morphine ≥ 60 mg daily, duloxetine 30 mg, and celecoxib 200 mg twice daily. Twenty-two adults were divided randomly into two equal groups: the SNS group (N = 11), received a sacral neurostimulator device and opioid analgesics, and the opioid group (N = 11), received increased opioid analgesics to control pain. Results: Visual analog scale scores were decreased in the SNS group at 24 h, 4 days, 1, and 2 weeks in SNS compared to the opioid group, medians (IQR) [4 (3–5) vs 6 (5–7), 3 (3–4) vs 5 (5–6), 3 (3–4) vs 5 (5–6), and 3 (3–3) vs 5 (4–6) P &lt; 0.001], daily morphine consumption was reduced in the SNS group compared to the opioid group, median (IQR) [90 (60–90) mg vs 120 (120–150) mg, P &lt; 0.001] and [30 (30–60) mg vs 150 (120–180) mg] during the first and second weeks. The SNS group had a better life quality compared to the opioid group after 2 weeks, median (IQR) was (123 (122.5–124) vs 117 (117–118.5) P &lt; 0.001), respectively. Conclusion: The SNS trial device showed effectiveness in managing severe chronic pelvic cancer pain.

275 - Preliminary analysis of stimulation parameters for sacral neuromodulation in different indications: A multi-center study from China

275 - Preliminary analysis of stimulation parameters for sacral neuromodulation in different indications: A multi-center study from China

Sacral neuromodulation update in 2024: Insights from the ICS workshop 2023

Purpose:This review is based on the International Continence Society (ICS) Workshop on Hands-On Sacral Neuromodulation (SNM)- Ideal Lead Placement presented at the Annual Congress in 2023. This workshop briefly reviewed appropriate patient selection, focused most of the time on hands on skills to teach appropriate needle and lead placement techniques. Six very experienced experts worked with attendees on lifelike models to teach them how to achieve lead placement efficiently and appropriately. Tips and tricks for getting the best responses were reviewed. Materials and methods: The review follows the structure adopted by workshop, where SNM-Ideal Lead Placement is discussed in four sections: main/extended indications and ideal patient profile, sacral neuromodulation techniques included basic evaluation (PNE), advanced evaluation, ideal lead placement and novel technology. Results:The learning objectives were achieved at the end of the workshop. These were: understanding the role of sacral neuromodulation, recognize the latest technological developments, their clinical implications and getting the best outcome with SNM, stress the importance of patient selection process and current SNM indications, reviewing standard surgical technique for optimal lead placement and gain understanding of choices for recharge versus fixed battery (as well as use in neurological disease). Conclusions:Hands-on training workshops on sacral neuromodulation is efficient training modules to ensure learning objectives for participants. Accurate needle/temporary lead placement, lead placement with permanent lead, smart programming with programmers are the main parts of hands-on training session with using realistic phantom and 3D printed models in workshop.

Sacral neuromodulation for urinary incontinence

Sacral neuromodulation (SNM) was first approved in Europe in 1994 and the United States in 1997. Since its initial approval, indications for SNM have expanded to include urinary urgency/frequency, urgency urinary incontinence (UUI), non-obstructive urinary retention, and fecal incontinence. In the realm of idiopathic overactive bladder (OAB) and UUI multiple studies have highlighted the effectiveness of this therapy with the most recent data reporting a success rate of 93% at 2 year follow-up. Additionally, SNM has been compared to various other therapies for OAB/UUI. SNM demonstrated superiority in terms of symptom improvement when compared to anticholinergic medication and similar efficacy to 200 units of intradetrusor onabotulinum toxin. SNM has also demonstrated similar effectiveness in management of neurogenic patients although there remains a paucity of high level data in these patients. With the introduction of systems with improved MRI conditionality ongoing studies aim to evaluate effectiveness within this population.

Bibliometric analysis of research on spinal cord and sacral neuromodulation in spinal cord injury.

Qualitative studies. Spinal cord injury (SCI) is one of the most devastating injuries to the central nervous system that places a major burden on society. Neuromodulation technology involving spinal cord stimulation (SCS) and sacral nerve modulation (SNM) is a promising technique for patients with SCI. However, there has been no bibliometric analysis of research in this field to date. Not applicable. Systematic analyses of countries, institutions, authors, journals, co-cited documents, keywords, genes and diseases were performed. Related gene and disease data from the citexs platform were also reviewed. A total of 7437 articles on SCS and SNM in SCI were retrieved from the Web of Science database. The search time was limited to 1985-01-01 to 2022-12-31. We identified a significant increase in research output on SCS and SNM in SCI in recent years, with a concentrated period of high publication activity. Multiple publications were identified on neuropathic pain, electronic stimulation, TNF, BDNF and STAT3 gene expression, indicating that complications and potential therapeutic strategies for SCI are a key focus in the field. Our study provides insights that may help to advance scientific research and potentially improve outcomes in patients with SCI.

Long-term Outcomes of Periurethral Sphincter Botulinum Toxin in Female Chronic Urinary Retention.

Nonneurogenic chronic urinary retention is an uncommon problem in young female individuals, and a well characterised causes is Fowler syndrome (primary disorder of urethral sphincter relaxation). Intermittent catheterisation is often challenging, and gold standard treatment sacral neuromodulation is not widely available. Urethral sphincter botulinum toxin injection has been shown to be effective cross-sectionally, however little is known about long-term outcomes. Female individuals presenting with urinary retention due to Fowler syndrome were reviewed retrospectively from a single tertiary referral centre over an 11-year period (2010-2021). One hundred units of onabotulinum toxin A (BoTX-A) was injected into the striated urethral sphincter in a divided dose by the periurethral approach. Efficacy and side effects were assessed 4 weeks after injection. Thirty-three female individuals with a mean age of 40.1±14.1 years received 165 unique urethral sphincter BoTX-A injections over 11 years. Nineteen individuals (57.6%) presented in acute urinary retention, and 28 (84.8%) were reliant on catheterisation. Twenty-one individuals (64%) responded to BoTX-A injections and had a significantly raised baseline maximum urethral closure pressure (MUCP), compared to nonresponders (114.6 cm H2O, P=0.012). Side effects were reported following 19 injections (11.5%) however, were mild and transient. Fifteen individuals received more than 1 botulinum toxin injection (median, 3 injections), with a median interval of 112 days (interquartile range) and efficacy persisted following repeat injections and no safety concerns were seen. Sphincter botulinum toxin through the periurethral approach is safe and effective following repeat injections, and offers a low-cost, minimally invasive alternative to managing female chronic urinary retention due to Fowler syndrome, particularly when there was a high baseline MUCP.

How to set-up an effective Sacral Neuromodulation service

Over the last 30 years, Sacral Neuromodulation (SNM) has become the first-line surgical treatment in patients with fecal and urgency urinary incontinence with over 400,000 patients implanted worldwide. Its favorable long-term functional results and the minimal invasiveness of the technique has broadened potential new indications. Also, more hospitals around the globe have engaged to offer the therapy despite there are important limitations for some regions for access. To obtain the best results, it is crucial to select the patients properly, do the implantation technique correctly, and follow-up the patients regularly. Even though there is an important momentum of SNM in pelvic floor disorders, there is no standardization on how to offer a proper SNM service. This article gives an overview of the main logistic fields to successfully set up a comprehensive and correct SNM provision.

Updates on the use of neuromodulation in geriatric patients.

In light of the updated AUA/SUFU guidelines on the diagnosis and treatment of overactive bladder (OAB), increased utilization of advanced therapies is expected in the coming years. The primary aim of this review is to summarize existing outcome and safety data on the use of neuromodulation in geriatric patients, as well as highlight recent advances in neuromodulation that may be particularly advantageous in the geriatric population. There are mixed data demonstrating efficacy of sacral neuromodulation by decade of life, with older individuals most often demonstrating lower odds of progressing to stage 2 implantation. However, a large majority of patients still undergo stage 2 implantation with no significant increase in complications reported when compared to younger cohorts. Neuromodulation is broadening to have wider indications outside of OAB, which may be particularly beneficial in the elderly population (fecal incontinence, nonobstructive urinary retention, and constipation). Posterior tibial nerve stimulation remains a well tolerated and efficacious treatment for OAB, with new FDA-approved implantable devices joining the commercial market, which may expand access for elderly populations. The data are encouraging and support the use of neuromodulation in geriatric patients.

The sensory system is a target for pharmaceutical therapy of overactive bladder

The concept that “the bladder is an unreliable witness” highlights the non-disease-specific nature of lower urinary tract symptoms (LUTS), which can arise regardless of anatomical differences between genders. This non-specificity has led to the broader classification of symptoms under LUTS, which include storage, voiding, and post-micturition symptoms. Overactive bladder (OAB) is characterised by urgency, often accompanied by frequency, nocturia, and, in some cases, incontinence. The symptoms of OAB do not always correlate with urodynamically proven idiopathic detrusor overactivity (IDO), indicating that afferent nerve activity plays a significant role. The complexity of bladder control involves a neural network spanning the brain, spinal cord, and peripheral ganglia. Current therapies, such as anticholinergics and beta-3 agonists, target both motor and sensory pathways, with emerging evidence suggesting that sensory modulation is crucial for effective treatment. Research using animal models has provided insights into the pharmacological mechanisms underlying bladder function, although these models have limitations in replicating human conditions. The importance of the sensory ‘web’ within the bladder’s mucosal and interstitial cell network is emphasised, as it significantly influences bladder compliance and sensory signalling. Recent advances, including the use of Onabotulinum toxin A and sacral neuromodulation, highlight the therapeutic potential of targeting sensory pathways in managing OAB symptoms.

Device-Related Reoperations 8 Years Following Sacral Neuromodulation Implantation in Older Women.

The objective was to describe long-term device-related reoperations at 8years following sacral neuromodulation (SNM) in women older than 65years for the indications of overactive bladder (OAB), fecal incontinence (FI), and/or idiopathic urinary retention (UR). The 2010-2019 Medicare 100% Outpatient Limited Dataset was used to identify women aged 65years and older who underwent SNM to treat OAB, FI, and/or UR. The primary study outcome was any device-related reoperation within 8years following initial implantable pulse generator (IPG) implantation defined as: IPG revision or removal; IPG replacement; or neuro-electrode revision or removal. Kaplan-Meier survival analysis was also performed to evaluate time to adverse event. The cohort included 32,454 women with a mean age of 74years. The most common indication for SNM was OAB (71%) followed by UI and FI (13%) and FI only (8%). Staged SNM procedures were performed more frequently (60%) than percutaneous nerve evaluation/full implants. The overall rate of device-related reoperations was 24% over 8years: 12% of patients underwent removal or revision of the neuro-electrode, 11% underwent removal or revision of the IPG, and 13% underwent replacement of the IPG. The mean follow-up was 3.9 ± 2.4years. The cumulative incidence of any device-related reoperations was 9.4% at 1year, 20% at 3years, and 43% at 8years. In the 8years following SNM implantation, the rate of device-related reoperation among female Medicare beneficiaries was 43%, and staged implants were associated with a 17% lower likelihood of undergoing any device-related reoperations.

Do Prophylactic Postoperative Antibiotics Prevent Sacral Neuromodulation Infections?

There are no definitive guidelines for use of postoperative antibiotics after sacral neuromodulation (SNM) leading to practice pattern variation among health care professionals. The objectives of this study were to determine if additional antibiotics beyond preoperative intravenous antibiotics and surgical preparation decrease postoperative infections and to determine if additional antibiotics are associated with other postoperative complications. This was a single-center, retrospective cohort study of all SNM procedures from 2014 to 2023 performed by 12 surgeons. Cohorts were stratified between patients who received preoperative antibiotics only (OnlyPreAbx) and patients who received both preoperative antibiotics and postoperative antibiotics (PrePostAbx) after either insertion of tined lead and/or after insertion of a neurostimulator. There were 212 patients included in this study: 70 (33.0%) in the OnlyPreAbx group and 142 (67.0%) in the PrePostAbx group. Of patients receiving postoperative antibiotics, 76 (53.5%) received cephalexin, 49 (34.5%) received sulfamethoxazole-trimethoprim, and 17 (12.0%) received alternative antibiotics. Six patients overall (2.8%) experienced infections after SNM. There was no difference in the rates of infection between groups (4 [1.9%] PrePostAbx vs 2 [0.9%] OnlyPreAbx, P = 0.99). Of the 4 patients with postoperative infections in the PrePostAbx group, 2 had cellulitis requiring antibiotics and 2 required full explantation. Of the 2 patients with postoperative infections in the OnlyPreAbx group, both patients required explantation. In a subanalysis comparing infected and noninfected patients, infected patients (n = 6) had higher rates of hypertension (n = 6, 100%; P = 0.02) and diabetes mellitus (n = 3, 50%; P = 0.05). Additional postoperative antibiotics did not decrease infection rates in patients undergoing SNM. Similar comparative analyses should be performed with larger sample sizes.

Gastric and sacral electrical stimulation for motility disorders-A clinical perspective.

Electrical stimulation of the gut has been investigated in recent decades with a view to treating various gastro-intestinal motility disorders including, among others, gastric electrical stimulation to relieve nausea and vomiting associated with gastroparesis and sacral neuromodulation to treat fecal incontinence and/or constipation. Although their symptomatic efficacy has been ascertained by randomized controlled trials, their mechanisms of action are not fully understood. This review summarizes the past year's literature on the mechanisms of action of gut electrical stimulation therapies, including their impact on the gut-brain axis.