Sacral Neuromodulation Device Research Articles

Sacral neuromodulation device biofilm differs in the absence and presence of infection, harbors antibiotic resistance genes, and is reproducible in vitro.

Sacral neuromodulation (SNM) is effective therapy for overactive bladder refractory to oral therapies, and non-obstructive urinary retention. A subset of SNM devices is associated with infection requiring surgical removal. We sought to compare microbial compositions of explanted devices in the presence and absence of infection, by testing phase, and other clinical factors, and to investigate antibiotic resistance genes present in the biofilms. We analyzed resistance genes to antibiotics used in commercially-available anti-infective device coating/pouch formulations. We further sought to assess biofilm reconstitution by material type and microbial strain in vitro using a continuous-flow stir tank bioreactor, which mimics human tissue with an indwelling device. We hypothesized that SNM device biofilms would differ in composition by infection status, and genes encoding resistance to rifampin and minocycline would be frequently detected. Patients scheduled to undergo removal or revision of SNM devices were consented per IRB-approved protocol (IRB 20-415). Devices were swabbed intraoperatively upon exposure, with controls and precautions to reduce contamination of the surrounding field. Samples and controls were analyzed with next-generation sequencing and RT-PCR, metabolomics, and culture-based approaches. Associations between microbial diversity or microbial abundance, and clinical variables were then analyzed using t-tests and ANOVA. Reconstituted biofilm deposition in vitro using the bioreactor was compared by microbial strain and material type using plate-based assays and scanning electron microscopy. Thirty seven devices were analyzed, all of which harbored detectable microbiota. Proteobacteria, Firmicutes and Actinobacteriota were the most common phyla present overall. Beta-diversity differed in the presence versus absence of infection (p = 0.014). Total abundance, based on normalized microbial counts, differed by testing phase (p < 0.001), indication for placement (p = 0.02), diabetes mellitus (p < 0.001), cardiac disease (p = 0.008) and history of UTI (p = 0.008). Significant microbe-metabolite interaction networks were identified overall and in the absence of infection. 24% of biofilms harbored the tetA tetracycline/minocycline resistance gene and 53% harbored the rpoB rifampin resistance gene. Biofilm was reconstituted across tested strains and material types. Ceramic and titanium did not differ in biofilm deposition for any tested strain. All analyzed SNM devices harbored microbiota. Device biofilm composition differed in the presence and absence of infection and by testing phase. Antibiotic resistance genes including to rifampin and tetracycline/minocycline, which are used in commercially-available anti-infective pouches, were frequently detected. Isolated organisms from SNM devices demonstrated the ability to reconstitute biofilm formation in vitro. Biofilm deposition was similar between ceramic and titanium, materials used in commercially-available SNM device casings. The findings and techniques used in this study together provide the basis for the investigation of the next generation of device materials and coatings, which may employ novel alternatives to traditional antibiotics. Such alternatives might include bacterial competition, quorum-sensing modulation, or antiseptic application, which could reduce infection risk without significantly selecting for antibiotic resistance.

6301732 Anaesthesia for caesarean delivery in a patient with sacral neuromodulation device

6301732 Anaesthesia for caesarean delivery in a patient with sacral neuromodulation device

Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database.

Over 350 000 sacral neuromodulation (SNM) devices have been implanted since approval by the Food and Drug Administration (FDA) in 1998. SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. We aim to provide an updated overview of real-world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation-setting. The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a repository for medical device safety reports. We performed MAUDE categorical (1/1/98-12/31/10) and keyword (1/1/11-9/30/21) searches for "Interstim." A random sample of 1000 reports was reviewed and categorized by theme. To corroborate our MAUDE database analysis, a legal librarian searched the Public Access to Court Electronic Records (PACER) database, as well as Bloomberg Law's dockets database for all lawsuits related to SNM devices. Our search of the MAUDE database returned 44 122 SNM-related adverse events (AEs). The figure illustrates the prevalence of event categories in the random sample. The largest proportion of reports (25.6%) related to a patient's need for assistance with device use, followed by loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 32% of non-shock pain, 30% of lead/device migration, and 27% of painful shock reports. Our legal search revealed only four lawsuits: one for patient complications after an SNM device was used off-label, one case of transverse myelitis after implant, one for device migration or poor placement, and the fourth claimed the device malfunctioned requiring removal and causing permanent injury. This review confirms the real-world safety of SNM devices and very low complication rates as seen in the original clinical trials. Our findings indicate that 43.2% (95% confidence interval 40.1%-46.3%) of SNM "complications" are not AEs, per se, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient, such as battery life. Similarly, the number of lawsuits is shockingly low for a device that has been in the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection-including at least one case in which SNM was used for a non-FDA approved indication-lack of appropriate follow-up, and/or provider inability to assist the patient with utilizing the device after implantation.

Removal of Sacral Neuromodulation Devices Is an Office Procedure

In some instances, sacral neuromodulation (SNM) devices need to be removed. Traditionally, permanent lead and/or implantable pulse generator (IPG) removals are done in the operating room under sedation. Our objective is to present our experience removing SNM components under local in the office. We performed a retrospective chart review from 2017-2022 of SNM lead and IPG removals performed under local anesthesia in the office by a single surgeon. Patient characteristics, outcomes and complications were reported. From 2017-2022 41 SNM leads with and without IPGs were removed in the office using local anesthesia. 88% were female, mean age 66 ± 15.8 years, and mean BMI 28.6 (19.1-49.4). The most common indications for SNM treatment were urgency incontinence (56%) and non-obstructive urinary retention (24%). 44% (18/41) of SNM device removals were leads removed after failed stage I and 56% (23/41) were leads with IPGs removed most commonly for decreased efficacy (52%). In the latter group, median time to removal was 3.1 (0.3-12.3) years, and 52% (12/23) required a separate medial incision for lead retrieval. 9% (2/23) required fluoroscopy, of which, one was planned secondary to BMI 49.4, and the other needed secondary to excessive scar tissue. No stage I failures required fluoroscopy. 7% (3/41) of leads required cutdown to the sacrum for removal with leads in place between 3.1-3.9 years. All leads were removed completely intact and there were no complications. Removal of SNM devices in the office using local anesthesia is effective, well-tolerated, and safe.

Five-year Results from the Prospective, Multicenter, Observational SOUNDS Study of Patients with Overactive Bladder Treated with the InterStim System for Sacral Neuromodulation

BackgroundAlthough sacral neuromodulation (SNM) for overactive bladder (OAB) is an established therapy, there is a lack of high-quality, long-term data on real-life practice. ObjectiveTo report on real-life therapeutic effectiveness, quality of life (QoL), disease severity, and safety as well as patient-reported symptom bother after approximately 5 yr of follow-up. Design, setting, and participantsA total of 291 OAB patients were enrolled at 25 French sites according to local standard of care. Sacral neuromOdUlation with InterStim therapy for intractable lower uriNary tract DySfunctions (SOUNDS) enrolled both de novo and replacement patients, and a total of 229 patients were permanently implanted. Outcome measurements and statistical analysisOver the course of the study, patients were followed up six times with two follow-ups in the year after implantation and annually thereafter. Of the patients, 154 completed the final follow-up after a mean of 57.7 ± 3.9 mo. Results and limitationsThe mean number of daily leaks in urinary urge incontinence (UI) patients was reduced from 4.4 ± 3.3 at baseline to 1.8 ± 2.6 after 5 yr in de novo and from 5.4 ± 4.9 to 2.2 ± 3.0 in replacement patients (both p < 0.001). Likewise, the number of voids in urinary frequency patients was reduced compared with baseline (de novo: reduced from 12.6 ± 4.0 [baseline] to 9.6 ± 4.3 [5 yr]; replacements: reduced from 11.5 ± 4.3 [baseline] to 9.2 ± 3.1 [5 yr]; both p < 0.05). Complete continence rates after 5 yr were 44% (25/57) in de novo and 33% (5/15) in replacement UI patients, and 68% (39/57) and 67% (10/15) of UI patients were categorized as therapy responders by showing a >50% improvement in leaks. Disease severity (Urinary Symptom Profile domain 2), Numeric Rating Scale–based symptom bother, and disease-specific QoL (Ditrovie) improved significantly in both groups at all visits (p < 0.001). Adverse events related to device or procedure occurred in 51% (140/274) of patients, with 66% (152/229) of the events being classified as minor (Clavien-Dindo grade I and II). Surgical revisions were reported in 39% (89/229), which include permanent explants in 15% (34/229) of patients. ConclusionsSOUNDS demonstrates the sustained effectiveness and QoL improvements of SNM in OAB patients after 5 yr in real-world conditions while maintaining an acceptable safety profile consistent with literature. Patient summaryThis study confirmed that French overactive bladder patients had a sustained symptom and bother reduction, and improvements in quality of life up to 5 yr after sacral neuromodulation device implantation.

MP37-02 SACRONEUROMODULATION SAFETY REPORTING: AN ANALYSIS OF THE FDA MAUDE DATABASE

You have accessJournal of UrologyCME1 Apr 2023MP37-02 SACRONEUROMODULATION SAFETY REPORTING: AN ANALYSIS OF THE FDA MAUDE DATABASE Caitlin Carlton, Colby Souders, Nathan Chertack, Ramy Goueli, Gary Lemack, Jennifer Anger, Lynn McClelland, and Maude Carmel Caitlin CarltonCaitlin Carlton More articles by this author , Colby SoudersColby Souders More articles by this author , Nathan ChertackNathan Chertack More articles by this author , Ramy GoueliRamy Goueli More articles by this author , Gary LemackGary Lemack More articles by this author , Jennifer AngerJennifer Anger More articles by this author , Lynn McClellandLynn McClelland More articles by this author , and Maude CarmelMaude Carmel More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003275.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Over 350,000 sacral neuromodulation (SNM) devices have been implanted since approval by the FDA in 1998 (Medtronic, 2022). SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. Here, we provide an updated on real-world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation-setting. METHODS: The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a repository for medical device safety reports. We performed MAUDE categorical (1/1/98-12/31/10) and keyword (1/1/11-9/30/21) searches for “Interstim”. A random sample of 1,000 reports was reviewed and categorized by theme. To corroborate this analysis, a legal librarian searched the Public Access to Court Electronic Records database, as well as Bloomberg Law’s dockets database for all lawsuits related to SNM devices. RESULTS: Our search of the MAUDE database returned 44,122 SNM-related AEs. Figure 1 illustrates the prevalence of event categories in the random sample. The largest proportion of reports (25.6%) related to a patient’s need for assistance with device use followed by loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 32% of non-shock pain, 30% of lead/device migration, and 27% of painful shock reports. Our legal search revealed only 4 lawsuits: patient complications after off-label SNM device use, transverse myelitis after implant, device migration or poor placement, and a claim of device malfunction requiring removal and causing permanent injury. CONCLUSIONS: This review confirms the real-world safety and very low complication rates of SNM devices, as seen in clinical trials. We found that 43.3% of SNM “complications” are not AEs, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient. Similarly, the number of lawsuits is shockingly low for a device that has been on the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection—including at least one case in which SNM was used for a non-FDA approved indication—lack of appropriate follow-up, and/or provider inability to assist the patient with utilizing the device after implantation. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e513 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Caitlin Carlton More articles by this author Colby Souders More articles by this author Nathan Chertack More articles by this author Ramy Goueli More articles by this author Gary Lemack More articles by this author Jennifer Anger More articles by this author Lynn McClelland More articles by this author Maude Carmel More articles by this author Expand All Advertisement PDF downloadLoading ...

MP37-07 COGNITIVE IMPAIRMENT, TECHNOPHILIA, AND SACRAL NEUROMODULATION DEVICE USE IN AN OLDER PATIENT POPULATION WITH OVERACTIVE BLADDER

You have accessJournal of UrologyCME1 Apr 2023MP37-07 COGNITIVE IMPAIRMENT, TECHNOPHILIA, AND SACRAL NEUROMODULATION DEVICE USE IN AN OLDER PATIENT POPULATION WITH OVERACTIVE BLADDER Chen Shenhar, Jacquelyn Booher, Lauren Gleich, Sarah Martin, Glenn T. Werneburg, Emily Slopnick, Sandip P. Vasavada, Bradley Gill, Howard B. Goldman, and Jacqueline Zillioux Chen ShenharChen Shenhar More articles by this author , Jacquelyn BooherJacquelyn Booher More articles by this author , Lauren GleichLauren Gleich More articles by this author , Sarah MartinSarah Martin More articles by this author , Glenn T. WerneburgGlenn T. Werneburg More articles by this author , Emily SlopnickEmily Slopnick More articles by this author , Sandip P. VasavadaSandip P. Vasavada More articles by this author , Bradley GillBradley Gill More articles by this author , Howard B. GoldmanHoward B. Goldman More articles by this author , and Jacqueline ZilliouxJacqueline Zillioux More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003275.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Anticholinergics, a common treatment for overactive bladder (OAB), are associated with new-onset dementia and their use for >3 months was recently cautioned against in all age groups. Non-anticholinergic therapies, including sacral neuromodulation (SNM), should therefore be optimized; however, data on SNM in older or cognitively impaired (CI) populations are limited. The aim of this study was to assess cognitive impairment, technophilia, and device utilization in an older population undergoing SNM for refractory OAB. METHODS: This is a secondary analysis of an ongoing IRB-approved prospective study on cognitive function and SNM outcomes, focusing on technophilia and device utilization. Patients aged ≥60 years undergoing test-phase SNM for refractory OAB were recruited. Cognitive function was assessed using the validated Montreal Cognitive Assessment (MoCA) tool, with scores <26/30 considered CI. Baseline functional status and technology comfort/use were assessed using a novel questionnaire, and OAB symptoms were assessed initially and at follow-up utilizing validated questionnaires (OAB-q SF, IIQ7, UDI-6, PGI-I). Patient device utilization, familiarity with communicator and ability to adjust amplitude/program were recorded at follow-up. Baseline technology use/comfort and post-implant device utilization were compared based on CI. RESULTS: Fifty-eight patients underwent test-phase (36 PNE, 22 Stage 1). Mean age was 73±8 years and 95% were women. Mean MoCA score was 23.1±4.4, and 67% met CI criteria. Forty-nine (85%) had successful test-phase, of which 45 patients have undergone full implant and 38 have available follow-up data. At baseline, patients with CI had lower use and comfort levels with various technologies (Table 1). At mean 4.1±2 months follow-up, patients with CI were less involved in changing programs (p=0.004) or amplitudes (p=0.007) on their own, but patient-reported improvement did not differ (Table 1). CONCLUSIONS: Older patients presenting for SNM for OAB have a high incidence of CI. Despite lower baseline self-reported use/comfort with technology and lower SNM device utilization post-implant among those with CI, patient-reported outcomes appear similar over short-term follow-up. Source of Funding: Investigator initiated Medtronic research grant © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e515 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Chen Shenhar More articles by this author Jacquelyn Booher More articles by this author Lauren Gleich More articles by this author Sarah Martin More articles by this author Glenn T. Werneburg More articles by this author Emily Slopnick More articles by this author Sandip P. Vasavada More articles by this author Bradley Gill More articles by this author Howard B. Goldman More articles by this author Jacqueline Zillioux More articles by this author Expand All Advertisement PDF downloadLoading ...

Sacral neuromodulation: Rechargeable versus non-rechargeable device. What would the patient preferences be in France?

Sacral neuromodulation (SNM) is a minimally invasive technique that provides effective treatment for the management of refractory overactive bladder (OAB), non-obstructive urinary retention (NOUR), and fecal incontinence (FI). This study assessed patient preferences between the currently available non-rechargeable SNM device and a new, full-body magnetic resonance imaging (MRI)-safe, smaller, rechargeable device. An online cross-sectional survey was conducted among French OAB, NOUR, FI patients, recruited via a market research vendor. To assess their preferences, patients were asked to indicate their level of agreement with 10 statements regarding the size of the device, its rechargeability, and the role of MRI using a 6-item Likert scale. A descriptive statistical analysis was performed. In all, 95 patients (68% women), mean age 50 years, were included in the study: 51% were treated for OAB; 44% received an oral treatment and 28% had SNM. Overall, 71% of the 95patients indicated a preference for the new device; 75% considered that recharging the device would not impact their lifestyle; 74% believed that the smaller size of the rechargeable device would facilitate their choice to be treated with SNM; 80% found full-body MRI compatibility important. Most patients may prefer the new rechargeable SNM device over the current "standard". Compatibility with full-body MRI and the smaller device size seemed the key features of the newer device that would influence their choice of being treated with SNM. Future national and international recommendations should consider a shared decision-making process between the physician and the patient.

Head and Neck MRI Imaging Performed Safely in a Patient with Sacral Neuromodulation Device: A Case Report

Introduction: Sacral neuromodulation is a well-established treatment option to manage refractory lower urinary tract and pelvic floor disorders. The technique involves implantation of a lead and an internal pulse generator that delivers electrical impulses to modulate the sacral area. Many patients worldwide have been implanted with MRI-non-compatible devices. Currently, MRI head only can be performed safely in these patients. Therefore, we present a case report of a patient who underwent MRI of the head as well as neck in the presence of a sacral neuromodulator without serious complications. Case Report: A 33-year-old lady known to have systemic lupus erythematosus, refractory overactive bladder, and recurrent urinary tract infection started complaining of right sided neck pain for 3 months in which she required MRI of the head and neck to further assess the nature of the pain. The patient was already implanted with sacral neuromodulator with excellent outcome to manage her refractory overactive bladder. Following careful discussion with the patient and radiologist, MRI study was conducted at 1.5 tesla and total procedure duration was 8 minutes for T1, T2 sagittal and axial cuts. The patient revealed feeling minimal tingling of the right lower limb and mild lower back pain during MRI, all of which disappeared once the study was terminated. Device was functioning well afterwards. Conclusion: MRI may be feasible for certain sacral neuromodulation patients under certain conditions without any serious adverse events.

Evaluation of progression from first to second stage sacral neuromodulation and unplanned device removal.

Sacral neuromodulation (SNM) is an advanced treatment option for patients with refractory overactive bladder (OAB) symptoms, urinary retention, and bowel disorders; it is usually performed in 2 separate procedures. This study aims to determine a cohort's progression rate from stage 1 to 2 and predict factors for progression and unplanned device removal or revision. A retrospective review was conducted in patients who underwent SNM at a single institution between June 2012 and May 2019. Progression rates from stage 1 to 2, patient characteristics, and indications for unplanned SNM removal or revision were recorded. Chi-square, Mann-Whitney U, and Fisher's exact tests were used for data analysis. A total of 128 patients underwent SNM for 1 or more of the following diagnoses: OAB (n=103), urinary retention (n=15), neurogenic bladder dysfunction (n=4), fecal incontinence (n=2), and constipation (n=4). The progression rate to stage 2 was 92.2% (118/128). Patients who failed to progress to stage 2 had additional diagnoses other than OAB, such as urinary retention or bowel disorders (p=0.007). Fifteen patients (12.7%) required SNM removal or revision within 4 years of surgery. Among these patients, the body mass index was significantly lower (p=0.036). Most patients (92.2%) progressed to stage 2. Patients with only OAB symptoms had a higher progression rate to stage 2. Single full-stage procedures may be considered in select patients to reduce morbidity, time, and costs.

The Impact of Fluoroscopy During Percutaneous Nerve Evaluation on Subsequent Implantation of a Sacral Neuromodulator Among Women With Pelvic Floor Disorders: A Randomized, Noninferiority Trial

To evaluate whether percutaneous nerve evaluation (PNE) without fluoroscopy is inferior to fluoroscopy use in women undergoing trials of sacral neuromodulation (SNM) for pelvic floor disorders (PFDs). In an unblinded noninferiority trial, women undergoing PNE were randomized to fluoroscopy or no fluoroscopy. The primary outcome was "success" and defined as implantation of the permanent SNM device within three months of PNE. At an expected 40% success and a 30% noninferiority threshold, 33 participants in each group were needed for 80% power (α = 0.05). Univariate analyses and a logistic regression model adjusting for univariate variables associated with the primary outcome were performed. From April 2016 to December 2018, 74 participants underwent PNE of which 36 underwent PNE with fluoroscopy and 38 without. The fluoroscopy group had less baseline mean daily voids compared to the no fluoroscopy group (10.79 ± 6.48 vs. 16.21 ± 10.05, p = 0.01). PNE performed without fluoroscopy had similar success (18/38, 47.4%) compared to fluoroscopy (21/36, 58.3%), meeting our noninferiority definition (difference 10.9%, 90% CI -8% to 30%, p = 0.049). In a logistic regression model adjusting for age, Charlson comorbidity index, stage of prolapse, and number of baseline voids per day, trial success was still similar between the two groups (adjOR 1.82, 95% CI 0.52 to 6.94, p = 0.36). PNE performed without fluoroscopy is noninferior to PNE with fluoroscopy use for the outcome of SNM device implantation within three months among women undergoing therapy for PFDs.

Improvements in Self-Reported Depression Following Treatment of Fecal Incontinence with Sacral Neuromodulation

To evaluate changes in self-reported depression after treatment of fecal incontinence (FI) with sacral neuromodulation. This is a subanalysis of data collected from March 2016 to October 2017 for an Institutional Review Board-approved retrospective cohort study. Demographic information, medical history, psychiatric comorbidities, and the Patient-Reported Outcomes Measurement Information System item bank t-scores were extracted from the electronic medical record. The differences in t-scores were compared with a two-sided paired t-test, and a p value <0.05 was considered statistically significant. Of the cohort (n = 24), most were Caucasian (88%), female (92%), nonsmokers (92%). Median age was 63.5 years (interquartile range 57.5-71.0 years) and median body mass index was 27.7 kg/m2 (range 18.3-42.9 kg/m2 ). A significant decrease in mean depression t-scores occurred after implantation of a sacral neuromodulation device, -4.5 (95% confidence interval [CI]: -8.7, -0.2, p = 0.04). Self-reported pain interference (p = 0.37) and physical function (p = 0.47) scores were similar following implantation. Individuals with comorbid anxiety reported the greatest improvement in depression (-6.5, 95% CI: -11.8, -1.1, p = 0.02). Treatment of FI with sacral neuromodulation was associated with improvement in self-reported depression with the greatest improvement in those with anxiety. Further prospective research is needed to corroborate these findings.

Long-term outcomes of sacral neuromodulation for lower urinary tract dysfunction: A 23-year experience.

To evaluate the long-term outcomes of sacral neuromodulation (SNM), and patient characteristics that may predict long-term success or complications. A single-center retrospective cohort study was performed of all patients who underwent SNM testing and implantation. Outcome results, resolution of symptoms, and device removal were reported. Multivariable logistic regression was used to identify predictors of success. Cox proportional hazards model was used to identify predictors for device removal. Four hundred and thrity four patients underwent SNM test phase of which 241 (median age 48.0 years, 91.7% [221/241] female) had device implantation and were followed up for median [range] time of 4.0 (3 months-20.5 years) years. Multivariable logistic regression showed that male gender (odds ratio: 0.314; 95% confidence interval: 0.164-0.601, p = .0005) was independently associated with decreased peripheral nerve evaluation success. At final follow-up for patients who originally had device implantation, median (interquartile range) percent of symptoms resolution of all patients was 60.0% (0%-90%) and 69.3% (167/241) had SNM successful outcomes. Cox proportional hazards model showed no difference for time to SNM device removal with respect to patient age, gender, or diagnosis. 69.3% (167/241) patients had at least 1 surgical re-intervention. The most common reason at first surgical re-intervention was lead change only (26.3%, 44/167). SNM is a minimally invasive procedure with good long-term success rates. There is a high revision rate but overall, SNM has a good safety profile and excellent long-term outcomes.

Do you really want to deactivate your sacral neuromodulation device during pregnancy? A single center case series

Introduction and hypothesisThe main objective of the study is to assess the efficacy and safety of sacral neuromodulation (SNM) during pregnancy.MethodsWe retrospectively enrolled patients who underwent SNM implantation in our center and subsequently became pregnant. The indication for SNM, timing of device de-activation (if performed), course of pregnancy and urological complications, duration of labor, childbirth term, delivery mode, congenital abnormalities and SNM dysfunctions after delivery were recorded.ResultsFourteen pregnancies were recorded among 11 women undergoing SNM. Indications for device implantation were urinary retention (7 cases) and dysfunctional voiding (4 cases). Two patients carried on two and three pregnancies, respectively, with the device turned off since the first trimester. They both had to return to self-catheterization and developed recurring urinary tract infections. No major urological complications were recorded among the remaining nine women that kept the device on during pregnancy. A cesarean section was performed in four cases for obstetric reasons, and in seven cases it was planned by the urologist and gynecologist to avoid lead damage/displacement. Three pregnancies resulted in a vaginal delivery, and no association with term of delivery or duration of labor was observed. No congenital abnormalities related to SNM or lead displacement are reported, and only one patient required device removal because of significant loss of efficacy after childbirth.ConclusionsThe use of SNM during pregnancy appears to be safe, without morbidity for the fetus. Moreover, risks associated with switching the device off may be greater than benefits and justify maintaining the electrical stimulation throughout pregnancy.

A rare case of tined lead migration of InterStim device into the rectum with subsequent novel combined surgical-endoscopic removal technique.

After the introduction of self-anchoring tined leads in 2002, lead migration after sacral neuromodulation (SNM) in the form of InterStimTM (Medtronic, Minneapolis, MN) has been reduced; however, it remains a considerable complication of this otherwise low-risk procedure. As intestinal perforation through lead migration or primary incorrect positioning portrays a rarity and has been scarcely reported in the literature, no algorithm for explantation in such cases has been determined. We present a case of a young man with an SNM device implant (InterStim II®) because of neurogenic urinary retention, who was admitted with inflammation, localized at the sacral lead insertion site. Our diagnostic algorithm revealed a tined lead electrode protruding into the rectum without concomitant abscess. We performed an interdisciplinary surgical approach combining regular incisions over the sacrum and buttocks for dissection of the lead and the implanted pulse generator, respectively, with an endoscopic transanal lead extraction. This method prevented further bacterial seeding in the surrounding tissues of the colon and, therefore, presacral abscess formation or sacral osteomyelitis. Combined surgical-endoscopic removal of the InterStim device is an effective and safe procedure that should be included in the armamentarium of urologists performing neuromodulation surgery in cases of intestinal perforation.

523 - Do failure of posterior tibial nerve stimulation precludes to use sacral neuromodulation in patient with overactive bladder?

Purpose To evaluate the outcomes of sacral neuromodulation (SNM) after failure of transcutaneous posterior tibial nerve stimulation (TPTNS) in patients with overactive bladder (OAB). Methods A retrospective study was conducted in 3 university hospitals and included all patients with OAB and treated with SNM after TPTNS had been tried between October 2008 and May 2018. The primary endpoint was the proportion of definitive SNM device implantation in patients with 50% objective and/or subjective improvement after a test period (stage 1). The secondary outcomes of interest were changes of the number of diurnal voids and nocturia episodes per 24 hours between the end of TPTNS and the end of stage 1. Results Overall, 28 of the 43 patients included achieved at least 50% objective and/or subjective improvement during stage 1 and underwent an Interstim II implantation (65.1%). The mean daytime frequency decreased significantly from 10.3/day at the end of TPTNS to 7.8 diurnal voids/day at the end of SNM stage 1 (P=0.01). The mean number of nocturia episodes decreased from 2.5/night at the end of TPTNS to 2.1/night at the end of stage 1, but this did not reach statistical significance (P=0.18). There was no other parameter significantly associated with response to SNM. Conclusion SNM might improve OAB symptoms in most patients who experienced no or poor efficacy with TPTNS. History of failed TPTNS should not preclude the use of SNM in OAB patients.

Five-year single center experience of sacral neuromodulation for isolated fecal incontinence or fecal incontinence combined with low anterior resection syndrome.

Sacral neuromodulation (SNM) has proven to be a safe and effective treatment for fecal incontinence (FI). For low anterior resection syndrome (LARS), however, SNM efficacy is still poorly documented. The primary aim of this study was to report on efficacy of SNM therapy for patients with isolated FI or LARS. Furthermore, we evaluated the safety of the procedure and the relevance of adequate follow-up. A retrospective analysis was performed upon a prospectively maintained database of all patients who underwent SNM therapy for isolated FI or LARS between January 2014 and January 2019. The Wexner and LARS scores were evaluated at baseline, during test phase, after definitive implantation and annually during follow-up. Treatment success was defined as at least 50% improvement of the Wexner score or a reduction to minor or no LARS. Out of 89 patients with isolated FI or LARS who had a SNM test phase, 62 patients were eligible for implantation of the permanent SNM device. At baseline, 3weeks, and 1, 2, 3, 4 and 5years after definitive implantation the median Wexner score of all patients was 18, 2, 4.5, 5, 5, 4 and 4.5, respectively, and 18, 4, 5.5, 5, 4, 3 and 4, respectively, for patients with FI and LARS. Patients with LARS more frequently required changes in program settings. SNM therapy is a safe and effective treatment for patients with isolated FI and patients with FI and LARS. Adequate follow-up is essential to ensure long-term effectivity, especially for LARS patients.

Two-year safety and efficacy outcomes for the treatment of overactive bladder using a long-lived rechargeable sacral neuromodulation system.

AimsSacral neuromodulation (SNM) therapy for overactive bladder (OAB) has proven long‐term safety and efficacy. Historically, the only commercially available SNM device was nonrechargeable requiring replacement surgery due to battery depletion. The Axonics System is the first rechargeable SNM device and is qualified to last a minimum of 15 years in the body. The study objective was to evaluate the safety and efficacy of this rechargeable SNM system. This study reports 2‐year outcomes.MethodsA total of 51 subjects were implanted with the Axonics System in a single nonstaged procedure. Subjects had OAB, confirmed on a 3‐day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72 hours). Test Responders were defined as subjects that were responders at 1 month postimplant. The efficacy analysis included therapy responder rates, change in the quality of life, and subject satisfaction reported in Test Responders (n = 30) and all implanted subjects (n = 37) that completed the follow‐up visits. Adverse events (AEs) are reported in all implanted subjects.ResultsAt 2 years, 90% of the Test Responders continued to respond to the therapy based on voiding diary criteria. Satisfaction with therapy was reported by 93% of subjects and 86% found their charging experience acceptable. Of the urinary incontinence Test Responders, 88% continued to be responders at 2 years, and 28% were completely dry. There were no unanticipated (AEs) or serious device‐related AEs.ConclusionsThe Axonics System® provides sustained clinically meaningful improvements in OAB subjects at 2 years. There were no serious device‐related AEs. Subjects reported continued satisfaction with their therapy.

MP30-03 A NOVEL SACRAL NEUROMODULATION INFECTION PROTOCOL IS ASSOCIATED WITH REDUCTION IN DEVICE INFECTION

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Female Incontinence: Therapy I (MP30)1 Apr 2020MP30-03 A NOVEL SACRAL NEUROMODULATION INFECTION PROTOCOL IS ASSOCIATED WITH REDUCTION IN DEVICE INFECTION Hayden Hill*, Thomas Dukovac, Amy Long, James Conner, and Colin Goudelocke Hayden Hill*Hayden Hill* More articles by this author , Thomas DukovacThomas Dukovac More articles by this author , Amy LongAmy Long More articles by this author , James ConnerJames Conner More articles by this author , and Colin GoudelockeColin Goudelocke More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000869.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Sacral Neuromodulation (SNM) device infection is an expensive and distressing complication that may occur in up to 10% of implants. There are a multitude of possible risk factors for infection including antibiotic selection, skin preparation, as well as duration and modality of pre-implantation testing. We sought to develop an infection protocol in order to minimize the risk of device infection, decrease the use of toxic antibiotic agents, eliminate post-procedure antibiotic prophylaxis, and mitigate the additional risk of staged testing. Analysis of all prior infections in our database demonstrated infection with S. aureus and thus our protocol included screening and treatment of patients for S. aureus colonization of the nares. METHODS: Data were collected prospectively from January 2014 to September 2019 and pre-protocol comparison data from October 2011 to December 2013 were analyzed retrospectively as controls. All patients undergoing SNM procedures underwent nasal swab to screen for S. aureus. Patients with positive nasal cultures were treated with 7 days of intranasal mupirocin and MRSA-positive individuals underwent preoperative prophylaxis with Vancomycin. Patients with negative screening cultures were treated preoperatively with cefazolin unless allergic. Patients undergoing staged-lead testing were evaluated at one week for possible implantation. Any device explant associated with signs or symptoms of infection was recorded as a device infection. No post-procedure prophylaxis was used. RESULTS: A total of 108 SNM procedures in 80 pre-protocol patients and 634 procedures in 383 protocol patients were included. Infection rates were significantly reduced in the protocol group with respect to total procedures (4/108, 3.7% vs 3/634, 0.47%, p=0.0013) and total patients (4/80, 5.0% vs 3/383, 0.78%, p=.0049). Within the protocol group, 84.2% (322/382) of patients were negative for S. aureus, 11.2% (43/382) were MRSA positive, and 4.4% (17/382) were MSSA positive. Patients undergoing full implant after a staged test rather than after successful percutaneous nerve evaluation increased significantly in the protocol group (61.5%, 48/78 vs 99.1%, 241/243, p<.0001). Average duration of staged-lead testing decreased from a mean of 9.7 days (95% CI [8.6-10.8]) to 8.0 days (95% CI [7.6-8.4]). CONCLUSIONS: Instituting an SNM device infection protocol was associated with a significant reduction in rates of infection. Infection rates decreased despite increased rates of staged-lead testing and elimination of post procedure antibiotic prophylaxis. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e438-e439 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hayden Hill* More articles by this author Thomas Dukovac More articles by this author Amy Long More articles by this author James Conner More articles by this author Colin Goudelocke More articles by this author Expand All Advertisement PDF downloadLoading ...

Do Failure of Posterior Tibial Nerve Stimulation Precludes to Use Sacral Neuromodulation in Patient With Overactive Bladder?

PurposeTo evaluate the outcomes of sacral neuromodulation (SNM) after failure of transcutaneous posterior tibial nerve stimulation (TPTNS) in patients with overactive bladder (OAB).MethodsA retrospective study was conducted in 3 university hospitals and included all patients with OAB and treated with SNM after TPTNS had been tried between October 2008 and May 2018. The primary endpoint was the proportion of definitive SNM device implantation in patients with 50% objective and/or subjective improvement after a test period (stage 1). The secondary outcomes of interest were changes of the number of diurnal voids and nocturia episodes per 24 hours between the end of TPTNS and the end of stage 1.ResultsOverall, 28 of the 43 patients included achieved at least 50% objective and/or subjective improvement during stage 1 and underwent an Interstim II implantation (65.1%). The mean daytime frequency decreased significantly from 10.3/day at the end of TPTNS to 7.8 diurnal voids/day at the end of SNM stage 1 (P=0.01). The mean number of nocturia episodes decreased from 2.5/night at the end of TPTNS to 2.1/night at the end of stage 1, but this did not reach statistical significance (P=0.18). There was no other parameter significantly associated with response to SNMConclusionsSNM might improve OAB symptoms in most patients who experienced no or poor efficacy with TPTNS. History of failed TPTNS should not preclude the use of SNM in OAB patients.