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Background: Irritable bowel syndrome (IBS) is a very common condition worldwide. Treatment options for severe IBS are few. Sacral neuromodulation (SNM) for patients with IBS has been shown to reduce symptoms and improve quality of life in the medium term. This study aimed to evaluate the long-term effectiveness and safety of SNM in diarrhoea-predominant and mixed IBS. Methods: A prospective cohort of patients with IBS treated with SNM were evaluated 1, 3, 5, and 10 years after implantation. The primary end-point was a change in the Gastrointestinal Symptom Rating Scale–Irritable Bowel Syndrome version questionnaire (GSRS-IBS) from baseline to 10-year follow-up (FU). Secondary end-points were change in the GSRS-IBS score from baseline to 5-year FU and change in the Irritable Bowel Syndrome–Impact Scale questionnaire (IBS-IS) from baseline to 5- and 10-year FU. Adverse events following SNM were observed. Results: Of 36 patients treated with SNM, 23 were eligible for 5-year FU and 13 for 10-year FU. The GSRS-IBS score was significantly reduced at both 5-year (p < 0.0001) and 10-year (p = 0.0007) FU. The IBS-IS score was also significantly improved at both 5 years (p < 0.0001) and 10 years (p = 0.0002). Fifty-six adverse events were registered. Five patients were explanted because of adverse events. Conclusion: SNM seems to offer an effective and safe treatment option for highly selected patients with diarrhoea-predominant and mixed IBS. Clinical trial registration: The present study has not been registered. The latest founding study was registered at ClinicalTrials.gov, NCT01948973. [ABSTRACT FROM AUTHOR]

Introduction and Hypothesis: The objective was to describe long-term device-related reoperations at 8 years following sacral neuromodulation (SNM) in women older than 65 years for the indications of overactive bladder (OAB), fecal incontinence (FI), and/or idiopathic urinary retention (UR). Methods: The 2010–2019 Medicare 100% Outpatient Limited Dataset was used to identify women aged 65 years and older who underwent SNM to treat OAB, FI, and/or UR. The primary study outcome was any device-related reoperation within 8 years 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. Results: The cohort included 32,454 women with a mean age of 74 years. 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 8 years: 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 ± 2.4 years. The cumulative incidence of any device-related reoperations was 9.4% at 1 year, 20% at 3 years, and 43% at 8 years. Conclusions: In the 8 years 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. [ABSTRACT FROM AUTHOR]

Purpose: Precise electrode placement is crucial for the success of sacral neuromodulation (SNM). The aim of this study was to explore a more accurate and convenient method for positioning punctures during the first stage of SNM. Methods: This retrospective study compared preoperative baseline values, intraoperative indicators, postoperative scores, and other clinical data from 130 patients who underwent SNM electrode implantation at our department between 2018 and 2023. The patients were divided into an experimental group and a control group to assess the advantages and feasibility of augmented reality (AR)-guided sacral nerve electrode implantation. Results: The experimental group experienced fewer intraoperative puncture attempts and achieved more accurate AR-guided localization punctures. Additionally, there were more responsive electrode contact points (2.74±0.51 vs. 2.46±0.74) and a lower initial voltage postimplantation (1.09±0.39 V vs. 1.69±0.43 V). The number of intraoperative x-ray fluoroscopies was significantly lower in the experimental group than in the control group (5.94±1.46 vs. 9.22±1.93), leading to a shorter overall operation time (61.32±11.27 minutes vs. 83.49±15.84 minutes). Furthermore, there was no need for additional local anesthetic drugs during the surgery in the experimental group. Comparative observations revealed no significant differences in intraoperative blood loss or the sacral hole location for electrode implantation between the 2 groups. Although the incidence of wound infection and the rate of permanent implantation in stage 2 were similar in both groups, the pain score on the first day postoperation was significantly lower in the experimental group than in the control group (2.62±0.697 vs. 2.83±0.816). Conclusions: AR-guided sacral nerve modulation implantation can reduce both the number of punctures and the duration of the operation while ensuring safety and effectiveness. This technique can enhance the contact points of the response electrode, effectively lower the initial response voltage, and stabilize the electrode. [ABSTRACT FROM AUTHOR]

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Abstract Background Organophosphate-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 report A 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. Conclusion This patient achieved long-term relief using sacral neuromodulation.

Background: Organophosphate-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 report: A 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. Conclusion: This patient achieved long-term relief using sacral neuromodulation. [ABSTRACT FROM AUTHOR]

Introduction/Purpose: 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. Materials/Methods: 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. Results: 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. Conclusions: 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. [ABSTRACT FROM AUTHOR]

Purpose: Our goal was to assess acute autonomic nervous system (ANS) response to direct sacral nerve root (SNR) stimulation in the context of lower urinary tract dysfunction. Materials and Methods: In this retrospective monocentric study, patients undergoing 2-stage sacral nerve modulation for overactive bladder, nonobstructive urinary retention, or chronic bladder pain syndrome between March 2022 and June 2023 were analyzed. A standardized stimulation protocol was applied during the lead implantation, each of the 4 contact points being sequentially stimulated at the amplitude required to elicit anal motor response. Stimulations were labeled as StimA, StimB, StimC, and StimD, ordered by ascending order of minimum amplitude required for anal motor response. Heart rate variability parameters were collected using PhysioDoloris Monitor, and computed through the time-domain (standard deviation of normal-to-normal intervals [SDNN], root mean square of successive differences), the frequency-domain (low frequency, high frequency) and the graphical (Analgesia Nociception Index [ANI]) methods. Results: Fifty patients were analyzed, including 35 females. Twelve patients had an underlying neurological disease. Efficacy was deemed achieved in 54% of patients. SDNN variability significantly increased during StimA to StimC, while maximum SDNN significantly increased only during StimA. ANI variability significantly increased during all 4 stimulations, while maximum ANI significantly increased only during StimA. Conclusions: Direct stimulation of SNR is responsible for a significant increase in ANS and relative parasympathetic nervous system activity, with a greater effect observed when the stimulation was delivered closer to the SNR. These results shed light on potential mechanisms underlying sacral nerve modulation, particularly regarding the treatment of ANS dysregulation in lower urinary tract dysfunction. [ABSTRACT FROM AUTHOR]

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.

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 (SNM) is an established, highly relevant, surgical therapy for faecal incontinence (FI). The spectrum of indications has evolved over time. Currently, these include a wide variety of pathophysiological and pathomorphological causes. However, they can extend beyond the exclusively faecal to include complex conditions such combined faecal and urinary dysfunction and low anterior resection syndrome (LARS). To improve the outcome of SNM further, crucial elements of the therapy such as electrode placement have been refined and standardized. This article addresses the scope of indications, highlights the results and the role of SNM in the treatment armamentarium of FI, and touches upon current trends.

Purpose This study assessed the long-term outcomes and quality of life in patients who underwent sacral neuromodulation (SNM) due to low anterior resection syndrome (LARS). Methods This single-center retrospective study, conducted from 2005 to 2021, included 30 patients (21 men; median age, 70 years) who had undergone total mesorectal excision with stoma closure and had no recurrence at inclusion. All patients were diagnosed with LARS refractory to conservative treatment. We evaluated clinical and quality-of-life outcomes after SNM through a stool diary, Wexner score, LARS score, the Fecal Incontinence Quality of Life (FIQL) questionnaire, and EuroQol-5D (EQ-5D) questionnaire. Results Peripheral nerve stimulation was successful in all but one patient. Of the 29 patients who underwent percutaneous nerve evaluation, 17 (58.62%) responded well to SNM and received permanent implants. The median follow-up period was 48 months (range, 18–153 months). The number of days per week with fecal incontinence episodes decreased from a median of 7 (range, 2–7) to 0.38 (range, 0–1). The median number of bowel movements recorded in patient diaries fell from 5 (range, 4–12) to 2 (range, 1–6). The median Wexner score decreased from 18 (range, 13–20) to 6 (range, 0–16), while the LARS score declined from 38.5 (range, 37–42) to 19 (range, 4–28). The FIQL and EQ-5D questionnaires demonstrated enhanced quality of life. Conclusion SNM may benefit patients diagnosed with LARS following rectal cancer surgery when conservative options have failed, and the treatment outcomes may possess long-term sustainability.

Introduction: Sacral neuromodulation (SNM) and onabotulinumtoxinA (BoNTA) injection are third‐line therapies for overactive bladder (OAB). Although the efficacy of each third‐line treatment has been well established in clinical trials, there is far less information about performing one third‐line therapy after the other. Our aim is thus to investigate the outcomes of post‐SNM BoNTA and post‐BoNTA SNM as "second" third‐line treatments. Methods: We retrospectively reviewed all OAB patients who had both SNM and BoNTA between 2013 and 2022. The primary endpoint was the response rates (>50% improvements) of the second third‐line treatments. Secondary endpoints were the proportion of the patients who achieved total dry, the duration of treatments of patients who had significant responses, and risk factors that are associated with treatment response or duration of treatments. Results: A total of 172 patients had two third‐line therapies. There were 104 patients who had post‐SNM BoNTA and 68 patients who had post‐BoNTA SNM. In the post‐SNM BoNTA group, 62.5% (65/104) had significant responses after BoNTA treatment. In the post‐BoNTA SNM group, 61.8% (44/68) had significant responses after SNM treatment. The proportions of patients who became dry were 21.2% and 23.5%, respectively. In the post‐SNM BoNTA group, spinal pathology is associated with a lower probability of a significant response (48.9% vs. 73.7%, p‐value = 0.0105). Conclusions: BoNTA or SNM remains a viable option for refractory OAB after patients fail from one another. Spinal pathology is associated with a poorer response of post‐SNM BoNTA. [ABSTRACT FROM AUTHOR]

Copyright of Die Urologie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Even if understanding of neuronal enteropathies, such as Hirschsprung's disease and functional constipation, has been improved, specialized therapies are still missing. Sacral neuromodulation (SNM) has been established in the treatment of defecation disorders in adults. The aim of the study was to investigate effects of SNM in children and adolescents with refractory symptoms of chronic constipation. Methods: A two‐centered, prospective trial has been conducted between 2019 and 2022. SNM was applied continuously at individually set stimulation intensity. Evaluation of clinical outcomes was conducted at 3, 6, and 12 months after surgery based on the developed questionnaires and quality of life analysis (KINDLR). Primary outcome was assessed based on predefined variables of fecal incontinence and defecation frequency. Key Results: Fifteen patients enrolled in the study and underwent SNM (median age 8.0 years (range 4–17 years)): eight patients were diagnosed with Hirschsprung's disease (53%). Improvement of defecation frequency was seen in 8/15 participants (53%) and an improvement of fecal incontinence in 9/12 patients (75%). We observed stable outcome after 1 year of treatment. Surgical revision was necessary in one patient after electrode breakage. Urinary incontinence was observed as singular side effect of treatment in two patients (13%), which was manageable with the reduction of stimulation intensity. Conclusions: SNM shows promising clinical results in children and adolescents presenting with chronic constipation refractory to conservative therapy. Indications for patients with enteral neuropathies deserve further confirmation. [ABSTRACT FROM AUTHOR]

Background: Lumbosacral plexus injury is a highly distressing clinical issue with profound implications for patients' quality of life. Since the publication of the first relevant study in 1953, there has been very limited progress in basic research and clinical treatment in this field, and the developmental trajectory and research priorities in this field have not been systematically summarized using scientific methods, leaving the future direction of this research to be explored. Methods: Utilizing publications from the Web of Science (WoS) database, our research employed bibliometric methodology to analyze the fundamental components of publications, synthesize research trends, and forecast future directions. Results: A total of 150 publications were included in our study, and the impressive advancement of research heat in this field can be attributed to the continuous increase in the number of papers, ranging from 14 papers in 2000 to 34 papers in 2023 over 5 years. Regarding the country, a central position in both quantity (H-index=125) and quality of publications (65 publications) is occupied by the United States, and close collaborations with other countries are observed. In terms of publication institutions, the highest number of publications (nine publications) is held by the Second Military Medical University. The journal with the most publications (five publications) is the Journal of Trauma-Injury Infection and Critical Care. A pivotal role has been played by basic medical research in the development of this field. Concerning hotspots, the focus of the research core can be divided into three clusters (etiology, diagnosis and treatment; molecular, cells and mechanisms; physiology, and pathology). Conclusion: This marks the inaugural bibliometric analysis of lumbosacral plexus injuries, offering a comprehensive overview of current publications. Our findings illuminate future research directions, international collaborations, and interdisciplinary relationships. Future research will emphasize clinical treatment and mechanism research, with a focus on sacral nerve stimulation and nerve transplantation. [ABSTRACT FROM AUTHOR]

Background: Sacral neuromodulation (SNM) is an effective approach for treating lower urinary tract dysfunction (LUTD), and stimulation programming is essential for successful treatment. However, research on SNM programming for various indications is limited. Thus, the authors aimed to determine whether there were differences in the stimulation parameters for different SNM indications and the appropriate programming recommendations. Materials and methods: Clinical data were retrospectively collected from patients with LUTD who underwent SNM and completed internal pulse generator implantation. The parameters with the highest patient satisfaction or the most symptom improvement during the test period were considered optimal and used to set the programming after internal pulse generator implantation. Results: After screening, 282 patients were enrolled and categorized into four groups based on the following indications: refractory overactive bladder (OAB) (n =61), neurogenic lower urinary tract dysfunction (nLUTD) (n= 162), interstitial cystitis/painful bladder syndrome (IC/BPS) (n =24), and idiopathic nonobstructive urinary retention (NOUR) (n= 35). When analyzing the optimal stimulus parameters, disparities in the stimulation amplitude and pulse frequency were noted among the four groups. The stimulation amplitude in the nLUTD group was higher than that in the idiopathic NOUR group (P=0.013). Differences in pulse frequency were observed between the refractory OAB and nLUTD groups (P<0.001) and between the refractory OAB and idiopathic NOUR groups (P =0.001). No differences in the electrode configuration or pulse width settings existed among the four groups. Conclusions: The stimulation parameters for SNM varied among the different indications. For the initial programming of stage I, most patients are recommended to start with stimulation amplitudes below 2 V, although patients with nLUTD may benefit from higher amplitudes. A standard pulse width of 210 µs is recommended for all patients. However, for individuals experiencing nLUTD or idiopathic NOUR, the pulse frequency can begin above the standard 14 Hz but not exceed 50 Hz. [ABSTRACT FROM AUTHOR]

Purpose: Percutaneous Tibial Neuromodulation (PTNM) is used to treat Overactive Bladder (OAB). This analysis summarizes patient adherence to PTNM treatment and examines trends of other third‐line therapy use during and after PTNM. Methods: Optum's deidentified Clinformatics® Data Mart Database (CDM) and CMS Research Identifiable Files were queried for adults with OAB symptoms and who underwent PTNM treatment (2019–2020). We evaluated the proportion of patients who completed 12 visits within 1 year, and defined patients as treatment compliant if 12 PTNM visits were completed within 12 weeks. We then identified the proportion of patients who used other third‐line therapies after PTNM and stratified these patients based on their PTNM therapy compliance status. Results: 2302 patients met selection criteria from CDM and 16,473 patients from CMS. The proportion of patients completing a full PTNM treatment course increased over time; from 16% at week 12% to 42% by week 52 (CDM) and 24% to 38% (CMS). Other third‐line therapy use increased over time and was higher for PTNM noncompliant versus compliant patients at 52 weeks: onabotulinumtoxinA was 6.5% versus 5.7% for noncompliant versus compliant (CMS, p = 0.0661) and 6.4% versus 4.9% (CDM, p = 0.035), SNM trial procedure was 6.5% versus 2.5% (CDM, p = 0.002) and 4.2% versus 2.0% (CMS, p = 0.010). Conclusions: Most patients are noncompliant with recommended PTNM treatment regimen. Albeit low, third‐line therapy was pursued more frequently by noncompliant patients. Given low compliance, the effectiveness of PTNM may be compromised. Alternative implantable technologies may be needed to assure effectiveness of neuromodulation. [ABSTRACT FROM AUTHOR]

Aim: Sacral neuromodulation (SNM) is approved for the treatment of faecal incontinence (FI) in a two‐stage technique. With standardized implantation, approximately 90% of patients undergo successful Stage I operation and proceed to a permanent implant (Stage II). The aim of this work was to explore the feasibility of SNM as a one‐stage procedure and report the 24‐week efficacy. Method: This study included patients diagnosed with idiopathic FI or FI due to an external anal sphincter defect ≤160° and one or more episodes of FI per week despite maximal conservative therapy. Patients were offered a one‐stage procedure if a motor response of the external anal sphincter was achieved in three or more poles with at least one at ≤1.5 mA at lead placement. Patients were followed for 24 weeks. Their evaluation included the Wexner/St Mark's Incontinence Score, Faecal Incontinence Quality of Life score (FIQoL), a visual analogue scale (VAS) for assessing patient satisfaction and a bowel habit diary. Results: Seventy‐three patients with a median age of 60 years (interquartile range 50–69 years) completed this prospective study. Episodes of FI were significantly reduced at the 24‐week follow‐up, from 13 (8–23) at baseline to 2 (0–5) (p‐value = 0002). A ≥50% reduction in the number of FI episodes was achieved in 92% of participants. The Wexner score improved significantly from 16 (14–17) at baseline to 9 (5–13) (p‐value < 0.001), and the St Mark's score improved significantly from 18 (16–20) to 11 (7–16) (p‐value < 0.001). All domains in the FIQoL score and VAS for patient satisfaction improved significantly following the one‐stage procedure. Conclusion: A one‐stage implantation procedure is feasible in selected patients with FI, significantly improving continence, quality of life and patient satisfaction after 24 weeks of follow‐up. [ABSTRACT FROM AUTHOR]

Objective: To retrospectively compare the efficacy and technical performance of a novel lead used for percutaneous nerve evaluation (PNE) during the testing phase for sacral nerve neuromodulation with the existing lead currently used. Materials and methods: Sixty-three PNE leads were inserted in 45 consecutive patients who underwent PNE with the novel helical electrodes, and the intra-operative and return clinic sensory threshold currents were recorded. This resulted in current measurements for 63 individual electrodes. Measurements were compared with 46 consecutive patients who previously underwent PNE using the standard lead with measurements for 63 individual electrodes. Current difference distributions for the two leads were compared using a Wilcoxon signed-rank test. Results: There was a statistically significant difference observed between the two types of PNE electrode. The new PNE lead demonstrated less drift in sensory threshold current during a 12-day test period in comparison to the old lead. Conclusion: The novel helical PNE electrodes demonstrate a significant improvement in current drift compared with the old style leads over a 12-day test period. Level of evidence: Level III [ABSTRACT FROM AUTHOR]

Voiding dysfunction and non-obstructive urinary retention are common conditions with debilitating patient symptoms. Treatment of these conditions can be challenging with limited conservative options available. Sacral Neuromodulation is a minimally invasive treatment which has been demonstrated to deliver good success rates in this patient population. It provides patients with a trial period to establish the likelihood of treatment success prior to implantation of a full system and can be reversed should the need arise.This review looks at the potential mechanisms of action of Sacral Neuromodulation in patients with voiding dysfunction or non-obstructive urinary retention, along with the literature evaluating success rates both in the short and long term. It aims to examine any possible predictive factors that may play a role in guiding patient selection and improving patient counselling. It also addresses gaps in the literature and areas where further research is needed.

Abstract Background A therapeutic effect of sacral neuromodulation (SNM) on fecal incontinence (FI) and quality of life has been proven in adults. SNM is, however, rarely used in pediatric cases. The aim of the study is to investigate effects of SNM in pediatric constipation in a prospective parallel-group trial. Methods A monocentric, randomized, unblinded, parallel-group trial is conducted. SNM is conducted in the invasive variant and in an innovative, external approach with adhesive electrodes (enteral neuromodulation, ENM). We include patients with constipation according to the ROME IV criteria and refractory to conventional options. Patients with functional constipation and Hirschsprung’s disease are able to participate. Participants are allocated in a 1:1 ratio to either SNM or ENM group. Clinical data and quality of life is evaluated in regular check-ups. Neuromodulation is applied continuously for 3 months (end point of the study) with follow-up-points at 6 and 12 months. Findings are analyzed statistically considering a 5% significance level (p ≤ 0.05). Outcome variables are defined as change in (1) episodes of abdominal pain, (2) episodes of FI, (3) defecation frequency, (4) stool consistency. Improvement of proprioception, influence on urinary incontinence, quality of life and safety of treatment are assessed as secondary outcome variables. We expect a relevant improvement in both study groups. Discussion This is the first trial, evaluating effects of neuromodulation for constipation in children and adolescents and comparing effects of the invasive and non-invasive application (SNM vs. ENM). Trial registration The study is registered with clinicaltrials.gov, Identifier NCT04713085 (date of registration 01/14/2021).

Objective: Sacral neuromodulation (SNM) has emerged as an effective therapy for refractory lower urinary tract dysfunction (LUTD). Remote programming holds promise in addressing the time and economic burdens associated with outpatient programming, especially for patients in the observation period following Stage I implant surgery (where the lead is implanted first without the pulse generator). The study aimed to explore the effectiveness and patient satisfaction of remote programming for Stage I SNM patients, and analyze the benefits patients gain from remote programming. Methods: This prospective study was conducted at multiple high-level clinical SNM centres in China. Patients requiring SNM implantation were enroled and divided into two groups based on patient preference: remote programming (RP) group and outpatient control (OC) group. Patient attitudes toward RP were assessed through questionnaires, and the degree of symptom improvement was compared between the two groups to explore the usability of RP. Results: A total of 63 participants from 6 centres were included in the study, with 32 belonging to the RP group. The remote programming system presents a high level of usability (98%) and willingness (satisfaction rate: 96.83%) in result of questionnaire. RP showed a significant advantage in improving patients' score of ICSI/ICPI (medianΔICSI/ICPI RP vs. OC= - 13.50 vs - 2, P=0.015). And slightly ameliorate urinary symptoms such as pain (medianΔVAS RP vs. OC= -1 vs 0, P= 0.164) and urgency (medianΔOBASS - 2.5 vs. -1, P= 0.,229), but the difference was not statistically significant. RP did not significantly impact the quality of life of patients (P=0.113), so do the rate of phase-two conversion (P= 0.926) or programming parameters. Conclusion: To the best of our knowledge, the presented study is the first multicenter research focusing on the remote programming of Stage I SNM patients. Through the clinical implementation and patient feedback, we demonstrate that remote programming is not inferior to in-person programming in terms of success rate, effectiveness, safety, and patient satisfaction. [ABSTRACT FROM AUTHOR]

Aim: Sacral neuromodulation (SNM) is a minimally invasive treatment option for functional constipation. Evidence regarding its effectiveness is contradictory, driven by heterogeneous study populations and designs. The aim of this study was to assess the effectiveness, safety and cost‐effectiveness of SNM in children and adults with refractory idiopathic slow‐transit constipation (STC). Method: OVID Medline, OVID Embase, Cochrane Library, the KSR Evidence Database, the NHS Economic Evaluation Database and the International HTA Database were searched up to 25 May 2023. For effectiveness outcomes, randomized controlled trials (RCTs) were selected. For safety outcomes, all study designs were selected. For cost‐effectiveness outcomes, trial‐ and model‐based economic evaluations were selected for review. Study selection, risk of bias and quality assessment, and data extraction were independently performed by two reviewers. For the intervention 'sacral neuromodulation' effectiveness outcomes included defaecation frequency and constipation severity. Safety and cost‐effectiveness outcomes were, respectively, adverse events and incremental cost‐effectiveness ratios. Results: Of 1390 records reviewed, 67 studies were selected for full‐text screening. For effectiveness, one cross‐over and one parallel‐group RCT was included, showing contradictory results. Eleven studies on safety were included (four RCTs, three prospective cohort studies and four retrospective cohort studies). Overall infection rates varied between 0% and 22%, whereas reoperation rates varied between 0% and 29%. One trial‐based economic evaluation was included, which concluded that SNM was not cost‐effective compared with personalized conservative treatment at a time horizon of 6 months. The review findings are limited by the small number of available studies and the heterogeneity in terms of study populations, definitions of refractory idiopathic STC and study designs. Conclusion: Evidence for the (cost‐)effectiveness of SNM in children and adults with refractory idiopathic STC is inconclusive. Reoperation rates of up to 29% were reported. [ABSTRACT FROM AUTHOR]

Introduction: Staged sacral neuromodulation (SNM) testing has been shown to have a high rate of progression to permanent implantation for the management of voiding dysfunction. Stage 1 lead placement (SNM‐I) can be performed under monitored anesthesia care (MAC) or general anesthesia (GA). MAC allows for interpretation of sensory and motor responses to optimize lead placement while GA only permits for motor assessment. However, patient discomfort and movement can make lead placement challenging during MAC. Herein we evaluate whether the anesthesia type impacts the progression rate to permanent implantation (SNM‐II). Materials and Methods: A retrospective chart review was performed for patients who underwent SNM‐I in the operating room for wet overactive bladder between 2005 and 2023. Patients were divided into two groups based on the type of anesthesia used, MAC or GA. Clinical variables and progression to SNM‐II were compared between cohorts. Progression to SNM‐II was based on ≥50% symptomatic improvement during a 1−2 week trial period following SNM‐I. Results: Of 121 patients included in the study, 95 (79%) underwent MAC and 26 (21%) GA for SNM‐I. No difference in the progression rate to SNM‐II was noted between groups (MAC, 68/95 patients, 72%; GA, 19/26, 73%; p = 0.39). We also found no difference when comparing the GA group to the 26 most recent MAC patients (MAC, 20/26 patients, 77%; GA, 19/26, 73%; p = 0.48). Conclusion: Types of anesthesia for SNM‐I did not affect rate of progression to SNM‐II. The result lends support to the reliance on motor responses alone for lead placement during SNM‐I. [ABSTRACT FROM AUTHOR]

Sacral neuromodulation (SNM) offers a therapeutic approach to urological patients suffering from idiopathic overactive bladder (OAB) syndrome, with or without incontinence and non-obstructive urinary retention (NOR), who are not responding to or are not compliant with conservative or medical therapies. The exact mechanism of action of SNM is not fully understood but modulation of the spinal cord reflexes and brain networks by peripheral afferents is regarded as the main pathway. Over the years, surgical techniques improved, leading to the development of the modern two-stage implantation technique. The quadripolar lead is positioned percutaneously under fluoroscopy guidance through the third sacral foramen following the trajectory of S3. The procedure can be performed under local or general anesthesia with the patient in prone position. Current applications of sacral neuromodulation in urology are increasing thanks to the recent improvements of the devices that make this a valuable option not only in conditions such as overactive bladder and non-obstructing urinary retention but also neurogenic lower urinary tract dysfunction. [ABSTRACT FROM AUTHOR]

Purpose: Utilization patterns of third‐line onabotulinumtoxinA for overactive bladder (OAB) symptoms—including discontinuation and use of other therapeutic options during or after treatment—are not well understood. This retrospective analysis of administrative claims was designed to characterize the unmet need for OAB treatment. Materials and Methods: A retrospective claims analysis of Optum's deidentified Clinformatics® Data Mart Database (2009–2021) was performed among patients with diagnosis of OAB newly starting onabotulinumtoxinA injection (2015–2017). Study measures were evaluated during an 18‐month pretreatment baseline and over a minimum of 36 months of follow‐up. These included number of injections, days between injections, other measures of onabotulinumtoxinA utilization, use of second‐line pharmacologic treatments, use of device and surgical treatment options, and complications. Results: Of 2505 eligible patients, 535 (21.4%; 66.8 ± 13.3 y, 87.3% females) continued onabotulinumtoxinA throughout the study. The remaining 1970 (78.6%; 71.4 ± 11.6 y, 79.1% females) were considered discontinuers. Of continuers, 57% received ≥5 treatments. Of discontinuers, 84% received ≤2 treatments. Anticholinergics and β3‐adrenoceptor agonist medication use declined in all patients from baseline to follow‐up; however, the absolute reduction in the proportion with any medication fill was similar across continuers versus discontinuers (21% vs. 18%, p < 0.0001). Sacral neuromodulation was initiated by 15/535 (3%) of continuers and 137/1970 (7%) of discontinuers (p < 0.0001). No patients initiated percutaneous tibial neuromodulation. Conclusions: Early discontinuation of onabotulinumtoxinA therapy for OAB is common and most discontinuers do not receive alternative treatments. Providers have the opportunity to educate OAB patients with un‐ or undertreated symptoms regarding alternative options. [ABSTRACT FROM AUTHOR]

Neuronal intranuclear inclusion disease is an uncommon neurodegenerative disorder. The diagnosis of this condition has become more definitive based on current research. However, treatment options remain limited. Neurogenic lower urinary tract dysfunction is one of the prevalent and significant complications, which is the result of its multi-system effects. Here, we present the case of a 48-year-old man diagnosed with neuronal intranuclear inclusion disease based on existing evidence and was complicated by neurogenic lower urinary tract dysfunction. Despite undergoing some medical treatments, his lower urinary tract symptoms, including urinary incontinence, incomplete or intermittent voiding, etc, continued to worsen while upper urinary tract injury developed. Based on careful consideration of the patient's condition and the available findings, we performed an unprecedented sacral neuromodulation on him. Implementation of sacral neuromodulation led to significant improvement in his urination function and alleviate kidney function damage. Our case suggests a potential therapeutic role for sacral neuromodulation in the treatment of neurogenic lower urinary tract dysfunction associated with neuronal intranuclear inclusion disease. Additional research is required to determine the effectiveness of sacral neuromodulation in managing neurogenic lower urinary tract dysfunction caused by various etiologies.

Abstract Objective: To show the experience of a Latin American public hospital, with SNM in the management of either OAB, NOUR or FI, reporting feasibility, short to medium-term success rates, and complications. Methods: A retrospective cohort was conducted using data collected prospectively from patients with urogynecological conditions and referred from colorectal surgery and urology services between 2015 and 2022. Results: Advanced or basic trial phases were performed on 35 patients, 33 (94%) of which were successful and opted to move on Implantable Pulse Generator (GG) implantation. The average follow-up time after definitive implantation was 82 months (SD 59). Of the 33 patients undergoing, 27 (81%)reported an improvement of 50% or more in their symptoms at last follow-up. Moreover, 30 patients (90%) with a definitive implant reported subjective improvement, with an average PGI-I "much better" and 9 of them reporting to be "excellent" on PGI-I. Conclusion: SNM is a feasible and effective treatment for pelvic floor dysfunction. Its implementation requires highly trained groups and innovative leadership. At a nation-wide level, greater diffusion of this therapy among professionals is needed to achieve timely referral of patients who require it.

Pelvic disorders affecting both male and female patients are major areas of concern for clinicians in cases where pharmacotherapy and behavioral therapy are not effective. In such cases, pelvic neuromodulation has become an alternative therapy that could relieve chronic pelvic pain and enhance the quality of life. The goal of this paper was to present a summary of the current therapeutic applications of various pelvic neuromodulation techniques and their efficacy in treating patients with a range of pelvic illnesses. Based on the available literature, this review assessed the validity and significance of the last 10 years’ advancements in the fields of sacral neuromodulation (SNM), posterior tibial nerve stimulation (PTNS), and pudendal neuromodulation (PNM), including meta-analyses, randomized controlled trials, and observational, prospective, and retrospective studies.

Abstract In this critical review, we explore the study design, strengths and limitations of the paper: “Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial.” The paper reports 24 month follow-up data of the landmark ROSETTA trial. This multi-centre, open-labelled parallel randomised trial allocated females 1:1 to receive Sacral Neuromodulation (SNM) or OnabotulinumtoxinA(BTX) 200 units (U). The primary outcome was change in mean daily urinary urgency incontinence episodes (UUIE) over 24 months. The study did not demonstrate a difference between treatments (-3.88 vs. -3.50 episodes per day), however women treated with BTX were more satisfied; but reported higher rates of UTI. The two treatments provide comparable third-line treatment options for patients with refractory urgency urinary incontinence.

Introduction Sacral neuromodulation and posterior tibial nerve stimulation for lower urinary tract dysfunction (LUTD) and overactive bladder yield good and reliable results. However, neuromodulation research is continuously evolving because there is still need for more patient-friendly treatment options in the therapeutic management of LUTD. Pudendal neuromodulation (PNM) has been emerging as a promising alternative treatment option for the last few decades. The aim of this study is to review the current state of the art of PNM. Material and methods A wide literature search was conducted in the field of PNM using Medline through the PubMed database and Elsevier using the Scopus database; a critical review of the results was then carried out. PNM has been studied in its various possible aspects: percutaneous PNM, transrectal/transvaginal PNM, and both percutaneous and transcutaneous dorsal genital nerve stimulation. Results Each technique was found to result in promising improvements in different clinical outcomes, with some trials reporting even better results than sacral neuromodulation. Conclusions As a result of a comparison between the various PNM techniques with both sacral neuromodulation and posterior tibial nerve stimulation, we think that PNM should be seen as seriously promising, and we believe it will expand the treatment options for overactive bladder. Even though several studies accordingly showed PNM to be safe and effective, a systematic review and meta-analysis were not feasible. PNM in its various techniques is a promising treatment for LUTD. Nevertheless, further research is needed to include it in treatment algorithms. [ABSTRACT FROM AUTHOR]

Objective: Success following urological procedures is traditionally defined through objective endpoints. This approach may not capture the impact on patient satisfaction. There is a paucity of literature evaluating patient‐centered metrics such as satisfaction and decisional regret in the field of urology. This study investigates long‐term satisfaction and decisional regret amongst patients who underwent sacral neuromodulation (SNM) for the treatment of refractory overactive bladder (OAB). Materials and Methods: This study retrospectively reviewed patients who underwent SNM for refractory OAB from 2015 to 2022 at a single institution serving an ethnically diverse and underrepresented community. Demographic data were collected through chart review and surveys conducted via telephone calls. Patient satisfaction and decisional regret was measured with the validated modified SDS‐DRS scale (satisfaction with decision scale‐decision regret scale). Descriptive statistics, Wilcoxan rank sum, and median regression analyses were performed using STATA 15.0 with p < 0.05 as significant. Results: Out of 191 patients who underwent SNM, 63 were unreachable (wrong number in chart, number not in service, patient did not answer, deceased). Eighty‐nine out of 128 patients reached agreed to participate (70% response rate). The mean time since surgery was 37.3 ±25.2 months. The median satisfaction with decision score was 4.0 (IQR: 3.7−4.7) with a score of 1 correlating with low satisfaction and a score of 5 correlating with high satisfaction. The median decisional regret score was 2.0 (IQR: 1.2−2.9) with a score of 1 correlating with low decisional regret and a score of 5 correlating with strong decisional regret. Ten patients reported complications after surgery, which was significantly associated with lower SDS and higher DRS scores (p < 0.01), and persisted after adjusting for age, body mass index, sex, and comorbidities (SDS β coef: −0.84, 95% CI: −1.5 to 0.15, p = 0.02; DRS β coef: 1.48, 95% CI: 0.55−2.41, p < 0.01). Conclusions: Patients who underwent SNM for refractory OAB overall had low regret and high satisfaction with their decision at an average 3 years of follow‐up. As expected, those who developed postoperative complications had worse scores. The inclusion of patient‐centric outcomes is imperative when determining the success of a surgical procedure and is useful for shared decision‐making when advancing to third‐line therapy for OAB. Longer‐term follow‐up is necessary to assess durability of high satisfaction and low regret over time. [ABSTRACT FROM AUTHOR]

The stimulation paradigm for sacral neuromodulation has remained largely unchanged since its inception. We sought to determine, in rats, whether stimulation-induced increases in bladder capacity correlated with the proportion of sensory pudendal (PudS) neurons at each stimulated location (L6, S1). If supported, this finding could guide the choice of stimulation side (left/right) and level (S2, S3, S4) in humans. Unexpectedly, we observed that acute stimulation at clinically relevant (low) amplitudes [1–1.5 × motor threshold (Tm)], did not increase bladder capacity, regardless of stimulus location (L6 or S1). More importantly for the ability to test our hypothesis, there was little anatomic variation, and S1 infrequently contributed nerve fibers to the PudS nerve. During mapping studies we noticed that large increases in PudS nerve activation occurred at amplitudes exceeding 2Tm. Thus, additional cystometric studies were conducted, this time with stimulation of the L6-S1 trunk, to examine further the relationship between stimulation amplitude and cystometric parameters. Stimulation at 1Tm to 6Tm evoked increases in bladder capacity and decreases in voiding efficiency that mirrored those produced by PudS nerve stimulation. Many animal studies involving electrical stimulation of nerves of the lower urinary tract use stimulation amplitudes that exceed those used clinically (∼1Tm). Our results confirm that high amplitudes generate immediate changes in cystometric parameters; however, the relationship to low-amplitude chronic stimulation in humans remains unclear. Additional studies are needed to understand changes that occur with chronic stimulation, how these changes relate to therapeutic outcomes, and the contribution of specific nerve fibers to these changes. NEW & NOTEWORTHY Acute low-amplitude electrical stimulation of sacral nerve (sacral neuromodulation) did not increase bladder capacity in anesthetized CD, obese-prone, or obese-resistant rats. Increasing stimulation amplitude correlated with increases in bladder capacity and pudendal sensory nerve recruitment. It is unclear how the high-amplitude acute stimulation that is commonly used in animal experiments to generate immediate effects compares mechanistically to the chronic low-amplitude stimulation used clinically. [ABSTRACT FROM AUTHOR]

Introduction: Chronic pelvic pain (CPP) affects over one fifth of women worldwide, and endometriosis is one of the most common causes. In the present study, we examined whether sacral neuromodulation (SNM) is effective in the treatment of refractory chronic pelvic pain in women with endometriosis. Material and methods: This multicenter prospective pilot study was started in 2017 and includes patients with chronic pelvic pain with no other obvious pathology than endometriosis. Other treatment options have been tried or they are unsuitable. Patients underwent SNM implantation. The main outcome was postoperative pain reduction and secondary outcome was quality of life. The following questionnaires were used to assess the outcomes: Brief pain inventory (BPI), clinical global impression ‐ improvement (CGI‐I), 15D‐measure of health‐related quality of life, and Biberoglu and Behrman (B&B) score. Results: A total of 35 patients underwent the SNM procedure and, at the time of analysis, 15 patients had returned one‐year questionnaires. The patients had a history of endometriosis for a median of 5.5 (interquartile range 2–9) years, with no correlation between the severity of symptoms and the duration of the disease (p = 0.158). A total of 31 patients (89%) were implanted with the internal pulse generator. There were statistically significant changes in BPI pain‐related items. Worst experienced daily pain decreased among those who returned 12‐month questionnaires from median 9 to 5 (p = 0.006), average daily pain from 6 to 3.5 (p = 0.004), and least daily pain from 3 to 1 (p = 0.004). Based on the CGI questionnaire (n = 14), at 12 months nine patients (60%) experienced great improvement in their symptoms, three patients (20%) much improvement and two patients (13%) minimal improvement. None of the patients experienced worsening of their symptoms. There was a statistically significant change in overall 15D score at 1 month (p < 0.001), 6 months (p = 0.001) and 12 months (p = 0.018), when the results were compared to baseline values. Median B&B score also improved significantly and decreased from a baseline value of 8 (4–12) to 4.5 (0–6), p = 0.002. Conclusions: Based on the preliminary findings of our study, SNM might be a promising treatment of CPP in endometriosis patients. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to seek predictive factors and develop a predictive tool for sacral nerve modulation (SNM) implantation in patients with non-obstructive urinary retention and/or slow urinary stream (NOUR/SS). Methods: This study was designed as a retrospective study including all patients who have undergone a two-stage SNM for NOUR/SS between 2000 and 2021 in 11 academic hospitals. The primary outcome was defined as the implantation rate. Secondary outcomes included changes in bladder emptying parameters. Univariate and multivariable logistic regression analysis were performed and determined odds ratio for IPG implantation to build a predictive tool. The performance of the multivariable model discrimination was evaluated using the c-statistics and an internal validation was performed using bootstrap resampling. Results: Of the 357 patients included, 210 (58.8%) were finally implanted. After multivariable logistic regression, 4 predictive factors were found, including age (≤ 52 yo; OR = 3.31 CI95% [1.79; 6.14]), gender (female; OR = 2.62 CI95% [1.39; 4.92]), maximal urethral closure pressure (≥ 70 cmH2O; OR: 2.36 CI95% [1.17; 4.74]), and the absence of an underlying neurological disease affecting the lower motor neuron (OR = 2.25 CI95% [1.07; 4.76]). Combining these factors, we established 16 response profiles with distinct IPG implantation rates, ranging from 8.7 to 81.5%. Internal validation found a good discrimination value (c-statistic, 0.724; 95% CI 0.660–0.789) with a low optimism bias (0.013). This allowed us to develop a predictive tool (https://predictivetool.wixsite.com/void). Conclusion: The present study identified 4 predictive factors, allowing to develop a predictive tool for SNM implantation in NOUR/SS patients, that may help in guiding therapeutic decision-making. External validation of the tool is warranted. [ABSTRACT FROM AUTHOR]

AimsSacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® System is the first Food and Drug Administration-approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN-SNM study was designed to evaluate UUI participants treated with the Axonics System. Two-year follow-up results are presented.MethodsOne hundred and twenty-nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3-day voiding diaries, ICIQ-OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post-treatment. As-treated and Completers analyses are presented.ResultsAt 2 years, 93% of the participants (n = 121 Completers at 2 years) were therapy responders, of which 82% achieved ≥ 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 ± 0.3 at baseline to 1.0 ± 0.2 at 2 years. Statistically significant improvements in ICIQ-OABqol were reported. All participants were able to recharge their device and 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device-related adverse events occurred.ConclusionsAt 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant-related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population.

IntroductionFaecal incontinence (FI) is a common condition with a significant impact on quality of life (QoL). Neuromodulation treatments delivered by members of the multidisciplinary team including sacral nerve stimulation (SNS) and percutaneous tibial nerve stimulation (PTNS) are options for FI refractory to conservative management. The aim of this study was to assess whether a successful treatment with one neuromodulation modality corresponds with success in the other.MethodsA retrospective review of a prospectively managed neuromodulation database identified 15 patients who had undergone both PTNS and SNS. The definition of success of each treatment was a >50% improvement in any of The St. Mark's Incontinence Score, Manchester Health Questionnaire, or weekly faecal urgency or FI episodes.ResultsComplete data from 12 patients was available for assessment and PTNS was delivered as the first treatment in nine patients. Overall, seven patients (58%) had successful PTNS treatment, with 10 (83%) having a successful SNS trials. Of the seven patients who had successful PTNS treatment, six patients (85.4%) went on to have success with SNS. Of the five patients who failed PTNS, four (80%) went on to have SNS success. Five (71%) of those who had positive PTNS outcomes had permanent SNS implantation as their final treatment decision.ConclusionThis study suggests that there is no clear relationship between successful PTNS treatment and an SNS trial period which may be explained by differing mechanisms of action or the potential placebo effect of PTNS. Further work is required to investigate any association in larger studies to inform clinical practice.

Chronic pelvic pain conditions such as pudendal neuralgia pose significant treatment difficulty due to their elusive etiology and diverse symptomatology. Initially approved as a third or fourth-line treatment of non-obstructive urinary retention and fecal incontinence, neuromodulation has also proven effective for pelvic pain associated with urinary dysfunction. Recently, sacral and pudendal neuromodulation has demonstrated efficacy in managing a spectrum of chronic pelvic conditions including refractory pudendal neuralgia. The individualized approach of peripheral neuromodulation has opened new avenues for tailored medical interventions, extending its application to conditions such as pudendal neuralgia, post sling pain, and vulvodynia. New technologies leading to miniaturized neuromodulation devices such as Freedom® stimulators (Curonix), allows us to implant leads and modulate nerves at precise pain targets. Further experience and research is needed to assess the impact of targeted neuromodulation on managing complex pelvic pain conditions.