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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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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]

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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]

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]

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]

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]

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). [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]

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]

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]

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]

Summary: Fecal incontinence (FI) is a common disease with higher incidence rates in the elderly population. Treatment of affected patients remains challenging and ranges from conservative management to surgical techniques. Despite all efforts patients often undergo several therapeutic measurements to achieve reasonable functional improvements. Although sacral neuromodulation still remains a key therapy with success rates up to 80%, a significant number of patients do not respond sufficiently and require further treatment. Several artificial bowel sphincter devices exist, which can lead to better functional control in selected patients. Notably, complications after these surgeries do occur frequently and the need for implant replacement is still considerable high. A novel anal band, developed by Agency for Medical Innovations (A.M.I., Austria) is currently under evaluation. This device, composed of silicone and polyester, is placed around the anus outside the external sphincter muscle complex aiming to improve stool continence via mechanical pressure. Early results of this new operation are eagerly awaited. [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]

Introduction and hypothesis: Sacral neuromodulation (SNM) is a commonly performed procedure for various conditions. Infection rates range as high as 10% and often require operative explantation with resultant increased cost and morbidity. Pouches impregnated with antibiotic have been utilized in cardiovascular procedures with decreasing infectious complications. TYRX is an antibiotic pouch utilizing minocycline and rifampin manufactured by Medtronic. The objective of this study is to investigate the utility of antimicrobial pouches for patients undergoing SNM. Methods: We retrospectively analyzed our patients undergoing SNM using an antimicrobial pouch and compared them with a historic cohort. Additional variables of interest included post-operative infection, diagnosis of diabetes, weight, and revision case or virgin implant. Results: A total of 170 cases were identified, ranging from March 2017 to November 2022. Overall infection rate was 2.9% with 0 in the antimicrobial pouch cohort (0%) versus 5 in the historic cohort (5.5%; p = 0.04). Groups were similar in terms of body habitus. The group receiving an antimicrobial pouch was noted to be older with a higher percentage of female patients. 85 patients received an antimicrobial pouch and 85 did not. Of the infections, 4 occurred in revision cases (6.9%) and 1 in a virgin implant (0.9%; p = 0.03). No difference was noted in infection rate with regard to a diagnosis of diabetes or body habitus. Conclusion: The use of antimicrobial pouches in SNM is associated with a decreased rate of infectious complications. Revision cases displayed a higher rate of infectious complications. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: Sacral neuromodulation (SNM) has been established as an effective third-line therapy for non-obstructive urinary retention and urinary urgency-frequency syndrome. Device infection, ranging from 2–10%, is a severe complication usually necessitating device explanation. This study sought to demonstrate an infection protocol founded upon established device implantation risk factors and novel approaches to reduce the incidence of device infection, while maintaining good antibiotic stewardship following best practice statements. Methods: A single-surgeon protocol was enacted from 2013 to 2022. Preoperatively, nasal swabs were cultured from each patient. If positive for methicillin-resistant Staphylococcus aureus or methicillin-sensitive Staphylococcus aureus, preoperative treatment with intranasal mupirocin was employed. Preoperative cefazolin was administered in patients with negative cultures or MSSA-positive. All protocol patients were given chlorhexidine wipes before surgery and prepped with a chlorhexidine scrub followed by alcohol/iodine paint. Post-procedural antibiotics were not given. Pre-protocol patients from 2011 to 2013 served as controls. Results: Pre-protocol (n = 87) patients had a significantly higher rate of device infection compared to protocol patients (n = 444) in both the percentage of patients experiencing device infection (4.6% vs 0.9%, p = 0.01) and percentage of procedures associated with device infection (2.9% vs 0.5%, p < 0.05). A successful culture of the nares was achieved in 91.4% of protocol patients, with 11.6% MRSA-positive. Risk ratio for infection of pre-protocol/protocol patients was 0.19 (0.05–0.77) with odds ratio 5.1 (1.3–20.0). Conclusions: Utilization of a novel SNM infection protocol tailored to a patient's preoperative MRSA colonization is associated with a reduction in the overall incidence of explant for device infection while avoiding prolonged postoperative antibiotic regimens. Clinical trial registration: The study was initiated prior to January 18, 2017 and does not meet the definition of an applicable clinical trial (ACT) as defined in section 402 (J) of the US PHS Act. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to evaluate the long‐term cost‐effectiveness of sacral neuromodulation in the treatment of severe faecal incontinence as compared with symptomatic management. Methods: In the public health field, a micro‐costing evaluation method was conducted from the perspectives of the health system and the society. The incremental cost‐effectiveness ratio was used as a decision index, and we considered various scenarios to evaluate the impact of the cost of symptomatic management and percutaneous nerve evaluation success rate in its calculation. Clinical data were retrieved from a consecutive cohort of 93 patients with severe faecal incontinence undergoing sacral neuromodulation after a failure of conservative (pharmacological and biofeedback) and/or surgical (sphincteroplasty) first‐line treatments were considered. Results: The long‐term incremental cost‐effectiveness ratio comparing sacral neuromodulation versus symptomatic management was 14347€/QALY and 28523€/QALY from the societal and health service provider's perspectives, respectively. If the definitive pulse generator implant success rate was 100%, incremental cost‐effectiveness would correspond to 6831€/QALY and 16761€/QALY, respectively. Conclusions: Sacral neuromodulation may be considered a cost‐effective technique in the long‐term treatment of severe faecal incontinence from the societal and health care sector perspectives. Improving patient selection and determining the predictive outcome factors for successful sacral neuromodulation in the treatment of faecal incontinence would improve cost‐effectiveness. [ABSTRACT FROM AUTHOR]

Objective: We systematically assessed all available evidence on the efficacy and safety of sacral neuromodulation (SNM) in pregnancy. Methods: On September 2022, a thorough search was done on Ovid, PubMed, Scopus, ProQuest, Web of Science, and The Cochrane Library. We chose studies that included pregnant women who had SNM previously. Two authors independently evaluated the quality of the study using a standardized tool of JBI. Studies were given a risk of bias rating of low, moderate, or high. Given the descriptive nature of this study, we utilized descriptive statistics to report demographic and clinical features. For continuous variables, we used mean and standard deviation, and for dichotomous data, we used frequencies and percentages. Results: Out of 991 abstracts screened, only 14 studies met our inclusion criteria and were included in the review. Overall, the quality of the evidence available from the literature is low based on the design of the included studies. Fifty‐eight women, including 72 pregnancies, had SNM. The indication of SNM implantation was filling phase disorders in 18 cases (30.5%), voiding dysfunction in 35 women (59.3%), IC/BPS in two cases (3.5%), and fecal incontinence. In 38 pregnancies (58.5%), the SNM status was ON during pregnancy. Forty‐nine cases delivered a full‐term baby (75.4%), 12 cases had pre‐term labor (18.5%), two miscarriages, and two postterm pregnancies happened. The most complications in patients with devices were urinary tract infection in 15 women (23.8%), urinary retention in six patients (9.5%), and pyelonephritis in two cases (3.2%). The findings revealed that when the device was deactivated, 11 cases out of the 23 patients (47.8%) had full‐term pregnancies, while in ON status, 35 out of the 38 pregnant women (92.1%) had full‐term pregnancies. Nine preterm labors in OFF (39.1%), and two in ON status (5.3%) were recorded. The results revealed that this difference was statistically significant (p = 0.002), and those who turned SNM of them off had more preterm labor. Although the studies reported all neonates had a healthy status, two children had chronic motor tic problems and a pilonidal sinus in a case with an active SNM in pregnancy. However, there was no association between the SNM status and pregnancy or neonatal complications (p = 0.057). Conclusion: SNM activation in pregnancy seems safe and effective. The choice of whether to activate or deactivate SNM should be made on an individual basis given the current SNM evidence. [ABSTRACT FROM AUTHOR]

We sought to evaluate the effectiveness and acceptability by patients of transcutaneous sacral roots neuromodulation (TSRN) by paravertebral placement of surface electrodes to treat pelvic pain and pelvic muscle stiffness. Pelvic pain is a disabling condition, often related to non‐relaxing pelvic muscles. Causes for the onset are often unclear; noninvasive treatment targeted at maintenance factors can be administered by nurses in some countries. previous studies have investigated the role of invasive stimulation for pelvic pain; TSRN has proved successful in other pelvic disorders. We conducted a pilot study on a sample of consecutive patients of both genders, reporting pelvic pain (chronic or not). Weekly sessions of TSRN with surface electrodes were performed; pain was recorded with the numeric rating scale (NRS) at baseline and after the end of the rehabilitation plan. Therapeutic success was defined as a reduction of 50% in pain scores. Twenty patients were enrolled, most complaining multiple symptoms apart from pain. Seven males had primary prostate pain syndrome, one had history of orthopaedic surgery, and eight had muscle stiffness (Median = 3 out of 4, IQR = [3;3], range [2;4]). Sixteen patients (12 males and 4 females) had chronic pelvic pain. The median NRS values in the sample at baseline was 4[5.5–7.5] with no significant differences between genders (p = 0.144) and decreased significantly (Me = 0.5, IQR[0.0–1.0], p < 0.001) after a median of 20 weekly sessions (range [10–30]). The results indicated clinically relevant benefit for all patients (ω2 = 0.689, 95%IC[0.505–0.793]) Decrease in pelvic muscle stiffness was significant (from Me = 3, IQR [3] to Me = 0, IQR[0–1], p < 0.0001) without differences between the genders (p = 0.711). No significant difference was found in the number of sessions required by males and females to achieve therapeutic success (p = 0.282). TSRN seems a promising treatment for pelvic pain and can be performed in outpatients' clinics with low costs and no invasivity. Further studies on larger, randomized samples are required to confirm these results. [ABSTRACT FROM AUTHOR]

The treatment of neurogenic bladder (NB) is a challenge because conventional therapy often fails. Sacral neuromodulation (SNM) is a minimally invasive technique and an unconventional treatment for neurogenic bladder. Its research is still in the exploratory stage. The research on its effectiveness and safety is not clear. To assess the effectiveness and safety of sacral neuromodulation (SNM) for neurogenic bladder (NB). By searching the PubMed databases and Cochrane Library databases, combined with the method of literature tracing, the clinical researches and works on neurogenic bladder and sacral neuromodulation therapy were collected. Two reviewers independently selected and extracted data, (1) determine whether the study meets the inclusion criteria and exclude the literature that meets the exclusion criteria. (2) Researchers' screening results and data, if there are differences in the results, will be discussed to eliminate the differences. (3) Read the full text of the literature carefully to determine the final literature to be included. (4) The relevant data of 11 independent studies, a total of 291 patients, were systematically reviewed using review manager 5.3 software. This research included 11 independent studies with a total of 291 patients. The improvements of main outcomes before and after SNM therapy were significant: incontinence episodes /24 h (WMD −2.52; 95%CI-3.14-1.90; p <0.001), frequency/24 h (WMD-5.96; 95%CI −6.27，-5.66; p <0.001), voiding volume (WMD 116.09 mL; 95%CI 86.68，145.51; p <0.001), cystometric capacity (WMD 129.84 mL; 95%CI 100.53, 159.15; p <0.001), post-void residual volume (WMD-198.00 mL; 95%CI-264.60, −131.40; p <0.001), clean intermittent self-catheterization/24 h (WMD-2.48; 95%CI −2.96, −2.00; p <0.001). This systematic review indicated that the sacral neuromodulation treatment for neurogenic bladder was effective and safe. [ABSTRACT FROM AUTHOR]

Purpose: Ulcerative colitis (UC) treatment is mainly based on immunosuppressive therapy. As anti-inflammatory effects of sacral neuromodulation (SNM) have been previously reported in animal models, we conducted a pilot study aimed at assessing clinical, biological, and endoscopic response but also safety of SNM use in UC refractory to medical therapy. Methods: Adult patients with histologically proven UC resistant to immunosuppressive therapy were invited to enroll in the study. Primary outcome was the rate of UC remission (UCDAI score ≤ 2, without any criteria > 1) at 8 weeks (W8). Secondary outcomes were biological and endoscopic response also evaluated at W8 and W16. Subsequently, every patient was followed every 6 months. Adverse events were prospectively collected for safety assessment during the follow-up. Results: Eight patients, with mean age 47 years old, suffering from UC for 2–13 years were included. There were no complications in relation to SNM procedure. The acceptance of the device was excellent in all patients. Clinical and endoscopic remission was obtained at W8 in one patient (12.5%) and three other patients (37.5%) were responders at W16. At review (mean follow-up of 4 years), two patients (25%) were in remission and two (25%) were responders. Conclusion: SNM application is safe in patients suffering from refractory UC. Effects on disease activity were mainly observed after 16 weeks. Larger prospective studies are mandatory, but SNM could be a way to reinforce medical therapy and reduce the use of immunosuppressive drugs. [ABSTRACT FROM AUTHOR]

Fecal incontinence (FI) is a diagnosis that is prevalent but often overlooked. With the devastating effect that FI has on patients, it is imperative that providers have the tools and knowledge to elicit information on FI symptoms from patients and provide management options for this condition. The historical management for patients with FI had not had significantly positive results until the emergence of sacral neuromodulation. This article discusses the historical background of the assessment and management of FI and the surgeries that have transformed treatment options for patients who suffer with this condition. (J GYNECOL SURG 39:142) [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: The objective was to accurately predict patient-centered subjective outcomes following the overactive bladder (OAB) treatments OnabotulinumtoxinA (OBTX-A) injection and sacral neuromodulation (SNM) using a neural network-based machine-learning approach. In the context of treatments designed to improve quality of life, a patient's perception of improvement should be the gold standard outcome measure. Methods: Cutting-edge neural network-based algorithms using reproducing kernel techniques were trained to predict patient-reported improvements in urinary leakage and bladder function as assessed by Patient Global Impression of Improvement score using the ROSETTA trial datasets. Blinded expert urologists provided with the same variables also predicted outcomes. Receiver operating characteristic curves and areas under the curve were generated for algorithm and human expert predictions in an out-of-sample holdout dataset. Results: Algorithms demonstrated excellent accuracy in predicting patient subjective improvement in urinary leakage (OBTX-A: AUC 0.75; SNM: 0.80). Similarly, algorithms accurately predicted patient subjective improvement in bladder function (OBTX-A: AUC 0.86; SNM: 0.96). The top-performing algorithms outcompeted human experts across outcome measures. Conclusions: Novel neural network-based machine-learning algorithms accurately predicted OBTX-A and SNM patient subjective outcomes, and generally outcompeted expert humans. Subtle aspects of the physician–patient interaction remain uncomputable, and thus the machine-learning approach may serve as an aid, rather than as an alternative, to human interaction and clinical judgment. [ABSTRACT FROM AUTHOR]

Copyright of Rehabilitation / Rehabilitacija is the property of University Rehabilitation Institute, Republic of Slovenia 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.)

Aims: Sacral neuromodulation (SNM) is an advanced therapy option for the treatment of overactive bladder (OAB), nonobstructive urinary retention, and fecal incontinence. The aim of this ongoing prospective, multicenter, global, postmarket study is to confirm safety and clinical performance of the InterStimTM Micro system for SNM in all indications. Reported here are the results for the OAB cohort through 6‐month follow‐up. Methods: Eligible OAB subjects that had a successful therapy evaluation were enrolled after implant of an InterStim Micro implantable pulse generator (IPG). Subjects completed voiding diaries and the Overactive Bladder Quality of Life questionnaire (OAB‐q) at baseline and follow‐up visits occurring at 3 months and 6 months postimplant. Safety was evaluated as device‐, procedure‐, or therapy‐related adverse events. The primary objective for the OAB cohort was to demonstrate an improvement in OAB‐q Health Related Quality of Life (HRQL) total score at 3 months postimplant compared to baseline. Results: Sixty‐eight OAB subjects were enrolled and implanted with an InterStim Micro IPG. Of those, 67 and 66 subjects completed the 3‐ and 6‐month follow‐up visits, respectively. The OAB‐q HRQL demonstrated a statistically significant improvement from baseline to 3‐month follow‐up with an average increase of 33 ± 24 points (n = 67, p < 0.001). The change was also observed at 6‐months with an average increase of 31 ± 23 points (n = 65) compared to baseline. Eighty‐two percent of subjects achieved the minimally important difference in HRQL score at 3‐ and 6‐month, respectively, with a change of 10 points or greater. The majority of subjects reported that their bladder condition was better at 3‐month (92.5%, 62/67) and 6‐month (89%, 59/66) compared to before they were treated with SNM therapy delivered by the InterStim Micro system. For subjects with urgency urinary incontinence (UUI), the average change from baseline to follow‐up in UUI episodes/day was −3.6 (95% CI: −4.7, −2.6; n = 62) at 3‐month and −3.7 (95% CI: −4.7, −2.7; n = 61) at 6‐month. Among subjects with urgency‐frequency (UF), the average change from baseline to follow up in voids/day was −4.5 (95% CI: −6.3, −2.7; n = 52) at 3‐months and −4.4 (95% CI: −6.0, −2.7; n = 52) at 6‐month. The cumulative incidence of device‐, procedure‐, or therapy‐ related adverse events was 7.4% (5/68). Out of these five related adverse events, there was one serious adverse event (1.5%, implant site pain) at the time of database snapshot. Conclusions: These data confirm the safety and clinical performance of the InterStim Micro device for subjects with OAB by demonstrating a significant improvement in OAB‐q HRQL score at 3‐month. Similar improvements were observed at 6 months in addition to an incidence of adverse events that is comparable to previously reported rates for SNM. [ABSTRACT FROM AUTHOR]

Introduction/Background: The pulse width (PW) parameter in sacral neuromodulation (SNM) is understudied, with no evidence‐based guidance available on optimal PW for urinary indications. The aim of this prospective, randomized, single‐blinded, 3 × 3 cross over design study was to estimate the effect of two PW settings (60 µs, 420 µs) compared to the industry standard (210 µs) on SNM efficacy, quality of life, and device parameters in patients who were stable and satisfied with their SNM treatment. Methods/Materials: Eligible patients were previously implanted and had urge incontinence or urgency‐frequency with satisfaction on SNM at time of enrollment. Patients completed a 3‐day voiding diary, validated questionnaires, and device interrogations with sensory threshold assessment at baseline and after a 4‐week period on each of the three PW settings, to which they were randomized. Eighteen participants completed the study, as called for by power analysis. Results: Eighteen patients were enrolled in the study. Mean age was 68 years and implant duration at the time of participation was 4.4 years. While PW variations did not produce significant differences in overall objective outcomes, device parameters, including sensory threshold amplitude and battery life differed significantly. Shortened PW necessitated higher amplitude while conserving battery life. Stimulus sensation location, quality, and intensity did not differ between PW. Standard PW was chosen by 11 patients after the study, 5 chose extended, and 2 chose shortened. Those who chose alternative PW achieved significant reductions in urinary frequency from enrollment −2.23 voids/day (p = 0.015). Upon sub‐analysis, patients reporting "much better" or "very much better" on extended PW achieved significant reductions in urinary frequency and nocturia at 5.6 and 0.4, compared to 8.5 and 2.16 at baseline (p = 0.005, p = <0.001). Whereas those reporting "much better" or "very much better" on shortened PW achieved significant reductions in urinary frequency at 5.15 compared to 7.35 (p = 0.026). There were no adverse events or complications. Conclusions: Overall SNM effectiveness was unchanged with alternative PW; however, 39% of patients preferred alternative to standard PW and achieved significant improvements in urinary symptoms with such. Shorter PW can also provide savings in estimated battery life without sacrificing therapeutic efficacy. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: The objective was to evaluate the stability of the urinary microbiome communities in women undergoing sacral neuromodulation (SNM) for urgency urinary incontinence (UUI). We hypothesized that clinical response to SNM therapy would be associated with changes in the urinary microbiome. Methods: Women completed the Overactive Bladder Questionnaire Short-Form, the International Consultation on Incontinence Questionnaire Short Form, and the Female Sexual Function Index at baseline and 3 months post-SNM implantation. Transurethral urinary specimens were obtained for microbiome analysis at baseline and 3 months postoperatively. The V4 region of the 16S rRNA gene (515F-806R) was amplified with region-specific primers, and Amplicon Sequence Variants (ASVs) were identified with a closed-reference approach of taxonomic classification. Alpha-diversity was calculated using the phylogenetic (i.e., Faith's phylogenetic diversity) and nonphylogenetic metrics (i.e., Shannon diversity, and Pielou's evenness) using the QIIME2 plugin. Longitudinal paired volatility analysis was performed using the DEICODE and Gemelli plugin to account for host specificity across both time and space. Results: Nineteen women who underwent SNM and provided both baseline and 3-month urine samples were included in this analysis. Women reported improvement in objective (number of UUI episodes) and subjective (symptom severity and health-related quality of life) measures. Ninety percent of the bacteria were classified as Bacteroidetes, Firmicutes, Proteobacteria, and Actinobacteria. No significant differences were observed in each subject's beta-diversity at 3 months compared with their baseline microbiome. Conclusions: Our descriptive pilot study of a cohort of women who had achieved objective and subjective improvements in UUI following SNM therapy demonstrates that the urinary microbiome remains relatively stable, despite variability amongst the cohort. [ABSTRACT FROM AUTHOR]

Copyright of Colo-Proctology 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.)

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.)

Introduction: Sacral neuromodulation (SNM) is an effective treatment of urinary and bowel dysfunction, including secondary to neurological disorders. The learning curve for the optimal electrode placement for SNM is steep, expensive, and limited by patient factors such as obesity and previous injuries. We aim to create a patient specific 3‐dimensional (3D) model for successful SNM training. Materials and Methods: A total of 26 urology residents who had different level of knowledge and experience were enrolled to the 3D SNM training program. The creation of 3D sacrum model has been started with evaluation of real patient computerized tomography images and creation of Digital Imaging and Communications in Medicine files. The segmented anatomic structures from the files then edited and stereolithographic files were generated for 3D‐model prints via Mimics© software. The 3D‐printed models were used for training and evaluation of participants during the SNM intervention was performed. The evaluation of 3D SNM model training was led by one mentor who is expert on SNM. Results: On the preprinted 3D sacrum model all 26 participants were requested to perform the essential steps to complete a SNM procedure and individual procedure time was recorded. The mean and median scores were 18.8 and 19, respectively according to Likert scores (min 11 max 28). Conclusions: SNM is increasing in popularity as a treatment option with physicians and patients with refractory symptoms. Few experienced specialists exist, and more effective training methods are needed to tackle the increasing demand, and individual patient anatomy. [ABSTRACT FROM AUTHOR]

Background/aim: Sacral neuromodulation (SNM) is a minimally invasive treatment that modulates spinal reflexes to regulate bladder, urinary sphincter, and pelvic floor and has successfully been used in the treatment of refractory voiding dysfunctions. The aim of this study was to present our experience with SNM in a tertiary referral center with the largest number of patients and review the safety and efficacy of the procedure. Materials and methods: A total of 42 patients with refractory lower urinary tract symptoms were included into the study. After an initial test period, patients who showed more than 50% improvement in their symptoms underwent the second stage of SNM. Twelve patients had overactive bladder (OAB), bladder pain syndrome/interstitial cystitis (BPS/IC) and 17 had urinary retention. The clinical success was examined during follow-up by voiding diary, urodynamics, and global response assessment. Results: Between February 2015 and December 2020, a total of 29 patients underwent stages I&II SNM procedures. The mean ages of patients in OAB/BPS group and retention group were 40 (37–57 years) and 35 (27–44 years), respectively. Mean follow-up time was at least 1 year. Overall, 58.5% success rate was observed in OAB, BPS/IC, and urinary retention groups. Global response assessment score in both groups increased significantly (p = 0.001). No statistically significant difference was found between success or failure rates when sex and age were variable parameters (p > 0.05). Conclusion: SNM appears to be an effective and safe treatment option in restoring voiding dysfunctions in patients with refractory idiopathic and neurogenic voiding dysfunctions. Our initial series revealed favorable results; however, further studies with larger series and longer follow-up are needed. [ABSTRACT FROM AUTHOR]

This report describes a 26‐year‐old woman who underwent sacral neuromodulation explant following lead migration and rectal wall penetration. Her device was implanted due to persistent urinary retention. The tined lead wire was dissected to the fascia and cut. The rectal part of the lead was removed with gentle traction. After implanting an SNM lead, complications may not manifest only as urinary symptoms. In our case, lead migration occurred after gastrointestinal symptoms, but without urinary tract symptoms. [ABSTRACT FROM AUTHOR]

Background: The rectosigmoid brake, characterised by retrograde cyclic motor patterns on high‐resolution colonic manometry, has been postulated as a contributor to the maintenance of bowel continence. Sacral neuromodulation (SNM) is an effective therapy for faecal incontinence, but its mechanism of action is unclear. This study aims to investigate the colonic motility patterns in the distal colon of patients with faecal incontinence, and how these are modulated by SNM. Methods: A high‐resolution fibreoptic colonic manometry catheter, containing 36 sensors spaced at 1‐cm intervals, was positioned in patients with faecal incontinence undergoing stage 1 SNM. One hour of pre‐ and post meal recordings were obtained followed by pre‐ and post meal recordings with suprasensory SNM. A 700‐kcal meal was given. Data were analysed to identify propagating contractions. Results: Fifteen patients with faecal incontinence were analysed. Patients had an abnormal meal response (fewer retrograde propagating contractions compared to controls; p = 0.027) and failed to show a post meal increase in propagating contractions (mean 17 ± 6/h premeal vs. 22 ± 9/h post meal, p = 0.438). Compared to baseline, SNM significantly increased the number of retrograde propagating contractions in the distal colon (8 ± 3/h premeal vs. 14 ± 3/h premeal with SNM, p = 0.028). Consuming a meal did not further increase the number of propagating contractions beyond the baseline upregulating effect of SNM. Conclusion: The rectosigmoid brake was suppressed in this cohort of patients with faecal incontinence. SNM may exert a therapeutic effect by modulating this rectosigmoid brake. [ABSTRACT FROM AUTHOR]

Objective: Patients with overactive bladder (OAB) refractory to first‐ and second‐line therapy may pursue third‐line therapies, including intradetrusor onabotulinum toxin‐A (BTX), peripheral tibial nerve stimulation (PTNS), and sacral neuromodulation (SNM). The factors that influence patient preference for each treatment modality have not yet been explored. This study sought to investigate the specific parameters that patients consider in choosing a third‐line therapy for OAB. Methods: Patients refractory to first‐ and second‐line therapies for OAB were identified in our outpatient clinic and asked to watch an educational video providing information on the risks and benefits of each third‐line treatment option. They were then given a questionnaire to rank their preference of therapy and select reasons for why they found each therapy favorable and unfavorable. Patients under age 18 years, non‐English speakers, those with a developmental disability, and those with a diagnosis of neurogenic bladder were excluded. Results: Of the 98 patients included in the study, 40 participants (40.8%) chose intradetrusor BTX injections, 34 (34.7%) chose PTNS, and 16 (16.3%) chose SNM as their first choice. Seven patients (7.1%) chose none of the offered therapies, and one patient (1.0%) chose all three therapies with equal preference. BTX was found most attractive for its long efficacy (47%); its least attractive feature was the potential need for self‐catheterization due to urinary retention (54%). PTNS was found most attractive for being a nonsurgical option (32%) and having no reported significant complications (39%); its least attractive feature was need for frequent office visits (61%). SNM was found most attractive for its potential for long‐term relief without frequent office visits (53%); its least attractive feature was need for an implanted device (33%). Patients opting for SNM had higher scores on Urinary Distress Inventory‐6 and Incontinence Impact Questionnaire‐7 questionnaires when compared to patients opting for BTX injections or PTNS (p < 0.05). 47.4% of patients eventually pursued a third‐line therapy. Of those, there was a 67.6% concordance rate between the therapy patients ranked first and the therapy they eventually underwent. Conclusions: Patients with more severe OAB symptoms opt for more invasive and less time‐consuming therapy with the potential for long‐term relief, namely SNM. Despite thorough counseling, many patients do not progress to advanced OAB therapies. Understanding factors that influence patients' affinity toward a specific type of treatment can aid with individualized counseling on third‐line OAB therapies. [ABSTRACT FROM AUTHOR]

Aims: The basic evaluation or percutaneous nerve evaluation (PNE) is a method to assess pre‐implantation therapeutic response in patients considering sacral neuromodulation for the treatment of refractory overactive bladder. A new PNE lead with a more robust design and greater distensibility designed to reduce the possibility of lead migration has recently been introduced to the market. The aim of this prospective, multicenter, global, postmarket study was to evaluate the clinical performance and safety of the new InterStim PNE lead with the foramen needle. Methods: Patients with overactive bladder were enrolled in this study. The primary objective of this study was to determine the proportion of subjects who demonstrated motor or sensory response(s) during lead placement using the InterStim PNE lead. Additional measures included the Patient Global Impression of Improvement (PGI‐I), patient satisfaction at the end of therapy evaluation, and change in bladder symptoms from baseline to the end of therapy evaluation (1‐week follow‐up visit). Results: One‐hundred and ten subjects met the inclusion and exclusion criteria and underwent a lead implant procedure. Of those, 108 had a successful procedure and 107 completed the 1‐week follow‐up visit. Ninety‐nine percent of subjects (109/110) had a motor or sensory response during needle placement (95% confidence interval [CI]: 95%–100%) and 97% of subjects (107/110) had a motor or sensory response during lead placement (95% CI: 92%–99%). The majority of subjects (88%, 95/108) reported their bladder condition was better at the follow‐up visit compared to before the PNE implant procedure, as reported in PGI‐I. Subjects reported being satisfied with how the therapy impacted their voiding symptoms (82%, 88/108) and that they would recommend this therapy (87%, 94/108) to other patients. Symptom improvement was demonstrated with urinary urge incontinence subjects having an average of 4.2 ± 3.4 urinary incontinence episodes/day at baseline and 2.2 ± 2.5 at follow‐up, and urinary frequency subjects having an average of 12.5 ± 4.4 voids/day at baseline and 10.5 ± 4.3 voids/day at follow‐up. Lead removal was deemed to be easy and safe by the implanting physician, with a total of three adverse device effects in 3/110 subjects. No event was categorized as serious and all were resolved without sequelae. Conclusions: The updated InterStim PNE lead with a more robust design and greater distensibility designed to reduce migration was shown to have a high rate of motor or sensory response during lead placement. Furthermore, subjects reported high rates of global improvements and amelioration of symptoms, and the lead was easy to remove with minimal morbidity. [ABSTRACT FROM AUTHOR]

Aims: Discuss the efficacy, safety, and future directions of neuromodulation in special populations of patients with neurological conditions. Methods: A literature review was done to find meta‐analyses, review articles, studies, and case reports of the use of neuromodulation, either sacral neuromodulation or percutaneous tibial nerve stimulation, in patients with various neurological conditions of interest. Results: Sacral neuromodulation (SNM) and posterior tibial nerve stimulation (PTNS) appear to be safe and effective in special neurological populations of patients with multiple sclerosis (MS), Parkinson's disease (PD), and spinal cord injury (SCI). The majority of publications are smaller retrospective case series. Outcomes appear similar to those seen in nonneurogenic patients but also partly depend on disability progression. Magnetic resonance imaging (MRI) compatibility has helped to improve eligibility for SNM in these special populations. Conclusions: In a small number of studies, SNM and PTNS appear to be safe and effective in special neurological populations of patients with MS, PD, and SCI. MRI compatibility has helped to improve eligibility for SNM in these special populations. Studies looking at SNM are limited by a small number of subjects, lack of prospective trials, and selection bias. Larger, randomized studies with long‐term follow up are needed to better predict response to SNM and PTNS in these populations [ABSTRACT FROM AUTHOR]

Sacral neuromodulation (SNM) is a well-established treatment modality for idiopathic overactive bladder and urgency incontinence, idiopathic fecal incontinence and non-obstructive urinary retention. This study describes the start-up phase of establishing the SNM service. Primary objective: To investigate the patient-reported outcome measures of SNM on lower urinary tract dysfunction symptoms. Secondary objectives: To investigate bowel function, sexual satisfaction and to monitor SNM safety. Twenty-two patients with refractory idiopathic and neurogenic lower urinary tract dysfunction were offered a two-stage test-phase procedure and SNM device implantation. On completing the study, the patients rated their satisfaction with the treatment using a five-point Likert scale and a bother score of urinary, bowel and sexual symptoms on a scale of 1–10 (the worst). Their complications were assessed. Nineteen patients (86%) were responders during the test phase and had the pulse generator implanted. Seventeen patients were very satisfied/satisfied. A statistically significant change in urinary symptoms bother score was observed in the idiopathic and neurogenic patients, a reduction from 10 to 4 (p =.0057) and 10 to 3 (p =.014), respectively. Eleven patients (58%) had symptoms from two or three pelvic compartments. Nine patients (47%) had complications. All but one event was resolved. SNM is safe in this heterogeneous group of patients with refractory lower urinary tract dysfunction of various etiologies. A substantial improvement was observed in the pelvic organ dysfunction, demanding a multidisciplinary approach. More studies are required to standardize the evaluation of the subjective and objective outcomes of SNM. [ABSTRACT FROM AUTHOR]

Patients with a defecation disorder may not evoke a normal defecation reflex, or the reflex may be excessive, as a dysfunction of the spinal autonomic nervous system. Treatment with various forms of lumbar and sacral neuromodulation have shown symptom improvement, but potential changes in autonomic functioning are rarely studied. Here we evaluate the effects on autonomic function of a single session of low-level laser therapy (LLLT) on the lumbar and sacral spine in 41 patients with chronic gastrointestinal motor dysfunction. The LLLT protocol used red LED light at a wavelength of 660 nm for 10 min and infrared LED light at a wavelength of 840 nm for 10 min, followed by infrared laser light at a wavelength of 825 nm for 10 min. Effects on the autonomic nervous system were assessed by measuring heart rate variability (HRV) changes. Respiratory Sinus Arrhythmia (RSA) and Root Mean Square of Successive Differences (RMSSD) were used to quantify parasympathetic reactivity; the Baevsky's Stress Index (SI) reflected sympathetic activity while the ratios SI/RSA and SI/RMSSD were used to show shifts in autonomic dominance. The results indicate that lumbar and sacral neuromodulation using light arrays reduced, whereas stimulation by the laser probes significantly increased parasympathetic activity. The light arrays increased whereas the laser probes significantly decreased sympathetic activity (SI). The entire protocol shifted the autonomic balance toward parasympathetic activity. The comparison of actual vs. sham neuromodulation proved that the change in HRV parameters was due to actual light stimulation and not due to the arrays and probe touching the skin. In conclusion, a single session of LLLT markedly affects autonomic nervous system activity reflected in changes in HRV which is only possible by generating activity in the spinal autonomic nerves. These results warrant a study into the effects of LLLT on restoring autonomic dysfunction in chronic refractory colonic motility disorders. [ABSTRACT FROM AUTHOR]

Background: Sacral neuromodulation (SNM) is a common treatment for patients with urinary and faecal incontinence. A close contact of the tined lead electrode with the targeted nerve is likely to improve functional outcome. The aim of this study was to compare the position of the SNM lead in relation to the sacral nerve by comparing different implantation techniques. Methods: This cadaver study was conducted at the Division of Anatomy of Vienna's Medical University in October 2020. We dissected 10 cadavers after bilateral SNM lead implantation (n = 20), using two different standardized implantation techniques. The cadavers were categorized as group A (n = 10), representing the conventional guided implantation group and group B (n = 10), where SNM implantation was conducted with the novel fluoroscopy-guided "H"-technique. The primary goal was to assess the distance between the sacral nerve and the lead placement. Results: The electrodes were inserted at a median angle of 58.5° (46–65°) in group A and 60° (50–65°) in group B, without reaching statistical significance. In 8 cadavers, the lead entered the S3 foramen successfully. The median distance of the lead to the nerve did not show a significant difference between both groups (E0: Group A: 0.0 mm vs. Group B: 0.0 mm, p = 0.969; E1: Group A: 0.0 mm vs. Group B: 0.5 mm p = 0.754; E2: Group A: 2.5 mm vs. Group B: 2.5 mm p = 1.000; E3: Group A: 3.5 mm vs. Group B: 4.0 mm p = 0.675). In 2 cases (20%) of the conventional group A, the lead was misplaced and located at the gluteal muscle. Perforation of the presacral fascia was observed in one lead placement in group A and in two placements in group B. Conclusions: Both standardized implantation techniques may ensure close electrode proximity to the targeted nerve. Misplacement of the electrode was more often observed with the conventional implantation technique. [ABSTRACT FROM AUTHOR]

Introduction: Sacral neuromodulation (SNM) is third‐line therapy approved for urge urinary incontinence (UUI) and urgency, and nonobstructive urinary retention. Multiple sclerosis (MS) patients often suffer from neurogenic lower urinary tract dysfunction (NLUTD). The utility of SNM in the MS population is limited by magnetic resonance imaging (MRI) incompatibility as routine MRIs to evaluate for disease progression are required. The Axonics System is the first Food and Drug Administration‐approved SNM device that is 1.5/3 T full‐body MRI‐conditionally safe. This study seeks to investigate the symptomatic improvement in MS patients after implantation of the Axonics System. Methods: All MS patients who elected for Axonics SNM from December 2019 to January 2021 were included. Demographics and scores were queried for urogenital distress inventory (UDI‐6), incontinence impact questionnaire (IIQ‐7), and global response assessment (GRA). Results: Fifteen MS patients with UUI were included. The time to follow‐up averaged 121 days. On UDI‐6, 12 patients reported improvement, 1 worsening, and 2 no change. Average UDI‐6 scores before and after implantation were 56.6 and 25.2 (p < 0.0001). Improvements were significant for all questions under stress urinary incontinence, UUI, and voiding difficulty subcategories. On IIQ‐7, 14 patients reported improvement and 1 reported worsening. Average IIQ‐7 scores before and after implantation were 59.0 and 22.2 (p < 0.001). Improvements were significant for travel, social, and emotional subcategories, but not for physical activity. The average GRA score was 6 ("moderately improved"). Conclusion: The majority of MS patients reported significant initial improvement in UUI and associated quality of life measures on validated questionnaires after implantation of the Axonics System. Future studies are needed to determine the long‐term outcomes and durability of this MRI full‐body conditionally‐safe system. [ABSTRACT FROM AUTHOR]