Search

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]

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]

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]

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]

Overactive bladder is a manageable condition, with first-line treatment options including antimuscarinics, beta-3 agonists, and posterior tibial nerve stimulation. Second-line options include onabotulinumtoxin-A bladder injections or sacral nerve stimulation. The choice of therapies should be guided by individual patient factors. Overactive bladder syndrome (OAB) is highly prevalent among women and has a negative impact on their quality of life. The current available treatments for OAB symptoms include conservative, pharmacological, or surgical modalities. To provide an updated contemporary evidence document regarding OAB treatment options and determine the short-term effectiveness, safety, and potential harms of the available treatment modalities for women with OAB syndrome. The Medline, Embase, and Cochrane controlled trial databases and clinicaltrial.gov were searched for all relevant publications up to May 2022. The risk of bias assessment followed the recommended tool in the Cochrane Handbook for Systematic Reviews of Interventions , and quality of evidence was assessed using the modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. A meta-analysis was performed where appropriate. Antimuscarinics and beta-3 agonists were significantly more effective than placebo across most outcomes, with beta-3 agonists being more effective at reducing nocturia episodes and antimuscarinics causing significantly higher adverse events. Onabotulinumtoxin-A (Onabot-A) was more effective than placebo across most outcomes, but with significantly higher rates of acute urinary retention/clean intermittent self-catheterisation (six to eight times) and urinary tract infections (UTIs; two to three times). Onabot-A was also significantly better than antimuscarinics in the cure of urgency urinary incontinence (UUI) but not in the reduction of mean UUI episodes. Success rates of sacral nerve stimulation (SNS) were significantly higher than those of antimuscarinics (61% vs 42%, p = 0.02), with similar rates of adverse events. SNS and Onabot-A were not significantly different in efficacy outcomes. Satisfaction rates were higher with Onabot-A, but with a higher rate of recurrent UTIs (24% vs 10%). SNS was associated with 9% removal rate and 3% revision rate. Overactive bladder is a manageable condition, with first-line treatment options including antimuscarinics, beta-3 agonists, and posterior tibial nerve stimulation. Second-line options include Onabot-A bladder injections or SNS. The choice of therapies should be guided by individual patient factors. Overactive bladder is a manageable condition. All patients should be informed and advised on conservative treatment measures in the first instance. The first-line treatment options for its management include antimuscarinics or beta-3 agonists medication, and posterior tibial nerve stimulation procedures. The second-line options include onabotulinumtoxin-A bladder injections or sacral nerve stimulation procedure. The therapy should be chosen based on individual patient factors. [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]

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]

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]

Aims: Percutaneous tibial nerve stimulation (PTNS) is a simple neuromodulation technique to treat an overactive bladder. It is unclear whether the response to PTNS would suggest a similar response to sacral nerve stimulation (SNS), and whether PTNS could be utilized as an alternative test phase for an SNS implant. This study assessed whether PTNS response was a reliable indicator for subsequent SNS trials. Methods: We performed a retrospective review of the hospital databases to collect all patients who had PTNS and who subsequently had an SNS trial in two tertiary hospitals from 2014 to 2020. Response to both interventions was assessed. A 50% reduction in overactive symptoms (frequency−volume charts) was considered a positive response. McNemar's tests using exact binomial probability calculations were used. The statistical significance level was set to 0.05. Results: Twenty‐three patients who had PTNS subsequently went on to a trial of SNS. All patients except one had previously poor response to PTNS treatment. Eight of them also failed the SNS trial. However, 15 patients (including the PTNS responder) had a successful SNS trial and proceeded with the second‐stage battery implantation. The difference in response rates between the PTNS and SNS trial was statistically significant (p < 0.001). Conclusions: Poor response to PTNS does not seem to predict the likelihood of patients responding to SNS. A negative PTNS trial should not preclude a trial of a sacral nerve implant. The predictive factors for good and poor responses will be the subject of a larger study. [ABSTRACT FROM AUTHOR]

Background: Sacral neuromodulation (SNM) is an advanced therapy that stimulates sacral spinal nerves to modulate bladder or bowel dysfunction and is approved for the treatment of overactive bladder, fecal incontinence, and non-obstructive urinary retention. Prior to implantation, a successful trial period must be performed via percutaneous nerve evaluation (PNE) or a staged trial to assess treatment efficacy. Ideal lead placement in the S3 foramen is imperative to produce an adequate response and successful outcome. Traditional lead placement with fluoroscopic guidance utilizes the anteroposterior (AP) and lateral views. In this abstract we describe an additional modification which may aid lead placement.Objective: This video demonstrates the bullseye technique to obtain S3 foramen access for optimal lead placement in SNM.Methods/material: Begin the procedure by placing the patient in the prone position. The medial edges of the S3 foramen are marked bilaterally in the AP view followed by a horizontal marking at the level of S3. The pelvis is imaged with live fluoroscopy starting at 0 degrees and then rotating the C-arm to 30 degrees. This rotation allows the "opening up" of the S3 foramen from an ellipsoid to an oval. The surgeon grasps the needle with a Kelly clamp, placing it at the level of the skin approximately 2 cm cephalad from the horizontal marking. Live fluoroscopy is performed to align the needle with the image intensifier to form the bullseye. Once the correct angle is identified, the needle is advanced. The procedure is repeated on the contralateral foramen.Results: The bullseye technique allows quick and predictable access into S3. It can potentially decrease operating time, minimize needle entries in PNE, and allows the surgeon to access S3 while maintaining proper medial orientation.Conclusion: The bullseye technique can assist surgeons in obtaining optimal access in SNM and can quickly be integrated into current practices. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to analyze the long-term outcomes of sacral nerve stimulation (SNS) in both idiopathic and neurogenic pelvic floor disorders in patients treated at a referral center. Methods: This retrospective observational study analyzed the records of 106 patients tested at our department from December 1999 to January 2017. The efficacy variables evaluated were the Global Response Assessment (range, 0%-100%) and, according to the clinical indication, other specific variables such International Consultation on Incontinence Questionnaire- Short Form, number of catheterizations or pads/day, and the numerical pain scale. The safety variables analyzed were complications (pain, migration, infection), reinterventions and explants. Patients' quality of life (QoL) and satisfaction with the procedure were evaluated through telephone interviews. Results: The clinical indications were overactive bladder (OAB) (n=36), urinary retention (UR) (n=37), bladder pain syndrome/ interstitial cystitis (BPS/IC) (n=19), fecal incontinence (FI) (n=8), and double incontinence (DI) (n=6). The implant rates according to the clinical indication were as follows: OAB, 55.6%; UR, 56.8%; BPS/IC, 63.15%; FI, 87.5%; and DI, 66.7%. Clinical and/or statistically significant improvements in all efficacy variables were observed. Loss of therapeutic effect at 75 months of follow-up was observed in 34% of patients. Device-related pain appeared in 25 patients (39%); in 20 patients, it was resolved by reprogramming and 5 patients required device removal. An overall improvement in QoL and high levels of satisfaction with the procedure were observed. More than 90% of patients would recommend SNS to a friend or relative. Conclusions: SNS is a minimally invasive procedure that offers a real alternative to patients with refractory pelvic floor dysfunction. Its safety profile is very favorable and it provides a long-lasting improvement in symptoms and QoL. [ABSTRACT FROM AUTHOR]

Intra-operative electrode placement for sacral neuromodulation (SNM) relies on visual observation of motor contractions alone, lacking complete information on neural activation from stimulation. This study aimed to determine whether electrophysiological responses can be recorded directly from the S3 sacral nerve during therapeutic SNM in patients with fecal incontinence, and to characterize such responses in order to better understand the mechanism of action (MOA) and whether stimulation is subject to changes in posture. Eleven patients undergoing SNM were prospectively recruited. A bespoke stimulating and recording system was connected (both intraoperatively and postoperatively) to externalized SNM leads, and electrophysiological responses to monopolar current sweeps on each electrode were recorded and analyzed. The nature and thresholds of muscle contractions (intraoperatively) and patient-reported stimulation perception were recorded. We identified both neural responses (evoked compound action potentials) as well as myoelectric responses (far-field potentials from muscle activation). We identified large myelinated fibers (conduction velocity: 36–60 m/s) in 5/11 patients, correlating with patient-reported stimulation perception, and smaller myelinated fibers (conduction velocity <15 m/s) in 4/11 patients (not associated with any sensation). Myoelectric responses (observed in 7/11 patients) were attributed to pelvic floor and/or anal sphincter contraction. Responses varied with changes in posture. We present the first direct electrophysiological responses recorded from the S3 nerve during ongoing SNM in humans, showing both neural and myoelectric responses. These recordings highlight heterogeneity of neural and myoelectric responses (relevant to understanding MOA of SNM) and confirm that electrode lead position can change with posture. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to determine whether the paradigm of surgical intervention for faecal incontinence (FI) has changed between 2000 and 2013. Method: This was a multi‐centre retrospective study of patients who had undergone either sacral neuromodulation (SNM) or delayed sphincter repair or sphincteroplasty (SR) as a primary surgical intervention for FI in five centres in Europe and one in the United States. The flow of patients according to the intervention, sustainability of the treatment at a minimum follow‐up of 5 years, complications and requirement for further interventions were recorded. Results: A total of 461 patients (median age 56 years, range 24–90 years, 41 men) had either SNM or SR as an index operation during the study period [SNM 284 (61.6%), SR 177 (38.4%)]. Among SNM patients, there were 169 revisional operations (change of battery and/or lead, re‐siting or removal). At the time of last follow‐up 203 patients (71.4%) continued to use SNM. Among SR patients, 30 (16.9%) had complications, most notably wound infection (22, 12.4%). During follow‐up 32 patients (18.1%) crossed over to SNM. Comparing two 4‐year periods (2000–2003 and 2007–2010), the proportion of patients operated on who had a circumferential sphincter defect of less than 90° was 48 (68%) and 45 (46%), respectively (P = 0.03), while those who had SNM as the primary intervention increased from 29% to 89% (P < 0.05). Conclusion: The paradigm of surgical intervention for FI has changed with increasing use of SNM. [ABSTRACT FROM AUTHOR]

Background: Sacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. The purpose of this study was to evaluate the position of SNM electrodes after using a standardized fluoroscopy-guided implantation technique. Methods: For this cadaver study, SNM electrodes were implanted bilaterally in 5 lower body specimens. The lower edge of the sacroiliac joint and the medial edge of the sacral foramina were marked using fluoroscopy to draw an 'H' with the crossing points identifying S3. After electrode placement the pelvis was dissected to describe the exact position of the SNM electrodes. Results: The electrodes were inserted at an angle with a median degree measure of 60° (range 50–65°) to the skin, with a median distance of 9 mm (range 0–13 mm) from the S3 marking. All electrodes entered the third sacral foramen. The median distance of the electrodes to the sacral nerve was 0 mm (range 0–3 mm) for the most proximal, 0.5 mm (range 0–5 mm) for the second, 2.25 mm (range 0–11 mm) for the third and 1.75 mm (range 0–16 mm) for the most distant electrode. There was neither a significant difference in the proximity of the electrodes to the nerve between the right and left side (proximal to distal electrode: p = 0.18, p = 0.16, p = 0.07, p = 0.07) nor between male and female cadavers (p = 0.25, p = 0.21, p = 0.66, p = 0.66). Conclusions: A standardized fluoroscopy-guided implantation technique enables a close contact between electrode and nerve. This can potentially result in an improved clinical outcome. [ABSTRACT FROM AUTHOR]

Aim: Pulse width (PW) influences neuromodulation by its impact on nerve fiber recruitment. A paucity of data regarding the manipulation of PW in sacral neuromodulation (SNM) exists. This study describes the clinical features and outcomes of PW manipulation for unsatisfactory SNM therapy. Methods: A retrospective, single‐institution review was performed of reprogrammed SNM patients between 2010 and 2019. Two cohorts were created: those with PW changes ± program changes and age‐matched controls with program changes alone. Patients lacking follow‐up and non‐InterStim II models were excluded. Results: Out of 710 SNM interrogations, 147 (20.7%) had PW changes and 80 met inclusion criteria. Most PW changes were shortened (61/80, 76.3%). Clinical features did not differ between cohorts except by indication for reprogramming. The most common indication for PW change was painful stimulation (34/80, 43%), whereas in controls it was suboptimal efficacy (76/80, 95%). Clinical success was stratified by indication. There was a higher improvement in efficacy in the PW cohort (61%, 17/28 vs. 36%, 27/76, p =.02). PW manipulation successfully relieved painful stimulation in 50% (17/34 vs. 0/3, p =.23), which was more likely with a shortened compared to extended PW (14/15, 93.3% vs. 0/6, 0%, p <.01). PW resulted in improvement in localization of the stimulus in 94% (17/18 vs. 0/1, p =.10). The subsequent lead revision or explant was significantly higher in the PW cohort (43% vs. 25%, p =.03). Conclusion: PW manipulation may aid the salvage of unsatisfactory SNM therapy. These findings represent an initial assessment of the role of PW in SNM, particularly regarding the efficacy and painful stimuli. The further prospective investigation is warranted. [ABSTRACT FROM AUTHOR]

Aim: The aim of this work was to review our institutional series of patients treated with sacral neuromodulation (SNM) for low anterior resection syndrome (LARS) and evaluate possible factors associated with therapeutic success. Method: Twenty‐five patients were treated with SNM for LARS between 2008 and 2019. SNM was performed as per our institutional protocol. Patients were evaluated with Wexner and LARS scores before and after SNM treatment. A visual analogue scale (1–10) was used to evaluate overall patient satisfaction with SNM. Results: There were significant differences between the mean LARS score values before (37.82) and after (29) SNM therapy (P < 0.004). The mean Wexner score was higher (16.24) before SNM treatment than afterwards (11.13) (P < 0.004). There was a direct relationship between the height of anastomosis and LARS score (P = 0.035): there were big changes in LARS scoring (pre‐/post‐SNM therapy) in patients with higher anastomoses, and vice versa. Patients who received radiotherapy scored lower in mean satisfaction (6.38) than patients without previous radiotherapy (8.22) (P = 0.008). There was an important positive association between Wexner score and patient satisfaction (P = 0.001): relevant changes in Wexner scoring after SNM therapy were associated with high patient satisfaction, and vice versa. Conclusion: Our study showed a relationship between changes in Wexner and LARS scores before and after SNM and overall patient satisfaction with SNM therapy. These findings also suggest patients with previous radiotherapy may have worse results with SNM (based on lower overall satisfaction), and that higher anastomoses have a greater impact on the post‐SNM LARS score. [ABSTRACT FROM AUTHOR]

Purpose: Sacral nerve stimulation is an effective treatment for patients suffering from fecal incontinence. However, less is known about predictors of success before stimulation. The purpose of this study was to identify predictors of successful sacral nerve stimulation in patients with idiopathic fecal incontinence. Methods: Consecutive female patients, receiving peripheral nerve evaluation and sacral nerve stimulation between September 2008 and October 2014, suffering from idiopathic fecal incontinence were included in this study. Preoperative patient's characteristics, anal manometry, and defecography results were collected prospectively and investigated by retrospective analysis. Main outcome measures were independent predictors of treatment success after sacral nerve stimulation. Results: From, all in all, 54 patients suffering from idiopathic fecal incontinence receiving peripheral nerve evaluation, favorable outcome was achieved in 23 of 30 patients after sacral nerve stimulation (per protocol 76.7%; intention to treat 42.6%). From all analyzed characteristics, wide anorectal angle at rest in preoperative defecography was the only independent predictor of favorable outcome in multivariate analysis (favorable 134.1 ± 13.9° versus unfavorable 118.6 ± 17.1°). Conclusions: Anorectal angle at rest in preoperative defecography might present a predictor of outcome after sacral nerve stimulation in patients with idiopathic fecal incontinence. [ABSTRACT FROM AUTHOR]

Purpose: To assess the activation of the different parts of the pelvic floor muscles (PFM) upon electrical stimulation of the sacral spinal nerves while comparing the different lead electrode configurations. Material and Methods: PFM electromyography (EMG) was recorded using an intravaginal multiple array probe with 12 electrodes pairs, which allows to make a distinction between the different sides and depths of the pelvic floor. In addition concentric needle EMG of the external anal sphincter was performed to exclude far‐field recording. A medtronic InterStim tined lead (model 3889) was used as stimulation source. Standard SNM parameters (monophasic pulsed square wave, 210 microseconds, 14 Hz) were used to stimulate five different bipolar electrode configurations (3+0−/3+2−/3+1−/0+3−/1+3−) up to and around the sensory threshold. Of each EMG signal the stimulation intensity needed to evoke the EMG signals as well as its amplitude and latency were determined. Linear mixed models was used to analyse the data. Results: Twenty female patients and 100 lead electrode configurations were stimulated around the sensory response threshold resulting in 722 stimulations and 12 times as many (8664) EMG recordings. A significant increase in EMG amplitude was seen upon increasing stimulation intensity (P <.0001). Large differences were noted between the EMG amplitude recorded at the different sides (ipsilateral>posterior>anterior>contralateral) and depths (deep>center>superficial) of the pelvic floor. These differences were noted for all lead electrodes configurations stimulated (P <.0001). Larger EMG amplitudes were measured when the active electrode was located near the entry point of the sacral spinal nerves through the sacral foramen (electrode #3). No differences in EMG latency could be withheld, most likely due to the sacral neuroanatomy (P >.05). Conclusions: A distinct activation pattern of the PFM could be identified for all stimulated lead electrode configurations. Electrical stimulation with the most proximal electrode (electrode #3) as the active one elicited the largest PFM contractions. [ABSTRACT FROM AUTHOR]

Background: In sacral neuromodulation (SNM) patients, it is thought the bellows response elicited upon sacral spinal nerve stimulation is reflex‐mediated. Therefore the mechanism of action of SNM is considered to be at the spinal or supraspinal level. These ideas need to be challenged. Objective: To identify the neural pathway of the bellows response upon sacral spinal nerve stimulation. Design, Setting, and Participants: Single tertiary center, prospective study (December 2017‐June 2019) including 29 patients with overactive bladder refractory to first‐line treatment. Intervention: Recording of the pelvic floor muscle response (PFMR) using a camcorder and electromyography (EMG) (intravaginal probe and concentric needles) upon increasing stimulation during lead or implantable pulse generator placement. Outcome Measurements and Statistical Analysis: The lowest stimulation intensity needed to elicit a visual PFMR and electrical PFMR was determined. Electrical PFMRs were subdivided according to their latency. Outcome: the association between visual and electrical PFMRs. Statistical analyses were performed using the weighted kappa coefficient. Results: Three different electrical PFMRs could be identified by surface and needle EMG, corresponding with a direct efferent motor response (R1), oligosynaptic (R2), and polysynaptic (R3) afferent reflex response. Only the R1 electrical PFMR was perfectly associated with the visual PFMR (κ = 0.900). Conclusions: The visual PFMRs upon sacral spinal nerve stimulation are direct efferent motor responses. A reopening of the discussion on the mechanism of action of SNM is possibly justified. [ABSTRACT FROM AUTHOR]

Background: Faecal incontinence is a debilitating condition that affects more than 10% of New Zealanders. In well‐selected cohorts, sacral nerve stimulation (SNS) offers a therapeutic option for patients refractory to conservative and other surgical treatments. The aim of this study was to define the clinical efficacy, rate of reinterventions and explants and healthcare costs associated with SNS in the New Zealand setting. Methods: Clinical records of all consecutive patients undergoing SNS at Auckland District Health Board between 2008 and 2019 were retrospectively reviewed and paired with the results of a postal survey to 100 patients who had retained the implant at August 2019. Results: Over the 10‐year period, 142 patients underwent stage 1 SNS, of which 126 (88.7%) progressed to a permanent implant and 108 (76.1%) had retained the implant at a median follow‐up of 41.2 months. SNS therapy significantly reduced weekly faecal incontinence episodes (P < 0.001), medication use (P < 0.001) and pad use (P = 0.01) at median 41.2 months. Complications were common, with infections in 9.2%, lead fractures in 4.9% and component migrations in 12.7%. The probability of retaining the same battery at 6.3 years was >90%. In total, reintervetion was necessary in 41.5% of the cohort. SNS therapy was expensive, costing >NZ$30 000 for implantation, increasing to >NZ$46 000 if a further reintervention was required. Conclusions: SNS is an effective long‐term therapy for faecal incontinence. However, it is expensive and associated with a high rate of reinterventions and explants. [ABSTRACT FROM AUTHOR]

Introduction: Management of idiopathic overactive bladder (iOAB) after the failure of sacral nerve modulation (SNM) is very challenging. To the best of our knowledge, no study has evaluated the use of botulinum toxin A (BoNT‐A) after SNM failure for iOAB. The aim of this study is to evaluate the tolerance and efficacy of BoNT‐A injection after the failure of SNM for iOAB. Methods: We conducted a retrospective multicentric analysis of all patients who had received either onabotulinumtoxinA or abobotulinumtoxinA intradetrusor injection for iOAB after SNM failure, between January 2004 and December 2017. The primary outcome was the percentage of success of first BoNT‐A injection (either resolution of their urinary incontinence or their frequency or more than 50% reduction in frequency). Secondary outcomes were results of urodynamic studies, complications, total number of injections, causes of withdrawal, and subsequent treatment. Results: Seventy‐six patients (62 female) were included. The percentage of success of first BoNT‐A injection was 43.4% (n = 33). All overactive bladder symptoms were significantly improved on the 3‐day bladder diary. Twenty‐eight patients (36.8%) were put under clean intermittent self‐catheterization transitory. After a mean follow‐up of 57.7 (±38.5) months, median number of injections was 2 (1‐15). Overall, 42 patients (55.2%) stopped injections during follow‐up. The estimated 36‐months discontinuation‐free rate was 48.1%. Mean cause of discontinuation was a primary failure (n = 32; 42.1%). Conclusion: BoNT‐A can be used in SNM nonresponders with a success rate of 43.4% but is associated with a high long‐term discontinuation rate. [ABSTRACT FROM AUTHOR]

Introduction and Objectives: Technology has brought about changes to the sacral neuromodulation (SNM) therapy and has rendered it as a minimally invasive procedure. The presence of tined lead, smaller implantable pulse generator, and the different available patient programmers are the factors new modifications this procedure; however, no enough data are available about patient satisfaction comparing these different parameters. We therefore conducted our study among SNM-implanted patients, assessing factors affecting long-term satisfaction. Patients and Methods: We conducted a cross-sectional study with a survey questionnaire for all SNM-implanted patients from December 2011 to May 2012. The survey questionnaire included information on patient demographics, level of satisfaction, and the need for combined medical therapy for symptom control, type of programmer used by patient, and their ability to use it efficiently. Results: A total of 117 patients visited the clinic in that duration, and 71 patients filled up the survey questionnaire, with a response rate of 60.7%, diagnosis OAB 41 (57.7%), chronic non-obstructive retention 15 (21.1%) and frequency-urgency syndrome 15 (21.1%). Forty-nine (69%) of patients were on SNM therapy alone, while 31% patients needed other forms of therapy for symptoms control. The types of patient programmers used were old programmers in 10 (14.1%), new programmers in 44 (62%), and twin programmers in 4 patients. Patient SNM therapy satisfaction level was 95.8%, while 3 patients (4.2%) were not satisfied. SNM therapy satisfaction showed that it was correlated with the need for combined therapy for symptoms control (correlation coefficient 0.341, p value = 0.004), but there was no correlation with age, duration of therapy, complication, or programmer type. Conclusion: SNM satisfaction in patients is mainly correlated with the need for additional medications for symptom control. [ABSTRACT FROM AUTHOR]

Aims: Botulinum toxin A (BTX‐A), sacral nerve stimulation (SNM), and posterior tibial nerve stimulation (PTNS) are established treatments for idiopathic overactive bladder (OAB) refractory to oral drug therapy. At the ICI‐RS meeting in Bristol in 2018 a think tank was convened to address the question of how to better manage drug‐resistant OAB/DO (detrusor overactivity). Methods: The think tank conducted a literature review and an expert consensus meeting focusing on the evidence for predicting response and adverse events (AEs) with the current therapies for drug‐resistant idiopathic OAB. Results: Several factors have been associated with poor outcomes using BTX‐A including increasing age, body mass index, male sex, and frailty. Voiding dysfunction with BTX‐A also appears to be more prevalent in those with increasing age, male sex, higher baseline postvoid residual and with poorer contractility as assessed by urodynamic parameters. SNM full implantation appears to be higher with the first stage tined lead placement procedure compared to percutaneous nerve evaluation. Urodynamics do not appear to predict outcomes with SNM. Patients with psychiatric comorbidity are more likely to experience AEs with SNM. Outcomes related to lead positioning and the number of active electrodes are mixed in predicting long term success. Patients with increased daytime frequency and lower first sensation of bladder filling were independent factors associated with success with PTNS. Conclusions: Further research is required to optimize these procedures and to better understand which patients will benefit from the various options available in managing refractory OAB. [ABSTRACT FROM AUTHOR]

Aim: Low anterior resection syndrome (LARS) can affect up to 70% of all patients with rectal cancer. In the last two decades, sacral nerve stimulation (SNS) has emerged as an effective treatment for faecal incontinence. There is some encouraging literature on the use of SNS in patients with LARS. The purpose of this review is to provide an up to date review on the utility of SNS on LARS. Method: A literature search was conducted using the MEDLINE, Embase and PubMed databases (January 1981–March 2019). Studies identified were appraised with standard selection criteria. Data points were extracted, and meta‐analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses. Results: Ten studies met the inclusion criteria and were included in this study. All studies used the Cleveland Clinic Incontinence Score (CCIS), whereas the low anterior resection syndrome score (LARS score) was used in three studies. Overall median improvement in the scoring system was 67.0% (range 35.5%–88.2%) after SNS implantation. There was a significant reduction in CCIS after SNS implantation (mean difference 11.23, 95% confidence interval 9.38–13.07, Z = 11.90, P < 0.00001). The LARS score was also significantly reduced after using SNS in patients with LARS (mean difference 17.87, 95% confidence interval 10.15–25.59, Z = 4.54, P < 0.00001). Conclusion: Use of SNS may provide symptomatic benefits for patients with LARS refractory to medical therapy. However, the current level of evidence remains limited. A large multicentre study of SNS for LARS using the validated LARS score is warranted. In addition, the cost‐effectiveness of SNS for patients with LARS needs further exploration. [ABSTRACT FROM AUTHOR]

Aims: To examine the impact of frailty on treatment outcomes for overactive bladder (OAB) in older adults starting pharmacotherapy, onabotulinumtoxinA, and sacral neuromodulation. Methods: This is a prospective study of men and women age ≥60 years starting pharmacotherapy, onabotulinumtoxinA, or sacral neuromodulation. Subjects were administered questionnaires at baseline and again at 1‐ and 3‐months. Frailty was assessed at baseline using the timed up and go test (TUGT), whereby a TUGT time of ≥12 seconds was considered to be slow, or frail. Response to treatment was assessed using the overactive bladder symptom score (OABSS) and the OAB‐q SF (both Bother and HRQOL subscales). Information on side effects/adverse events was also collected. Mixed effects linear modeling was used to model changes in outcomes over time both within and between groups. Results: A total of 45 subjects enrolled in the study, 40% (N = 18) of whom had a TUGT ≥12 seconds. Both TUGT groups demonstrated improvement in OAB symptoms over time and there were no statistically significant differences in these responses per group (all P‐values >.05). Similar trends were found for both OAB‐q SF Bother and OAB‐q SF HRQOL questionnaire responses. Side effects and adverse events were not significantly different between groups (all P's >.05). Conclusions: Adults ≥60 years of age starting second‐ and third‐line treatments for OAB, regardless of TUGT time, demonstrated improvement in OAB symptoms at 3 months. These findings suggest that frail older adults may receive comparable benefit and similar rates of side effects compared with less frail older individuals. [ABSTRACT FROM AUTHOR]

The urinary bladder has two functions: urine storage and voiding. Clinically, two major categories of lower urinary tract symptoms can be defined: storage symptoms such as incontinence and urgency, and voiding symptoms such as feeling of incomplete bladder emptying and slow urinary stream. Urgency to void with or without incontinence is called overactive bladder (OAB). Slow urinary stream, hesitancy, and straining to void with the feeling of incomplete bladder emptying are often called underactive bladder (UAB). The underlying causes of OAB or UAB can be either non-neurogenic (also referred to as idiopathic) and neurogenic, for example due to spinal cord injury or multiple sclerosis. OAB and UAB can be treated conservatively by lifestyle intervention or medication. In the case that conservative treatment does not provide sufficient benefit, electrical stimulation can be used. Sacral neurostimulation or neuromodulation (SNM) is offered as a third-line therapy to patients with non-neurogenic OAB or UAB. In SNM, the third or fourth sacral nerve root is stimulated and after a test period, a neuromodulator is implanted in the buttock. Until recently only a non-rechargeable neuromodulator was approved for clinical use. However, nowadays, a rechargeable sacral neuromodulator is also on the market, with similar safety and effectiveness to the non-rechargeable SNM system. The rechargeable device was approved for full body 1.5T and 3T MRI in Europe in February 2019. Regarding neurogenic lower urinary tract dysfunction, electrical stimulation only seems to benefit a selected group of patients. [ABSTRACT FROM AUTHOR]

Introduction: Commercially approved implantable systems for sacral neuromodulation require the implantation of a multipolar lead subcutaneously connected to an implantable pulse generator (IPG). Eliminating the need for an IPG would eliminate the need for tunneling of the lead, reduce procedure time, infection risk, and the need for IPG replacement. The objective was to demonstrate the feasibility of implanting the AHLeveeS System in the S3 Foramen to stimulate the S3 sacral nerve. Materials and Methods: A first‐in‐human, prospective, single center, nonrandomized, acute feasibility clinical investigation at the Maastricht University Medical Center+. Patients with refractory overactive bladder underwent acute implantation of the AHLeveeS neurostimulator before the InterStim procedure. Outcome measurements included motor responses, procedural time and a scoring of the difficulty of the implant and explant procedure. Retrospectively, qualitative responses to the stimulation protocol were assessed by video motion analyses. Only descriptive statistics were used. Results: During the stimulation a motor response to stimulation was seen in four of the five subjects. In all implantations the AHLeveeS was correctly placed. The median time for complete procedure was 24 minutes. The implant and explant procedures were successfully performed and no device or procedure related adverse events occurred. Conclusions: The results from this acute first‐in‐human study demonstrate the feasibility of implantation and acute stimulation of the sacral nerve with this mid‐field powered system. Future clinical studies will focus on safety and efficacy of a chronically implanted device. [ABSTRACT FROM AUTHOR]

Background: Sacral neuromodulation (SNM) is a widely used therapeutic option for fecal incontinence (FI). Larger series are mainly from Western countries, while few reports address the results of SNM in less developed or less wealthy countries. The aim of the present study was to evaluate the efficacy of SNM in patients with FI in Latin America. Methods: A retrospective study was conducted on patients with FI who had SNM between 2009 and 2016 at 15 specialized colorectal surgery centers in Latin America. Main outcomes measures were functional outcomes, postoperative complications, requirement of revisional surgery, and requirement of device removal. All patients had failed conservative management and had clinical assessment including recording of the validated Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS) and, when available, anal manometry and endoanal ultrasound. Patients were followed up for a median of 36.7 (1–84) months. Results: One hundred and thirty-one patients [119 females, median age of 62.2 (range 19–87) years] were included. The most common etiology of FI was obstetric injury (n = 60; 45.8%). After successful test lead implantation, the stimulator was permanently placed in 129 patients (98.5%). One patient failed to respond in the test phase and one patient did not proceed to permanent implantation for insurance reasons. Nineteen patients (14.7%) had 19 complications including infection (n = 5, 3.8%), persistent implant site pain (n = 5, 3.8%), generator/lead dislodgment (n = 5, 3.8%), malfunctioning device (n = 3, 2.3%), and hematoma (n = 1, 0.7%). Reimplantation after the first and second stages was necessary in 2 (1.5%) and 3 patients (2.3%), respectively. The device removal rate was 2.2%. At a median follow-up of 36.7 (range 1–84) months, the CCF-FIS significantly improved from a preoperative baseline of 15.9 ± 2.98 to 5.2 ± 3.92 (95%CI: 15.46 vs 4.43; p < 0.0001). Overall, 90% of patients rated their improvement as "significant". Conclusions: Sacral nerve stimulation for FI is safe and efficient, even in less wealthy or less developed countries. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: Sexual function is being increasingly recognized as an important patient-reported outcome. Sacral neuromodulation (SNM) is a treatment with an expanding list of indications. The effect of sacral neuromodulation on sexual function has been examined in a number of studies with variable results. In this review, we aim to systematically review the literature and pool the data if appropriate.Methods: The literature search was conducted primarily on the Healthcare Databases Advanced Search (HDAS) platform using the Medline, EMBASE and CINHAL search engines. Of 196 initial citations, 17 articles met our predefined inclusion criteria. Thirteen studies reported enough information to be included in our meta-analysis. RevMan5 software was used for analysis.Results: Eight of 17 studies reported a positive effect of SNM on sexual function. Pooled analysis of data from 11 studies involving 573 patients before SNM and 438 patients after SNM showed significant improvement in sexual function (SMD = −0.39; 95% CI: −0.58 to −0.19; p = 0.0001). The results remained significant in most subgroup analyses except in patients suffering from fecal incontinence.Conclusions: SNM in women with pelvic floor disorders, especially bladder dysfunction, seems to have a positive effect on sexual function. This needs to be verified in adequately powered primary research using sexual function as the primary outcome. [ABSTRACT FROM AUTHOR]

Background Urgency urinary incontinence (UUI) is a chronic condition for which sacral neuromodulation (SNM) (InterStim/Medtronic) and onabotulinumtoxinA (BTX) (BotoxA/Allergan) are utilized. These therapies have not been compared over extended time. Objective To compare UUI episodes (UUIE) over 24 mo following SNM or BTX. Design, setting, and participants Multicenter, open-label, randomized, extension trial (February 2012–July 2016) at nine US medical centers involving 386 women with ≥6 UUIE over 3 d inadequately managed by medications. Participants were clinical responders to treatment: ≥50% reduction in UUIEs after SNM placement or 1 mo post BTX. Intervention SNM ( n = 194) versus 200 U BTX ( n = 192). SNM reprogrammings occurred throughout the 24 mo. After 6 mo, two additional BTX injections were allowed. Outcome measurements and statistical analysis Primary outcome: change in mean daily UUIE over 24 mo. Secondary outcomes: no UUIE, ≥75% and ≥50% UUIE reduction; Overactive Bladder Questionnaire Short Form; Urinary Distress Inventory short form; Incontinence Impact Questionnaire; Patient Global Impression of Improvement; Overactive Bladder Satisfaction of Treatment Questionnaire; and adverse events (AEs). Primary analysis used a linear mixed model. Results and limitations Outcome data were available for 260/298 (87%) clinical responders. No difference in decreased mean UUIE was found over 24 mo (−3.88 vs −3.50 episodes/d,95% confidence interval [CI] = −0.14–0.89; p = 0.15), with no differences in UUI resolution, ≥75% or ≥50% UUIE reduction. BTX group maintained higher satisfaction (mean difference = −9.14, 95% CI = −14.38–−3.90; p < 0.001), treatment endorsement (mean difference = −12.16, 95% CI = −17.7–−6.63; p < 0.001) through 24 mo. Other secondary measures did not differ. Recurrent urinary tract infections (UTIs) were higher after BTX (24% vs 10%; p < 0.01), 6% required intermittent catheterization post second injection. SNM revision and removals occurred in 3% and 9% patients, respectively. Conclusions Both treatments offered sustainable UUI improvement, and higher BTX dosing had low clean intermittent catheterization rates, but with UTI risk. SNM revision/removal rates were low due to standardized lead placement with strict treatment response definitions. Patient summary We compared a large group of US women with severe urgency urinary incontinence (UUI) who received sacral neuromodulation (InterStim) or onabotulinumtoxinA (Botox A) therapy during a 2-yr period. We found that both therapies had similar success in reducing UUI symptoms, and adverse events were low. However, women in the BotoxA group had higher satisfaction and endorsement with their treatment, but with a higher chance of a urinary tract infection. We conclude that both therapies offer sustained reduction in daily incontinence over 2 yr. [ABSTRACT FROM AUTHOR]

Context Neuromodulation is considered in patients with non-neurogenic lower urinary tract dysfunction (LUTD) not responsive to conservative treatment. Objective To systematically review the available studies on efficacy and safety of sacral neuromodulation (SNM) and percutaneous tibial nerve stimulation (PTNS) in non-neurogenic LUTDs not responsive to conservative treatments. Evidence acquisition A literature research was conducted in PubMed/Medline and Scopus, restricted to articles in English, published between January 1998 and June 2017, with at least 20 patients and 6 mo of follow-up. Evidence synthesis Twenty-one reports were identified. Concerning SNM, the improvement of ≥50% in leakage episodes ranged widely between 29% and 76%. Overall dry rate ranged between 43% and 56%. Overall success/improvement rate in PTNS varied between 54% and 59%. Symptom improvement or efficacy in interstitial cystitis/bladder pain syndrome patients appeared to be lower compared with other indications in both techniques. Safety data showed fewer side effects in patients submitted to PTNS. Conclusions Neuromodulation gives good results and is a safe therapy for patients with overactive bladder or chronic nonobstructive urinary retention with long-lasting efficacy. Moreover, PTNS has been shown to have good success rates and fewer side effects compared with SNM. These data have to be confirmed with long-term follow-up. Patient summary Sacral neuromodulation can improve low urinary tract symptoms in selected patients; it appears to be a safe therapy for nonresponders to standard medical therapies. Percutaneous tibial nerve stimulation (PTNS) is a less invasive technique that gives good results in short time with fewer side effects. However, we must consider that PTNS has not been tested in the long term and results are lower if compared with SNM. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To evaluate the long‐term efficacy of sacral nerve stimulation (SNS) in children with constipation and describe patient benefit and parent satisfaction. Methods: Using a prospective patient registry, we identified patients <21 years old with constipation treated with SNS for >2 years. We compared symptoms, medical treatment, PedsQL Gastrointestinal Symptom Scale (GSS), Fecal Incontinence Quality of Life Scale (FIQL), and Fecal Incontinence Severity Index (FISI) before SNS and at follow‐up. We contacted parents to administer the Glasgow Children's Benefit Inventory (GCBI) and a parent satisfaction questionnaire. Key Results: We included 25 children (52% male, median age 10 years): 16 had functional constipation, six anorectal malformation, two tethered spinal cord, and one Hirschsprung's disease. Defecation frequency did not change after SNS but patients reporting fecal incontinence decreased from 72% to 20% (P<.01) and urinary incontinence decreased from 56% to 28% (P=.04). Patients using laxatives decreased from 64% to 44% (ns) and patients using antegrade enemas decreased from 48% to 20% (P=.03). GSS, most FIQL domains, and FISI were improved at follow‐up. Six (24%) patients had complications requiring further surgery. Of the 16 parents contacted, 15 (94%) parents indicated positive health‐related benefit and all would recommend SNS to other families. Conclusions & Inferences: Sacral nerve stimulation is a promising and durable treatment for children with refractory constipation, and appears particularly effective in decreasing fecal incontinence. Although a quarter of patients experienced complications requiring additional surgery, nearly all parents reported health‐related benefit. Future studies to identify predictors of treatment response and complications are needed. [ABSTRACT FROM AUTHOR]

Aim The aim of this study was to investigate the efficacy of sacral neuromodulation ( SNM) in the treatment of faecal incontinence and concomitant urinary incontinence in women with a history of obstetric anal sphincter injury ( OASIS). Method In this prospective study, consecutive women with faecal incontinence following OASIS accepted for SNM were screened for concomitant urinary incontinence. The primary outcome was the change in urinary incontinence score on the International Consultation on Incontinence Questionnaire for Urinary Incontinence, Short Form ( ICIQ- UI- SF), between baseline and 12 months. Secondary outcomes included the change in St Mark's score, sexual function and quality of life, change in grade of urinary incontinence and disappearance of urgency. Results From March 2012 to September 2014, 39 women with combined faecal incontinence and urinary incontinence received SNM. Thirty-seven women were available for analysis after 12 months. The mean reduction in the ICIQ- UI- SF score between the baseline and 12 months was 5.8 (95% CI 3.7-8.0, P < 0.001). ICIQ- UI- SF was reduced in 29 (78%) women, urinary incontinence resolved in 13/37 (35%, 95% CI 20%-50%) patients, and urgency disappeared in 14/33 (42%, 95% CI 26%-59%). The mean reduction in the St Mark's score was 10.6 (95% CI 8.6-12.7, P < 0.001). Disease-specific quality of life, Euroqual 5-dimension visual analogue scale ( EQ-5D VAS) and several areas of sexual function changed significantly for the better. Conclusion More than three-quarters of the women with combined faecal and urinary incontinence following OASIS reported a successful outcome with reduction in ICIQ- UI- SF at 12 months after SNM. [ABSTRACT FROM AUTHOR]

Purpose: Sacral neuromodulation (SNM) therapy is indicated for some refractory urological conditions. The electrode lead position in sacral x-rays during routine follow-up may predict the outcome of SNM therapy. To determine whether the radiographic position of the electrode in the sacral foramen predicted the long-term outcome of SNM therapy. Methods: This was a retrospective study of patients who underwent InterStim SNM at Toronto Western Hospital by 2 surgeons from July 2013 to March 2014. The position of electrodes in relation to the sacral bone was assessed on follow-up sacral x-rays. In the lateral view, we determined the location of the radio-opaque marker of the electrode relative to the inner surface of the sacrum (P3, D3, P2, D2, P1, D1, P0, and D0). In the anteroposterior view, the angle between a line through the spinous process shadow and the electrode was measured (0°-30°, 30°-60°, 60°-90°, >90°, or medial). Dissatisfied patients were defined as those who did not improve based on a voiding diary or those who needed salvage treatment after SNM. The primary endpoint was to determine whether the electrode lead position on sacral x-rays predicted the outcome of SNM therapy. Results: A total of 69 patients (61 female and 8 male patients) were included, with a median age of 55 years. Forty-two of the patients (60.9%) had refractory overactive bladder, 21 (30.4%) suffered from chronic urinary retention, and 6 (8.7%) had lower urinary tract symptoms and chronic pelvic pain syndrome. The univariate analysis did not show any correlation between SNM response and the electrode position or angle. Dummy regression analysis using response to implantation as the dependent outcome variable did not show any significance for any of the predictors. Conclusions: Our study did not show a correlation between the long-term response to SNM and the electrode position on follow-up sacral x-rays. In this study, electrode lead position in sacral x-ray at follow-up was not correlated with the outcome of SNM therapy. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: To evaluate the effects of sacral neuromodulation (SNM) on pregnancy and the impact of delivery on SNM function. Methods: A systematic search was conducted through January 2016. We selected studies including women who had SNM and a subsequent pregnancy. Results: Out of 2,316, eight studies were included, comprising 22 patients (26 pregnancies). SNM indications were Fowler's syndrome in 11, urinary retention in 6, fecal incontinence in 1, fecal and urinary urgency in 1, overactive bladder in 1, intractable interstitial cystitis in 1, and myelodysplasia in 1. SNM stayed on in 8 pregnancies. In the remaining 18 pregnancies in which the device was deactivated, 7 had recurrent urinary tract infections, including 1 with pyelonephritis and 2 who requested reactivation owing to recurrent symptoms. Outcomes were reported in 25 pregnancies, 16 had Cesarean section (CS) and 9 had vaginal delivery, including 2 operative deliveries. Out of 25, two infants had pilonidal sinus and motor tic disorder (exhibited at the age of 2 years), both from the same mother. After delivery, SNM was functioning in 15 (60%), 4 required reprogramming, and 3 required replacement (1 had recurrence of fecal incontinence after her operative delivery with evidence of displaced leads and 1 patient reported decreased SNM effects after her two CS), and 3 decided to remove the device (2 out of 3 patients were free of symptoms after SNM deactivation and requested removal). Conclusion: Within the current limited evidence, the decision regarding SNM activation or deactivation should be individualized. A registry for those patients is recommended. [ABSTRACT FROM AUTHOR]

Objectives: The study aimed to evaluate whether the duration of complaints in patients with overactive bladder syndrome or non-obstructive urinary retention predicts the outcome of sacral neuromodulation (SNM). Methods: All patients that underwent a SNM test period evaluation between 2011 and 2014, were included in this study. The duration of complaints was listed in 3 categories: (a) 0-5 years, (b) 5-10 years and (c) 10 years or longer. Analyses with chi square tests were performed to evaluate whether the duration of complaints are associated with outcome of SNM. Results: In total, 130 patients were included. Most patients had a complaint duration of 0-5 years (n = 60). The test period was successful in 56% (n = 74) of the total group. Analyses showed that the duration of complaints is not significantly associated with outcome of SNM (p = 0.752), even when subdivided per indication, and also when possible confounders such as age at test and indication are taken into account (p = 0.720). Conclusion: Based on the results of this study, there is no relationship between duration of complaints and SNM out-come. SNM seems to remain a feasible treatment option, despite of possible anatomical or physiological changes within the lower urinary tract. [ABSTRACT FROM AUTHOR]

Aim The purpose of this trial was to compare the effectiveness of sacral neuromodulation ( SNM) with a submucosal injection of collagen (Permacol®) in women with faecal incontinence following obstetric anal sphincter injury ( OASIS). Method This single-blinded randomized controlled trial at two hospital units in Norway included women with faecal incontinence following OASIS. Eligible women who had had a successful percutaneous nerve evaluation were randomly assigned to SNM or Permacol®. The primary outcome was the difference in the St Mark's incontinence score between baseline and 6 months. Secondary outcomes were changes in the disease-specific quality of life ( FIQL) and urinary incontinence ( ICIQ- UI- SF) scores. Results Fifty-eight women were randomly assigned to SNM ( n = 30) and Permacol® ( n = 28). The reduction in the St Mark's score between baseline and 6 months was 11.2 ( SD 5.3) in the SNM group vs 2.3 ( SD 5.0) in the Permacol® group, resulting in a difference of 8.9 (95% CI: 6.1-11.7, P < 0.0001). The differences in the four scales of FIQL (lifestyle, coping, depression, embarrassment) were 0.90 (95% CI: 0.50-1.30, P < 0.001), 1.05 (0.62-1.47, P < 0.001), 0.52 (95% CI: 0.16-0.87, P = 0.005) and 0.95 (95% CI: 0.50-1.40, P < 0.001), respectively, in favour of SNM. The difference in the ICIQ- UI- SF was 5.0 (95% CI: 1.97-8.02, P = 0.002) in favour of SNM. There were nine minor adverse events in the SNM group compared with seven in the Permacol® group ( P = 0.77). Conclusion SNM was superior to Permacol® in terms of reduction of St Mark's score, ICIQ- UI- SF and the change of the FIQL in women with faecal incontinence following OASIS. [ABSTRACT FROM AUTHOR]

Purpose: Sacral neuromodulation has been reported as a treatment for severe idiopathic constipation. This study aimed to evaluate the long-term effects of sacral neuromodulation by following patients who participated in a prospective, open-label, multicentre study up to 5 years. Methods: Patients were followed up at 1, 3, 6, 12, 24, 36, 48 and 60 months. Symptoms and quality of life were assessed using bowel diary, the Cleveland Clinic constipation score and the Short Form-36 quality-of-life scale. Results: Sixty-two patients (7 male, median age 40 years) underwent test stimulation, and 45 proceeded to permanent implantation. Twenty-seven patients exited the study (7 withdrawn consent, 7 loss of efficacy, 6 site-specific reasons, 4 withdrew other reasons, 2 lost to follow-up, 1 prior to follow-up). Eighteen patients (29%) attended 60-month follow-up. In 10 patients who submitted bowel diary, their improvement of symptoms was sustained: the number of defecations per week (4.1 ± 3.7 vs 8.1 ± 3.4, mean ± standard deviation, p < 0.001, baseline vs 60 months) and sensation of incomplete emptying (0.8 ± 0.3 vs 0.2 ± 0.1, p = 0.002). In 14 patients (23%) with Cleveland Clinic constipation score, improvement was sustained at 60 months [17.9 ± 4.4 (baseline) to 10.4 ± 4.1, p < 0.001]. Some 103 device-related adverse events were reported in 27 (61%). Conclusion: Benefit from sacral neuromodulation in the long-term was observed in a small minority of patients with intractable constipation. The results should be interpreted with caution given the high dropout and complication rate during the follow-up period. [ABSTRACT FROM AUTHOR]

Aim The purpose of this study was to assess the efficacy of percutaneous nerve evaluation ( PNE) in women with faecal incontinence ( FI) following obstetric anal sphincter injury and to relate the outcomes to baseline factors, with special emphasis on the extent of the sphincter defect. Method This was a prospective study at a tertiary colorectal referral unit at the University Hospital of North Norway conducted from 2012 to 2014. Sixty-three women underwent a 3-week PNE using a tined lead and the Verify® external neurostimulator. The primary outcome was efficacy, defined as the percentage reduction in weekly FI episodes, and patients with a reduction of 50% or more were defined as responders. Baseline factors affecting the primary outcome were explored. Sphincter defects were classified with a validated three-dimensional endoanal ultrasound defect score. Results Fifty-six (89%) of the 63 women were responders with a reduction in weekly FI episodes of 94.5%, from a median (interquartile range) of 4.8 (2.0-11.0) to 0.5 (0-2.0) ( P < 0.001). Twenty-nine (52%) reported no weekly FI episodes, and urgency episodes disappeared in 18 (32%). In the multivariable linear regression model, efficacy was related to concomitant urinary incontinence ( P = 0.04), body mass index ( BMI) ( P = 0.03) and pain during PNE ( P = 0.046) but not to the extent of the sphincter defect ( P = 0.1). Responders had a higher St Mark's score than nonresponders ( P = 0.046). Conclusions The vast majority of women had successful PNE tests. Responders had higher baseline St Mark's scores than nonresponders. Efficacy was related to concomitant urinary incontinence, BMI and pain, not to the extent of the sphincter defect. [ABSTRACT FROM AUTHOR]

Introduction: Sacral neuromodulation (SNM) remains one of the few effective treatments for refractory bladder and bowel dysfunction. However, SNM is associated with frequent need for surgical intervention, in many cases because of a failed battery. A rechargeable SNM system, with a manufacturer-reported battery life of 15 years or more, has entered post-market clinical testing in Europe but has not yet been approved for clinical testing in the United States. Areas covered: We review existing neuromodulation technologies for the treatment of lower urinary tract and bowel dysfunction and explore the limitations of available technology. In addition, we discuss implantation technique and device specifications and programming of the rechargeable SNM system in detail. Lastly, we present existing evidence for the use of SNM in bladder and bowel dysfunction and evaluate the anticipated trajectory of neuromodulation technologies over the next five years. Expert commentary: A rechargeable system for SNM is a welcome technological advance. However surgical revision not related to battery changes is not uncommon. Therefore, while a rechargeable system would be expected to reduce costs, it will not eliminate the ongoing maintenance associated with neuromodulation. No matter the apparent benefits, all new technologies require extensive post-market monitoring to ensure safety and efficacy. [ABSTRACT FROM AUTHOR]

Aim Sacral nerve stimulation (SNS) lead implantation is a straightforward procedure for individuals with intact spinal vertebrae. When sacral anomalies are present, however, the anatomical and radiological reference points used for the accurate placement of the electrode may be absent or difficult to identify. Method We describe an innovative surgical procedure of percutaneous nerve evaluation for SNS in a patient with faecal incontinence secondary to a congenital imperforate anus and partial sacral agenesis using a surgical imaging platform (O-arm system) under neurophysiological control. Results Using intra-operative CT and neuronavigation, the insertion point at the skin was identified. The lead was introduced into the right-sided S3 foramen and placed at the correct depth. An appropriate motor response was obtained after stimulation and neurophysiological control confirmed that the right S3 root was being stimulated. Conclusion Our experience showed that O-arm guided navigation can be used to overcome the difficulty of SNS lead placement in patients with partial sacral agenesis who have faecal incontinence. [ABSTRACT FROM AUTHOR]

Purpose: Functional constipation in children and adolescents is a common and invalidating condition. In a minority of patients, symptoms persist despite optimal conservative therapy. The aim of this study was to evaluate whether the short-term effects of sacral neuromodulation (SNM) in children and adolescents with constipation are sustained over prolonged period of time. Methods: Patients aged 10-20 years, with refractory constipation, fulfilling the Rome III criteria, were included in our study. If SNM test treatment showed >50 % improvement in defecation frequency, a permanent stimulator was implanted. Primary outcome measure was defecation frequency during 3 weeks. Secondary endpoints were abdominal pain and Wexner score. To assess sustainability of treatment effect, a survival analysis was performed. Cross-sectional quality of life was assessed using the EQ-5D VAS score. Results: Thirty girls, mean age 16 (range 10-20), were included. The mean defecation frequency increased from 5.9 (SD 6.5) in 21 days at baseline to 17.4 (SD 11.6) after 3 weeks of test treatment ( p < 0.001). During test treatment, abdominal pain and Wexner score decreased from 3.6 to 1.5 and 18.6 to 8.5 ( p < 0.001), respectively. Improvement of symptoms sustained during a median follow-up of 22.1 months (12.2-36.8) in 42.9 % of patients. On a scale from 0 to 100, quality of life was 7 points lower than the norm score (mean 70 vs. 77). Conclusion: SNM is a therapeutic option for children with chronic constipation not responding to intensive oral and/or laxative therapy, providing benefits that appear to be sustained over prolonged period of time. [ABSTRACT FROM AUTHOR]

Fecal incontinence is a devastating condition, vastly under-reported, and may affect up to 18% of the population. While conservative management may be efficacious in a large portion of patients, those who are refractory will likely benefit from appropriate surgical intervention. There are a wide variety of surgical approaches to fecal incontinence management, and knowledge and experience are crucial to choosing the appropriate procedure and maximizing functional outcome while minimizing risk. In this article, we provide a comprehensive description of surgical options for fecal incontinence to help the clinician identify an appropriate intervention. [ABSTRACT FROM PUBLISHER]

Background: Sacral neuromodulation is well established in the treatment of refractory, non-neurogenic lower urinary tract dysfunction, but its efficacy and safety in patients with lower urinary tract dysfunction of neurological origin is unclear. Only few case series have been reported for multiple sclerosis. We prospectively evaluated the efficacy and safety of sacral neuromodulation in patients with multiple sclerosis.Methods: Seventeen patients (13 women, 4 men) treated with sacral neuromodulation for refractory neurogenic lower urinary tract dysfunction caused by multiple sclerosis were prospectively enrolled (2007-2011). Patients had to have stable disease and confirmed neurogenic lower urinary tract dysfunction. Voiding variables, adverse events, and subjective satisfaction were assessed.Results: Sixteen (94 %) patients had a positive test phase with a >70 % improvement. After implantation of the pulse generator (InterStim II), the improvement in voiding variables persisted. At 3 years, the median voided volume had improved significantly from 125 (range 0 to 350) to 265 ml (range 200 to 350) (p < 0.001), the post void residual from 170 (range 0 to 730) to 25 ml (range 0 to 300) (p = 0.01), micturition frequency from 12 (range 6 to 20) to 7 (range 4 to 12) (p = 0.003), and number of incontinence episodes from 3 (range 0 to 10) to 0 (range 0 to 1) (p = 0.006). The median subjective degree of satisfaction was 80 %. Only two patients developed lack of benefit. No major complications occurred.Conclusions: Chronic sacral neuromodulation promises to be an effective and safe treatment of refractory neurogenic lower urinary tract dysfunction in selected patients with multiple sclerosis. [ABSTRACT FROM AUTHOR]

Aim The efficacy of sacral nerve stimulation ( SNS) in low anterior resection syndrome ( LARS) is largely undocumented. A review of the literature was carried out to study this question. Method Pubmed, Medline and Cochrane databases were searched for relevant articles up to August 2014. Studies were included if they evaluated the use of SNS following rectal resection and assessed at least one of the following end-points: bowel function, quality of life and ano-neorectal physiology. No restrictions on language or study size were made. Results Seven papers were identified including one case report and six prospective case series. These included 43 patients with a median follow-up of 15 months. After peripheral nerve evaluation definitive implantation was carried out in 34 (79.1%) patients. Overall, 32 (94.1%) of the 34 patients experienced improvement of symptoms which, based on intention to treat, was 32/43 (74.4%). Conclusion The review suggests that SNS for faecal incontinence in LARS has success rates comparable to its use for other forms of faecal incontinence. [ABSTRACT FROM AUTHOR]

Sacral nerve stimulation (SNS) was originally developed in the field of urinary incontinence. Without adaptation, it was subsequently applied to treat faecal incontinence. SNS has now become a first line therapy for this socially disabling condition, however the mechanism of action is unknown. This review examines the evidence for stimulation parameters currently used for SNS in humans and considers the potential electrophysiological effects of changing these parameters. However, without a proper understanding of the physiology of SNS, changing stimulation parameters remains empirical. [ABSTRACT FROM AUTHOR]

Aim In Europe during the last decade sacral nerve stimulation ( SNS) or sacral neuromodulation ( SNM) has been used to treat faecal incontinence ( FI) and constipation. Despite this, there is little consensus on baseline investigations, patient selection and operative technique. A modified Delphi process was conducted to seek consensus on the current practice of SNS/ SNM for FI and constipation. Method A systematic literature search of SNS for FI and constipation was conducted using PubMed. A set of questions derived from the search and expert opinion were answered on-line on two occasions by an international panel of specialists from Europe. A 1-day face-to-face meeting of the experts finalized the discussion. Results Three hundred and ninety-three articles were identified from the literature search, of which 147 fulfilled the inclusion criteria. Twenty-two specialists in FI and constipation from Europe participated. Agreement was achieved on 43 (86%) of 50 domains including the set-up of service, patient selection, baseline investigations, operative technique and programming of the device. The median of agreement was 95% (35-100%). Conclusion Consensus was achieved on the majority of domains of SNS/ SNM for FI and constipation. This should serve as a benchmark for safe and quality practice of SNS/ SNM in Europe. [ABSTRACT FROM AUTHOR]