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Competing Interests: Declaration of competing interest The authors declare no competing interests.

Introduction: Despite the growing body of literature on sacral neuromodulation (SNM) outcomes, research focusing on male patients remains limited and often represented by small cohorts nested within a larger study of mostly women. Herein, we evaluated the outcomes of SNM in a male-only cohort with overactive bladder (OAB), fecal incontinence (FI), chronic bladder pain, and neurogenic lower urinary tract dysfunction (NLUTD)., Materials and Methods: This retrospective cohort study included 64 male patients who underwent SNM insertion between 2013 and 2021 at a high-volume tertiary center. Indications for SNM therapy included OAB, FI, chronic pelvic pain, and NLUTD. Descriptive statistics, Fisher's and t-test were used in analysis., Results: The mean age was 57.7 ± 13.4 years, and the most frequent reason for SNM insertion was idiopathic OAB (72%), FI (16%), pelvic pain (11%), and NLUTD (11%). A majority (84%) of men received treatment prior to SNM insertion. 84% reported satisfaction and 92% symptom improvement within the first year, and these improvements persisted beyond 1 year in 73% of patients. Mean follow up was 52.7 ± 21.0 months. The complication rate was 23%, and the need for adjunct treatments was significantly reduced (73% to 27%, p < 0.001). Treatment outcomes did not differ significantly between various indications for SNM therapy or the presence of benign prostatic hyperplasia (BPH)., Conclusion: SNM is an effective and safe procedure for male patients with neurogenic and non-neurogenic OAB, pelvic pain, and FI. Over 70% of patients experienced symptomatic improvement and remained satisfied in the mid to long term follow up. BPH does not seem to hinder treatment outcomes.

Sacral neuromodulation (SNM) is a well-established treatment in the management of refractory overactive bladder (OAB), non-obstructive retention, and fecal incontinence. However, the use and management of SNM in pregnant women remains elusive. We present a noteworthy case involving a patient diagnosed with Clara-Fowler syndrome who underwent SNM during the early stages of pregnancy. The sacral neuromodulator remained activated throughout the pregnancy upon patient's request. After vaginal delivery the patient encountered device dysfunction, ultimately attributed to electrode migration. After repositioning of a new electrode in the contralateral sacral root, the patient successfully recovered spontaneous voiding with no post void residual. This case suggests that SNM may not have detrimental effects on pregnancy or fetal development. However, the intricate physiological changes associated with pregnancy and vaginal delivery may contribute to electrode migration, warranting careful consideration in the management of pregnant patients undergoing SNM., (Copyright © 2024 The Authors. Published by Elsevier Masson SAS.. All rights reserved.)

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 (KINDL R ). 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., (© 2024 The Authors. Neurogastroenterology & Motility published by John Wiley & Sons Ltd.)

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., (© 2024 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland.)

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)., (© 2024. The Author(s).)

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.

Objective: To show the experience of a Latin American public hospital, with SNM in the management of either OAB, NOUR or FI, reporting feasibility, short to medium-term success rates, and complications., Methods: A retrospective cohort was conducted using data collected prospectively from patients with urogynecological conditions and referred from colorectal surgery and urology services between 2015 and 2022., Results: Advanced or basic trial phases were performed on 35 patients, 33 (94%) of which were successful and opted to move on Implantable Pulse Generator (GG) implantation. The average follow-up time after definitive implantation was 82 months (SD 59). Of the 33 patients undergoing, 27 (81%)reported an improvement of 50% or more in their symptoms at last follow-up. Moreover, 30 patients (90%) with a definitive implant reported subjective improvement, with an average PGI-I "much better" and 9 of them reporting to be "excellent" on PGI-I., Conclusion: SNM is a feasible and effective treatment for pelvic floor dysfunction. Its implementation requires highly trained groups and innovative leadership. At a nation-wide level, greater diffusion of this therapy among professionals is needed to achieve timely referral of patients who require it., Competing Interests: Conflicts to interest: none to declare, (© 2024. Federação Brasileira de Ginecologia e Obstetrícia. All rights reserved.)

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., (© 2024 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland.)

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., (© 2024 Wiley Periodicals LLC.)

Objectives: Sacral neuromodulation (SNM) therapy standard of care relies on visual-motor responses and patient-reported sensory responses in deciding optimized lead placement and programming. Automatic detection of stimulation responses could offer a simple, consistent indicator for optimizing SNM. The purpose of this study was to measure and characterize sacral evoked responses (SERs) resulting from sacral nerve stimulation using a commercial, tined SNM lead., Materials and Methods: A custom external research system with stimulation and sensing hardware was connected to the percutaneous extension of an implanted lead during a staged (tined lead) evaluation for SNM. The system collected SER recordings across a range of prespecified stimulation settings (electrode configuration combinations for bipolar stimulation and bipolar sensing) during intraoperative and postoperative sessions in 21 subjects with overactive bladder (OAB) and nonobstructive urinary retention (NOUR). Motor and sensory thresholds were collected during the same sessions., Results: SERs were detected in all 21 subjects. SER morphology (number of peaks, magnitude, and timing) varied across electrode configurations within and across subjects. Among subjects and electrode configurations tested, recordings contained SERs at motor threshold and/or sensory threshold in 75% to 80% of subjects., Conclusions: This study confirmed that implanted SNM leads can be used to directly record SERs elicited by stimulation in subjects with OAB and NOUR. SERs were readily detectable at typical SNM stimulation settings and procedural time points. Using these SERs as possible objective measures of SNM response has the capability to automate patient-specific SNM therapy, potentially providing consistent lead placement, programming, and/or closed-loop therapy., Competing Interests: Conflict of Interest Colin Goudelocke is a paid consultant for Medtronic. Julia P. Slopsema, Lisa M. Jungbauer Nikolas, Katie C. Bittner, Anne E. Miller, and Sarah J. Offutt are employees of Medtronic., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate the clinical efficacy of long-term spinal and sacral programmable neurostimulation for pelvic organ dysfunction in patients with myelodysplasia and chronic dysfunction of the bladder and rectum., Material and Methods: A retrospective study included 32 children aged 1-17 years (mean 10.7) with myelodysplasia, pelvic organ dysfunction and ineffective therapy including botulinum therapy and exclusion of tethered spinal cord syndrome. All children underwent comprehensive urodynamic examination with analysis of bladder and residual urine volume, mean flow rate, intravesical pressure and total urine volume, as well as electromyographic examination. Examination was carried out before surgery, after 6, 12 and 36 months. We applied urinary diary, NBSS questionnaire and urodynamic examination data. All patients underwent neurological examinations (neurological status, magnetic resonance imaging of the spinal cord, computed tomography and radiography of the spine, electroneuromyography). The study was conducted at the neurosurgical department of the Republican Children's Clinical Hospital in Ufa between 2014 and 2022. There were 32 implantations of epidural neurostimulators for pelvic organ dysfunctions., Results: P atients used epidural spinal and sacral stimulation up to 6 times a day for 10-15 min turning on the pulse generator. This method significantly increased urinary volume, decreased episodes of urinary leakage and fecal incontinence, residual volume after urination and number of periodic catheterizations compared to baseline data. Sixteen patients were very satisfied, 10 ones were moderately satisfied, and 2 patients were not satisfied with therapy. The number of bladder catheterizations per day decreased by 51.1%. Urine volume significantly increased from 131.5±16.1 to 236±16.7 ml, intravesical pressure decreased from 23.5±4.2 to 18.5±2.1 cm H 2 O (by 20.3%)., Conclusion: Chronic epidural spinal and sacral stimulation can improve the quality of life in patients with pelvic organ dysfunction. This technique may be effective for pelvic organ dysfunction caused by myelodysplasia.

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., (© 2023 Wiley Periodicals LLC.)

Introduction: We aimed to analyze the long-term cost of overactive bladder third-line treatments., Methods: This insurance claims review analyzed the 2015 to 2020 MarketScan (MKS) claims data set subjects age ≥ 18, diagnosis of overactive bladder (OAB) using ICD-9/ICD-10 codes and receipt of treatment for percutaneous tibial nerve stimulation, sacral neuromodulation (SNM), or botulinum A. Age, gender, treatment types, and cost were extracted. Treatment costs were aggregated at the level of patient and treatment type for total payment and patient contribution by combining copay, coinsurance, and deductible. We used the Wilcoxon rank-sum test for continuous and chi-square test for categorical variables. SAS v9.4 was used for analyses. Significance was set at P < .05., Results: We identified 17,755 patients from the commercial claims MKS and 10,912 patients from the Medicare supplemental (MDC) database with mean age 50.7±11.1 and 75.5±7.6 years, respectively, who underwent ≥ 1 third-line OAB treatment. Patients receiving third-line treatment were predominantly female (84.9%, MKS, 74.8%, MDC). Long-term costs over a 15-year period were estimated. Percutaneous tibial nerve stimulation is the most expensive in terms of total net payment ($105,337.50 MKS, $94,102.50 MDC) and patient contribution ($9177.60 MKS, $3921.00 MDC). Total net payment for botulinum A was $67,968 (MSK), $54,261 (MDC), and patient contribution cost was $2850 (MSK), $1110 (MDC). The most cost-effective option was SNM in terms of both total net payment ($5179.10 MKS, $6099.00 MDC) and patient contribution ($59.10 MKS, $60.00 MDC)., Conclusions: SNM was the most cost-effective third-line treatment for OAB looking over a 15-year period in terms of both total net payment and patient contribution.

Pelvic surgery for endometriosis is associated with a risk of bladder and digestive sequelae. Sacral neuromodulation (SNM) has been shown to be effective in the treatment of overactive bladder (OAB) and voiding dysfunction (VD). This study aimed to evaluate the efficacy of sacral neuromodulation (SNM) in treating voiding dysfunction (VD) following endometriosis surgery. A retrospective analysis was conducted on data from women who underwent SNM testing for persistent VD after endometriosis surgery. The study included 21 patients from a French tertiary referral center. Patient characteristics, lower urinary tract symptoms, urodynamic findings, SNM procedures, and outcomes were assessed. The primary outcome was the success of SNM treatment for VD. After a median follow-up of 55 months, 60% of patients achieved successful outcomes, with significant improvements of VD and quality of life. Moreover, more than half of patients who required clean intermittent self-catheterization (CISC) before SNM were able to wean off CISC. Complications such as infections and paraesthesia were observed, but overall, SNM was found to be effective and well tolerated. Age and the interval between endometriosis surgery and SNM testing were associated with treatment success. This study adds to the limited existing literature on SNM for VD after endometriosis surgery and suggests that SNM can be a valuable therapeutic option for these patients. Further research is needed to identify predictive factors and mechanisms underlying the effectiveness of SNM in this context. MRI-compatible and rechargeable devices, has improved the feasibility of SNM for these patients. In conclusion, SNM offers promise as a treatment option for persistent VD after endometriosis surgery, warranting further investigation. LEVEL OF EVIDENCE: 4., (Copyright © 2023 Elsevier Masson SAS. All rights reserved.)

Objectives: In adult patients with chronic refractory constipation, invasive sacral neuromodulation (SNM) has been applied successfully. There is a need for less invasive solutions while providing comparable therapeutic effects in children and adolescents. We present a prospective, interventional case-control study on the application of noninvasive SNM., Materials and Methods: Patients with chronic constipation refractory to conservative treatment were prospectively included in the study from 2018 to 2021 and randomized to either SNM (SNM group: single current stimulation for 24 h/d, frequency 15 Hz, pulse width 210 μs, intensity 1-10 mA) or conventional treatment (controls: full range of pharmacologic and nonpharmacologic options). Treatment was conducted for 12 weeks. Treatment effects were collected with specialized questionnaires and quality-of-life analysis (KINDL R ). Outcome variables were defecation frequency, stool consistency, fecal incontinence (FI) episodes, and abdominal pain., Results: Analysis was conducted in 28 patients with SNM and 31 controls (median age 7.0, range 3-16 years). Overall responsiveness to treatment was 86% of the SNM group and 39% of the control group (p < 0.001). All outcome variables were positively influenced by SNM treatment. Defecation frequency improved in 46% of patients with SNM and in 19% of controls (p = 0.026), as did stool consistency in 57% of patients with SNM and in 26% of controls (p = 0.014). Fecal incontinence was significantly reduced in 76% of patients with SNM (n = 16/21 vs 42% of controls [n = 11/26], p = 0.042). Quality of life improved significantly during SNM treatment (71.32 [baseline] vs 85.00 [after 12 weeks], p < 0.001) and confirmed a positive influence of SNM treatment compared with the control group (85.00 [SNM after 12 weeks] vs 79.29 [controls after 12 weeks], p = 0.047)., Conclusions: Outcome of noninvasive SNM treatment in patients with chronic refractory constipation is better than conventional treatment., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To report the experience of a university hospital center with sacral neuromodulation for patients with bladder voiding disorders., Material and Methods: All patients who underwent sacral neuromodulation between 1998 and 2022 for bladder voiding disorders were included. Medical records were analyzed retrospectively, and population, efficacy and follow-up data were collected., Results: A total of 134 patients underwent test implantation and 122 patients were analyzed. 68 patients (56%) were implanted with a definitive neuromodulation device. Mean age was 43±16 years and BMI 25.5±5.4kg/m 2 . 74% were women. Bladder voiding disorder was due to sphincter hypertonia in 51% of cases, with associated bladder hypocontractility in 29%. The spontaneous micturition rate after implantation increased from 34% to 92%. Implantation results appeared to be better in patients with sphincter hypertonia, whether or not associated with bladder hypocontractility. The benefit was most often present with a frequency of 5Hz (54.4%). Side-effects were present in 52% of cases at 5 years, and in 85% of cases were pain in relation to the implanted devices. They resolved under medical treatment or after revision of the device (27% of cases at 5 years)., Conclusion: SNM is effective in micturition recovery, but has side effects. Urodynamic mechanism and etiology may provide clues for modulating NMS box settings and determining predictive factors for NMS success. Data from other centers are needed to identify reliable predictive factors., (Copyright © 2023 Elsevier Masson SAS. All rights reserved.)

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 (T m )], 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 2T m . 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 1T m to 6T m 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 (∼1T m ). 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.

Aims: Sacral neuromodulation (SNM) is a well-accepted, minimally invasive modality for patients with overactive bladder (OAB). Successful response to SNM is defined as at least 50% improvement in key symptoms, evaluated in a bladder diary (BD). BDs provide much useful information on bladder behavior during daily life. The aim of this study is to investigate BD parameter changes during SNM therapy in patients with OAB., Materials and Methods: The International Consultation on Incontinence Questionnaires (ICIQ)-BD was filled out by 34 patients with OAB, for three days at baseline and after three weeks of subthreshold sensory stimulation. The patients were considered responders for SNM when 50% improvement was seen in the BD. They underwent implantation of an internal pulse generator (IPG), and subsequently, an ICIQ-BD and a visual analog scale (VAS) evaluating bladder satisfaction during three days were filled out six weeks, six months, and one year after IPG implantation., Results: IPGs were implanted in 29 patients (85%). The BD showed a significant decrease in 24-hour leakage at three weeks from 4.2 to 0.6 (-86%, p < 0.001), similar significant decreases at six weeks and six months, and at one year (-80%). Voided volume (VV) at corresponding bladder sensation codes was not different between baseline and at three weeks of tined-lead procedure (TLP) (p > 0.05), and at six weeks (p > 0.05), six months (p > 0.1), and one year of IPG (p > 0.08). After three weeks of TLP, urgency episodes decreased from 4.8 to 3.4 (-30%, p = 0.025), with 59% reduction at six-weeks IPG (p < 0.001) and 49% at six-months IPG (p = 0.013). At one year, a decrease from 4.7 to 2.3 (52% reduction, p = 0.017) was noted. VAS showed the strongest correlation with urgency (p < 0.001) and frequency (p = 0.006). No significant correlation was found with VV (p = 0.87)., Conclusions: Our study describes how bladder sensation parameters change over time in patients on SNM. VV does not significantly increase, nor does frequency significantly decrease over the first year. Leaks and the percentage of urgency episodes significantly decrease, reaching a plateau level between six-weeks and six-months SNM., (Copyright © 2022 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

Objectives: It is estimated that 3.8% to 12.5% of patients develop a device infection during the two to four weeks of the sacral neuromodulation (SNM) test, leading to removal of the entire system. It is possible to prolong the test phase up to the clinician's decision, particularly when benefits are unclear. The aim of our study is to assess the device infection rate in a prolonged SNM test., Materials and Methods: We retrospectively enrolled patients who performed a prolonged SNM test (at least eight weeks) in the last five years (2017-2021). All procedures were performed using a standardized technique and the same prophylactic antibiotic protocol. In case of a clinical suspicion of infection, all components were explanted. Patient information (age at implantation, medical history of diabetes, metabolic syndrome, immunologic diseases, or chronic immunosuppressive therapy), surgical data (operative time, intraoperative complications), and infection data (timing of onset, symptoms reported, wound culture results) were recorded., Results: We enrolled 232 patients who underwent a prolonged SNM test (mean duration 65.5 days). A local infection that led to the removal of the entire system occurred in six patients (2.6%). The gluteal pocket was always involved, and in two cases, infection was also extended to the exit point of the extension wire. No significant correlations with clinical data were found. Infection occurred beyond four weeks in two cases, between three and four weeks in three cases, and within two weeks in one case. Intraoperative wound culture was performed in five of six patients, and Staphylococcus aureus (S aureus) was isolated in four cases. One culture test gave negative bacterial growth results., Conclusions: The infection rate of a prolonged eight-week SNM test is low and does not differ from that reported in the literature for a two-to-four-week SNM test. S aureus remains the most frequent bacterium involved., (Copyright © 2022 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

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., (© 2023 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).)

Objectives: In patients with detrusor overactivity with impaired contractility (DOIC), it is difficult to relieve abnormal lower urinary tract symptoms during both storage and voiding using sacral neuromodulation (SNM) with constant frequency stimulation (CFS). We sought to evaluate the efficacy and safety of SNM using variable frequency stimulation (VFS) in patients with DOIC by comparing it with outcomes of SNM with CFS., Materials and Methods: Between September 2020 and May 2021, we prospectively enrolled 20 patients with DOIC, confirmed on urodynamic examination, and administered SNM with VFS. The patients were followed up and required to maintain voiding diaries and record scale scores of overactive bladder symptoms, psychology and quality of life, uroflowmetry, ultrasonic postvoid residual urine, and adverse events at baseline and during the CFS and VFS phases., Results: The average testing phase was 26.3 ± 4.1 days. Compared with baseline values, overactive bladder symptom, psychologic health questionnaire, and quality of life scores, in addition to voiding frequency, urgency incontinence frequency, daily catheterization volume of voiding diary, and ultrasonic postvoid residual (PVR) decreased significantly during both the CFS and VFS phases (p < 0.05). The average voided volume, functional bladder capacity, and maximum urine flow rate significantly increased during the CFS and VFS phases (p < 0.05). In the VFS phase, voiding frequency, urgency incontinence frequency, daily catheterization volume of voiding diary, and ultrasonic PVR further decreased (p < 0.05), whereas functional bladder capacity, maximum urine flow rate, quality of life score, overactive bladder symptom score, and psychologic health questionnaire score further improved compared with results obtained in the CFS phase (p < 0.05). In the VFS phase, the success rate of further improvement of symptoms was 85.0%, and no new complications were noted., Conclusions: SNM that converts CFS into VFS may be an effective treatment option for patients with DOIC, exhibiting no increase in adverse events., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

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 cmH 2 O; 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., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

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., (© 2023 Association of Coloproctology of Great Britain and Ireland.)

Background: Although sacral neuromodulation (SNM) for overactive bladder (OAB) is an established therapy, there is a lack of high-quality, long-term data on real-life practice., Objective: To report on real-life therapeutic effectiveness, quality of life (QoL), disease severity, and safety as well as patient-reported symptom bother after approximately 5 yr of follow-up., Design, Setting, and Participants: A total of 291 OAB patients were enrolled at 25 French sites according to local standard of care. Sacral neuromOdUlation with InterStim therapy for intractable lower uriNary tract DySfunctions (SOUNDS) enrolled both de novo and replacement patients, and a total of 229 patients were permanently implanted., Outcome Measurements and Statistical Analysis: Over the course of the study, patients were followed up six times with two follow-ups in the year after implantation and annually thereafter. Of the patients, 154 completed the final follow-up after a mean of 57.7 ± 3.9 mo., Results and Limitations: The mean number of daily leaks in urinary urge incontinence (UI) patients was reduced from 4.4 ± 3.3 at baseline to 1.8 ± 2.6 after 5 yr in de novo and from 5.4 ± 4.9 to 2.2 ± 3.0 in replacement patients (both p < 0.001). Likewise, the number of voids in urinary frequency patients was reduced compared with baseline (de novo: reduced from 12.6 ± 4.0 [baseline] to 9.6 ± 4.3 [5 yr]; replacements: reduced from 11.5 ± 4.3 [baseline] to 9.2 ± 3.1 [5 yr]; both p < 0.05). Complete continence rates after 5 yr were 44% (25/57) in de novo and 33% (5/15) in replacement UI patients, and 68% (39/57) and 67% (10/15) of UI patients were categorized as therapy responders by showing a >50% improvement in leaks. Disease severity (Urinary Symptom Profile domain 2), Numeric Rating Scale-based symptom bother, and disease-specific QoL (Ditrovie) improved significantly in both groups at all visits (p < 0.001). Adverse events related to device or procedure occurred in 51% (140/274) of patients, with 66% (152/229) of the events being classified as minor (Clavien-Dindo grade I and II). Surgical revisions were reported in 39% (89/229), which include permanent explants in 15% (34/229) of patients., Conclusions: SOUNDS demonstrates the sustained effectiveness and QoL improvements of SNM in OAB patients after 5 yr in real-world conditions while maintaining an acceptable safety profile consistent with literature., Patient Summary: This study confirmed that French overactive bladder patients had a sustained symptom and bother reduction, and improvements in quality of life up to 5 yr after sacral neuromodulation device implantation., (Copyright © 2023. Published by Elsevier B.V.)

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., (© 2023 Wiley Periodicals LLC.)

Sacral neuromodulation (SNM) is a safe, efficacious, and minimally invasive advanced therapy that involves electrical stimulation to sacral nerve root to modulate neural pathway. Indications for SNM include symptoms of overactive bladder (OAB), urinary incontinence, urinary retention, urgency and frequency and, regarding bowel dysfunction, fecal incontinence . In Europe and Canada, indication is also established for chronic constipation. The mechanism of action is still not fully elucidated and complete understanding is yet to be determined. It is proposed that SNM modulates neural circuits in both central and peripheral pathways, thus having an impact on the brain, as well as on the bladder-targeting neuronal activity. Another possible significant effect on irregular bladder activity is through inhibition of the bladder afferent pathways by stimulation of the pudendal nerve. Over the past two decades, with more than 300 000 treated patients, SNM has confirmed its efficacy to relieve refractory OAB symptoms, as well as urinary retention or fecal incontinence. First SNM applications in Croatia were uneventful and we are glad to offer our patients this novel therapy in the future., (Sestre Milosrdnice University Hospital.)

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., (© 2023. The Author(s).)

Background: 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., Objective: To assess the effectiveness and safety of sacral neuromodulation (SNM) for neurogenic bladder (NB)., Methods: 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., Results: 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)., Conclusion: This systematic review indicated that the sacral neuromodulation treatment for neurogenic bladder was effective and safe.

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., (© 2022. The International Urogynecological Association.)

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., (© 2023 Wiley Periodicals LLC.)

Background: Neuromodulative treatment for the treatment of overactive bladder has been used in clinical practice since its introduction in the early 1980s., Objectives: Description and update of the various neuromodulative techniques (tibial nerve stimulation, sacral and pudendal neuromodulation), presentation of their effectiveness and safety, and evaluation of their evidence for clinical practice., Materials and Methods: Literature search in PubMed and Embase, inclusion of studies according to the following criteria: evidence level, timeliness, length of follow-up and number of female patients according to the author's preference., Results: The efficacy and safety of both percutaneous tibial nerve stimulation (PTNS) and sacral neuromodulation (SNM) has been proven by studies with an evidence level of 1. Long-term data of up to 20 years are available for SNM, while long-term data for PTNS are limited. Permanent implants for tibial nerve stimulation are promising new developments. Pudendal neuromodulation (PNM) is suitable for more complex indications but is surgically more challenging., Conclusions: Both PTNS and SNM are suitable for broad application in clinical practice. PTNS can be offered as an alternative to pharmacotherapy, while SNM provides the most convincing clinical data of all neuromodulative therapies., (© 2023. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Background: 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., 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)., Discussion: 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.

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., (© 2022. The International Urogynecological Association.)

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., (© 2022 The Authors. Neurourology and Urodynamics published by Wiley Periodicals LLC.)

Objectives: To evaluate if electrodiagnostic tools can advance the understanding in the effect of sacral neuromodulation (SNM) on pelvic floor activity, more specifically if SNM induces changes in pelvic floor muscle (PFM) contraction., Materials and Methods: Single tertiary center, prospective study (October 2017-May 2018) including patients with overactive bladder syndrome undergoing SNM. Electromyography of the PFM was recorded using the Multiple Array Probe Leiden. The procedure consisted of consecutive stimulations of the lead electrodes with increasing intensity (1-3, 5, 7, 10 V). Recordings were made after electrode placement (T0) and three weeks of SNM (T1). Patients with >50% improvement were defined as responders, others as nonresponders. For the analyses, the highest electrical PFM response (EPFMR), defined as the peak-to-peak amplitude of the muscle response, was identified for each intensity. The sensitivity (intensity where the first EPFMR was registered and the normalized EPFMR as percentage of maximum EPFMR) and the evolution (EMFPR changes over time) were analyzed using linear mixed models., Results: Fourteen patients were analyzed (nine responders, five nonresponders). For nonresponders, the PFM was significantly less sensitive to stimulation after three weeks (T0: 1.7 V, T1: 2.6 V). The normalized EPFMR was (significantly) lower after three weeks for the ipsilateral side of the PFM for the clinically relevant voltages (1 V: 36%-23%; p = 0.024, 2 V: 56%-29%; p = 0.00001; 3 V: 63%-37%; p = 0.0002). For the nonresponders, the mean EPFMR was significantly lower at 8/12 locations at T1 (T0: 109 μV, T1: 58 μV; mean p = 0.013, range <0.0001-0.0867). For responders, the sensitivity and evolution did not change significantly., Conclusions: This is the first study to describe in detail the neurophysiological characteristics of the PFM, and the changes over time upon sacral spinal root stimulation, in responders and nonresponders to SNM. More research is needed to investigate the full potential of EPFMR as a response indicator., (Copyright © 2022. Published by Elsevier Inc.)

Introduction: Sacral neuromodulation (SNM) aims to improve anorectal function in patients with disorders of anal continence and rectal emptying. The mechanism of action of SNM is not well known, and its indications are still under evaluation. We report the functional results and morbidity of a prospective cohort treated between 2002 and 2019., Results: A total of 284 patients (of 423 tested) had implantation of a SNM. Five patients (1.8%) were lost to follow-up. Among those who had implantation, the indications for SNM were anal incontinence (n=376), refractory constipation (n=17), anterior resection syndrome (n=13), solitary rectal ulcer syndrome (n=7), and chronic inflammatory bowel disease (IBD) (n=10). The morbidity rate was 2.7% (Dindo-Clavien>2), 33 patients (11%) required explantation for infection (n=5), pain (n=2), inefficacy (n=24) or other reasons (rectal cancer) (n=3). It was necessary to change the stimulator in 68 patients (24%) during the follow-up period. Regarding the group of patients with anal incontinence, functional results showed improvement of the incontinence score in 40% and of quality of life in 25% after a mean follow-up of 55months., Conclusion: SNM constitutes a mini-invasive treatment associated with low morbidity. Its' efficacy in anal incontinence makes it a priority approach. Other indications are still under evaluation; while results are promising, they are highly variable., (Copyright © 2021. Published by Elsevier Masson SAS.)

Introduction: The massive spread of COVID-19 affected many aspects of medical and surgical services. Many patients with sacral neuromodulation (SNM) devices needed integrated follow-up and close communication regarding the programming of the device. In this study, we aimed to explore the effect of COVID-19 lockdown on patients with SNM devices., Materials and Methods: This was a multicenter study designed and conducted in four centers performing SNM (Toronto Western Hospital, Toronto, Canada; King Abdulaziz University Hospital, Jeddah, Saudi Arabia; Al-Amiri Hospital, Kuwait City, Kuwait; and Austin and Western Health, University of Melbourne, Australia). An online questionnaire was created through Google Forms and circulated among patients with SNM devices in all four mentioned centers. The questionnaire was sent to patients during the forced lockdown period in each country., Results: A total of 162 responses were received by September 2020. Data showed that most patients had their device implanted before the lockdown period (92.5%, 150/162). Most patients did not experience any contact difficulties (91.9%, 149/162). When patients were requested for their preference of programming, 89.5% (145/162) preferred remote programming. Correlation analysis did not show any significant relation between patient diagnosis and COVID-19-related difficulties or preferences., Conclusion: The difficulties with access to care experienced during the pandemic and the patient's expressed willingness to participate in virtual care should provide impetus for manufacturers of SNM devices to move forward with developing remote programming capabilities., (Copyright © 2021 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

Background: Bladder symptoms are common in Parkinson disease (PD), affecting quality of life. Medications commonly used such as antimuscarinics can cause frequently intolerable side effects, and therefore, new, better tolerated approaches are needed. Neuromodulation techniques have an established role in urologic disorders; these techniques include tibial nerve stimulation (TNS) and sacral neuromodulation (SNM), which are localized therapies lacking the side effects associated with medication., Objectives: This study aimed to undertake a systematic review of the literature reporting the use of neuromodulation techniques for the treatment of bladder symptoms in PD and related conditions., Materials and Methods: A systematic search of data bases was conducted including MEDLINE, CENTRAL, and Web of Science. Studies were required to present specific outcomes for individuals with PD for neuromodulation interventions., Results: Ten primary studies were identified concerning detailed outcomes of neuromodulation on bladder symptoms in PD, including seven for TNS, one for SNM, and one using transcranial magnetic stimulation (TMS). Two further mixed cohort studies documented minimal data on individuals with PD. All studies demonstrated benefit in a range of outcome measures following neuromodulation. Two randomized sham-controlled studies were carried out using TNS, with one clearly demonstrating superiority over sham, although difficulties with achieving believable yet ineffective sham treatment are highlighted. Further studies reported limited, uncontrolled outcomes of SNM in patients with PD, demonstrating benefit., Conclusions: Evidence from case series suggests benefit from TNS in PD, with limited literature on SNM or TMS. Placebo effect from neuromodulation is a concern, and only limited controlled data exist. Future well-designed and sham-controlled studies need to be completed to provide definitive data on the benefit of neuromodulation in PD. Definitively proving the utility of a neuromodulation modality will allow better treatment of bladder symptoms without the need for pharmacologic measures that cause side effects., (Copyright © 2022 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

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., (© 2022 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland.)

Objectives: This study aimed to assess the neurophysiological basis behind troubleshooting in sacral neuromodulation (SNM). Close follow-up of SNM patients with program parameter optimization has proven to be paramount by restoring clinical efficacy and avoiding surgical revision., Materials and Methods: A total of 34 successful SNM patients (28 overactive bladder wet, six nonobstructive urinary retention) with an implantable pulse generator were included. All possible bipolar and monopolar electrode settings were tested at sensory threshold (ST) to evaluate sensory (mapped on a perineal grid with 1 cm 2 coordinates) and motor (peak-to-peak amplitude and latency of muscle action potential) responses of the pelvic floor. Pelvic floor muscle electromyography was recorded using a multiple array probe, placed intravaginally. Parametric tests were used for paired data: repeated-measures ANOVA or t-test. A nonparametric test was used for paired data: Friedman ANOVA or Wilcoxon signed rank (WSR) test; p < 0.05 was considered statistically significant. If significant, ANOVA was followed by Dunn-Bonferroni post hoc analysis., Results: Monopolar configurations showed significantly lower STs-1.38 ± 0.73 V vs 1.76 ± 0.89 V (paired t-test: p < 0.0001)-and presented with significantly higher peak-to-peak amplitudes-115.67 ± 79.03 μV vs 90.77 ± 80.55 μV (WSR: p = 0.005)-than bipolar configurations. When polarity was swapped, configurations with the cathode distal to the anode showed significantly lower STs, 1.73 ± 0.91 V vs 1.85 ± 0.87 V (paired t-test: p = 0.003), and mean peak-to-peak amplitudes, 81.32 ± 72.82 μV vs 100.21 ± 90.22 μV (WSR: p = 0.0001). Cathodal changes resulted in more changes in sensory responses than anodal changes (χ 2 test: p = 0.044). In cathodal changes only, peak-to-peak amplitudes were significantly higher when the distance between electrodes was maximally spread (WSR: p = 0.046)., Conclusions: From a neurophysiological point of view, monopolar configurations stimulated more motor nerve fibers at lower STs, therefore providing more therapeutic efficiency. Swapping polarity or changing the position of the cathode led to different sensory and motor responses, serving as potential reprogramming options., (Copyright © 2021 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.)

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., (© 2022 Wiley Periodicals LLC.)

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 &lt; 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., (© 2022 Wiley Periodicals LLC.)

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., (© 2022 Wiley Periodicals LLC.)

Objective: 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., Materials and Methods: 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., Results: 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., Conclusions: 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.

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., (© 2022. The Author(s).)

Introduction: The urinary disorders of the patients with Parkinson's disease are complex and have a negative impact on their quality of life. None of therapy is considered effective ; whether drug or surgical. Sacral neuromodulation, recommended in other neurological pathologies such as multiple sclerosis, has never been studied in the patients with Parkinson's disease. The objective of our study is to assess the efficacy of sacral neuromodulation in the patients with Parkinson's disease., Material and Method: Multicentric retrospective cohort study, of 22 parkinsonian patients who underwent a sacral neuromodulation test. Epidemiological, clinical and urodynamic data were collected for each patient. A long-term effectiveness telephone survey was conducted., Results: Twenty two patients with Parkinson's disease had a sacral neuromodulation test. 17/22 (77%) had Idiopathic Parkinson's Disease and 5/22 (23%) had Systematized Multi Atrophy. Clinically, the indication for the sacral neuromodulation test was overactive bladder in 68% of the cases. Urodynamically, detrusor hyperactivity is found in 12 patients (8 MPI, 4 AMS). Sacral neuromodulation was effective in only 7 patients (6 MPI and 1 AMS). Rather, the profile of the patient in whom NMS is effective is female, mature, and with PID. The long-term effectiveness of NMS is disappointing. Only 2 permanently implanted patients retained urinary benefit., Conclusion: NMS improves urinary symptoms in the patients with Parkinson's disease in 32% of cases. It fluctuates over time and loses its effectiveness in the long term., (Copyright © 2021 Elsevier Masson SAS. All rights reserved.)

Background: SOUNDS strengthens the evidence basis of sacral neuromodulation (SNM) for overactive bladder (OAB) through real-world data., Objective: To analyze diary-based effectiveness, quality of life (QoL), disease severity, symptom bother, and safety data for SNM with the InterStim system up to 3 yr after implantation., Design, Setting, and Participants: Twenty-five representative French sites enrolled 291 patients with OAB followed according to the local standard of care. Overall, 229 patients received a de novo or replacement InterStim implant and had four follow-up visits, two within the first yr and annually thereafter. A total of 190 patients completed the fourth follow-up visit after a mean of 33.7 ± 3.7 mo., Outcome Measurements and Statistical Analysis: The effectiveness outcomes measured were changes in daily voids and leaks and the therapy responder rates. Other outcomes included validated QoL data (Ditrovie and EuroQol 5-dimension 5-level questionnaires), disease severity (Urinary Symptom Profile [USP]), symptom bother rated using a numeric rating scale (NRS), and safety data. Follow-up data were compared to baseline results using the Wilcoxon signed-rank test., Results and Limitations: Average daily voids and leaks were significantly reduced at all time points up to 3 yr after implantation (p < 0.05) except for voids at 21 mo in the group receiving a replacement device. The therapeutic response for urinary urge incontinence at the fourth follow-up was 72% for the de novo group and 86% for the replacement group. Disease-specific QoL (Ditrovie), OAB-specific symptom severity (USP domain 2), and NRS-rated disease bother were significantly improved at all visits (p < 0.001). Device- or procedure-related adverse events occurred in 49% of patients, with 68% of the events classified as minor (Clavien-Dindo grade I or II). Surgical revisions were performed in 33% of patients, including permanent removal in 13%, over a mean exposure time of 44.4 ± 15.3 mo., Conclusions: This study confirms the safety and effectiveness of SNM for OAB and improvements in QoL and disease bother in real life., Patient Summary: Our study in French patients with overactive bladder showed that disease symptoms and bother were significantly reduced and quality of life was significantly improved over a study duration of approximately 3 yr after implantation of a device to stimulate nerves that control the bladder. This trial is registered at ClinicalTrials.gov as NCT02186041., (Copyright © 2021. Published by Elsevier B.V.)

Objective: To evaluate the effectiveness of sacral neuromodulation therapy (SNM) for lower urinary tract symptoms (LUTS) caused by neurological diseases., Methods: This prospective cohort study enrolled patients that developed LUTS secondary to neurological disorders. All patients underwent staged SNM. A 5-day voiding diary was used to evaluate their response to the stage 1 procedure. Implantation of the full system during the stage 2 procedure was undertaken in patients that had ≥50% improvement on their voiding diary., Results: Twenty-one patients were included in the study with the following neurological aetiologies: diabetes mellitus ( n  = 2), myelitis ( n  = 3), multiple sclerosis ( n  = 5), spinal cord injury ( n  = 10) and cerebrovascular accident ( n  = 1). Fifteen patients underwent the stage 1 procedure successfully; their mean age was 47.5 years and the mean follow-up was 29 months. SNM resulted in significantly increased voided volume/void/day, decreased leaking episodes/day, decreased postvoiding residual/day and decreased number of clean intermittent catheterization/day compared with baseline. Five patients were highly satisfied, nine were moderately satisfied and one patient was not satisfied with the therapy., Conclusion: SNM was an effective therapy for LUTS caused by neurological disease and there was a high rate of patient satisfaction.