Sacral Neuromodulation: Device Improvement and Current Applications in Urology.

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.

[Prolonged spinal and sacral neurostimulation in children with pelvic organ dysfunction: preliminary analysis]. / Dlitel'naya spinal'naya i sakral'naya neirostimulyatsiya u detei pri narusheniyakh funktsii tazovykh organov: predvaritel'nyi analiz.

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: Patients 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 H2O (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.

Sacral neuromodulation for constipation and fecal incontinence in children and adolescents - study protocol of a prospective, randomized trial on the application of invasive vs. non-invasive technique.

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).

Effects of upper limbs' neuromuscular electrical stimulation (NMES) superimposed to voluntary contraction added to a protocol of intradialytic leg cycle ergometer exercise, in muscle strength, functional capacity and quality of life of adult patients with CKD: a randomized clinical trial protocol.

OBJECTIVE: To investigate the effects of unilateral upper limbs' (ULM) neuromuscular electrical stimulation (NMES) superimposed on a voluntary contraction added to a protocol of intradialytic leg cycle ergometer exercise on muscle strength, functional capacity and quality of life of adult patients with chronic kidney disease (CKD). METHODS: This randomized controlled clinical trial will be carried out at a Brazilian University Hospital. The patients will be evaluated and randomly allocated to an intervention group (i.e., unilateral NMES on the upper limb without hemodialysis fistula for 20 min and leg cycle ergometer for 30 min) or a control group (i.e., unilateral NMES-Sham on the upper limb without hemodialysis fistula for 20 min and leg cycle ergometer for 30 min). The patients will be treated for 8 weeks, with three weekly treatment sessions totaling 24 sessions. MEASUREMENTS: ULM muscle strength, functional capacity, quality of life and also the feasibility, safety and patient adherence to the exercise protocol. All physical measurements will be collected by trained researchers before treatment (week 0) and at the end of treatment (week 9), always in the second hemodialysis session of the week. It will be used in an intention-to-treat analysis. RESULTS/CONCLUSIONS: The outcomes of this clinical trial protocol may help to know the possible benefits of unilateral ULM' NMES superimposed on a voluntary contraction added to a protocol of leg cycle ergometer for patients with CKD and to aid clinical decisions about future implementation or not of this technique (NMES) in intradialytic physical training programs.

20 years of neuromuscular electrical stimulation in COPD.

Although a lung disease, COPD is also associated with extrapulmonary manifestations including, among others, limb muscle dysfunction. Limb muscle dysfunction is a key systemic consequence of COPD that impacts patients' physical activity, exercise tolerance, quality of life and survival. Deconditioning is the main mechanism underlying the development of limb muscle dysfunction in COPD, which can be partially improved with exercise. However, some patients may not be able to tolerate exercise because of incapacitating breathlessness or unwillingness to undertake whole-body exercise. Alternative training modalities that do not give rise to dyspnoea, such as neuromuscular electrical stimulation (NMES), are urged. Over the past 20 years, NMES in COPD has presented conflicting conclusions in meta-analysis. In this review, we try to understand the reason for this result by analysing possible biases and factors that brought conflicting conclusions. We discuss the population (the intervention group, but also the control group), the outcome measures, the frequency of stimulation, the rehabilitation protocol (i.e. NMES alone versus standard care/rehabilitation or NMES plus conventional exercise training versus conventional exercise training alone or NMES versus sham treatment) and the trial design. The main reason for this discrepancy is the lack of dedicated guidelines for NMES. Further research is urged to determine the optimal parameters for an NMES programme. Despite this, NMES appears to be an effective means of enhancing quadriceps strength and exercise capacity in COPD with the potential to break the vicious circle induced by the disease and COPD patients' lifestyle.

Theory and application of TTFields in newly diagnosed glioblastoma.

BACKGROUND: Glioblastoma is the most common primary malignant brain tumor in adults. TTFields is a therapy that use intermediate-frequency and low-intensity alternating electric fields to treat tumors. For patients with ndGBM, the addition of TTFields after the concurrent chemoradiotherapy phase of the Stupp regimen can improve prognosis. However, TTFields still has the potential to further prolong the survival of ndGBM patients. AIM: By summarizing the mechanism and application status of TTFields in the treatment of ndGBM, the application prospect of TTFields in ndbm treatment is prospected. METHODS: We review the recent literature and included 76 articles to summarize the mechanism of TTfields in the treatment of ndGBM. The current clinical application status and potential health benefits of TTFields in the treatment of ndGBM are also discussed. RESULTS: TTFields can interfere with tumor cell mitosis, lead to tumor cell apoptosis and increased autophagy, hinder DNA damage repair, induce ICD, activate tumor immune microenvironment, reduce cancer cell metastasis and invasion, and increase BBB permeability. TTFields combines with chemoradiotherapy has made progress, its optimal application time is being explored and the problems that need to be considered when retaining the electrode patches for radiotherapy are further discussed. TTFields shows potential in combination with immunotherapy, antimitotic agents, and PARP inhibitors, as well as in patients with subtentorial gliomas. CONCLUSION: This review summarizes mechanisms of TTFields in the treatment of ndGBM, and describes the current clinical application of TTFields in ndGBM. Through the understanding of its principle and application status, we believe that TTFields still has the potential to further prolong the survival of ndGBM patients. Thus,research is still needed to explore new ways to combine TTFields with other therapies and optimize the use of TTFields to realize its full potential in ndGBM patients.

Impact of glioma peritumoral edema, tumor size, and tumor location on alternating electric fields (AEF) therapy in realistic 3D rat glioma models: a computational study.

Objective.Alternating electric fields (AEF) therapy is a treatment modality for patients with glioblastoma. Tumor characteristics such as size, location, and extent of peritumoral edema may affect the AEF strength and distribution. We evaluated the sensitivity of the AEFs in a realistic 3D rat glioma model with respect to these properties.Approach.The electric properties of the peritumoral edema were varied based on calculated and literature-reported values. Models with different tumor composition, size, and location were created. The resulting AEFs were evaluated in 3D rat glioma models.Main results.In all cases, a pair of 5 mm diameter electrodes induced an average field strength >1 V cm-1. The simulation results showed that a negative relationship between edema conductivity and field strength was found. As the tumor core size was increased, the average field strength increased while the fraction of the shell achieving >1.5 V cm-1decreased. Increasing peritumoral edema thickness decreased the shell's mean field strength. Compared to rostrally/caudally, shifting the tumor location laterally/medially and ventrally (with respect to the electrodes) caused higher deviation in field strength.Significance.This study identifies tumor properties that are key drivers influencing AEF strength and distribution. The findings might be potential preclinical implications.

An Adaptive Hammerstein Model for FES-Induced Torque Prediction Based on Variable Forgetting Factor Recursive Least Squares Algorithm.

Modeling the muscle response to functional electrical stimulation (FES) is an important step during model-based FES control system design. The Hammerstein structure is widely used in simulating this nonlinear biomechanical response. However, a fixed relationship cannot cope well with the time-varying property of muscles and muscle fatigue. In this paper, we proposed an adaptive Hammerstein model to predict ankle joint torque induced by electrical stimulation, which used variable forgetting factor recursive least squares (VFFRLS) method to update the model parameters. To validate the proposed model, ten healthy individuals were recruited for short-duration FES experiments, ten for long-duration FES experiments, and three stroke patients for both. The isometric ankle dorsiflexion torque induced by FES was measured, and then the test performance of the fixed-parameter Hammerstein model, the adaptive Hammerstein model based on fixed forgetting factor recursive least squares (FFFRLS) and the adaptive Hammerstein model based on VFFRLS was compared. The goodness of fit, root mean square error, peak error and success rate were applied to evaluate the accuracy and stability of the model. The results indicate a significant improvement in both the accuracy and stability of the proposed adaptive model compared to the fixed-parameter model and the adaptive model based on FFFRLS. The proposed adaptive model enhances the ability of the model to cope with muscle changes.

Treatment of the infected sacral nerve stimulator: A scoping review.

BACKGROUND: Sacral nerve stimulators (SNSs) are a widely accepted, efficacious surgical option to treat patients who have failed conservative management for overactive bladder, nonobstructive urinary retention, fecal incontinence, or pelvic pain. As with all implanted devices, there are associated risks for surgical site and implant infections. There are currently no clear published data or guidelines regarding treating such infections. AIMS: We present a scoping review aiming to examine the existing literature on the treatment approaches of infected SNSs. METHODS: A scoping review was conducted using Preferred Reporting Items for Systematic Review and Meta-Analysis. The search strategy focused on "sacral modulation," and "infection," and "explantation," and conservative management methods such as "antibiotics." A search was conducted on medical databases, and a grey literature search was performed. RESULTS: Thirty articles were included for data extraction. Articles were published between 2006 and 2022. Outcomes were reported for 7446 patients. Two hundred and seventy-four infection events were reported, giving an overall 3.7% infection rate. Most infection events were treated with explantation, although there is some discussion on the role of conservative management using oral and intravenous antibiotics in the literature. Articles also discussed considerations for future reimplantation after explantation of SNS. CONCLUSIONS: There are currently no treatment protocols in the literature to help guide whether a patient is suited to conservative or surgical management. There is future scope for developing treatment algorithms to guide clinicians for optimal treatment of infected sacral neuromodulation devices.

Radiation exposure during sacral neuromodulation lead placement: Multi-institutional descriptive study.

OBJECTIVES: Fluoroscopy has significantly improved lead placement and decreased surgical time for implantable sacral neuromodulation (SNM). There is a paucity of data regarding radiation and safety of fluoroscopy during SNM procedures. Our study aims to characterize fluoroscopy time and dose used during SNM surgery across multiple institutions and assess for predictors of increased fluoroscopy time and radiation dose. METHODS: Electronic medical records were queried for SNM procedures (Stage 1 and full implant) from 2016 to 2021 at four academic institutions. Demographic, clinical, and intraoperative data were collected, including fluoroscopy time and radiation dose in milligray (mGy). The data were entered into a centralized REDCap database. Univariate and multivariate analysis were performed to assess for predictive factors using STATA/BE 17.0. RESULTS: A total of 664 procedures were performed across four institutions. Of these, 363 (54.6%) procedures had complete fluoroscopy details recorded. Mean surgical time was 58.8 min. Of all procedures, 79.6% were performed by Female Pelvic Medicine and Reconstructive Surgery specialists. There was significant variability in fluoroscopy time and dose based on surgical specialty and institution. Most surgeons (76.4%) were considered "low volume" implanters. In a multivariate analysis, bilateral finder needle testing, surgical indication, surgeon volume, and institution significantly predicted increased fluoroscopy time and radiation dose (p < 0.05). CONCLUSIONS: There is significant variability in fluoroscopy time and radiation dose utilized during SNM procedures, with differences across institutions, surgeons, and subspecialties. Increased radiation exposure can have harmful impacts on the surgical team and patient. These findings demonstrate the need for standardized fluoroscopy use during SNM procedures.

Rehabilitative effects of electrical stimulation on gait performance in stroke patients: A systematic review with meta-analysis.

BACKGROUND: Electrical stimulation techniques are widely utilized for rehabilitation management in individuals with stroke patients. OBJECTIVES: This review aims to summarize the rehabilitative effects of electrical stimulation therapy on gait performance in stroke patients. METHODS: This review included randomized controlled trials (RCT) investigating the therapeutic effects of electrical stimulation in stroke patients throughout five databases. This review qualitatively synthesized 20 studies and quantitatively analyzed 11 RCTs. RESULTS: Functional electrical stimulation (FES) was the most commonly used electrical stimulation type to improve postural stability and gait performance in stroke patients. The clinical measurement tools commonly used in the three studies to assess the therapeutic effects of FES were Berg balance scale (BBS), 10-meter walk test (10MWT), 6-minute walk test (6mWT), and gait velocity. The BBS score and gait velocity had positive effects in the FES group compared with the control group, but the 10MWT and 6mWT showed the same effects between the two groups. The heterogeneity of BBS scores was also high. CONCLUSION: The results of this review suggest that electrical stimulation shows little evidence of postural stability and gait performance in stroke patients, although some electrical stimulations showed positive effects on postural stability and gait performance.

Effects of a full-body electrostimulation garment application in a cohort of subjects with cerebral palsy, multiple sclerosis, and stroke on upper motor neuron syndrome symptoms.

OBJECTIVES: Dysfunction of the central nervous system may inflict spastic movement disorder (SMD). Electrical stimuli were identified as promising therapeutic option. Electrical stimulation provided by a 58-electrode full body garment was investigated based on data from regular trial fittings. METHODS: Data from 72 testees were investigated. Age averages 36.6 (19.8) ys with 44 females. The cohort spans infantile cerebral paresis (CP) (n=29), multiple sclerosis (MS) (n=23) and stroke (n=20). Data were stratified by etiology and an entry BBS Score<45. RESULTS: Effect sizes (Cohen`s d) related BBS, TUG, FGA, 10mWT, WMFT, EQ5D5L and Pain. Significance levels are indicated by *: p<0.05, **: p<0.01, ***: p<0.001, (t): p<0.1: CP: 1.64***, 0.29*, 1.59***, 0.76(t), 1.00***, 0.5*, 1.28***; MS: 1.83***, 0.83***, 1.28**, 1.07***, 0.93*, 1,11**, 0.78*; Stroke: 1.28**, 0.78**, 0.89, 0.92**, 0.71, 1.26*, 0.78*. CONCLUSIONS: Multi-site transcutaneous electrical stimulation may increase ambulation related skills in subjects with SMD stemming from CP, MS and stroke. The results indicate effects on static and dynamic balance, fall risk, mobility, upper extremity improvement and an overall increase in health utility and a reduction in spasticity related pain. Effects are immediate as well as sustained. These results may inspire individual trial fittings and inform further controlled trials.

Real-time prediction of bladder urine leakage using fuzzy inference system and dual Kalman filtering in cats.

The use of electrical stimulation devices to manage bladder incontinence relies on the application of continuous inhibitory stimulation. However, continuous stimulation can result in tissue fatigue and increased delivered charge. Here, we employ a real-time algorithm to provide a short-time prediction of urine leakage using the high-resolution power spectrum of the bladder pressure during the presence of non-voiding contractions (NVC) in normal and overactive bladder (OAB) cats. The proposed method is threshold-free and does not require pre-training. The analysis revealed that there is a significant difference between voiding contraction (VC) and NVC pressures as well as band powers (0.5-5 Hz) during both normal and OAB conditions. Also, most of the first leakage points occurred after the maximum VC pressure, while all of them were observed subsequent to the maximum VC spectral power. Kalman-Fuzzy method predicted urine leakage on average 2.2 s and 1.6 s before its occurrence and an average of 2.0 s and 1.1 s after the contraction started with success rates of 94.2% and 100% in normal and OAB cats, respectively. This work presents a promising approach for developing a neuroprosthesis device, with on-demand stimulation to control bladder incontinence.

Neuromuscular electrical stimulation changes glucose, but not its variability in type 2 diabetes: a randomized clinical trial.

Neuromuscular electrical stimulation (NMES) can be an alternative to conventional exercising. This randomized clinical trial evaluated the effect of NMES in type 2 diabetes patients. Twenty-eight individuals with type 2 diabetes were assigned to NMES (n=14) or NMES-placebo (n=14) applied to knee extensor muscles for 60 minutes. Glucose variability, microvascular function and endothelial function were evaluated through continuous glucose monitoring system, near infrared spectroscopy and flow-mediated dilatation, respectively. Glucose levels (mg/dl) decreased 2h (184 ± 11 vs 223 ±15), 3h (179 ± 12 vs 219 ±14) and 4h (177 ± 12 vs 212 ±12) after NMES, in comparison to NMES-placebo. No differences in glucose variability were found: coefficient of variation (%) at 0-6h (11.4±1.3 vs 11.4±1.2), 6-12h (9.8±1.0 vs 11.6±1.6), 12-18h (15.5±2.0 vs 11.4±2.1), 18-24h (12.8±2.3 vs 10.0±1.6); standard deviation (mg/dl) at 0-6h (21.6±2 vs 24.6±3.5), 6-12h (19.5±1.8 vs 20.3±2.8), 12-18h (29.9±3.5 vs 21.3±2.8),18-24h (22.8±4.1 vs 16.6±2.0) and mean amplitude of glycemic excursions (mg/dl) 54.9±25.0 vs 70.3±35.7. Endothelial and microvascular functions did not change. In conclusion, one acute NMES session was strong enough to trigger glucose reduction in individuals with type 2 DM, but it failed to induce any significant change in glucose variability, endothelial and microvascular functions.

A controlled randomized trial with a 12-week follow-up investigating the effects of medium-frequency neuromuscular electrical stimulation on pain, VMO thickness, and functionality in patients with knee osteoarthritis.

BACKGROUND: One of the major contributors to disability in Knee osteoarthritis (KOA) patients is weakness in the Quadriceps Femoris muscle. Neuromuscular electrical stimulation (NMES) has been used in rehabilitation for patients suffering from muscle weakness. Thus, the purpose of the study was to assess the effectiveness of NMES and exercise therapy, for improving pain, muscle weakness and function among patients with KOA. METHODS: A randomized controlled trial was conducted with 75 female patients diagnosed with KOA. Participants were divided into three intervention groups: NMES-only, exercise therapy (Exs) alone, and a combination of NMES and exercise (NMES + Exs). All patients underwent 12 supervised treatment sessions, three times a week. Outcome measures included pain intensity measured by visual analog scale (VAS), knee flexion range of motion (FROM), thigh muscle girth (TG), thickness of the Vastus Medialis Oblique (VMO), timed up and go test (TUG), six-minute walk test (6MWT), and WOMAC scores. Statistical analyses (ANOVA and Kruskal-Wallis) methods were done to compare the amounts at the baseline, immediately after treatment and after 12 weeks. RESULTS: The NMES group exhibited a significant reduction in pain at the 12-week follow-up compared to the other groups(p = 0.022). The NMES + Exs group showed better outcomes in terms of FROM, TG, and VMO thickness post-intervention (p < 0.0001, p < 0.004, p = 0.003, respectively) and at the 12-week follow-up (p < 0.0001, p < 0.0001, p < 0.0001, respectively). Additionally, NMES was superior in improving TUG and 6MWT post-intervention (p < 0.0001, p = 0.038, respectively) and during the follow-up assessments (p < 0.0001, p = 0.029, respectively). The NMES + Exs group achieved better WOMAC stiffness scores at both post-intervention and follow-up evaluations (p < 0.0001, p < 0.0001, respectively). Furthermore, at the 12-week follow-up, NMES + Exs group outperformed the others in WOMAC pain and function subscales (p = 0.003, p = 0.017, respectively), while the NMES group demonstrated better WOMAC total scores compared to the other groups (p = 0.007). CONCLUSION: The combination of NMES and exercise seems to be an efficient approach for managing KOA, as it enhances knee flexion range and TG, increases VMO thickness, and improves WOMAC scores. On the other hand, NMES alone was found to be effective in improving the physical function of KOA patients. TRIAL REGISTRATION: IRCT20101228005486N7 (06-02-2020).

Pediatric Down Syndrome Upper Airway Stimulation: Patient Selection and Post-Implantation Optimization.

OBJECTIVE: The Food and Drug Administration recently approved upper airway stimulation (UAS) for children with Down Syndrome and persistent obstructive sleep apnea who meet certain inclusion and exclusion criteria. Although there is a robust experience with this therapy in the adult population, established protocols used in adults are not directly transferrable to a complex pediatric population. This review aims to combine the protocols from several institutions for patient selection and postimplantation optimization, including a protocol for Drug-Induced Sleep Endoscopy in children with Down Syndrome, preactivation threshold measurements, device titration, and follow-up sleep studies. STUDY DESIGN: Expert panel development of best Practice algorithm. SETTING: Multi-institutional investigator review. METHODS: An expert panel was assembled of pediatric otolaryngologists with extensive experience in hypoglossal nerve stimulation in children with Down Syndrome. Thirty statements were created during an initial drafting session. A modified Delphi method was used assess consensus among the panel. RESULTS: After 2 rounds of Delphi surveys, 29 statements met criteria for consensus. One statement did not meet consensus. The statements were grouped into several categories to facilitate presentation. CONCLUSIONS: A standardized approach to UAS for children with Down Syndrome must take into account the unique challenges inherent to treating a complex pediatric population with a high rate of sensory processing disorders. This expert panel has met consensus on several statements that will guide clinicians as this novel therapy is adopted.

Who Progresses to Third-Line Therapies for Overactive Bladder? Trends From the AQUA Registry.

INTRODUCTION: Overactive bladder (OAB) patients who do not achieve satisfactory results with second-line OAB medications should be offered third-line therapies (percutaneous tibial nerve stimulation, sacral neuromodulation, onabotulinumtoxinA bladder injection [BTX-A]). We aimed to determine which clinical factors affect progression from second- to third-line OAB therapy. METHODS: Between 2014 and 2020, the AUA Quality Registry was queried for adult patients with idiopathic OAB. For the primary outcome, patient and provider factors associated with increased odds of progression from second- to third-line therapy were assessed. Secondary outcomes included median time for progression to third-line therapy and third-line therapy utilization across subgroups. RESULTS: A total of 641,122 patients met inclusion criteria and were included in analysis. Of these, only 7487 (1.2%) received third-line therapy after receiving second-line therapy. On multivariate analysis, patients aged 65 to 79, women, White race, history of dual anticholinergic and ß3 agonist therapy, metropolitan area, government insurance, and single specialty practice had the greatest odds of progressing to third-line therapy. Black and Asian race, male gender, and rural setting had lower odds of progressing to third-line therapy. BTX-A was the most common therapy overall (40% BTX-A, 32% sacral neuromodulation, 28% percutaneous tibial nerve stimulation). The median time of progression from second- to third-line therapy was 15.4 months (IQR 5.9, 32.4). Patients < 50 years old and women progressed fastest to third-line therapy. CONCLUSIONS: Very few patients received third-line therapies, and the time to progression from second- to third-line therapies is > 1 year. The study findings highlight a potential need to improve third-line therapy implementation.

Baiona's Consensus Statement for Fecal Incontinence. Spanish Association of Coloproctology.

Faecal incontinence (FI) is a major health problem, both for individuals and for health systems. It is obvious that, for all these reasons, there is widespread concern for healing it or, at least, reducing as far as possible its numerous undesirable effects, in addition to the high costs it entails. There are different criteria for the diagnostic tests to be carried out and the same applies to the most appropriate treatment, among the numerous options that have proliferated in recent years, not always based on rigorous scientific evidence. For this reason, the Spanish Association of Coloproctology (AECP) proposed to draw up a consensus to serve as a guide for all health professionals interested in the problem, aware, however, that the therapeutic decision must be taken on an individual basis: patient characteristics/experience of the care team. For its development it was adopted the Nominal Group Technique methodology. The Levels of Evidence and Grades of Recommendation were established according to the criteria of the Oxford Centre for Evidence-Based Medicine. In addition, expert recommendations were added briefly to each of the items analysed.

Effectiveness, safety and cost-effectiveness of sacral neuromodulation for idiopathic slow-transit constipation: a systematic review.

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.

Mechanism of Action of Tibial Nerve Stimulation in the Treatment of Lower Urinary Tract Dysfunction.

BACKGROUND AND OBJECTIVE: Tibial nerve stimulation (TNS) has long been used to effectively treat lower urinary tract dysfunction (LUTD). Although numerous studies have concentrated on TNS, its mechanism of action remains elusive. This review aimed to concentrate on the mechanism of action of TNS against LUTD. MATERIALS AND METHODS: A literature search was performed in PubMed on October 31, 2022. In this study, we introduced the application of TNS for LUTD, summarized different methods used in exploring the mechanism of TNS, and discussed the next direction to investigate the mechanism of TNS. RESULTS AND CONCLUSIONS: In this review, 97 studies, including clinical studies, animal experiments, and reviews, were used. TNS is an effective treatment for LUTD. The study of its mechanisms primarily concentrated on the central nervous system, tibial nerve pathway, receptors, and TNS frequency. More advanced equipment will be used in human experiments to investigate the central mechanism, and diverse animal experiments will be performed to explore the peripheral mechanism and parameters of TNS in the future.