Transcutaneous Neuromodulation Research Articles

Transcutaneous neuromodulation versus oxybutynin for neurogenic detrusor overactivity in persons with spinal cord injury: A randomized, investigator blinded, parallel group, non-inferiority controlled trial

Study design This study is a randomized, investigator-blinded, controlled trial with a non-inferiority design. Objective To investigate the effectiveness of neuromodulation by transcutaneous electrical stimulation of the somatic afferent nerves of the foot in neurogenic detrusor overactivity (NDO) in persons with spinal cord injury (SCI) and compare its effectiveness with oral oxybutynin. Setting The study was conducted in a rehabilitation in-patient ward of a tertiary care hospital. Methods Twenty-nine persons with SCI with NDO, either sex, aged 18 years and above were randomized into two groups, one group receiving oral oxybutynin (5 mg thrice a day for two weeks) and the other transcutaneous electrical stimulation (5 Hz, 200 µs pulse, biphasic, amplitude up to 60 mA, 30 min/day for two weeks). Bladder capacity was evaluated by clinical bladder evaluation (i.e. bladder capacity measured by adding leak volume, voiding volume if any, and post-void residue using a catheter) and cystometric bladder capacity by one-channel cystometry. Maximum cystometric pressure was evaluated by one-channel water cystometry. Data were analyzed with Fisher's Exact, t-test, and Wilcoxon rank sum tests. Results Bladder capacity improved significantly in the oxybutynin and neuromodulation groups as measured by one-channel water cystometry (136 ml vs. 120.57 ml) and clinical evaluation (138.93 ml vs. 112 ml). The increase in the neuromodulation group achieved the pre-decided non-inferiority margin of 30 ml over the oxybutynin group when measured by one-channel water cystometry but not by clinical evaluation. Maximum cystometric pressure did not significantly improve in either group when compared with the baseline. Conclusion Transcutaneous neuromodulation and oxybutynin effectively increased bladder capacity in persons with SCI with NDO. Neuromodulation by once-a-day transcutaneous electrical stimulation was non-inferior to thrice-a-day oxybutynin when evaluated by one-channel water cystometry. Trial registration: Clinical Trials Registry India identifier: CTRI/2018/05/013735.

A Finite Element Approach for Forearm Neuromodulation: Impact of Electrode Size on the Current Density

Electrical impedance myography is a transcutaneous neuromodulation method for assessing muscle conditions through the application of a high-frequency, low-intensity current to the muscle region of interest (ROI). It has been shown that the mechanisms underpinning these findings are controversial as studies showed that the current reaching the target structure may not be enough to activate tissue due to various factors. It has been shown that anatomical properties as well as non-anatomical factors including electrode shape and size, inter-electrode distance may affect the outcome. This study was conducted to investigate the impact of the different sizes of the electrodes on the current density of the ROI. It may not be feasible to investigate these parameters impact on the outcome using experimental procedures. Alternatively, the computational methos have been used as a tool to study electrical stimulation of bio-computational models. The neuromodulators can be designed and developed using such advanced methods. This study investigates the impact of the electrode size on the current distributions. The fundamental anatomical layers of the human forearm were generated based on standard dimensions using concentric shapes. A sinusoidal bipolar current pulse was applied on the different sizes of electrodes to simulate current distribution within the associated anatomical layers. It was shown that the electrode size has a significant impact on the induced current density of the target anatomical layer.

Development and Validation of an IoT Neurostimulator for the Treatment of Neurogenic Bladder.

Neurogenic bladder is a dysfunction in the lower urinary tract due to damage to the nervous system. One of the treatments that has shown important results is transcutaneous neuromodulation. The neuromodulation equipment available on the market does not allow remote activation or offer many resources for adjusting the parameters of the generated stimulus, as most devices operate with pre-established parameters in closed packages. For this reason, customizing therapy for each individual can be difficult. Therefore, the objective was to develop and validate a neuromodulation device capable of being remotely programmed and properly monitored. Materials and methods for validating devices were used according to the Brazilian Regulatory Standard (NBR), which deals with general requirements for the basic safety and essential performance of electromedical devices. After verifying the reliability of the device, which was capable of generating a biphasic and symmetrical wave, measured by an oscilloscope, considered safe by the technical requirements, it was tested in a real application. Users reported feeling a comfortable stimulus, similar to other previously used devices, and considered the device easy to use. In this way, it was possible to demonstrate the reliability and validity of the developed device.

Clinical Efficacy and Mechanism of Transcutaneous Neuromodulation on Functional Dyspepsia.

Prokinetics and proton pump inhibitors are first-line drugs for functional dyspepsia (FD) patients. However, no available treatment is effective for most FD patients, and the pathogenesis is still unclear. The purpose of this study was to investigate the therapeutic effect of transcutaneous neuromodulation (TN) on FD and its potential mechanisms. Fifty-seven FD patients were enrolled in the study and randomly divided into 3 groups (TN Neiguan (PC6) group, TN Zusanli (ST36) group, and sham TN group) that received corresponding treatment respectively for 4 weeks. Then, all the patients enrolled received TN PC6 combined with ST36 treatment for another 4 weeks. Dyspepsia symptom questionnaire, Medical outcomes study item short form health survey (SF-36), Hospital Anxiety and Depression Scale were used to assess the severity of symptoms. Gastric accommodation, gastric emptying rate, and related parameters of electrogastrogram were used to assess the pathophysiological mechanism of FD. The possible gastrointestinal hormonal mechanism involved was assessed by detecting serum ghrelin, neuropeptide Y, and vasoactive intestinal peptide. The possible duodenal inflammation mechanism involved was assessed by detecting duodenal mucosa. TN treatment reduced the dyspepsia symptom score ( P <0.05) and improved the quality of life. After TN treatment, the gastric accommodation ( P <0.01), the gastric emptying rate ( P <0.01), and the percentages of preprandial ( P <0.05) and postprandial ( P <0.05) gastric slow waves (GSW) were increased. The proportions of preprandial ( P <0.05) and postprandial ( P <0.05) gastric electrical rhythm disorder were reduced. The double acupoint combination therapy further enhanced the therapeutic effect of single acupoint. In addition, the levels of ghrelin ( P <0.001) and neuropeptide Y ( P <0.001) were significantly increased, the level of vasoactive intestinal peptide ( P <0.001) was significantly decreased, and the total number of mast cells ( P <0.001) in the duodenal bulb was significantly decreased after double acupoints combination therapy. TN treatment significantly improves the dyspepsia symptoms of FD patients and their quality of life. TN treatment increases the percentage of normal GSW, reduces the proportion of gastric electrical rhythm disorder, and improves the gastric accommodation and gastric emptying rate. The therapeutic effect of TN may be caused by regulating gastrointestinal hormone secretion and alleviating local inflammatory responses in duodenum. In addition, the improvement of TN on GSW was closely related to the decrease of bradygastria.

Effect and mechanism of needleless transcutaneous neuromodulation on gastrointestinal function after pancreaticoduodenectomy

Background Gastrointestinal motility disorders tend to develop after pancreaticoduodenectomy (PD). The objectives of this study were: (1) to investigate the impact of needleless transcutaneous neuromodulation (TN) on the postoperative recuperation following pancreaticoduodenectomy (PD), and (2) to explore the underlying mechanisms by which TN facilitates the recovery of gastrointestinal function after PD. Methods A total of 41 patients scheduled for PD were randomized into two groups: the TN group (n = 21) and the Sham-TN group (n = 20). TN was performed at acupoints ST-36 and PC-6 twice daily for 1 h from the postoperative day 1 (POD1) to day 7. Sham-TN was performed at non-acupoints. Subsequent assessments incorporated both heart rate variation and dynamic electrogastrography to quantify alterations in vagal activity (HF) and gastric pacing activity. Results 1)TN significantly decreased the duration of the first passage of flatus (p < 0.001) and defecation (p < 0.01) as well as the time required to resume diet (p < 0.001) when compared to sham-TN;2)Compared with sham-TN, TN increased the proportion of regular gastric pacing activity (p < 0.01);3) From POD1 to POD7, there was a discernible augmentation in HF induced by TN stimulation(p < 0.01);4) TN significantly decreased serum IL-6 levels from POD1 to POD7 (p < 0.001);5) TN was an independent predictor of shortened hospital stay(β = − 0.349, p = 0.035). Conclusion Needleless TN accelerates the recovery of gastrointestinal function and reduces the risk of delayed gastric emptying in patients after PD by enhancing vagal activity and controlling the inflammatory response.

Effectiveness of Transcutaneous Neuromodulation on Abductor Muscles Electrical Activity in Subjects with Chronic Low Back Pain: A Randomized, Controlled, Crossover Clinical Trial.

Non-specific chronic low back pain (NSCLBP) is a major cause of functional impairment, resulting in consequences like job absenteeism and reduced quality of life. Risk factors such as muscle weakness and tightness have been implicated. Electromagnetic fields have therapeutic effects on human tissue, including pain relief and muscle relaxation. This study aimed to examine the impact of a tape with magnetic particles (MPT) applied to the lumbar area on abductor muscle strength and surface electromyography (sEMG) of the Gluteus Medius and Tensor of the Fascia Lata muscles in individuals with NSCLBP. It was carried out a double-blind, randomized, controlled, crossover trial and with test retest, with 41 consecutive patients younger than 65 years who previously diagnosed with NSCLBP to assess the effect of a MPT over hip abductor muscle strength and activity. sEMG and force data were obtained during the Hip Stability Isometric Test (HipSIT). The HipSIT was used to assess the abduction strength using a hand-held dynamometer and sEMG. The HipSIT uses the maximum voluntary isometric contraction (MVIC). Four trials were recorded and the mean extracted for analysis. The tape was applied with either a MPT or a sham magnetic particle tape (SMPT) bilaterally without tension on from L1 to L5 paravertebral muscles. The significant increase in the recruitment of fibers and the significant increase in the maximum voluntary contraction by applying MPT with respect to the SMPT, correspond to the increases in the Peak Force and the decrease in the time to reach the maximum force (peak time) of both muscles. Application of a MPT in patients with NSCLBP suggests an increase in muscle strength of the Gluteus Medius and Tensor Fascia Lata bilaterally during the HipSIT test. Lumbar metameric neuromodulation with MPT improves muscle activation of the hip musculature.

Management of auricular transcutaneous neuromodulation and electro-acupuncture of the vagus nerve for chronic migraine: a systematic review.

Migraine is a type of primary headache that is accompanied by symptoms such as nausea, vomiting, or sensitivity to light and sound. The aim of this study was to conduct a systematic review on the effectiveness of non-invasive neuromodulation, auricular transcutaneous vagus nerve stimulation (at-VNS), and electro-ear acupuncture of the vagus nerve in patients with migraine headaches. Six databases were searched from inception to 15 June 2022 for clinical trials, in which at least one group received any form of non-invasive neuromodulation of the vagus nerve for managing migraine with outcomes collected on pain intensity and related disability. Data, including participants, interventions, blinding strategy, outcomes, and results, were extracted by two reviewers. The methodological quality was assessed with the PEDro scale, ROB, and Oxford scale. The search identified 1,117 publications with nine trials eligible for inclusion in the review. The methodological quality scores ranged from 6 to 8 (mean: 7.3, SD: 0.8) points. Low-quality evidence suggests some positive clinical effects for the treatment of chronic migraine with 1 Hz with at-VNS and ear-electro-acupuncture compared with the control group at post-treatment. Some of the studies provided evidence of the relationship between chronic migraine and a possible positive effect as a treatment with at-VNS and the neurophysiological effects using fMRI. Six of the studies provided evidence using fMRI of the relationship between chronic migraine and a possible positive effect as a treatment with at-VNS and the neurophysiological effects. Regarding all included studies, the level of evidence with the Oxford scale was level 1 (11.17%), six studies were graded as level 2 (66.66%), and two studies were graded as level 3 (22.2%). With the PEDro score, five studies got a low methodological score < 5 and only four got a score superior to 5, being highly methodological quality studies. For ROB, most of the studies were high risk and only a few of them received a low risk of bias. The pain intensity, migraine attacks, frequency, and duration were measured by three studies with positive results at post-treatment. And only 7% reported adverse events using at-VNS. All studies reported results at a post-treatment period in their respective main outcomes. And all studies with fMRI provided strong evidence of the relationship between the Locus Coeruleus, Frontal Cortex, and other superior brain areas with the auricular branch of the Vagus nerve with at-VNS. Some positive effects regarding the effect of non-invasive neuromodulation, auricular transcutaneous vagus nerve stimulation (at-VNS), and electro-ear acupuncture of the vagus nerve on migraine is reported in the current literature, but there are not enough data to obtain strong conclusions. This systematic review was registered in the PROSPERO database (registration number: CRD42021265126).

Differences between brain responses to peroneal electrical transcutaneous neuromodulation and transcutaneous tibial nerve stimulation, two treatments for overactive bladder.

To compare brain responses to peroneal electrical transcutaneous neuromodulation (peroneal eTNM®) and transcutaneous tibial nerve stimulation (TTNS), two methods for treating overactive bladder (OAB), using functional magnetic resonance imaging (fMRI). The present study was not designed to compare their clinical efficacy. This study included 32 healthy adult female volunteers (average age 38.3 years (range 22-73)). Brain MRI using 3 T scanner was performed during three 8-min blocks of alternating sequences. During each 8-min block, the protocol alternated between sham stimulation (30 s) and rest (30 s) for 8 repeats; then peroneal eTNM® stimulation (30 s) and rest (30 s) for 8 repeats; then, TTNS stimulation (30 s) and rest (30 s) for 8 repeats. Statistical analysis was performed at the individual level with a threshold of p = 0.05, family-wise error (FWE)-corrected. The resulting individual statistical maps were analyzed in group statistics using a one-sample t-test, p = 0.05 threshold, false discovery rate (FDR)-corrected. During peroneal eTNM®, TTNS, and sham stimulations, we recorded activation in the brainstem, bilateral posterior insula, bilateral precentral gyrus, bilateral postcentral gyrus, left transverse temporal gyrus, and right supramarginal gyrus. During both peroneal eTNM® and TTNS stimulations, but not sham stimulations, we recorded activation in the left cerebellum, right transverse temporal gyrus, right middle frontal gyrus, and right inferior frontal gyrus. Exclusively during peroneal eTNM® stimulation, we observed activation in the right cerebellum, right thalamus, bilateral basal ganglia, bilateral cingulate gyrus, right anterior insula, right central operculum, bilateral supplementary motor cortex, bilateral superior temporal gyrus, and left inferior frontal gyrus. Peroneal eTNM®, but not TTNS, induces the activation of brain structures that were previously implicated in neural control of the of bladder filling and play an important role in the ability to cope with urgency. The therapeutic effect of peroneal eTNM® could be exerted, at least in part, at the supraspinal level of neural control.

Effect duration of the initial course of peroneal electrical Transcutaneous NeuroModulation in patients with overactive bladder

The aim of this prospective 12-month follow-up study is to evaluate the persistence of the treatment effect achieved during the initial course of peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM®) in patients with overactive bladder (OAB). This study enrolled 21 female patients who participated in two previous clinical studies designed to assess the efficacy and safety of peroneal eTNM®. The patients were left without subsequent OAB treatment and were invited to attend regular follow-up visits every 3months. The patient's request for additional treatment was considered an indicator of the withdrawal of the treatment effect of the initial course of peroneal eTNM®. The primary objective was the proportion of patients with persisting treatment effect at follow-up visit 12months after initial course of peroneal eTNM®. Descriptive statistics are presented using median, correlation analyses were computed using a nonparametric Spearman correlation. The proportion of patients with persistent therapeutic effect of the initial course of peroneal eTNM® was 76%, 76%, 62% and 48% at 3, 6, 9 and 12months, respectively. There was a significant correlation between patient reported outcomes and the number of severe urgency episodes with or without urgency incontinence as reported by patients at each follow-up visit (p = 0.0017). The treatment effect achieved during the initial phase of peroneal eTNM® persists for at least 12months in 48% of patients. It is likely that the duration of effects is dependent on the length of the initial therapy.

The Journal of Urology® Home Study Course 2023 Volume 209/210.

The Journal of Urology® Home Study Course 2023 Volume 209/210.

This Month in Adult Urology.

This Month in Adult Urology.

Transcutaneous Neuromodulation for Constipation and Fecal Incontinence in Children: A Systematic Review and Meta-Analysis.

Constipation is a disorder with a multifactorial origin. Constipation has a varied clinical presentation, including infrequent defecation of bulky stools and episodes of retentive fecal incontinence. Neuromodulation has been used to treat many health problems, with promising results. To conduct a systematic review of randomized clinical trials based on the effects of transcutaneous neuromodulation in treating constipation and retentive fecal incontinence in children and adolescents. A systematic review of randomized clinical trials was performed. Medline (PubMed), PEDro, SciELO, Cochrane (CENTRAL), Embase, and Scopus databases were searched from March 2000 to August 2022. We included clinical trials evaluating transcutaneous neuromodulation in children with constipation and fecal incontinence compared or associated with other types of treatment. Two reviewers independently selected relevant studies, assessed the methodological quality, and extracted the data. Three studies with 164 participants were included in this review. Two meta-analyses were generated based on these studies. These analyses revealed that transcutaneous neuromodulation is an effective adjuvant treatment modality that improves children's constipation and retentive fecal incontinence. The methodological quality of the included studies was classified as high based on the assessment of the quality of evidence, with a high degree of confidence based on the GRADE system. Transcutaneous neuromodulation is an effective adjuvant treatment modality for children with constipation and retentive fecal incontinence.

Brain Response Induced by Peroneal Electrical Transcutaneous Neuromodulation Invented for Overactive Bladder Treatment, as Detected by Functional Magnetic Resonance Imaging

ObjectivesIn this study, we aimed to investigate whether peroneal electrical Transcutaneous Neuromodulation invented for overactive bladder (OAB) treatment elicits activation in brain regions involved in neural regulation of the lower urinary tract. Materials and MethodsAmong 22 enrolled healthy female volunteers, 13 were eligible for the final analysis. Functional magnetic resonance imaging (fMRI) (Siemens VIDA 3T; Erlangen, Germany) was used to compare the brain region activation elicited by peroneal electrical Transcutaneous Neuromodulation with the activation elicited by sham stimulation. Each subject underwent brain fMRI recording during eight 30-second periods of rest, alternating with 30-second periods of passive feet movement using the sham device, mimicking the motor response to peroneal nerve stimulation. Subsequently, fMRI recording was performed during the analogic “off-on” stimulation paradigm using peroneal electrical transcutaneous neuromodulation. Magnetic resonance imaging data acquired during both paradigms were compared using individual and group statistics. ResultsDuring both peroneal electrical Transcutaneous Neuromodulation and sham feet movements, we observed activation of the primary motor cortex and supplementary motor area, corresponding to the cortical projection of lower limb movement. During peroneal electrical Transcutaneous Neuromodulation, we observed significant activations in the brain stem, cerebellum, cingulate gyrus, putamen, operculum, and anterior insula, which were not observed during the sham feet movement. ConclusionsOur study provides evidence that peroneal electrical Transcutaneous Neuromodulation elicits activation of brain structures that have been previously implicated in the perception of bladder fullness and that play a role in the ability to cope with urinary urgency. Our data suggest that neuromodulation at the level of supraspinal control of the lower urinary tract may contribute to the treatment effect of peroneal electrical Transcutaneous Neuromodulation in patients with OAB.

Overactive bladder, lack of habituation, and central sensitisation: The sympathetic skin response as a possible diagnostic marker and neuromodulation as a treatment

Objectives1) to characterise clinically, neurophysiologically and manometrically the overactive bladder (OAB); 2) to objectify the lack of habituation in OAB; 3) to quantify the comorbidities associated with CS (central sensitisation); and 4) to evaluate the effect of neuromodulation (NM) of the tibialis posterior nerve in OAB. Material and methodsForty-seven patients, retrospective observational pre-post study.Intervention: manometric biofeedback and posterior tibial transcutaneous NM (PTNM), 8 sessions.Outcome variables: a) clinical (daytime urinary frequency [DUF] and nocturnal urinary frequency [NUF]), b) neurophysiological (latency, amplitude and percentage of habituation); c) comorbidities associated with CS; d) manometric (maximum and average pressure); at the beginning/end of treatment. ResultsAge, 58.91 ± 13.27 years. Comorbidities associated with CS, 1.98 ± 0.32 (range 1–5 pathologies). Percentage of habituation, 88.6%. PTNM decreased DUF (10.4 ± 4.86 to 6.21 ± 1.87 episodes; P = .0001), and NUF (3.02 ± 1.66 to 1.17 ± 1 episodes; P = .0001). PTNM increased maximum (38.46 ± 23.06 to 42.61 ± 19.46 mmHg; P = .0964), and mean (7.63 ± 3.56 to 8.66 ± 4.76 mmHg; P = .1639) pressure. NMTP modified latency (1.32 ± 0.32 to 1.38 ± 0.32 s; P = .3397), and reduced amplitude (1.98 ± 1.28 to 1.67 ± 1.44 mV; P = .0004) and habituation (88.6 ± 23.5% at 70 ± 30.2%; P = .0001) of sympathetic skin response (SSR). ConclusionThe lack of habituation is a neurophysiological phenomenon present in OAB. PTNM improved clinical and neurophysiological variables. SSR is a neurophysiological test capable of objectifying lack of habituation and could characterize other response patterns (alteration of the ascending, central, descending or postganglionic pathway).

Electrical devices for functional visceral pain.

Several studies have documented correction of dysmotility in several regions of the gastrointestinal tract based on electrical stimulation of extrinsic nerves supplying those regions. In this issue of Neurogastroenterology and Motility, Ma et al. (2023) document the effect of transcutaneous neuromodulation applied by acustimulation at ST36 for ineffective esophageal motility in patients with gastroesophageal reflux disease. In addition to motor effects, there were also significant effects on GERD symptoms, raising the question whether extrinsic electrical nerve stimulation of the gut can reduce symptoms through effects that target sensation. This brief review summarizes evidence regarding the application of electrical acustimulation, transauricular electrical stimulation, and sacral electrical or magnetic stimulation to reduce abdominal or pelvic pain.

Clinical efficacy and mechanism of transcutaneous neuromodulation on ineffective esophageal motility in patients with gastroesophageal reflux disease.

Esophageal motility disorder is one of the pathogenesis of gastroesophageal reflux disease (GERD). The clinical and functional relationship between the ineffective esophageal motility (IEM) and GERD have been found. PPI is a widely used drug of this diaease, but some patients have poor efficacy. The purpose of this study was to investigate the efficacy and possible mechanism of Transcutaneous Neuromodulation in these patients. Fifty-six patients with GERD with IEM were enrolled and randomly divided into two groups, one group was TN ST-36 group, the other group was sham TN group. The GERD questionnaire (GerdQ), quality of life score, MOS item short from health survey (SF-36), Hospital Anxiety and Depression Scale (HADS) were used to assess the severity of symptoms. High-resolution esophageal manometry (HRM) test was performed to assess low esophageal sphincter (LES) pressure and distal contractile integral (DCI). The heart rate variability (HRV) test was performed to assess autonomic nervous function. Compared with sham TN, chronic TN treatment decreased the GERD-Q score (p< 0.001). The anxiety score (p= 0.058) and depression score (p= 0.156) were decreased, but there were no statistical differences. Chronic TN treatment also significantly improved the quality of life of patients, mainly in physical function, physical pain, overall health, vitality, social function, emotional function, and mental health. Acute TN treatment increased the DCI (p< 0.001) and LES pressure (p< 0.001) significantly and decreased the combined percentage of failed and weak peristalsis (p< 0.001). Concurrently, acute TN enhanced vagal activity (p< 0.001). IEM is an important link in the pathogenesis of GERD. Chronic TN treatment can significantly improve the clinical symptoms of patients. Acute TN treatment can significantly increase LES pressure and DCI and reduce the frequency of esophageal lost peristalsis and weak peristalsis. The improvement of esophageal motility in GERD patients with IEM by TN treatment may be related to the regulation of autonomic nervous function.

Stress and Urgency Urinary Incontinence: Clinical-Urodynamic Correlation and Rehabilitation Management in Daily Clinical Practice

(a) To correlate the clinical with the urodynamic diagnosis in a series of patients with UUI (urgency urinary incontinence) and SUI (stress urinary incontinence); (b) establish age, clinical and urodynamic differences; and (c) demonstrate the effectiveness of individualized rehabilitation treatment based on the clinical-urodynamic diagnosis in patients with SUI and UUI in the daily clinical practice of a third-level rehabilitation service. Retrospective study of 60 patients with SUI and UUI. Urodynamic study: (a) free flowmetry; (b) filling cystomanometry; (c) pressure-flow study. Outcome variables: daytime (DUF) and nighttime (NUF) urinary frequency, strength of the pelvic floor muscles (PFM) measured by manometry (maximum and mean pressure), and use of absorbents/day. Rehabilitation treatment: (a) pelvic floor muscle training (PFMT); (b) biofeedback (BFB), transcutaneous neuromodulation of the posterior tibial nerve (TTNM). Age, clinical, and urodynamic differences have been observed between patients with UUI versus SUI. UUI is more frequent in older patients (UUI 67.3 ± 10.19 years vs SUI 58.6 ± 8.54 years), p = 0.0028. Patients with UUI, when compared with patients with SUI, present more episodes of DUF (7.7 ± 5.1 vs 5.5 ± 3.99) and NUF (2.51 ± 1.67 vs 1.46 ± 1.42). Patients with SUI use more absorbents/day than patients with UUI (2.7 ± 1.53 vs 1.37 ± 1.5), p = 0.0243. The urodynamic study (UDS) confirmed the clinical diagnosis in UUI in 64.7%, while in SUI, it was only confirmed in 35.1%. In the urodynamic analysis (free flowmetry), patients with UUI have smaller bladders than patients with SUI (voiding volume in UUI 275.8 ± 178.95 vs 411.03 ± 203.62 in SUI), p = 0.083. The maximum flow (Qmax) is higher in patients with SUI compared to UUI (19.6 ± 7.07 vs 16.06 ± 8.54), p = 0.0836. In filling cystomanometry, the bladders of patients with UUI are smaller than those with SUI (bladder capacity UUI 266.3 ± 52.76 vs 308.6 ± 49.72 ml in SUI), p = 0.023. In SUI, the BFB/PFMT significantly improved DUF, NUF, PFM pressure, and absorbent use. In UUI, the BFB plus TTNM improved DUF, NUF, and the maximum and mean PFM pressure with statistical difference, while the use of absorbents decreased with a tendency to significance. There are age, clinical, manometric, and urodynamic differences in patients with UUI when compared with patients with SUI. UUI occurs in older patients; they present a greater number of daytime and nocturnal urinary frequency episodes and use fewer absorbents than patients with SUI. Patients with UUI evacuate a smaller urine volume have a lower peak flow (in flowmetry) and a lower bladder capacity (in cystomanometry) than patients with SUI. The rehabilitation treatment proposed in daily clinical practice (PFMT/BFB with or without TTNM improves SUI and UUI). In this study, the UDS has shown a greater clinical-urodynamic correlation in UUI than in SUI.

Peroneal Electrical Transcutaneous NeuroModulation as a New Treatment for Patients with Overactive Bladder: An Initial Clinical Experience

Introduction: The aim of this study was to determine whether peroneal electrical Transcutaneous NeuroModulation (peroneal eTNM®) using the URIS® neuromodulation system can be used in individuals with refractory overactive bladder (OAB). Methods: Eighteen female patients with idiopathic OAB who failed previous behavioral and pharmacological therapy were enrolled. Patients were treated with the URIS® neuromodulation system using active electrodes placed on the popliteal fossa, targeting the peroneal nerve for 30 min once a week for 12 weeks. Changes in OAB symptoms and patient-reported outcomes from baseline to the end of the study were analyzed. A nonparametric Wilcoxon signed-rank test was used to assess changes in variables. Statistical significance was defined as p ≤ 0.05. Results: We observed a significant reduction in micturition frequency (p = 0.022), number of severe urgency episodes (p < 0.001), urgency incontinence episodes (p = 0.001), and nocturia episodes (p = 0.027). A decrease in Patient Perception of Bladder Condition score (p < 0.001) was also observed. Posttreatment, 15 patients (83.3%) reported a moderate or significant reduction in their bladder bother. Throughout the study, two adverse events were recorded with no causal relationship to the study treatment. Discussion/Conclusions: Our study documented a significant reduction in all OAB symptoms and an improvement in all patient-reported outcomes in patients treated with peroneal eTNM® using the URIS® neuromodulation system.

Time course for urethral neuromuscular reestablishment and its facilitated recovery by transcutaneous neuromodulation after simulated birth trauma in rats

The aims of the study were to determine the time-course of urinary incontinence recovery after vaginal distension (VD), elucidate the mechanisms of injury from VD leading to external urethral sphincter (EUS) dysfunction, and assess if transcutaneous electrical stimulation (TENS) of the dorsal nerve of the clitoris facilitates recovery of urinary continence after VD. Rats underwent 4-h VD, 4-h sham VD (SH-VD), VD plus 1-h DNC TENS, and VD plus 1-h sham TENS (SH-TENS). TENS or SH-TENS were applied immediately and at days 2 and 4 post-VD. Micturition behavior, urethral histochemistry and histology, EUS and nerve electrophysiology, and cystometrograms were evaluated. VD induced urine leakage and significantly disrupted EUS fibers and nerve-conduction (VD vs SH-VD group;p < 0.01). Urine leakage disappeared 13 days post-VD (p < 0.001). Structural and functional recovery of EUS neuromuscular circuitry started by day 6 post-VD, but did not fully recover by day 11 post-VD (p > 0.05). TENS significantly decreased the frequency of urine leakage post-VD (days 5–7;p < 0.01). We conclude that rat urinary continence after VD requires 2 weeks to recover, although urethra structure is not fully recovered. TENS facilitated urinary continence recovery after VD. Additional studies are necessary to assess if TENS could be used in postpartum women.

Peroneal Electric Transcutaneous NeuroModulation (eTNM®): A Novel Method for the Treatment of the Overactive Bladder.

Overactive bladder syndrome (OAB) is a prevalent medical problem with a significant impact on the quality of life of the affected individuals. Pharmacotherapy is considered the main treatment method, although it is discontinued in a significant proportion of patients due to inefficacy or associated side effects. If pharmacotherapy fails, patients can undergo peripheral neuromodulation of the somatic nerves of the lower limb or sacral neuromodulation; however, neither of these represents an ideal therapeutic tool. The Peroneal electric Transcutaneous NeuroModulation (Peroneal eTNM®), based on the selective stimulation of the peroneal nerve, is the new fully noninvasive neuromodulation method intended to treat OAB. The URIS® neuromodulation system, engineered to provide Peroneal eTNM®, consists of the URIS® device, URIS® active electrodes, and the biofeedback foot sensor (BFS). The unique design of the URIS® device and URIS® active electrodes allows for the use of a low voltage and current during neuromodulation, which significantly reduces the unpleasant sensations. The BFS allows for precise localization of the active electrodes and for continuous adjustment of the voltage and frequency to achieve the optimal therapeutic effect. The URIS® system adopts several principles of telemedicine, which makes it compatible with the US Food and Drug Administration (FDA) and European Union (EU) regulations for home-based use. This article describes both the Peroneal eTNM® method and the URIS® neuromodulation system, including its technical specifications and data from laboratory testing. Preclinical and early clinical data demonstrate the feasibility of this new method for noninvasive OAB treatment and possible implications for clinical practice.