Does choice of anesthesia during stage 1 sacral neuromodulation testing influence outcomes?

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.

Reducing scratching behavior in atopic dermatitis patients using the EMDR treatment protocol for urge: A pilot study.

Background: Itch, and thereby the scratching behavior, is a common complaint in atopic dermatitis. Scratching damages the skin, which in turn worsens the itch. This itch-scratch cycle perpetuates the skin condition and has a major impact on the patient's quality of life. In addition to pharmacological treatment, psychological interventions show promising results in reducing scratching behavior. Objectives: To investigate the effect of treatment according the EMDR treatment protocol for urge on scratching behavior of atopic dermatitis patients in a controlled study. Methods: This study applies a multiple baseline across subjects design. Six patients were randomly allocated to different baseline lengths and all of them started registration of scratching behavior at the same day, using a mobile phone application. Nocturnal scratching was registered by a smart watch application. The total study duration was 46 days and was equal for all patients. Treatment consisted of two sessions using the EMDR treatment protocol for urge. Furthermore, standardized measures were used to assess disease activity, quality of life, and self-control. The nonoverlap of all pairs effect size was calculated for the daily measure data. Results: One patient dropped out. Visual inspection suggests that the scratching behavior decreased over time in all patients. Furthermore, a moderate effect size of the treatment is found. During the baseline phase, scratching behavior fluctuated considerably and showed a slight negative trend. Outcomes of disease activity decreased over time and patients' self-control and quality of life improved after treatment. Nocturnal scratching behavior did not change after the intervention. Conclusion: The results of the visual analysis of day time scratching behavior, disease activity, quality of life, and self-control seem promising. These findings pave the way for future research into the effect of the new intervention on other skin conditions suffering from scratching behavior, such as prurigo nodularis.

Five-year Results from the Prospective, Multicenter, Observational SOUNDS Study of Patients with Overactive Bladder Treated with the InterStim System for Sacral Neuromodulation.

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.

The effect of vitamin D on urgent urinary incontinence in postmenopausal women.

INTRODUCTION AND HYPOTHESIS: Conflicting results have been reported on the effect of vitamin D supplementation on urinary incontinence (UI). Therefore, the aim of this study was to evaluate the effect of consuming vitamin D oral supplements on improving urge UI (UUI) in postmenopausal women with vitamin D deficiency. METHODS: This randomized clinical trial was conducted in 2019-2020 in postmenopausal women with UUI or nocturia more than once at night with vitamin D levels less than 30 ng/ml. After recording the severity of UI and its impact on the patient's daily life, patients were randomly divided into two groups of 45 patients: one taking vitamin D3 (50,000 IU) tablets and one taking placebo weekly for 8 weeks. RESULTS: There was no significant difference between the two groups in terms of the severity of UI and the frequency of nocturia before treatment. However, after treatment, in the vitamin D group, the severity of UI and the frequency of nocturia significantly reduced. Before treatment, the impact of UI on patients' daily life was reported to be high in more than 70% of patients in both groups, which was not significantly different; however, after treatment, its impact was significantly reduced in the vitamin D group. CONCLUSIONS: The findings of the present study showed that in postmenopausal women with UUI or nocturia, weekly use of vitamin D 50,000 IU tablets for 8 weeks can reduce the severity of UI and the frequency of nocturia, and reduce their impact on disruption in daily life.

Effect of Nigella sativa L. seed oil on urinary incontinence and quality of life in menopausal women: A triple-blind randomized controlled trial.

Increased urinary incontinence is one of the most common changes during menopause. This study aimed to investigate the effect of Nigella sativa L. seed oil on urinary incontinence and quality of life (QoL) (primary outcomes) and sexual function (secondary outcome) in menopausal women. In this triple-blind randomized controlled trial, 60 women in Tabriz-Iran were equally allocated into two treatment and control groups using block randomization. The women applied 2-3 drops of Nigella sativa L. seed oil or placebo on their stomachs below the novel twice a day for 8 weeks. The data collection instruments were completed at baseline and just after the intervention. After intervention, the mean rank score of mixed urinary incontinence was significantly lower (p = .04) and the mean score of the incontinence-QoL was significantly higher (mean difference 12.63, 95% CI 2.33 to 22.93; p = .017) in the treatment group than the control group. However, there were no significant differences in stress incontinence, urge incontinence, sexual function, and menopause-specific QoL of women between the groups (p > .05). The results indicated the positive effect of the Nigella sativa L. seed oil on mixed incontinence and incontinence-QoL; nevertheless, to make a certain conclusion, further studies are required.

Development of an implant technique and early experience using a novel implantable pulse generator with a quadripolar electrode array at the tibial nerve for refractory overactive bladder.

OBJECTIVES: Tibial nerve stimulation is an effective treatment for overactive bladder (OAB) and has been utilized as an in-person recurring session treatment option for many years. The primary objective of this study was to evaluate the safety and efficacy of a long-term implantable device and the method of utilizing a retrograde approach to place the device (a percutaneous implantable pulse generator [pIPG] with integrated quadripolar electrodes) at the tibial nerve (Protect PNS; Uro Medical Corp.). METHODS: A novel retrograde implant technique was developed through multiple cadaveric dissections to percutaneously implant a chronic, wireless, minimally invasive pIPG device with integrated quadripolar electrodes (now licensed to Uro Medical) at the tibial nerve. A proof-of-concept pIPG device approved as part of an FDA IDE was designed to gain early experience in subjects with refractory OAB. The pIPG was implanted in the office under local anesthesia using the novel retrograde approach, and stimulation was activated using an external wireless energy source called a transmitter. Initially, a pilot study was designed to compare outcomes in subjects randomized to either percutaneous tibial nerve stimulation (PTNS) or Protect PNS. However, due to the small sample sizes available at this time, it was not possible to compare the two groups. Thus, the purpose of this manuscript is to describe the outcome of subjects who underwent implantation of the Protect PNS system. Twelve-month safety and efficacy were evaluated. RESULTS: Nine subjects were enrolled in the randomized pilot study; 5 to the pIPG group and 4 to PTNS, and all completed the 13-week primary endpoint. Subsequently, two subjects in the PTNS group chose to cross over and have the pIPG implanted after 13 weeks. Outcomes of the seven subjects who underwent implantation of the pIPG are described. No complications related to the office procedure were noted. Two of the older model pIPG devices became nonresponsive at 1 and 4 weeks and were replaced. Six minor adverse events were reported and resolved. Subjects reported improvement in urge urinary incontinence (UUI) episodes, OAB symptoms, and quality of life. Subjects impanted with a pIPG reported a 50% reduction in UUI as early as 1 week. CONCLUSIONS: Results of this pilot study suggest that retrograde percutaneous implantation of a pIPG is a safe, minimally invasive one-stage office procedure for treatment for urge incontinence related OAB symptoms, without significant complications after 12 months follow-up. Future studies will be required to compare outcomes among treatment modalities.

Thalamic volume and functional connectivity are associated with nicotine dependence severity and craving.

Tobacco smoking is associated with deleterious health outcomes. Most smokers want to quit smoking, yet relapse rates are high. Understanding neural differences associated with tobacco use may help generate novel treatment options. Several animal studies have recently highlighted the central role of the thalamus in substance use disorders, but this research focus has been understudied in human smokers. Here, we investigated associations between structural and functional magnetic resonance imaging measures of the thalamus and its subnuclei to distinct smoking characteristics. We acquired anatomical scans of 32 smokers as well as functional resting-state scans before and after a cue-reactivity task. Thalamic functional connectivity was associated with craving and dependence severity, whereas the volume of the thalamus was associated with dependence severity only. Craving, which fluctuates rapidly, was best characterized by differences in brain function, whereas the rather persistent syndrome of dependence severity was associated with both brain structural differences and function. Our study supports the notion that functional versus structural measures tend to be associated with behavioural measures that evolve at faster versus slower temporal scales, respectively. It confirms the importance of the thalamus to understand mechanisms of addiction and highlights it as a potential target for brain-based interventions to support smoking cessation, such as brain stimulation and neurofeedback.

Correlation Between Transurethral Interventions and Their Influence on Type and Duration of Postoperative Urinary Incontinence: Results from a Systematic Review and Meta-Analysis of Comparative Studies.

Objective: To perform a systematic review to assess the incidence of transient (<6 months) and persistent (>6 months) stress urinary incontinence (SUI), urge urinary incontinence (UUI), and mixed urinary incontinence (MUI) after transurethral surgeries for benign prostatic hyperplasia. Materials and Methods: A systematic literature search was performed using Embase, PubMed, and Web of Science. We included studies comparing monopolar (M)/bipolar (B) transurethral resection of the prostate (TURP) vs ablation vs enucleation procedures. Incidence of incontinence was assessed using Cochran-Mantel-Haenszel Method and reported as odds ratio (OR), 95% confidence interval (CI), and p-values. Statistical significance was set at p < 0.05 Evidence Synthesis: Twenty-eight studies were included. Incidence of transient SUI was 4.6%, 6.0%, 3.0%, and 2.4% after ablation, enucleation, M-TURP, and B-TURP, respectively. Incidence of persistent SUI was 1.1% after ablation, 1.7% after enucleation and M-TURP, and 1.0% after B-TURP. Incidence of transient UUI was 2.0%, 7.3%, 4.4%, and 2.8% after ablation, enucleation, M-TURP, and B-TURP, respectively. Incidence of persistent UUI was 2.2% after M-TURP. The incidence of transient MUI was 5.1%, 0.8%, 5.4%, and 0.9% after ablation, enucleation, M-TURP, and B-TURP, respectively. Incidence of persistent MUI was 3.1% after ablation and 4.8% after M-TURP. Incidence of transient and persistent SUI and UUI did not differ after TURP vs enucleation. Incidence of transient (OR 3.32, 95% CI 0.41-26.65, p = 0.26) and persistent SUI (OR 4.79, 95% CI 0.52-43.89, p = 0.17) was not significantly higher after ablation. Incidence of transient UUI was not significantly higher after ablation (OR 2.62, 95% CI 0.04-166.01, p = 0.65), whereas persistent UUI did not differ. Incidence of transient MUI was significantly higher after enucleation (OR 3.26, 95% CI 1.51-7.05, p = 0.003). Incidence of transient and persistent MUI did not differ after TURP vs ablation. Conclusions: Ablation, enucleation, and TURP have an impact on all forms of incontinence, but this is transient in most cases with no difference between the groups, except for MUI, which was higher after enucleation vs M-TURP.

Initial experience using the Axonics sacral neuromodulation system in patients with multiple sclerosis.

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

Outcomes of a complementary and alternative medicine based on vitamins, herbal products, and amino acid as a first line treatment in idiopathic overactive bladder syndrome in men and women without bladder outlet obstruction.

OBJECTIVE: To evaluate the efficacy and tolerability of a complementary and alternative medicine (CAM) called Kubiker (Naturmed, Montegranaro, FM, Italy), consisting of vitamins (C and D), herbal products (cucurbita maxima, capsicum annum, polygonum cuspidatum), and amino acid L-Glutamine, as first line treatment of (OAB). MATERIALS AND METHODS: According to institutional protocols, data on patients addressing to a tertiary referral centre for OAB symptoms were recorded. OAB was evaluated through validated questionnaires including ICIQ-SF, USS, and OAB-q-SF. Patients with previous antimuscarinic or ß3 agonist treatment, neurological disease or pathologies which may mimic OAB, including infections, were excluded. Only unobstructed patients were considered and were given CAM twice daily for 12 weeks. After treatment, symptoms were re-evaluated repeating previous questionnaires and PGI-I was given to evaluate perceived improvement. RESULTS: A total of 41 patients were evaluated and 35 respected inclusion criteria and were enrolled. All subjects had a full compliance and adherence with CAM medication intake. The median patient's age was 65 (56-73). Male were 8 (22.9%) while females were 27 (77.1%). Median baseline OAB-q SF and ICIQ-SF scores were 18 (15-25) and 9 (6-13), respectively. After treatment, 85.7% patients had a clinical benefit, with a significant reduction of OAB symptoms, also according to USS (p < 0.01). The median OAB-q SF and ICIQ-SF scores were 10 (7-15) and 6 (0-8) (p < 0.01). CAM was successful with an improvement in subjective patient's satisfaction, with a median PGI-I score of 2 (1-3). Patients (men and women) who still had UUI after 3 months CAM medication were eight (22.8%), and among them, those who did not refer any therapeutic benefit were five (14.3%). CONCLUSIONS: According to our study, CAM may be useful medication for a first line treatment of uncomplicated idiopathic OAB cases, providing a nonnegligible effects on symptoms. However, further studies are mandatory to draw definitive conclusions.

The effectiveness of different electrical nerve stimulation protocols for treating adults with non-neurogenic overactive bladder: a systematic review and meta-analysis.

INTRODUCTION AND HYPOTHESIS: Electrical nerve stimulation is a widely used treatment for overactive bladder but there is no consensus regarding the best placement of electrodes or protocols. We hypothesised that some non-implanted neurostimulation protocols would be more effective compared to others for treating urinary symptoms and improving quality of life among adults diagnosed with non-neurogenic overactive bladder. METHODS: A systematic review and meta-analyses of randomized clinical trials were performed in five electronic databases: PubMed/MEDLINE, Lilacs, CINAHL, Web of Science, and PEDro. The main outcome was urinary symptoms-frequency, nocturia, and urgency-and the secondary outcome quality of life. Some protocol characteristics were extracted, e.g., frequency, pulse width, intensity, intervention time, and electrode placement. RESULTS: Nine randomized controlled trials were included. Tibial neurostimulation showed better results than sacral neurostimulation for urge incontinence (mean difference = 1.25 episodes, 95% CI, 0.12-2.38, n = 73). On the pooled analysis, the different neurostimulation protocols-intravaginal, percutaneous tibial, and transcutaneous tibial nerve stimulation-demonstrated similar results for urinary frequency, nocturia, and urgency as well as quality of life. In general, effect sizes from meta-analyses were low to moderate. The best reported parameters for percutaneous tibial nerve stimulation were 20-Hz frequency and 200-µs width, once a week. CONCLUSIONS: There was evidence that tibial neurostimulation is more effective than sacral neurostimulation for urge incontinence symptoms among patients with non-neurogenic overactive bladder. Overall, there was no superiority of an electrical nerve stimulation electrode placement and protocol over others considering urinary symptoms and quality of life. Further studies with three-arm trials are necessary. This study was registered at PROSPERO: CRD4201810071.

Patient-tailored healthcare and tibial nerve neuromodulation in the treatment of patients with overactive bladder symptoms.

PURPOSE: The aim of this study was to demonstrate features predictive of treatment response for patient-tailored overactive bladder (OAB) intervention with an implantable tibial neurostimulator using patient and technical prediction factors. MATERIALS AND METHODS: This study was designed as a follow-up study based on parameter settings and patients' preferences during the pilot and extended study of the implantable tibial nerve stimulator (RENOVA™ iStim system). For this study, we compared all treatment parameters (stimulation amplitude, frequency, and pulse width) and usage data (duration of treatment) during the different follow-up visits. RESULTS: We obtained usage data from a total of 32 patients who were implanted with the system between February and September 2015. Age, sex, body mass index (BMI) and previous experience with percutaneous tibial nerve stimulation (PTNS) treatment were considered as possible prediction factors for treatment success. However, only BMI was considered a statistically significant prediction factor (p = 0.042). A statistically significant increase in mean treatment level was seen in the responder group during the 3 month follow-up visit (mean: 6.7 mA, SD 0.416) as compared with the initial system activation visit (mean: 5.8 mA, SD 0.400) (p = 0.049). No other visits demonstrated statistically significant changes in both groups (responders and nonresponders) during the defined timepoints. CONCLUSION: This data underscores the need to use patient-tailored OAB treatment. BMI was found to be a negative predictive factor for treatment success. However, it was not possible to develop a specific responder model. A model predicting response to treatment could be useful for implementing shared decision making.

Machine learning provides an accurate prognostication model for refractory overactive bladder treatment response and is noninferior to human experts.

OBJECTIVE: The increasing wealth of clinical data may become unmanageable for a physician to assimilate into optimal decision-making without assistance. Utilizing a novel machine learning (ML) approach, we sought to develop algorithms to predict patient outcomes following the overactive bladder treatments OnabotulinumtoxinA (OBTX-A) injection and sacral neuromodulation (SNM). MATERIALS AND METHODS: ROSETTA datasets for overactive bladder patients randomized to OBTX-A or SNM were obtained. Novel ML algorithms, using reproducing kernel techniques were developed and tasked to predict outcomes including treatment response and decrease in urge urinary incontinence episodes in both the OBTX-A and SNM cohorts, in validation and test sets. Blinded expert urologists also predicted outcomes. Receiver operating characteristic curves were generated and AUCs calculated for comparison to lines of ignorance and the expert urologists' predictions. RESULTS: Trained algorithms demonstrated outstanding accuracy in predicting treatment response (OBTX-A: AUC 0.95; SNM: 0.88). Algorithms accurately predicted mean decrease in urge urinary incontinence episodes (MSE < 0.15) in OBTX-A and SNM. Algorithms were superior to human experts in response prediction for OBTX-A, and noninferior to human experts in response prediction for SNM. CONCLUSIONS: Novel ML algorithms were accurate, superior to expert urologists in predicting OBTX-A outcomes, and noninferior to expert urologists in predicting SNM outcomes. Some aspects of the physician-patient interaction are subtle and uncomputable, and thus ML may complement, but not supplant, a physician's judgment.

The effect of vitamin D deficiency and supplementation on urinary incontinence: scoping review.

INTRODUCTION AND HYPOTHESIS: Vitamin D receptors are found in skeletal and smooth muscle cells throughout the body, specifically in the bladder detrusor muscle. We reviewed the current literature on the association between vitamin D deficiency and urinary incontinence (UI), and whether vitamin D supplementation plays a role in the treatment of UI symptoms. METHODS: We performed a scoping review of all available studies. PubMed, Google Scholar, and PEDro databases were searched from inception until August 2020 with the keywords "urinary incontinence," "pelvic floor disorders," "lower urinary tract symptoms," "overactive bladder," and various terms for vitamin D. No language restrictions were imposed. The reference lists of all retrieved articles were also searched. RESULTS: The search revealed 12 studies of different research methodologies after elimination. In 6 out of the 7 cross-sectional studies reviewed, a significant association between vitamin D deficiency or insufficiency and the onset and severity of UI was found. In 2 out of the 3 prospective studies included, no association between vitamin D intake and UI was found; however, both randomized controlled trials that were reviewed found that vitamin D supplementation is effective for the treatment of UI. CONCLUSIONS: The existing literature supports an association between low levels of serum vitamin D and UI. Initial evidence regarding the effect of vitamin D supplementation on UI is accumulating, yet additional, comprehensive research is warranted to establish these findings.

Transcutaneous electrical nerve stimulation as add-on therapy in children receiving anticholinergics and/or mirabegron for refractory daytime urinary incontinence: A retrospective cohort study.

AIMS: To investigate if children with daytime urinary incontinence (DUI) and overactive bladder (OAB) refractory to standard urotherapy and medicinal treatment, would experience improvement in symptoms after add-on treatment with transcutaneous electrical nerve stimulation (TENS). METHODS: Children were retrospectively enrolled from tertiary referral centers at Aarhus and Aalborg University Hospitals. All data were retrieved from the patients' journals. All children were prescribed TENS as an add-on treatment to the highest-tolerable dose of medicinal treatment in a standardized regime of 2 h a day for around 3 months. Primary endpoints were the number of wet days per week (WDPW) and incontinence episodes per day. Effect of treatment was defined as greater or equal to 50% reduction in the frequency of DUI episodes. Secondary endpoints were to establish predictive factors for the effect of treatment using logistic regression. RESULTS: Seventy-six children diagnosed with DUI and OAB refractory to treatment with standard urotherapy and pharmacological treatment, at the age of 5-16 years were included from February 2017 to February 2020. A reduction in WDPW (from 6.31 [5.86-6.61] to 4.27 [3.45-4.90], p < 0.05) and incontinence episodes per day (from 2.45 [1.98-2.91] to 1.43 [1.07-1.80], p < 0.05) was observed. Twelve patients became completely dry. At 6 months follow-up, seven of the 12 complete responders had relapsed while five remained dry. A history of constipation before TENS was a predictor of poor treatment response (p = 0.016). CONCLUSIONS: TENS as add-on to anticholinergic treatment seems effective in a number of children with treatment-refractory DUI.

Update on sacral neuromodulation and overactive bladder in pediatrics: A systematic review. / Puesta al día en neuromodulación y vejiga hiperactiva en pediatría: una revisión sistemática.

OBJECTIVES: Sacral electrical stimulation has been used for more than a century as an alternative therapy for adult urinary syndromes. In the literature, several studies have validated the efficacy of this technique based on clinical and urodynamic criteria. Nevertheless, few studies have shown beneficial results in children with overactive bladder. MATERIAL AND METHODS: We performed a systematic review of studies assessing the impact of sacral electroestimulation treatment on overactive bladder in children. The search identified 389 potentially eligible items. Of them, 14 studies published between 2001and 2019 met the study criteria and were selected for systematic review. RESULTS: All of papers included in this review individually demonstrated a high efficiency rate with good shortterm results, as well as safety in its use due to its minimalrate of adverse effects. However, the comparison of the results obtained in all of them was not possible because the high variety and heterogeneity in the different studies. The main limitation is that there is still no standard protocol for the application of this therapy in the pediatric population. CONCLUSION: This review revealed the promising benefits of sacral electroneuromodulation in pediatric patients with overactive bladder. However, more studies with strictly meet pediatric overactive bladder diagnosis and management criteria should be done to protocolize and clarify the effectiveness of this therapeutic approach.

OBJETIVO: La estimulación eléctrica a nivel sacro ha sido usada durante más de un siglo como una alternativa terapéutica más en el manejo de los síndromes urinarios entre la población adulta. A lo largo de la literatura múltiples estudios han corroborado la eficacia de esta técnica, basándose en resultados clínicos y criterios urodinámicos. Sin embargo, son escasos los estudios que analizan los potenciales beneficios de esta modalidad terapéutica en niños con vejiga hiperactiva.MATERIAL Y MÉTODOS: Realizamos una revisión sistemática de los estudios que analizan el impacto de la electroestimulación nerviosa sacra en el tratamiento de la vejiga hiperactiva en pediatría. La búsqueda identificó 389 trabajos potencialmente elegibles. De entre todos ellos, 14 estudios publicados entre 2001 y 2019 reunieron los criterios adecuados para ser seleccionados y formaron parte de la presente revisión sistemática. RESULTADOS: Todos los estudios incluidos en esta revisión demostraron de forma individual la alta eficacia y unos buenos resultados a corto plazo con esta terapia, así como su seguridad, dada la baja tasa de efectos adversos de la misma. Sin embargo, la comparación de estos resultados en todos estos estudios no fue posible, debido a la gran variedad y heterogeneidad en la metodología y la forma de expresión de los resultados entre todos ellos. El motivo que genera esta gran diversidad de resultados entre los diferentes trabajos incluidos en esta revisión es la falta de un protocolo estándar para la aplicación de esta terapia en la población pediátrica.CONCLUSIÓN: En conclusión, esta revisión revela los prometedores beneficios de la electroterapia nerviosaa nivel sacro en los pacientes pediátricos con vejiga hiperactiva. Sin embargo, es necesario realizar más estudios que analicen los efectos de este tratamiento. La metodología de los mismos deberá ser estricta, con unos criterios estandarizados sobre la inclusión de los pacientes, el diagnóstico de vejiga hiperactiva, y la medición de la eficacia obtenida. Así, será posible realizar protocolos de aplicación de esta modalidad terapéutica, y sus efectos podrán ser esclarecidos.

Axonics® system for treatment of overactive bladder syndrome and urinary urgency incontinence.

Introduction: Overactive bladder and urge urinary incontinence affect millions of women and men and results in billions of dollars in health-care expenses. First- and second-line therapy includes behavioral modifications and/or pharmacotherapies however, many patients' symptoms remain or progress on these treatments. There has been concern regarding the detrimental side effects of the most widely prescribed medications for these bladder symptom management.Areas covered: As a result, there has been increased interest in continuous sacral neuromodulation, an FDA approved therapy for refractory urinary urgency and urge urinary incontinence. In this article, we specifically review current research on the efficacy and patient/provider satisfaction and safety profile of the Axonics® System. In addition, we address the current state of sacral neuromodulation and potential future direction and applicability.Expert opinion: The Axonics® system is a safe effective device for the treatment of overactive bladder and urinary urge incontinence. Additionally, it affords patient's the convenience of a rechargeable, compact, MRI safe system. It should be noted that the rechargeable system, while allowing for approximately 15 years of battery and lead life, may have its challenges in terms of charge burden. Furthermore, this system is easily adapted for experienced implanters of sacral neuromodulating devices.

[Functional results and satisfaction in 44 patients after implantation of a NS3-type sacral neurostimulator for refractory idiopathic overactive bladder followed at 43 months, single-center series]. / Résultats fonctionnels et satisfaction chez 44 patients post implantation de neurostimulateur sacré type NS3 pour une hyperactivité vésicale réfractaire, d'origine idiopathique, suivi à 43 mois, série monocentrique.

OBJECTIVES: Sacred neuromodulation (SNM) has been used in France since 1997 for the management of non-neurogenic urinary disorders that do not respond to first-line pharmacological treatment. The aim of this study is to analyze the clinical efficacy and satisfaction of patients with refractory idiopathic overactive bladder (OAB) treated with SNM. METHODS: This single-center retrospective series included 59 patients with refractory OAB of idiopathic origin and eligible for the SNM between January 2010 and December 2017. Demographic data, history of pelvic surgery, complications according to Clavien-Dindo classification, as well as revision and explantation rates were collected. All the patients included underwent a test phase. Therapeutic success for the test phase and definitive implantation was defined by≥50% improvement. Satisfaction was a secondary criteria. RESULTS: Of the 59 patients tested for SNM, 44 patients had a permanent implantation, of which 36 (82%) were women and 8 (12%) were men. The median age of the study was 55 years old. The median follow-up was 43 months [21,2-66,5]. All of the patients had an idiopathic refractory OAB. The median time between test and final implantation was 28 days [18-35]. The success rate for all patients tested was 60% (34/59). In patients implanted, 34 patients (77%) had clinical improvement. Adverse events had to be managed including multiple re-parameterizations (n=13), device revision (n=16), or even device implantation (n=8). The satisfaction rate was 82% (36/44). CONCLUSION: With a median follow-up of 43 months, this retrospective study on NMS shows the efficacy of second-line SNM for idiopathic OAB. This technique remains minimally invasive but with significant adverse events when informing our patients. LEVEL OF EVIDENCE: 3.

Review of the rechargeable sacral neuromodulation system to treat refractory overactive bladder.

Overactive bladder is a medical condition that requires management. If left untreated, it may severely affect quality of life. When first- and second-line treatments fail, sacral neuromodulation can be a safe and effective option for patients with refractory overactive bladder. This article reviews the rechargeable sacral neuromodulation (Axonics).

Pivotal Study of Leadless Tibial Nerve Stimulation with eCoin® for Urgency Urinary Incontinence: An Open-Label, Single Arm Trial.

PURPOSE: A novel leadless tibial nerve stimulator provides a primary battery-powered, coin-sized, minimally invasive option to deliver automatic low-duty cycle stimulation for overactive bladder syndrome therapy. A pivotal trial was conducted to evaluate the safety and efficacy of this investigational device, eCoin®, for treating refractory urgency urinary incontinence. MATERIALS AND METHODS: This was a prospective, open-label, single arm trial carried out at 15 U.S. medical centers involving 137 subjects with refractory urgency urinary incontinence. After implantation in the lower leg above the fascia over the tibial nerve, eCoin delivered automated stimulation sessions for the duration of the study. The primary efficacy measure was the proportion of subjects who achieved a 50% or greater reduction from baseline in urgency urinary incontinence episodes after 48 weeks of therapy. The primary safety measure was device-related adverse events at the same time point. RESULTS: Of 137 subjects enrolled, 133 were implanted with eCoin, and 132 were included in the intention-to-treat population. Of those 132 subjects, 98% were female, mean±SD age was 63.9±10.9 years, and baseline daily urgency urinary incontinence episodes were 4.3±3.1. The primary efficacy analysis showed 68% (95% CI: 60%-76%) of subjects experienced at least a 50% reduction in urgency urinary incontinence episodes at 48 weeks post-activation; 16% of implanted subjects experienced device-related events through 52 weeks post-implantation. CONCLUSIONS: eCoin demonstrated clinical benefit for treating overactive bladder syndrome with automatic delivery of an intermittent low-duty cycle and implanted with a minimally invasive, brief procedure.