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.

Primary care providers practice patterns regarding female pelvic floor disorders.

INTRODUCTION: Pelvic floor disorders (PFDs) pose substantial physical and psychological burdens for a growing number of women. Given the ubiquity of these conditions and known patient reluctance to seek care, primary care providers (PCPs) have a unique opportunity to increase treatment and provide appropriate referrals for these patients. METHODS: An online survey was administered to PCPs to assess provider practices, knowledge, comfort managing and ease of referral for PFDs. Logistic regression was used to assess the association between demographic/practice characteristics of PCPs and two primary outcomes of interest: discomfort with management and difficulty with referral of PFDs. RESULTS: Of the 153 respondents to the survey, more felt comfortable managing stress urinary incontinence (SUI) and overactive bladder (OAB), compared with pelvic organ prolapse (POP) and faecal incontinence (FI) and were less likely to refer patients with urinary symptoms. Few providers elicited symptoms for POP and FI as compared with SUI and OAB. Provider variables that were significantly associated with discomfort with management varied by PFD, but tended to correlate with less exposure to PFDs (eg, those with fewer years of practice, and internal medicine and family physicians as compared with geriatricians); whereas the factors that were significantly associated with difficulty in referral, again varied by PFD, but were related to practice characteristics (eg, specialist network, type of practice, practice setting and quantity of patients). CONCLUSION: These findings highlight the need to increase PCPs awareness of PFDs and develop effective standardised screening protocols, as well as collaboration with pelvic floor specialists to improve screening, treatment and referral for patients with PFDs.

The Impact of an Overactive Bladder Care Pathway on Longitudinal Patient Management.

IMPORTANCE: Implementation of an overactive bladder (OAB) care pathway may affect treatment patterns and progression. OBJECTIVES: This study aimed to assess the effect of OAB care pathway implementation on treatment patterns for women with OAB. STUDY DESIGN: This retrospective cohort study evaluated women with OAB, before (January 1, 2015-December 31, 2017) and after (January 1, 2019-December 31, 2021) care pathway initiation. Care pathway use included standardized counseling, early introduction of therapy, and close follow-up. Primary outcomes included OAB medication use, follow-up visits, third-line therapy, and time to third-line therapy. RESULTS: A total of 1,349 women were included: 1,194 before care pathway implementation and 155 after. Patients after implementation were more likely to have diabetes mellitus (P = 0.04) and less likely to smoke (P = 0.01). Those managed via a care pathway were more likely to use any medication or third-line therapy within 1 year after consultation (61.3% vs 25.0%; P < 0.001). This included higher proportions receiving a medication (50.3% [95% confidence interval (CI), 41.8%-57.6%] vs 23.3% [95% CI, 20.9%-25.7%]; P < 0.001) and progressing to third-line therapy (22.6% [95% CI, 15.7%-28.9%] vs 2.9% [95% CI, 2%-3.9%]; P < 0.001). Among those who underwent third-line treatment, care pathway use was associated with shorter time to third-line therapy (median, 10 days [interquartile range, 1-56 days] vs 29 days [interquartile range, 7-191 days]; P = 0.013). Those managed via a care pathway were less likely to have additional clinic visits for OAB within 1 year after initial consultation (12.3% vs 23.9%; P < 0.001). CONCLUSIONS: Use of an OAB care pathway was associated with higher rates of oral medication and third-line therapy yet decreased follow-up office visits. Use of an OAB care pathway may promote consistent and efficient care for women with OAB.

[Sacral magnetic stimulation in overactive bladder syndrome: comparative analysis of protocols with a frequency of 1 and 5 Hz]. / Sakral'naya magnitnaya stimulyatsiya pri sindrome giperaktivnogo mochevogo puzyrya: sravnitel'nyi analiz protokolov s chastotoi 1 i 5 Gts.

Peripheral magnetic stimulation (pMS) has shown its effectiveness in the treatment of lower urinary tract symptoms, such as symptoms of an overactive bladder (OAB). The perineal region (pelvic floor) and the sacral roots area (projection S3 of the root) are used as the locus of stimulation. The published literature presents protocols with different parameters of stimulation, while each of them reliably demonstrates clinical efficacy, however, no comparative studies have been found to select priority stimulation modes when analyzing available sources. OBJECTIVE: To compare the efficacy and safety of different frequency - 1 and 5 Hz - modes of sacral MS in patients with symptoms of OAB. MATERIAL AND METHODS: A single blind prospective randomized comparative clinical study included 59 patients with OAB symptoms. The patients were divided by simple randomization into the group 1 (n=30), which received MS 3 times a week for 5 weeks with a frequency of 1 Hz per sacral root area (S2-S4), and the group 2 (n=29), in which stimulation was performed at a frequency of 5 Hz, while the remaining parameters and duration of therapy were identical to group 1. RESULTS: Sacral pMS with different frequency modes (1 and 5 Hz) is reliably equally effective against the clinical symptoms of OAB, which is confirmed by the absence of significant intergroup differences. In patients receiving MS with a frequency of 5 Hz, there was a more pronounced increase in maximum cystometric capacity, normalization of the maximum and average urine flow velocity and regression of the residual urine volume (p<0.001, p=0.007, p=0.011 and p=0.012 compared with group 1). The greatest difference in indicators was observed in the increase in the maximum cystometric capacity - +31±25 ml at MS with a frequency of 1 Hz and +109±96 ml at MS with a frequency of 5 Hz (p<0.001). MS is a safe procedure and is well tolerated by patients. CONCLUSION: pMS when exposed to the area of S2-S4 roots for 20 minutes 3 times a week with a course for 5 weeks is reliably effective against the clinical symptoms of OAB at different frequency modes (1 and 5 Hz). At the same time, MS with a frequency of 5 Hz may have an advantage over stimulation of 1 Hz in terms of its effect on urodynamic parameters (maximum cystometric capacity, peak and average urine flow velocity and residual urine volume), which may be associated with a large inhibitory effect on detrusor.

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.

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.

Review: Lower urinary tract dysfunction in animal models of Parkinson's disease (PD): Translational aspects for the treatment of PD patients with overactive bladder.

Although the loss of dopaminergic neurons in the substantia nigra and consequent motor symptoms are the hallmarks of Parkinson's disease (PD), several non-motor symptoms may appear prior to these typical motor symptoms. While a variety of non-motor symptoms have emerged as the primary predictor of PD patients' quality of life, even though motor symptoms are undoubtedly distressing. According to a study, the prevalence of lower urinary tract symptoms (LUTS) varies between 27% and 64%, suggesting that PD-related lower urinary tract dysfunction may be affected by the disease stage, the presence of concomitant conditions affecting the lower urinary tract, and other autonomic dysfunctions. Animal models can serve as a platform for research into the causes of PD-related dysfunction and the evaluation of cutting-edge therapeutic approaches although the majority of animal research have been directed toward motor symptoms of PD. At present, the cause of lower urinary tract dysfunction in PD has not been fully clarified although the increasing evidence showing the multiple mechanisms underlying PD-related LUTS has emerged. In this chapter we summarize the findings of basic research in the studies of the lower urinary tract dysfunction using with different animal PD models and we try to shed light on the translational aspects for the development of future treatment modalities in PD patients with LUTS.

Shifts in patient preference of third-line overactive bladder therapy after introduction of the implantable tibial nerve stimulator.

INTRODUCTION: Third-line therapies for overactive bladder (OAB) that are currently recommended include intravesical Onabotulinumtoxin-A injections (BTX-A), percutaneous tibial nerve stimulation (PTNS), and sacral neuromodulation (SNM). The implantable tibial nerve stimulator (ITNS) is a novel therapy that is now available to patients with OAB. OBJECTIVE: The objective of this study was to analyze shifts in patient preference of third-line therapies for OAB after introducing ITNS as an option among the previously established therapies for non-neurogenic OAB. METHODS: A survey was designed and distributed via SurveyMonkey to the platform's audience of U.S. adults of age 18 and older. Screening questions were asked to include only subjects who reported symptoms of OAB. Descriptions of current AUA/SUFU guideline-approved third-line therapies (BTX-A, PTNS, and SNM) were provided, and participants were asked to rank these therapies in order of preference (stage A). Subsequently, ITNS was introduced with a description, and participants were then asked to rank their preferences amongst current guideline-approved therapies and ITNS (stage B). Absolute and relative changes in therapy preferences between stage A and stage B were calculated. Associations between ultimate therapy choice in stage B and participant characteristics were analyzed. RESULTS: A total of 485 participants completed the survey (62.5% female). The mean age was 49.1 ± 36.5 years (SD). The most common OAB symptoms reported were urgency urinary incontinence (UUI) (73.0%) and urinary urgency (68.0%). 29.2% of patients had tried medication for OAB in the past, and 8.0%-10.3% of patients were previously treated with a third-line therapy for OAB. In stage A, participants ranked their first choice of third-line therapy as follows: 28% BTX-A, 27% PTNS, and 13.8% SNM. 26.6% of participants chose no therapy, and 4.5% chose all three equally. In stage B, participants ranked their first choice as follows: 27.6% BTX-A, 19.2% PTNS, 7.8% SNM, and 19.2% ITNS. 21.9% of participants chose no therapy and 4.3% chose all four equally as their first choice. There were both absolute and relative declines in proportions of patients interested in BTX-A, SNM, and PTNS as their first choice of third-line therapy with the introduction of ITNS. Patients originally interested in PTNS in stage A had the greatest absolute change after the introduction of ITNS with 7.8% of participants opting for ITNS in stage B. Those interested in SNM in stage A had the largest relative change in interest, with 43.5% of those originally interested in SNM opting for ITNS in stage B. Finally, with the introduction of ITNS, the number of participants initially not interested in any third-line therapy declined by an absolute change of 4.7% and relative change of 17.6%. Participants experiencing concurrent stress urinary incontinence (SUI) symptoms were more likely to choose a current guideline-approved third-line therapy than ITNS or no therapy at all (p = 0.047). Those who had prior experience with third-line therapies were more likely to choose a third-line therapy other than ITNS as their ultimate choice of therapy in stage B. Of those who had chosen a guideline-approved third-line therapy in stage B (not ITNS), 13.6% had prior experience with BTX-A, 14.7% with PTNS, and 32 (11.2%) with SNM (p < 0.001, p < 0.001, p = 0.009, respectively). CONCLUSION: From our study, it appears that ITNS may attract a subset of patients who would not have otherwise pursued current guideline-approved third-line therapies for OAB. When patients are provided with descriptions of third-line OAB therapies including ITNS as an option, ITNS appears to compete with SNM and PTNS. It is possible that ITNS will provide patients with a different phenotype of neuromodulation therapy that can appeal to a niche OAB population. Given that ITNS devices have been introduced relatively recently to the market, their application will largely depend on cost and payer coverage, provider bias, and patient comorbidities. Further study is needed to understand how these factors interact with and influence patient preference of advanced OAB therapy to understand which patients will most benefit from this treatment modality.

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.

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.

Long-Term Cost Analysis of Third-Line Treatment Options for Overactive Bladder.

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

A Multicenter Study Evaluating the FREquency of Use and Efficacy of a Novel Closed-Loop Wearable Tibial Neuromodulation System for Overactive Bladder and Urgency Urinary Incontinence (FREEOAB).

OBJECTIVE: To evaluate the effectiveness and safety of a novel wearable neuromodulation system incorporating embedded electromyographic evaluation, representing the first closed-loop wearable therapy for bladder control. METHODS: This 12-week, multicenter, open-label, single-arm study of subjects with overactive bladder assessed response of bladder diary parameters and quality of life (QOL) metrics. Subjects used the transcutaneous tibial neuromodulation system, either once or three times weekly, with evaluations at weeks 1, 4, 8, and 12. Enrolled subjects (N = 96) were assessed for changes in urinary frequency, urgency, and urgency urinary incontinence episodes, and QOL changes using various questionnaires. RESULTS: In the intent-to-treat population (N = 96, mean age 60.8 ± 13.0years, 88.5% female), significant reductions in 3-day diary parameters were observed for daily voids, incontinence, and urgency episodes at 12weeks. QOL improvements exceeded the minimal clinically important difference for all QOL questionnaires. Long-term results remained robust at 12months. Device-related adverse events were mild and there were no device-related serious adverse events. Mean therapy compliance at 12weeks was 88.5%. High satisfaction rates were reported for the device overall. CONCLUSION: The Avation device demonstrates promising efficacy in treating adults with overactive bladder and urge urinary incontinence. At 12weeks, both diary parameters and QOL indicators showed significant improvement and remained robust at 12months. The device had a favorable safety profile with high compliance and patient satisfaction. This novel, closed-loop wearable tibial neuromodulation system represents a significant advancement in bladder control therapy, offering a noninvasive, patient-centered alternative with improved accessibility and ease of use.

Current position of neuromodulation for bladder pain syndrome/interstitial cystitis.

PURPOSE OF REVIEW: Despite established effectiveness in overactive bladder and nonobstructive retention, neuromodulation's application in interstitial cystitis/bladder pain syndrome (IC/BPS) remains a topic of ongoing research. The purpose of this article is to review recent developments in neuromodulation as treatment of IC/BPS offering guidance for healthcare practitioners dealing with IC/BPS cases. RECENT FINDINGS: Recent research underlines the promising role of sacral, tibial and pudendal neuromodulation in management of IC/BPS symptoms. Studies reveal encouraging outcomes, particularly in alleviating urgency and frequency symptoms. However, while urgency and frequency symptoms tend to improve, comprehensive pain relief remains a challenge. Percutaneous tibial nerve stimulation (PTNS) and transcutaneous tibial nerve stimulation (TTNS) stand out due to their minimal invasive nature. Existing literature points to the need for larger prospective studies with extended follow-up periods to validate the efficacy and sustainability of neuromodulation. SUMMARY: Neuromodulation is a promising treatment modality for refractory IC/BPS. Due to the minimal invasive nature, they should be tried before rigorous surgery. However, the limited quantity of available data and the variability in pain relief outcomes necessitate cautious interpretation. The review emphasizes the need for further research.

What Is in the Pipeline on Investigational Neuromodulation Techniques for Lower Urinary Tract Dysfunction: A Narrative Review.

OBJECTIVES: Overactive bladder (OAB) affects millions of patients worldwide. Its treatment is challenging but improves the patient's quality of life. Besides standard techniques for neuromodulation (sacral and pudendal neuromodulation and posterior tibial nerve stimulation), several new techniques have been investigated to treat symptoms of refractory OAB. The purpose of the present review is to outline the state of the art of new neuromodulation techniques for lower urinary tract dysfunction (LUTD). MATERIALS AND METHODS: In March 2023, a comprehensive MEDLINE, EMBASE, and Scopus search was carried out (keywords: LUTD, new technologies, neuromodulation, LUTS, OAB, painful bladder syndromes, etc). Articles were included according to inclusion (randomized controlled trials, prospective trials, large retrospective studies) and exclusion (case reports, outcomes not clearly expressed in full text, animal studies) criteria. The reference lists of the included studies also were scanned. Both adult and pediatric populations were included, in addition to both neurogenic and nonneurogenic OAB. A narrative review was then performed. RESULTS: Peroneal neuromodulation, transcutaneous electrical nerve stimulation, magnetic nerve stimulation, and parasacral transcutaneous neuromodulation are the most studied investigative techniques and were shown to yield promising results in treating OAB symptoms. Most studies showed promising results even in the complex scenarios of patients with OAB refractory to standard treatments. Comparing investigational techniques with standard of care and their respective clinical outcomes and safety profiles, and confronting their pros and cons, we reasonably believe that once such treatment modalities are further developed, they could play a role in the OAB treatment algorithm. CONCLUSIONS: Although the described neuromodulation techniques are being intensely studied, the available results are not yet sufficient for any guidelines to recommend their use.

Systematic review and meta-analysis of urinary incontinence prevalence and population estimates.

INTRODUCTION: Incontinence impacts the quality-of-life of people suffering from the disease. However, there is limited information on the prevalence of incontinence due to the stigma, lack of awareness, and underdiagnosis. OBJECTIVE: This study aims to conduct a systematic review and meta-analysis of overactive bladder (OAB) and nonobstructive urinary retention (NOUR). METHODS: The authors conducted a systematic review following the PRISMA guidelines using Embase, MEDLINE, and PubMed databases to identify the relevant publications in the English language. Two reviewers independently assessed the articles and extracted the data. Review papers were assessed for content and references. A meta-analysis of proportions was conducted using the RStudio software. To address the age heterogeneity, a subanalysis was conducted. Pooled data were overlayed on the Canadian population and a sample of 10 populous countries to estimate the number of people suffering from incontinence. RESULTS: Twenty-eight and eight articles were selected for OAB and NOUR, respectively. The pooled prevalence of OAB in men and women was 12% (95% CI: 9%-16%) and 15% (95% CI: 12%-18%), respectively. The estimated prevalence of NOUR was 15.6%-26.1% of men over 60 and 9.3%-20% of women over 60. The subanalysis pooled prevalence of OAB in men and women was 11% (95% CI: 8%-15%) and 12% (95% CI: 9%-16%), respectively. We estimated that 1.4-2.5 million women and 1.3-2.2 million men suffer from OAB in Canada. CONCLUSION: Urinary incontinence is an under-reported and underdiagnosed prevalent condition that requires appropriate treatment to improve a patient's quality-of-life.

Sensing in Sacral Neuromodulation: A Feasibility Study in Subjects With Urinary Incontinence and Retention.

OBJECTIVES: Sacral neuromodulation (SNM) therapy standard of care relies on visual-motor responses and patient-reported sensory responses in deciding optimized lead placement and programming. Automatic detection of stimulation responses could offer a simple, consistent indicator for optimizing SNM. The purpose of this study was to measure and characterize sacral evoked responses (SERs) resulting from sacral nerve stimulation using a commercial, tined SNM lead. MATERIALS AND METHODS: A custom external research system with stimulation and sensing hardware was connected to the percutaneous extension of an implanted lead during a staged (tined lead) evaluation for SNM. The system collected SER recordings across a range of prespecified stimulation settings (electrode configuration combinations for bipolar stimulation and bipolar sensing) during intraoperative and postoperative sessions in 21 subjects with overactive bladder (OAB) and nonobstructive urinary retention (NOUR). Motor and sensory thresholds were collected during the same sessions. RESULTS: SERs were detected in all 21 subjects. SER morphology (number of peaks, magnitude, and timing) varied across electrode configurations within and across subjects. Among subjects and electrode configurations tested, recordings contained SERs at motor threshold and/or sensory threshold in 75% to 80% of subjects. CONCLUSIONS: This study confirmed that implanted SNM leads can be used to directly record SERs elicited by stimulation in subjects with OAB and NOUR. SERs were readily detectable at typical SNM stimulation settings and procedural time points. Using these SERs as possible objective measures of SNM response has the capability to automate patient-specific SNM therapy, potentially providing consistent lead placement, programming, and/or closed-loop therapy.

Pilot Study of a Novel At-Home Posterior Tibial Nerve System for Overactive Bladder Syndrome.

IMPORTANCE: Urgency urinary incontinence and overactive bladder are common conditions. Third-line therapies are often underutilized because of either being too invasive or being burdensome for the patient. OBJECTIVE: We aimed to determine the efficacy and acceptability of a noninvasive, home-based posterior tibial nerve treatment system for the treatment of overactive bladder syndrome. STUDY DESIGN: In this pilot study, 10 postmenopausal women with urgency urinary incontinence were given the SoleStim System for home-based posterior tibial nerve stimulation. Symptoms at baseline and completion of the 8-week study were determined by 3-day voiding diary and quality-of-life questionnaire (Overactive Bladder Questionnaire) to assess for reduction in incontinence episodes. RESULTS: All patients were 100% adherent to the SoleStim System application over the 8-week period and reported statistically significant reductions in the mean number of voids (-16.3%, P = 0.022), urgency episodes (-31.2%, P = 0.02), and urgency urinary incontinence episodes (-31.4%, P = 0.045). Forty percent of participants reported a decrease of ≥50% in their urgency urinary incontinence episodes. SoleStim was scored a value of 1.8 ± 2.0 (mean ± SD) on a 10-point usability scale, indicating that it was highly acceptable from an ease-of-use perspective. No adverse events were reported. CONCLUSIONS: The SoleStim System improved key overactive bladder (frequency, urgency, and urgency urinary incontinence episodes) and quality-of-life metrics. The results from this pilot study suggest that the SoleStim System may be a safe, effective, and highly acceptable at-home overactive bladder therapy.

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

OBJECTIVES: In 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 METHODS: Among 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. RESULTS: During 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. CONCLUSIONS: Our 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.

The brain, gut, and bladder health nexus: A conceptual model linking stress and mental health disorders to overactive bladder in women.

OBJECTIVE: A small, but growing literature links stressors and mental health disorders (MHDs) across the life course to overactive bladder (OAB) and urinary incontinence symptoms. Mechanisms by which stressors and MHDs may impact bladder health are not fully understood, limiting novel prevention and treatment efforts. Moreover, potential biopsychosocial mechanisms involving the brain and gut have not been considered in an integrated, comprehensive fashion. METHODS: Members of the prevention of lower urinary tract symptoms Research Consortium developed conceptual models to inform research on biopsychosocial mechanisms through which stress and MDHs may impact bladder health among girls and women, focusing on brain and gut physiology. RESULTS: Two conceptual models were developed-one to explain central (brain-based) and peripheral (gut-based) mechanisms linking stressors and MHDs to OAB and bladder health, and one to highlight bidirectional communication between the brain, gut, and bladder. Traumatic events, chronic stressors, and MHDs may lead to a maladaptive stress response, including dysregulated communication and signaling between the brain, gut, and bladder. Gut bacteria produce molecules and metabolites that alter production of neurotransmitters, amino acids, short-chain fatty acids, and inflammatory immune response molecules that mediate communication between the gut and brain. Microbiota signal neurogenesis, microglia maturation, and synaptic pruning; they also calibrate brain-gut-bladder axis communication through neurotransmission and synaptogenesis, potentially influencing bladder symptom development. Life course trajectories of risk may be prevented or interrupted by central and peripheral resources for neuropsychological resilience. CONCLUSIONS: Depicted pathways, including brain-gut-bladder communication, have implications for research and development of novel prevention and treatment approaches.