A Pilot Study of the Effect of Transcutaneous Spinal Cord Stimulation on Micturition-Related Brain Activity and Lower Urinary Tract Symptoms After Stroke.

PURPOSE: Transcutaneous spinal cord stimulation (TSCS) is a novel neuromodulation modality developed to promote functional restoration in patients with neurological injury or disease. Previous pilot data suggest that lower urinary tract dysfunction (LUTD) due to stroke may be partially alleviated by TSCS. In this study, we examine the mechanism of this effect by evaluating bladder-related brain activity in patients before and after TSCS therapy and comparing it to healthy volunteers. MATERIALS AND METHODS: Patients who developed storage LUTD after a stroke and healthy volunteers without LUTD were recruited. Patients and healthy volunteers underwent simultaneous urodynamics and functional MRI. Patients then completed 24 biweekly sessions of TSCS and underwent another simultaneous urodynamics-functional MRI study. Clinical outcomes were assessed using validated questionnaires and voiding diary. RESULTS: Fifteen patients and 16 healthy volunteers completed the study. Following TSCS, patients exhibited increased blood-oxygen-level-dependent activity in areas including periaqueductal grey, the insula, the lateral prefrontal cortex, and motor cortex. Prior to TSCS therapy, healthy controls exhibited higher blood-oxygen-level-dependent activity in 17 regions, including multiple regions in the prefrontal cortex and basal ganglia. These differences were attenuated after TSCS with no frontal brain differences remaining between healthy volunteers and stroke participants who completed therapy. Neuroimaging changes were complemented by clinically significant improvements in questionnaire scores and voiding diary parameters. CONCLUSIONS: TSCS therapy modulated bladder-related brain activity, reducing differences between healthy volunteers and stroke patients with LUTD. These changes, alongside improved clinical outcomes, suggest TSCS as a promising approach for LUTD management.

Resilience as an Independent Predictor of Bowel Related Quality of Life After Spinal Cord Injury.

Bowel dysfunction remains a prominent priority in the rehabilitation of patients with spinal cord injuries (SCIs). However, our understanding of the factors that influence bowel-related quality of life (QoL) in this population remains limited. This study aimed to investigate the potential role of resilience, defined as an individual's capacity to cope with and adapt to adversity, as a predictor of bowel-related QoL among the patients with SCI. A cohort of adult patients with SCI who received bowel and bladder care at an outpatient clinic within a large rehabilitation hospital was identified through a prospectively collected database. Resilience was measured using the Spinal Cord Injury-Quality of Life (SCI-QOL) Resilience Short Form, whereas bowel QoL was assessed using the Irritable Bowel Syndrome-Quality of Life (IBS-QoL) questionnaire. Univariate and multivariate regression analyses were employed to identify predictors of bowel-related QoL. The examined variables included age, gender, level and completeness of injury, time since injury, hand function, resilience, and the severity of bowel dysfunction as measured using the Neurogenic Bowel Dysfunction Score (NBDS). A total of 73 patients participated in this study, with a mean age of 44.01 ± 13.43 years and comprising mostly men (n = 57, 78%). The results revealed a significant correlation between resilience scores and the total score of IBS-QoL (ρ = -0.47, p < 0.0001). The multivariate analysis demonstrated that both resilience and the severity of bowel dysfunction were significant independent predictors of bowel-related QoL, with resilience demonstrating a stronger association. Overall, this study elucidates the importance of resilience in shaping patients' perceptions of their bowel health within the SCI population. In addition to the more expected determinants of bowel-related QoL, such as the severity of bowel dysfunction, resilience emerged as a notable factor. Accordingly, integrating interventions that enhance resilience within bowel rehabilitation programs may yield improvements in patients' perceived bowel health beyond the benefits achievable through bowel function enhancement alone.

Content, face, and construct validity of the Irritable Bowel Syndrome Quality of Life (IBS-QOL) as a measure of bowel-related quality of life in spinal cord injury.

INTRODUCTION: Neurogenic bowel dysfunction is commonly encountered after a spinal cord injury (SCI), leading to a tremendous impact on quality of life (QOL). The neurogenic bowel dysfunction score (NBDS) is commonly used to measure the severity of bowel dysfunction and predict QOL. However, there is no comprehensive instrument to assess bowel-specific QOL for SCI patients. Instead, the Irritable Bowel Syndrome-Quality of Life (IBS-QOL) questionnaire evaluates the impact of bowel dysfunction on several aspects of QOL, although this questionnaire has not been validated for the SCI population. Motivated by the compelling need of instruments to accurately evaluate the QOL in patients who develope NBD after SCI, we aimed to assess the construct, content, and face validity of IBS-QOL in this population. METHODS: Adult SCI patients with at least 3 months after their injury were recruited from the outpatient clinic of a national rehabilitation hospital. Patients completed the NBDS and IBS-QOL via telephone interview or paper survey in the clinic. Content and face validity were assessed via interviews with professionals with expertise in providing chronic care for SCI, as well as a subgroup of patients. Construct validity was assessed using the hypotheses testing method. Internal consistency was assessed using Cronbach's ⍺. Factor analysis was performed to assess the dimensionality of the IBS-QOL in the SCI population. RESULTS: A total of 106 patients with a median age of 45.5 years (interquartile range: 21-79) participated in the study. The majority of the sample were men (n = 82, 77%) and had endured thoracolumbar injuries (n = 74, 71.2%). Twelve patients (seven English- and five Spanish speakers) and six professionals took part in content/face validation interviews. The median IBS-QOL total score was 15.91/100 (interquartile range: 4.55-33.14). IBS-QOL differentiated the subgroups of patients with severe bowel symptoms in terms of uneasiness, sweating, or headaches during bowel emptying (p = 0.0003), time spent on bowel emptying (p = 0.0065), flatus incontinence (p = 0.0076), and overall satisfaction with bowel function (p < 0.001), demonstrating its adequate construct validity. Interviews with the patients and professionals supported the comprehensiveness, comprehensibility, and relevance of IBS-QOL for assessment of bowel-related QOL in the SCI population. Item-level analysis of professional responses showed that 97% of questions were relevant to the construct and population of interest. Internal consistency analysis yielded a Cronbach's ⍺ of 0.9684. Exploratory factor analysis yielded six underlying factors which cumulatively accounted for 72.21% of the total variance, reflecting the dimensionality of bowel-related QOL in SCI population. DISCUSSION: IBS-QOL questionnaire is a comprehensive measure of bowel-related QOL which encompasses the concerns of SCI patients. Our findings support the content, face and construct validity of IBS-QOL as a measure of bowel-related QOL in SCI. Further studies are warranted to assess the reliability and responsiveness of IBS-QOL, and to evaluate its performance across different patient populations.

Health Care Economic Burden of Treatment and Rehabilitation for Neurogenic Lower Urinary Tract Dysfunction: A Systematic Review.

PURPOSE: The clinical, social, and economic impacts of neurogenic lower urinary tract dysfunction (NLUTD) on individuals and health care systems are thought to be immense, yet the true costs of care are unknown. The aims of this study are to illuminate the global costs related to the current state of care for NLUTD. MATERIALS AND METHODS: A systematic review of the literature was performed using MEDLINE, the National Health Service Economic Evaluation Database, and the Cochrane Specialized Urology and Incontinence Registers. Studies reporting the health care costs of NLUTD were identified. All steps of the review were performed by 2 independent reviewers. Costs were converted to 2022 U.S. dollars and reported for different categories of services. RESULTS: A total of 13 studies were included in the final review (12 from high-income economy, and 1 from an upper-middle-income economy). Routine maintenance care varied notably across studies in terms of included services. Annual supportive costs ranged from $2,039.69 to $12,219.07 with 1 study estimating lifetime costs of $112,774 when complications were considered. There were limited data on the costs of care from the patient's perspective. However, catheters and absorbent aids were estimated to be among the costliest categories of expenditure during routine care. More invasive and reconstructive treatments were associated with significant costs, ranging between $18,057 and $55,873. CONCLUSIONS: NLUTD incurs a variety of health care expenditures ranging from incontinence supplies to hospitalizations for management of complications and leads to a significant burden for health care systems over the patient's lifetime. Approaches to NLUTD that focus on functional rehabilitation and restoration, rather than on management of complications, may prove to be a less costly and more effective alternative.

Predictors of prolonged hospitalization and perioperative complications following mid-urethral sling mesh removal.

PURPOSE: To assess preoperative and perioperative characteristics associated with increased length of stay and major complications after mid-urethral sling mesh removal. METHODS: We performed an IRB-approved retrospective analysis of patients who underwent mid-urethral sling mesh removal. Demographic data and baseline surgical characteristics were collected. Operative reports and hospital/clinic notes were reviewed for complications which were categorized using the Clavien-Dindo Classification scheme. Length of stay was deemed abnormal if greater than 1 day. Complications were assessed using multivariate regression analysis. RESULTS: A total of 468 patients were identified as having undergone mid-urethral sling mesh removal. Mean age was 56 (± 11.1). 431 patients had either retropubic or transobturator slings. 241 patients underwent retropubic or groin exploration as a part of their mesh removal. A prolonged length of stay was noted in 73 patients (15.6%) and 13 patients (2.8%) experienced a Clavien Grade 3 complication. Pre-operative narcotic/benzodiazepine use, concomitant surgical procedure, bladder injury, increased ASA class, and major complications had an increased odds of a prolonged length of stay. Patients who experienced a bladder injury, groin/suprapubic incision, and estimated blood loss of over 400 mL had an increased odds of Clavien Grade 3 complications. CONCLUSIONS: Patient characteristics and perioperative factors are associated with increased length of stay and major complications after mid-urethral sling mesh removal.

A Readily Scalable, Clinically Demonstrated, Antibiofouling Zwitterionic Surface Treatment for Implantable Medical Devices.

Unlike growth on tissue, microbes can grow freely on implantable devices with minimal immune system intervention and often form resilient biofilms that continuously pump out pathogenic cells. The efficacy of antibiotics used to treat infection is declining due to increased rates of pathogenic resistance. A simple, one-step zwitterionic surface modification is developed to significantly reduce protein and microbial adhesion to synthetic materials and demonstrate the successful modification of several clinically relevant materials, including recalcitrant materials such as elastomeric polydimethylsiloxane. The treated surfaces exhibit robust adhesion resistance against proteins and microorganisms in both static and flow conditions. Furthermore, the surface treatment prevents the adhesion of mammalian fibroblast cells while displaying no cytotoxicity. To demonstrate the clinical efficacy of the novel technology in the real-world, a surface-treated, commercial silicone foley catheter is developed that is cleared for use by the U.S. Food and Drug Administration (K192034). 16 long-term catheterized patients received surface-treated catheters and completed a Patient Global Impression of Improvement (PGI-I) questionnaire. 10 out of 16 patients described their urinary tract condition post implantation as "much better" or "very much better" and 72% (n = 13) of patients desire to continue using the surface-treated catheter over conventional latex or silicone catheters.

The Effect of Non-invasive Spinal Cord Stimulation on Anorectal Function in Individuals With Spinal Cord Injury: A Case Series.

Spinal cord injury (SCI) is a devastating condition that impacts multiple organ systems. Neurogenic bowel dysfunction (NBD) frequently occurs after a SCI leading to reduced sensation of bowel fullness and bowel movement often leading to constipation or fecal incontinence. Spinal Neuromodulation has been proven to be a successful modality to improve sensorimotor and autonomic function in patients with spinal cord injuries. The pilot data presented here represents the first demonstration of using spinal neuromodulation to activate the anorectal regions of patients with spinal cord injuries and the acute and chronic effects of stimulation. We observed that spinal stimulation induces contractions as well as changes in sensation and pressure profiles along the length of the anorectal region. In addition, we present a case report of a patient with a SCI and the beneficial effect of spinal neuromodulation on the patient's bowel program.

Noninvasive spinal neuromodulation mitigates symptoms of idiopathic overactive bladder.

BACKGROUND: Overactive bladder (OAB) affects 12 to 30% of the world's population. The accompanying urinary urgency, frequency and incontinence can have a profound effect on quality of life, leading to depression, social isolation, avoidance of sexual activity and loss of productivity. Conservative measures such as lifestyle modification and pelvic floor physical therapy are the first line of treatment for overactive bladder. Patients who fail these may go on to take medications, undergo neuromodulation or receive injection of botulinum toxin into the bladder wall. While effective, medications have side effects and suffer from poor adherence. Neuromodulation and botulinum toxin injection are also effective but are invasive and not acceptable to some patients. METHODS: We have developed a novel transcutaneous spinal cord neuromodulator (SCONE™,) that delivers multifrequency electrical stimulation to the spinal cord without the need for insertion or implantation of stimulating electrodes. Previously, multifrequency transcutaneous stimulation has been demonstrated to penetrate to the spinal cord and lead to motor activation of detrusor and external urethral sphincter muscles. Here, we report on eight patients with idiopathic overactive bladder, who underwent 12 weeks of SCONE™ therapy. RESULTS: All patients reported statistically significant clinical improvement in multiple symptoms of overactive bladder, such as urinary urgency, frequency and urge incontinence. In addition, patients reported significant symptomatic improvements as captured by validated clinical surveys. CONCLUSION: SCONE™ therapy represents the first of its kind therapy to treat symptoms of urgency, frequency and urge urinary incontinence in patients with OAB. TRIAL REGISTRATION: The study was listed on clinicaltrials.gov ( NCT03753750 ).

The Association of Physical Activity and Urinary Incontinence in US Women: Results from a Multi-Year National Survey.

OBJECTIVES: To evaluate the relationships between physical activity, both work and recreational, and urinary incontinence among women. METHODS: We assessed women aged 20 years and older in 2008-2018 NHANES (National Health and Nutrition Examination Survey) cycles who answered self-reported urinary incontinence and physical activity questions. Weighted, multivariate logistic regression model was used to determine the association between incontinence and physical activity levels after adjusting for age, body mass index, diabetes, race, parity, menopause and smoking. RESULTS: A total of 30,213 women were included in analysis, of whom 23.15% had stress incontinence, 23.16% had urge incontinence, and 8.42% had mixed incontinence (answered "yes" to both stress and urge incontinence). Women who engaged in moderate recreational activity were less likely to report stress and urge incontinence (OR 0.79, 95% CI 0.62-0.99 and OR 0.66, 95% CI 0.48-0.90, respectively). Similarly, women who engaged in moderate activity work were less likely to report stress, urge and mixed incontinence (OR 0.84, 95% CI 0.70-0.99; OR 0.84, 95% CI 0.72-0.99; and OR 0.66 95% CI 0.45-0.97, respectively). CONCLUSIONS: Moderate physical activity and greater time spent participating in moderate physical activity are associated with a decreased likelihood of stress, urge and mixed incontinence in women. This relationship holds for both recreational and work-related activity. We hypothesize that the mechanism of this relationship is multifactorial, with moderate physical activity improving pelvic floor strength and modifying neurophysiological mediators (such as stress) involved in the pathogenesis of incontinence.

Do improvements in upper extremity motor function affect changes in bladder management after cervical spinal cord injury?

INTRODUCTION: One of the most important predictors of clean intermittent catheterization (CIC) adoption after spinal cord injury (SCI) is upper extremity (UE) motor function at discharge from rehabilitation. It is not clear however if post-discharge improvements in UE motor function affect future bladder management decisions. METHODS: We assessed persons with cervical SCI in the National Spinal Cord Injury Dataset for the years 2000-2016 who underwent motor examination at discharge from rehabilitation and again at 1-year follow-up. Individuals were stratified based on a previously described algorithm which categorizes the ability to independently perform CIC based upon UE motor scores. Improvements in the predicted ability to self-catheterize over the first year after rehabilitation discharge were evaluated in relation to bladder management. RESULTS: Despite 15% of our SCI cohort improving from "less than able to independently catheterize" to "able to independently catheterize", more patients in the overall cohort dropped out of CIC (175/643 = 27.2%) than adopted CIC (68/548 = 12.4%) (P < .001). We found that in those initially categorized as "less than able to independently catheterize" at the time of rehabilitation discharge, CIC adoption was not significantly different at 1-year follow-up whether or not there was motor improvement to "able to independently catheterize" (12.7% vs 9.2% respectively, P = 0.665). Between these two groups, CIC dropout was also equivalent (34.3% vs 30.0% respectively, P = 0.559). CONCLUSIONS: In the first year after rehabilitation, more overall SCI patients transition away from CIC than convert to CIC. Significant improvements in UE motor function during the first year after rehabilitation discharge do not appear to affect bladder management decisions.

Home-Based SCONETM Therapy Improves Symptoms of Neurogenic Bladder.

A wide range of dysfunction can occur after a stroke including symptoms such as urinary urgency, frequency, and urge incontinence. The Spinal Cord Neuromodulator (SCONETM) reactivates and retrains spinal neural networks. The present case study introduces initial evidence that home-based, self-administered SCONE therapy may be a safe and effective method of delivering this neuromodulation modality and may have the ability to minimize clinic visits, which is especially salient in today's public health environment.

The effect of stroke on micturition associated brain activity: A pilot fMRI study.

OBJECTIVE: Cerebral stroke is a unique model for studying the role of the brain in lower urinary tract (LUT) control. By its nature, stroke must change the activity of the brain to cause LUT dysfunction. The objective of this study was to describe changes in micturition-related brain activity in patients who develop LUT symptoms (LUTS) after a cerebral stroke. MATERIALS AND METHODS: Healthy controls (HC, n = 10) and patients who developed storage LUTS after a cerebral stroke (n = 7) were recruited. Functional magnetic resonance imaging was used to assess brain activity in each subject. In the task-based block design, blood-oxygen-level-dependent (BOLD) signal was detected during rest, active bladder filling, and bladder voiding. BOLD signal intensity was compared between HCs and stroke subjects during bladder filling, voiding, and voiding initiation. RESULTS: Stroke subjects exhibited higher activity in the periaqueductal gray and cerebellum during bladder filling and bladder voiding. HCs exhibited more intense activity in higher centers, such as the cingulate cortex, motor cortex, and the dorsolateral prefrontal cortex in each of the phases examined. CONCLUSIONS: Subjects with stroke-related LUTS exhibit a specific pattern of brain activity during bladder filling and voiding. There appears to be a greater reliance on primitive centers (cerebellum, midbrain) than in healthy controls during both phases of the micturition cycle. We hypothesize that these findings may reflect loss of connectivity with higher brain centers after a stroke.

Enabling respiratory control after severe chronic tetraplegia: an exploratory case study.

Respiratory dysfunction is one of the most debilitating effects of spinal cord injury (SCI) impacting the quality of life of patients and caregivers. In addition, breathing difficulties impact the rehabilitation routine a patient may potentially undergo. Transcutaneous electrical spinal cord neuromodulation (TESCoN) is a novel approach to reactivate and retrain spinal circuits after paralysis. We demonstrate that acute and chronic TESCoN therapy over the cervical spinal cord positively impacts the breathing and coughing ability in a patient with chronic tetraplegia. ln addition, we show that the improved breathing and coughing ability are not only observed in the presence of TESCoN but persisted for a few days after TESCoN was stopped.NEW & NOTEWORTHY Noninvasive spinal neuromodulation improves breathing and coughing in a patient with severe and complete tetraplegia.

Urinary Retention in Spinal Cord Injury.

A 43-year-old woman with paralysis and neurogenic bladder secondary to a gunshot wound presented with worsening urinary incontinence and urinary tract infections. On workup she was found to have two large bladder stones with diameters of around 11 cm. She was managed with antibiotics and surgical removal. This case highlights the importance of a multidisciplinary team in managing patients with spinal cord injuries.

Transcutaneous Electrical Spinal Cord Neuromodulator (TESCoN) Improves Symptoms of Overactive Bladder.

Neuromodulation is a therapeutic technique that is well-established in the treatment of idiopathic Lower urinary tract (LUT) dysfunction such as overactive bladder (OAB). We have recently developed a novel neuromodulation approach, Transcutaneous Electrical Spinal Cord Neuromodulation (TESCoN) and demonstrated its acute effects on LUT dysfunction after spinal cord injury (SCI) during urodynamic studies. We found that TESCoN can promote urinary storage and induce urinary voiding when delivered during urodynamic studies. The objective of this study was to determine whether TESCoN can retrain the spinal neural networks to induce chronic improvement in the LUT, such that positive changes can persist even in the absence of stimulation. In addition, we wished to examine the effect of TESCoN on LUT dysfunction due to multiple pathologies. To achieve this objective, 14 patients [SCI = 5, stroke = 5, multiple sclerosis (MS) = 3, and idiopathic OAB (iOAB) = 1] completed 24 sessions of TESCoN over the course of 8 weeks. Patients completed urodynamic studies before and after undergoing TESCoN therapy. Additionally, each subject completed a voiding diary and the Neurogenic Bladder Symptom Score questionnaire before and after receiving TESCoN therapy. We found that TESCoN led to decreased detrusor overactivity, improved continence, and enhanced LUT sensation across the different pathologies underlying LUT dysfunction. This study serves as a pilot in preparation for a rigorous randomized placebo-controlled trial designed to demonstrate the effect of TESCoN on LUT function in neurogenic and non-neurogenic conditions. NEW AND NOTEWORTHY: Non-Surgical modality to reduce incidence of urinary incontinence and improve neurogenic bladder symptom scores (NBSS) in individuals with neurogenic bladder due to spinal cord injury or stroke.

Anal Sphincteroplasty in the Minimally Invasive Era: Assessment of National Trends and Complications.

Fecal incontinence is a debilitating and underreported condition. Despite introduction of novel therapies in recent years, anal sphincteroplasty (AS) remains the surgical choice for certain patients. Previous reports have primarily focused on single-surgeon or single-center experience with AS. The purpose of this study was to assess patient characteristics and perioperative outcomes of AS using a national cohort. Patients (n = 586) who underwent AS as a primary procedure between 2009 and 2015 were identified by the CPT code as recorded in the study and were evaluated and examined for association with 30-day complications. The number of sphincteroplasties performed decreased seven-fold between 2009 and 2015. Wound infection, wound dehiscence, and urinary tract infection were the most common complications, occurring in 30 (5.1%), 12 (2.1%), and 6 (1%) patients, respectively. Preoperative steroid use and surgeon specialty were associated with wound complications on multivariate analysis. We present the first national study of patients undergoing AS and identify factors that predispose to wound complications. In addition, we demonstrate that the number of anal sphincteroplasties performed in the United States is decreasing dramatically, likely because of novel therapy for fecal incontinence. We hope that this study will assist in patient counseling and call attention to preserving surgical training as utilization of AS rapidly declines.