Tibial Nerve Stimulation Research Articles

Management of Fecal Incontinence: Etiology, Diagnostic Approach, and Conservative Therapy

Background: Fecal incontinence is a common problem especially in the elderly resulting in a reduced quality of life. Summary: The etiology of fecal incontinence is often multifactorial with little options for a causal therapy. The mechanisms causing incontinence can be detected by sophisticated methods in most of the patients. Using therapeutic algorithms, incontinence can be improved or even continence restored in many patients. Key Messages: Diagnostic work-up starts with history, digital investigation, and anoproctoscopy. The specialist will further investigate with anorectal manometry, anal endosonography, and electromyography of the external anal sphincter muscle. Nonoperative therapy comprises hygienic methods, medical therapy, intraanal electrostimulation, and training methods like pelvic floor exercises or biofeedback. Second-line conservative therapies are tibial nerve stimulation, transanal irrigation, or anal inserts.

Unilateral and Bilateral Transcutaneous Tibial Nerve Stimulation in Women With Overactive Bladder Syndrome: A Randomized Controlled Study (UBTTNS-OAB Study).

The efficacy of unilateral versus bilateral Transcutaneous Tibial Nerve Stimulation (TTNS) for women with Overactive Bladder Syndrome (OAB) remains uncertain. To compare the efficacy of unilateral and bilateral TTNS in the tibial region in women with OAB. This randomized, controlled, triple-blind clinical trial included women with OAB or urgency-predominant urinary incontinence (UUI). Participants were randomized (1:1) into the Unilateral Tibial Group or Bilateral Tibial Group. Before treatment, they underwent a pre-assessment including peripheral sensitivity examination and completion of sociodemographic data and seven validated questionnaires on urinary symptoms, quality of life, sleep, and psycho-emotional aspects. TTNS interventions were administered twice weekly (12 sessions, 30 min each). Posttreatment, participants underwent another physical examination and completed the same questionnaires, with a 30-day follow-up. Categorical variables were analyzed using Chi-square or Fisher's Exact Test, while numerical variables were assessed with the Mann-Whitney test. Group comparisons over time utilized intention-to-treat ANOVA (p < 0.05). Thirty-five women participated: 17 in the unilateral group and 18 in the bilateral group. Mean ages were 55.1 (±14.7) years and 52.7 (±12.6) years, respectively (p = 0.680). Initial OAB severity (ICIQ-OAB) did not differ significantly between groups (p = 0.561). Both groups showed significant improvement in ICIQ-OAB scores: unilateral group from 10.1 (±3.4) to 5.8 (±3.4) (p < 0.001), bilateral group from 9.3 (±3.3) to 5.1 (±4) (p < 0.001), with no intergroup difference (p = 0.395). Improvement in UUI symptoms was observed: unilateral group from 2.2 (±1.4) to 0.7 (±1.5), bilateral group from 1.5 (±1.9) to 0.2 (±0.5), without significant intergroup difference (p = 0.645). Quality of life scores improved similarly between groups (p = 0.055). TTNS appears to be effective in improving bladder storage and UUI symptoms in women with OAB, with no difference between unilateral and bilateral applications. Brazilian Registry of Clinical Trials (REBEC) (RBR: 96f2fgkn).

Transcutaneous Tibial Nerve Stimulation for Quality-of-Life Improvement and Sleep Deficiency in Women with Primary Dysmenorrhea: A Randomized Clinical Trial.

Background: Primary dysmenorrhea is a leading cause of chronic cyclic pelvic pain, contributing to a reduced quality of life and sleep disturbances in women. The objective of this study was to assess the effectiveness of transcutaneous tibial nerve stimulation (TTNS) in improving the quality of life, sleep, and overall health perceptions of participants compared to a control group of women with dysmenorrhea over short-term, medium-term, and long-term periods. Methods: A single-blind, controlled clinical trial was conducted, with participants randomly assigned to an experimental group (receiving TTNS) or a control group (receiving sham TTNS). Both groups underwent 12, weekly 30 min sessions using the NeuroTrac™ PelviTone electrostimulation device. Outcomes related to quality of life, sleep deficiency, and overall improvement were evaluated at three time points: short-term (post-treatment), medium-term (1-3 months), and long-term (6 months). Results: Of the 61 participants initially randomized (31 in the experimental group and 30 in the control group), 55 completed the study and were included in the final analysis. A statistically significant improvement was observed in the experimental group in both physical and mental health components, as measured by the SF-36v2® questionnaire, following 12 weeks of intervention, compared to the control group, persisting 6 months after the intervention. Additionally, statistically significant differences in overall improvement were noted between the two groups, as measured by the PGIC questionnaire at the end of treatment (p = 0.0103) and 6 months post-treatment (p = 0.0432). Conclusions: TTNS appears to be a safe and effective strategy for enhancing quality of life and overall health in women with PD, potentially reducing the reliance on pharmacological treatments or more invasive methods.

Is Our Limited Understanding of the Effects of Nerve Stimulation Resulting in Poor Outcomes and the Need for Better "Rescue Programming" in SNM and PTNS, and Lost Opportunities for New Sites of Stimulation? ICI-RS 2024.

Sacral neuromodulation (SNM) and percutaneous tibial nerve stimulation (PTNS) are strongly recommended by international guidelines bodies for complex lower urinary tract dysfunctions. However, treatment failure and the need for rescue programming still represent a significant need for long-term follow-up. This review aimed to describe current strategies and future directions in patients undergoing such therapies. This is a consensus report of a Think Tank discussed at the Annual Meeting of the International Consultation on Incontinence - Research Society (ICI-RS), June 6-8, 2024 (Bristol, UK): "Is our limited understanding of the effects of nerve stimulation resulting in poor outcomes and the need for better 'rescue programming' in SNM and PTNS, and lost opportunities for new sites of stimulation?" Rescue programming is important from two different perspectives: to improve patient outcomes and to enhance device longevity (for implantable devices). Standard SNM parameters have remained unchanged since its inception for the treatment of OAB, nonobstructive urinary retention, and voiding dysfunction. SNM rescue programming includes intermittent stimulation (cycling on), increased frequency and changes in pulse width (PW). The effect of PW setting on SNM outcomes remains unclear. Monopolar configurations stimulate more motor nerve fibers at lower stimulation voltage; hence, this could be an option in patients who failed bipolar stimulation in the long term. Unfortunately, there is little evidence for rescue programming for PTNS. However, the development of implantable devices for intermittent stimulation of the tibial nerve may increase long-term adherence to therapy and increase interest in alternative programming. There has been recent promising neurostimulation targeting the pudendal nerve (PNS), especially in BPS/IC. More recently, preliminary data addressed the benefits of high-frequency bilateral pudendal nerve block for DESD and adaptive PNS on both urgency and stress UI in women. The exploration of rescue programming and new stimulation sites remains underutilized, and there are opportunities that could potentially expand the therapeutic applications of nerve stimulation. By broadening the range of target sites, clinicians may be able to tailor treatments according to individual patient needs and underlying conditions, thereby improving overall outcomes. However, further studies are still needed to increase the level of evidence, potentially allowing for an individualized treatment both in patients who are candidates for electrostimulation and in those who have already received surgical implants but seek a better outcome.

Percutaneous Tibial Nerve Stimulation's Impact on Sexual Function in Female Patients with Neurogenic Detrusor Overactivity, Sexual Dysfunction, and Multiple Sclerosis.

Background/Objectives: Multiple sclerosis (MS) frequently results in both urinary and sexual dysfunction, which significantly impairs quality of life. Conventional treatments for bladder dysfunction often prove insufficient, leading to the exploration of alternative therapies such as percutaneous tibial nerve stimulation (PTNS). This study aimed to assess the impact of PTNS on sexual function and bladder symptoms in female MS patients with neurogenic detrusor overactivity (NDO) and female sexual dysfunction (FSD). Methods: A total of 65 female MS patients with NDO were evaluated and underwent 12 weeks of standardized PTNS treatment. Sexual function was assessed using the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale-Revised (FSDS-R), while bladder symptoms were evaluated using the OAB-v8 questionnaire. Participants were grouped based on the presence of sexual dysfunction and distress and compared to a control group of 20 patients who declined PTNS. Results: Significant improvements were observed in FSFI scores across multiple domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) in the treatment groups (p < 0.05). Additionally, 58.46% of patients showed positive responses to PTNS regarding overactive bladder symptoms (OAB-v8 score), while the control group showed no significant changes. Conclusions: PTNS appears to be an effective therapeutic option for improving sexual function and urinary symptoms in female MS patients with NDO and FSD, offering a promising non-invasive alternative for managing these conditions.

ID: 329569 Peripheral Nerve Stimulation of the Posterior Tibial Nerve for Chemotherapy Induced Neuropathy

ID: 329569 Peripheral Nerve Stimulation of the Posterior Tibial Nerve for Chemotherapy Induced Neuropathy

171 - Comparison of the Transcutaneous Posterior Tibial Nerve Stimulation and Solifenacin Treatments’ Effects in Women with Overactive Bladder

171 - Comparison of the Transcutaneous Posterior Tibial Nerve Stimulation and Solifenacin Treatments’ Effects in Women with Overactive Bladder

170 - Transcutaneous Posterior Tibial Nerve Stimulation on Demand During Multichannel Urodynamics: A New Approach in the Management of Overactive Bladder

170 - Transcutaneous Posterior Tibial Nerve Stimulation on Demand During Multichannel Urodynamics: A New Approach in the Management of Overactive Bladder

Transcutaneous Tibial Nerve Stimulation for Pain Management in Women with Primary Dysmenorrhea: A Randomized Clinical Trial.

Primary dysmenorrhea is considered one of the main causes of pelvic pain during a woman's childbearing years, resulting in poor quality of life. The objective was to evaluate the effectiveness of transcutaneous tibial nerve stimulation (TTNS) in painful symptomatology improvement and non-steroidal anti-inflammatory drug (NSAID) intake reduction in women with primary dysmenorrhea (PD) compared with a control group in the short, medium, and long terms. A single-blind, controlled clinical trial was developed. Participants were randomized to the experimental (TTNS) and control group (sham TTNS). Both groups received 12-weekly 30-min sessions with a NeuroTracTM PelviTone electrostimulation device. The intensity and severity of pain and non-steroidal anti-inflammatory drug (NSAID) intake were evaluated in the short-term (after treatment), medium-term (1-3 months), and long-term (6 months). A total of 61 participants were randomized, with a split of 31 (experimental group) and 30 (control group), but 55 participants completed the study and were analyzed. Statistically significant differences between both groups in the maximum pain intensity decrease (F = 4.88, p = 0.0043) measured with the visual analogue scale, as well as NSAID intake decrease (F = 4.68, p = 0.011) and days of their ingestion (F = 4.57, p = 0.012) occurred in the short term. Furthermore, significant decreases in the total number of NSAIDs ingested during the cycle (F = 3.82, p = 0.011) and the number of days on which patients ingested NSAIDs (F = 3.59, p = 0.015) in the medium-long term occurred. TTNS could be an effective and safe strategy to reduce pain caused by PD, which could reduce or complement the use of pharmacological techniques and other more invasive methods.

Editorial Comment on “Two-year Pivotal Study Analysis of the Safety and Efficacy of Implantable Tibial Nerve Stimulation With eCoin for Urgency Urinary Incontinence”

Editorial Comment on “Two-year Pivotal Study Analysis of the Safety and Efficacy of Implantable Tibial Nerve Stimulation With eCoin for Urgency Urinary Incontinence”

Editorial Comment on “Two-year Pivotal Study Analysis of the Safety and Efficacy of Implantable Tibial Nerve Stimulation With eCoin for Urgency Urinary Incontinence”

Editorial Comment on “Two-year Pivotal Study Analysis of the Safety and Efficacy of Implantable Tibial Nerve Stimulation With eCoin for Urgency Urinary Incontinence”

Updates on the use of neuromodulation in geriatric patients.

In light of the updated AUA/SUFU guidelines on the diagnosis and treatment of overactive bladder (OAB), increased utilization of advanced therapies is expected in the coming years. The primary aim of this review is to summarize existing outcome and safety data on the use of neuromodulation in geriatric patients, as well as highlight recent advances in neuromodulation that may be particularly advantageous in the geriatric population. There are mixed data demonstrating efficacy of sacral neuromodulation by decade of life, with older individuals most often demonstrating lower odds of progressing to stage 2 implantation. However, a large majority of patients still undergo stage 2 implantation with no significant increase in complications reported when compared to younger cohorts. Neuromodulation is broadening to have wider indications outside of OAB, which may be particularly beneficial in the elderly population (fecal incontinence, nonobstructive urinary retention, and constipation). Posterior tibial nerve stimulation remains a well tolerated and efficacious treatment for OAB, with new FDA-approved implantable devices joining the commercial market, which may expand access for elderly populations. The data are encouraging and support the use of neuromodulation in geriatric patients.

Effects of cerebellar transcranial direct current stimulation on the excitability of spinal motor neurons and vestibulospinal tract in healthy individuals.

Cerebellar transcranial direct current stimulation (ctDCS) modulates cerebellar cortical excitability in a polarity-dependent manner and affects inhibitory pathways from the cerebellum. The cerebellum modulates spinal reflex excitability via the vestibulospinal tract and other pathways projecting to the spinal motor neurons; however, the effects of ctDCS on the excitability of spinal motor neurons and vestibulospinal tract remain unclear. The experiment involved 13 healthy individuals. ctDCS (sham-ctDCS, anodal-ctDCS, and cathodal-ctDCS) was applied to the cerebellar vermis at 2mA with an interval of at least 3 days between each condition. We measured the maximal M-wave (Mmax) and maximal H-reflex (Hmax) in the right soleus muscle to assess the excitability of spinal motor neurons. We applied galvanic vestibular stimulation (GVS) for 200 ms at 100 ms before tibial nerve stimulation to measure Hmax conditioned by GVS (GVS-Hmax) and calculated the change rate of Hmax by GVS as the excitability of vestibulospinal tract. We measured the Mmax, Hmax, and GVS-Hmax before, during, and after ctDCS in the sitting posture. No main effects of tDCS condition, main effects of time, or interaction effects were observed in Hmax/Mmax or the change rate of Hmax by GVS. It has been suggested that ctDCS does not affect the excitability of spinal motor neurons and vestibulospinal tract, as measured by neurophysiological methods, such as the H-reflex, in healthy individuals in a sitting posture. Effect of ctDCS on other descending pathways to spinal motor neurons, the neurological mechanism of tDCS and the cerebellar activity during the experiment may have contributed to these results. Therefore, we need to investigate the involvement of the cerebellum in Hmax/Mmax and the change rate of Hmax by GVS under different neuromodulation techniques and postural conditions.

Posterior Tibial Nerve Stimulation With versus Without Mirabegron: A Randomized Controlled Trial.

To compare change in urgency urinary incontinence episodes (UUIEs) in women undergoing posterior tibial nerve stimulation (PTNS) plus mirabegron versus PTNS plus placebo for the treatment of refractory urgency urinary incontinence (UUI). The primary hypothesis was that combination therapy is superior to monotherapy. A randomized controlled trial was performed in individuals identifying as female aged ≥ 18 years with UUI symptoms refractory to second-line treatment or who could not tolerate antimuscarinic medications. Both participants and providers were blinded to medication treatment allocation. Participants were randomized (1:1) to PTNS plus mirabegron or PTNS plus placebo. Participants completed a 3-day bladder diary prior to and after 12-week treatment. Validated symptom distress and impact questionnaires were obtained pre- and post-treatment. The primary outcome was change in mean number of UUIEs on a 3-day bladder diary pre- versus post-treatment between arms. Primary and secondary outcomes were analyzed via sample t tests. Fifty-four subjects were randomized, mean ± SD baseline age 56.2±15.6 years and body mass index 35.0±9.4 (kg/m2); no differences were noted in any clinical-demographic characteristics. There was a significant difference between arms in mean pre- to post-treatment UUIEs, 9.4±3.9, mirabegron versus 5.3±5.5, placebo (p=0.007). Significant differences were found pre- compared with post-treatment in urinary frequency, Overactive Bladder Questionnaire Short Form Symptom Bother and Symptom Health-Related Quality of Life scores. In subjects undergoing PTNS treatment for refractory UUI and OAB-wet symptoms, the addition of a β-3 agonist produced significant improvement in both objective and subjective overactive bladder symptom outcomes compared with PTNS plus placebo.

Reduction of Overactive Bladder Medications in Spinal Cord Injury With Self-Administered Neuromodulation; a Randomized Trial.

To evaluate if self-administered bladder neuromodulation with transcutaneous tibial nerve stimulation can safely replace overactive bladder medications in people with spinal cord injury. We performed a 3-month, randomized, investigator-blinded, tibial nerve stimulation vs sham-control trial in adults with spinal cord injury and neurogenic bladder performing intermittent catheterization and taking overactive bladder medications. The primary outcome was a reduction in bladder medications while maintaining stable bladder symptoms and quality of life based on pre-post Neurogenic Bladder Symptom Score and the Incontinence-QOL questionnaire, respectively. Secondary outcomes included changes in pre-post cystometrogram, 2-day voiding diaries, and an anticholinergic medication side effect survey. Fifty people consented to the study, with 42 completing the trial. No dropouts were due to stimulation issues. All baseline demographics and surveys were comparable at baseline. Cystometrogram parameters were also comparable at baseline, except the stimulation group had a higher proportion of loss of bladder compliance compared to the control group. At the end of the trial, a significantly greater percentage of the tibial nerve stimulation group were able to reduce medications (95% v 68%), by a 26.2% difference in medication reduction (95% confidence interval 1.17%-51.2%). Function and quality of life surveys and cystometrograms at the end of the trial were alike between groups. Transcutaneous tibial nerve stimulation satisfaction surveys and adherence to protocol were high. In people with chronic spinal cord injury performing intermittent catheterization, transcutaneous tibial nerve stimulation can be an option to reduce or replace overactive bladder medications.

Long term safety, continuation rates and subjective and objective success of Posterior Tibial Nerve Stimulation for Overactive Bladder

Introduction:Posterior tibial nerve stimulation (PTNS) is currently offered to patients with refractory overactive bladder (OAB). We aim to evaluate the efficacy, safety and long-term continuation of PTNS over 11 years. Methods:We conducted a retrospective cohort study on all patients who underwent PTNS from 2012 to 2023. The primary outcomes were change in urinary frequency over 24 hours, maximum voided volume (MVV), number of episodes of urgency urinary incontinence (UUI) and patient perception of intensity of urgency scale (PPIUS). Results:We identified 81 patients. 83% of patients completed 12 treatments of PTNS, and 54% of those that did not complete their full course of treatment stated that this was due to inefficacy. 33% of patients underwent PTNS ‘top ups’ as needed. Only 1 patient reported an adverse effect of musculoskeletal leg pain.28% of patients reported a subjective improvement of their symptoms by 50% or more. There was an average reduction in daytime frequency by 0.6 episodes (p = 0.033), an increase in MVV by 13mls (p = 0.927), a reduction in UUI episodes each day by 0.7 (p = 0.008) and a reduction in average PPIUS by 0.4 (p = 0.024). Conclusion:PTNS remains a safe treatment option for patients with refractory OAB with evidence of both subjective and objective improvement to most symptoms. The majority of our patients completed a 12-week cycle but only 1 in 3 chose to have further PTNS ‘top ups’ and only 1 in 5 are continuing with PTNS for long term management of their OAB.

Tibial nerve stimulation in the management of primary sexual dysfunction in patients with multiple sclerosis: a pilot randomized control trial.

Sexual dysfunction (SD) is a common symptom that affects 40-90% of patients with multiple sclerosis (MS). Previous studies have highlighted the negative impact of sexual dysfunction in the mental health status and overall quality of life in patients with MS. The aim of this study was to examine the effects of transcutaneous tibial nerve stimulation (TTNS) in the primary SD symptoms in patients with MS. A total of 40 participants were randomized (1:1 ratio) to either TTNS or Sham group and received three 20min sessions over the course of two months. Pre and post intervention SD was evaluated using the Multiple Sclerosis Intimacy Questionnaire (MISQ-15). Statistically significant improvements in the aspects of primary sexual dysfunction were observed in the TTNS group pre-post intervention (specifically erectile function (for males)/vaginal lubrication (for females) (p < .001), orgasm quality and satisfaction for both male and female patients (p < .001), sexual desire (p < .05) and bladder related symptomatology (p < .005). In the sham group pre-post intervention, the only observed improvement was in the sexual desire aspect (p < .05). Post intervention the groups significantly differed erectile function/vaginal lubrication and orgasm quality and satisfaction (p < .05). Our findings underline the efficacy of TTNS in improving primary SD symptoms as well as bladder problems in both male and female patients with MS. TTNS demonstrated significant improvement in the following domains: erectile function, vaginal lubrication, orgasm quality, satisfaction, bladder-related symptoms, and sexual desire.

Update on Overactive Bladder Therapeutic Options.

Millions of Americans are burdened by overactive bladder (OAB) syndrome and the psychogenic and economic hardships that accompany it. Several theories attempt to explain OAB as a neurogenic dysfunction, myogenic dysfunction, urothelial dysfunction, or decreased expression of a channel protein secondary to bladder outlet obstruction. Given that the etiology of OAB is a working theory, the management of OAB is also an evolving subject matter in medicine. There are uncertainties surrounding the pathophysiology of OAB, the strength of a clinical diagnosis, and accurate reporting because of the disease's stigma and decreased use of health care. This is a narrative review that used PubMed, Google Scholar, Medline, and ScienceDirect to review literature on current and future OAB therapies. Currently, first-line treatment for OAB is behavioral therapy that uses lifestyle modifications, bladder-control techniques, and psychotherapy. Second-line therapy includes antimuscarinic agents or beta 3 adrenergic agonists, and studies have shown that combination therapy with antimuscarinics and beta 3 adrenergic agonists provides even greater efficacy than monotherapy. Third-line therapies discussed include onabotulinumtoxinA, posterior tibial nerve stimulation, and sacral neuromodulation. OnabotulinumtoxinA has been FDA-approved as a nonpharmaceutical treatment option for refractory OAB with minimal side effects restricted to the urinary tract. Posterior tibial nerve modulation and sacral neuromodulation are successful in treating refractory OAB, but the costs and complication rates make them high-risk procedures. Therefore, surgical intervention should be a last resort. Estrogen therapy is effective in alleviating urinary incontinence in postmenopausal women, consistent with the association between estrogen deficiency and genitourinary syndrome. Potassium channel activators, voltage-gated calcium channel blockers, and phosphodiesterase inhibitors look to be promising options for the future of OAB management. As new therapies are developed, individuals with OAB can better personalize their treatment to maximize their quality of life and cost-effective care.

Efficacy of Percutaneous vs Transcutaneous Posterior Tibial Nerve Stimulation in Overactive Bladder Syndrome: A Randomized Clinical Trial

Efficacy of Percutaneous vs Transcutaneous Posterior Tibial Nerve Stimulation in Overactive Bladder Syndrome: A Randomized Clinical Trial

Two-year Pivotal Study Analysis of the Safety and Efficacy of Implantable Tibial Nerve Stimulation With eCoin for Urgency Urinary Incontinence

ObjectiveTo evaluate the continued effectiveness and safety of the eCoin Implantable Tibial Nerve Stimulator system (ITNS) for urgency urinary incontinence in patients with overactive bladder.The one-year pivotal study was extended through two years. The ITNS is a novel and recently FDA-approved therapy. MethodsA prospective, multicenter, single-arm trial was conducted on 137 subjects with refractory urgency urinary incontinence to evaluate eCoin ITNS therapy. A 3-day voiding diary was collected along with the overactive bladder questionnaire, Patient Global Impression of Improvement, and a custom Likert scale on subject satisfaction. The primary efficacy measure was the proportion of subjects who achieved at least 50% reduction from baseline in number of urgency urinary incontinence episodes. The primary safety measure was device-related adverse events. Results72 subjects completed the 96-week evaluation. 78% (95% CI: 67% - 87%) experienced at least 50% reduction in urgency urinary incontinence episodes; 48% (95% CI, 36%-60%) experienced at least 75% reduction, and 22% (95% CI, 13%-33%) were dry on a 3-day diary. Subjects reported a decrease from baseline in their urgency urinary incontinence episodes/day of 2.61 (SD 2.97) and 2.97 (SD 2.64) at 48 weeks and 96 weeks, respectively. 91.3% did not require additional medications for overactive bladder. No serious or unanticipated adverse events were reported in this extension phase. ConclusionsThe eCoin ITNS demonstrated consistent continuing effectiveness and safety in treating overactive bladder patients with urgency urinary incontinence. The findings support it as an excellent treatment option for refractory patients.