Immediate and Long-Term Effects of Tibial Nerve Stimulation on the Sexual Behavior of Female Rats.

OBJECTIVES: There are limited treatment options for female sexual dysfunction (FSD). Percutaneous tibial nerve stimulation (PTNS) has shown improvements in FSD symptoms in neuromodulation clinical studies, but the direct effects on sexual function are not understood. This study evaluated the immediate and long-term effects of PTNS on sexual motivation and receptivity in a rat model of menopausal women. Our primary hypothesis was that long-term PTNS would yield greater changes in sexual behavior than short-term stimulation. MATERIALS AND METHODS: In two experiments, after receiving treatment, we placed ovariectomized female rats in an operant chamber in which the female controls access to a male by nose poking. We used five treatment conditions, which were with or without PTNS and no, partial, or full hormone priming. In experiment 1, we rotated rats through each condition twice with behavioral testing immediately following treatment for ten weeks. In experiment 2, we committed rats to one condition for six weeks and tracked sexual behavior over time. We quantified sexual motivation and sexual receptivity with standard measures. RESULTS: No primary comparisons were significant in this study. In experiment 1, we observed increased sexual motivation but not receptivity immediately following PTNS with partial hormone priming, as compared with priming without PTNS (linear mixed effect models; initial latency [p = 0.34], inter-interval latency [p = 0.77], nose poke frequency [p = 0.084]; eight rats). In experiment 2, we observed trends of increased sexual receptivity (linear correlation for weekly group means; mounts [p = 0.094 for trendline], intromissions [p = 0.073], lordosis quotient [p = 0.58], percent time spent with a male [p = 0.39], decreased percent time alone [p = 0.024]; four rats per condition), and some sexual motivation metrics (linear correlation for weekly group means; nose pokes per interval [p = 0.050], nose poke frequency [p = 0.039], decreased initial latency [p = 0.11]; four rats per condition) when PTNS was applied long-term with partial hormone priming, as compared with hormone-primed rats without stimulation. CONCLUSIONS: PTNS combined with hormone priming shows potential for increasing sexual motivation in the short-term and sexual receptivity in the long-term in rats. Further studies are needed to examine variability in rat behavior and to investigate PTNS as a treatment for FSD in menopausal women.

Effects of Posterior Tibial Nerve Stimulation on Fecal Incontinence: An Umbrella Review.

PURPOSE: This study aimed to summarize relevant data from previous systematic reviews (SRs) and conduct comprehensive research on the clinical effects of posterior tibial nerve stimulation (PTNS), via the transcutaneous posterior tibial nerve stimulation (TPTNS) or percutaneous posterior tibial nerve stimulation (PPTNS) method on fecal incontinence (FI). MATERIALS AND METHODS: In adherence to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, a systematic search was conducted on PubMed, Embase, Scopus, and Web of Science databases. We included English-language, full-text SRs reporting outcomes for FI following either PPTNS or TPTNS. The quality of included studies was assessed using the Joanna Briggs Institute checklist. In addition, reanalyzing the meta-analyses was conducted using Comprehensive Meta-Analysis (CMA) software version 3.0 to achieve effect sizes and the level of statistical significance was set at p ≤ 0.05. RESULTS: From a total of 835 citations, 14 SRs met our inclusion criteria. Four of these also conducted a meta-analysis. Most SRs reported an overall improvement in different study parameters, including bowel habits and quality of life. However, there were major inconsistencies across the results. The most studied outcome was FI episodes, followed by incontinence score. The summary outcomes showed no statistically significant changes in comparing PTNS with sham or sacral nerve stimulation (SNS) for FI (p > 0.05). However, the results of subgroup analysis based on the type of intervention in the control group revealed that FI episodes were significantly fewer than in the PTNS arm, whereas PTNS led to fewer episodes of FI than did the sham. In terms of incontinence score, the results showed that PTNS compared with sham did not change the incontinence score; however, SNS improved the score significantly in one eligible study for reanalysis when compared with PTNS (p < 0.001). CONCLUSIONS: The findings of the current umbrella review suggest that PTNS can potentially benefit patients with FI. However, this is concluded from studies with a limited population, disregarding the etiology of FI and with limited follow-up duration. Therefore, caution must be taken in contemplating the results.

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 Outcome of Transcutaneous Posterior Tibial Nerve Stimulation in the Treatment of Functional Non-Retentive Fecal Incontinence in Children.

BACKGROUND: Functional non-retentive fecal incontinence (FNRFI) is a psychologically upsetting and embarrassing issue and affects children's quality of life negatively. AIM OF THIS STUDY: Evaluation of the short and long-term effect of Bilateral transcutaneous posterior tibial nerve stimulation (BTPTNS) in the treatment of FNRFI in children and its impact on the quality of life (QoL). Methodology: The current randomized controlled study included 94 Children with FNRFI who were randomly allocated into two equal groups. Group A received BTPTNS and Group B Received Sham BTPTNS. Follow-up was planned for 24 months for manometric findings, incontinence score, Incontinence episodes, and the QoL. RESULTS: The incontinence score was significantly decreases in Group A more than what was reported in Group B at 6, 12, 24 months follow up . In group A 53.2% of the included children who received BTPTNS showed a decrease in the incontinence episodes more than 75% and among them, 23.4% were fully continent. All the QoL domains were significantly improved in Group A after 6, 12, and 24 months when compared with Group B. CONCLUSION: BTPTNS can be a good modality in the treatment of FNRFI with favorable long-term maintenance of its effect together with a remarkable positive impact on all domains of QoL.

bTUNED: transcutaneous tibial nerve stimulation for neurogenic lower urinary tract dysfunction.

OBJECTIVE: To present the protocol for a randomized controlled trial (RCT) evaluating the efficacy and safety of transcutaneous tibial nerve stimulation (TTNS) for refractory neurogenic lower urinary tract dysfunction (NLUTD). STUDY DESIGN AND RESULTS: bTUNED (bladder and TranscUtaneous tibial Nerve stimulation for nEurogenic lower urinary tract Dysfunction) is an international multicentre, sham-controlled, double-blind RCT investigating the efficacy and safety of TTNS. The primary outcome is success of TTNS, defined as improvements in key bladder diary variables at study end compared to baseline values. The focus of the treatment is defined by the Self-Assessment Goal Achievement (SAGA) questionnaire. Secondary outcomes are the effect of TTNS on urodynamic, neurophysiological, and bowel function outcome measures, as well as the safety of TTNS. CONCLUSIONS: A total of 240 patients with refractory NLUTD will be included and randomized 1:1 into the verum or sham TTNS group from March 2020 until August 2026. TTNS will be performed twice a week for 30 min during 6 weeks. The patients will attend baseline assessments, 12 treatment visits and follow-up assessments at the study end.

Transcutaneous tibial nerve electrical stimulation versus vaginal electrical stimulation in women with overactive bladder syndrome: Is there a role for short-term interventions?

OBJECTIVE: To assess the efficacy of vaginal electrical stimulation (VS) versus transcutaneous tibial nerve electrical stimulation (TTNS) in women with overactive bladder syndrome (OAB). MATERIAL AND METHODS: Sixty-nine patients were randomized to receive 12 sessions of VS versus TTNS, or no treatment (control group-CG), over 6 weeks. OAB impact according to international consultation on incontinence questionnaire overactive bladder module (ICIQ-OAB), symptoms discomfort scores and voiding diaries were evaluated at baseline, 6 weeks and 1-month post-treatment. RESULTS: Both TTNS (mean difference = -4.2; 95% confidence interval [CI] = -6.5 to -1.9) and VS (-3.8; -6.0 to -1.6) were associated with significant reduction of ICIQ-OAB scores, as well as discomfort sensation (-3.9; -6.2 to -1,7; p < 0.001 for the TTNS and -2.8; -5.0 to -0.6; p = 0.01 for the VS) at 6 weeks when compared to CG (p < 0.001). ICIQ-OAB score remained low only in the TTNS group when compared to the CG (-3.6; -6.0 to -1.2/p = 0.00) 1 month after treatment. Discomfort symptoms improved in both active groups when compared to CG (TTNS [-3.2; -5.2 to -1.2; p < 0.001] and VS groups [-2.6; -4.7 to -0.6; p = 0.01]). No statistically differences were found in primary outcomes comparing TTNS and VS Secondary analysis showed significant improvement in urinary urgency incontinence episodes (UUI) in both TTNS and VS, but CG. UUI episodes were still reduced in the VS group and urgency in the TTNS group 1-month post-treatment. CONCLUSION: Short-term interventions (6 weeks) of TTNS and VS were both effective in treating women with OAB. TTNS provided residual effects at one-month postintervention on ICIQ-OAB score.

A Randomized, Double-Blind, Controlled Trial of Percutaneous Tibial Nerve Stimulation With Pelvic Floor Exercises in the Treatment of Childhood Constipation.

INTRODUCTION: The management of childhood constipation is challenging. Pelvic floor dysfunction (PFD) is one of the most common causes of childhood constipation. Percutaneous tibial nerve stimulation (PTNS) with pelvic floor exercises (PFE) has achieved a satisfactory outcome in the elderly individuals and women with PFD. The efficacy of PTNS with PFE in childhood constipation has not been established. METHODS: A randomized, double-blind, controlled trial with 84 children who met the inclusion criteria was conducted. All participants were randomly assigned to PTNS with PFE or sham PTNS with PFE groups and received their individual intervention for 4 weeks with a 12-week follow-up evaluation. The spontaneous bowel movements (SBM) ≥3 per week were the main outcomes, and the risk ratio (RR) with 95% confidence interval (CI) were calculated. High-resolution anorectal manometry and surface electromyography were used for the assessment of pelvic floor function, and the adverse effects were assessed based on symptoms. RESULTS: At the end of the follow-up period, 26 patients (61.9%) in the PTNS with PFE group and 15 patients (35.7%) in the sham group had ≥3 SBM per week compared with baseline (net difference 26.2%, 95% CI 5.6%-46.8%; RR 2.750, 95% CI 1.384-5.466; P < 0.05). PFD remission occurred in 49 children, 33 (78.6%) in the PTNS with PFE group and 16 (38.1%) in the sham group (RR 2.063, 95% CI 1.360-3.128, P < 0.05). No adverse effects occurred. DISCUSSION: PTNS with PFE is a safe and effective method in the treatment of childhood constipation, particularly in children with PFD or dyssynergic defecation.

Efficacy of transcutaneous posterior tibial nerve stimulation in functional constipation.

Most children with functional constipation (FC) improve with conventional treatments. However, a proportion of children have poor treatment outcomes. Management of intractable FC may include botulinum toxin injections, transanal irrigation, antegrade enemas, colonic resections, and in some cases sacral nerve stimulation (SNS). SNS is surgically placed, not readily available and expensive. Posterior tibial nerve stimulation (PTNS) allows transmission of electronic impulses and retrograde stimulation to the sacral nerve plexus in a portable, simple and non-invasive fashion. To assess the efficacy and safety of transcutaneous PTNS for the treatment of FC in children. Single-center, prospective interventional study. Children 4-14 years with Rome IV diagnosis of FC received ten daily PTNS (30 min/day) sessions. Electrodes placed over skin of ankle. Strength of stimulus was below pain threshold. Outcomes were assessed during treatment and 7 days after. Twenty-three subjects enrolled. Two children excluded (acute gastroenteritis, COVID-19 contact). Twenty completed the study (4-14 years), (8.4 ± 3.2 years, 71.4% female). We found significant improvement in the consistency of bowel movements (BM) (p = 0.005), fecal incontinence (FI) (p = 0.005), abdominal pain presence (p = < 0.001) and intensity (p = 0.005), and a significant for improvement in blood in stools (p = 0.037). There was 86.3% improvement in abdominal pain. 96.7% reported treatment satisfaction. Only one child required rescue therapy. CONCLUSION: We found significant improvement in stool consistency, FI, abdominal pain, and hematochezia. This suggests that transcutaneous PTNS could be a promising noninvasive treatment for FC in children. Large studies are needed. WHAT IS KNOWN: • Functional constipation is one of the most common disorders in children. • Current management of functional constipation consists of an integrative approach that includes medications, diet and behavioral strategies. WHAT IS NEW: • Posterior tibial nerve stimulation is a novel noninvasive and easy to use therapy that can improve stool consistency, fecal incontinence and blood in stools.

[Therapeutic value of neuromodulation in women]. / Stellenwert der Neuromodulation bei der Frau.

BACKGROUND: Neuromodulative treatment for the treatment of overactive bladder has been used in clinical practice since its introduction in the early 1980s. OBJECTIVES: Description and update of the various neuromodulative techniques (tibial nerve stimulation, sacral and pudendal neuromodulation), presentation of their effectiveness and safety, and evaluation of their evidence for clinical practice. MATERIALS AND METHODS: Literature search in PubMed and Embase, inclusion of studies according to the following criteria: evidence level, timeliness, length of follow-up and number of female patients according to the author's preference. RESULTS: The efficacy and safety of both percutaneous tibial nerve stimulation (PTNS) and sacral neuromodulation (SNM) has been proven by studies with an evidence level of 1. Long-term data of up to 20 years are available for SNM, while long-term data for PTNS are limited. Permanent implants for tibial nerve stimulation are promising new developments. Pudendal neuromodulation (PNM) is suitable for more complex indications but is surgically more challenging. CONCLUSIONS: Both PTNS and SNM are suitable for broad application in clinical practice. PTNS can be offered as an alternative to pharmacotherapy, while SNM provides the most convincing clinical data of all neuromodulative therapies.

The Role of Percutaneous Tibial Nerve Stimulation (PTNS) in Low Anterior Resection Syndrome (LARS): A Systematic Review and Meta-analysis.

PURPOSE: The aim of the present study was to evaluate the pooled efficacy of percutaneous tibial nerve stimulation (PTNS) in patients with low anterior resection syndrome (LARS). MATERIAL AND METHODS: This study was based on the Cochrane Handbook for Systematic Reviews of Interventions and the PRISMA guidelines. The primary endpoint was the pooled effect size of PTNS in LARS score (LARSS). Secondary endpoints included incontinence (Fecal Incontinence Score-FIC, Obstructive Defecation Syndrome-ODS), sexual functionality and quality of life (QoL) questionnaires, and manometric evaluations. Continuous outcomes were reported as weighted mean difference (WMD), with the corresponding 95% confidence interval (95% CI). Quality evaluation was performed via the National Institutes of Health (NIH) quality assessment tool. RESULTS: Overall, 5 studies were included. PTNS resulted to reduced LARSS values (WMD: - 5.68, 95%CI: - 7.73, - 3.63, p < 0.001). A similar effect was noted in St Mark's FIC (p < 0.001) and ODS (p = 0.02) score. An improvement in several QoL scales was found. There was no effect in sexual functionality and manometric measurements. Compared to sham, PTNS significantly improved LARSS. CONCLUSIONS: The application of PTNS in patients with LARS results in an improvement in multiple clinical parameters, including defecation functionality and quality of life. Due to several study limitations, further high quality RCTs are required to delineate the exact efficacy of PTNS.

Characteristics associated with subjective and objective measures of treatment success in women undergoing percutaneous tibial nerve stimulation vs sham for accidental bowel leakage.

INTRODUCTION AND HYPOTHESIS: In randomized trials both percutaneous tibial nerve stimulation (PTNS) and sham result in clinically significant improvements in accidental bowel leakage (ABL). We aimed to identify subgroups who may preferentially benefit from PTNS in women enrolled in a multicenter randomized trial. METHODS: This planned secondary analysis explored factors associated with success for PTNS vs sham using various definitions: treatment responder using three cutoff points for St. Mark's score (≥3-, ≥4-, and ≥5-point reduction); Patient Global Impression of Improvement (PGI-I) of ≥ much better; and ≥50% reduction in fecal incontinence episodes (FIEs). Backward logistic regression models were generated using elements with significance of p<0.2 for each definition and interaction terms assessed differential effects of PTNS vs sham. RESULTS: Of 166 women randomized, 160 provided data for at least one success definition. Overall, success rates were 65% (102 out of 158), 57% (90 out of 158), and 46% (73 out of 158) for ≥3-, ≥4-, and ≥5-point St Mark's reduction respectively; 43% (68 out of 157) for PGI-I; and 48% (70 out of 145) for ≥50% FIEs. Of those providing data for all definitions of success, 77% (109 out of 142) met one success criterion, 43% (61 out of 142) two, and 29% (41 out of 142) all three success criteria. No reliable or consistent factors were associated with improved outcomes with PTNS over sham regardless of definition. CONCLUSIONS: Despite exploring diverse success outcomes, no subgroups of women with ABL differentially responded to PTNS over sham. Success results varied widely across subjective and objective definitions. Further investigation of ABL treatment success definitions that consistently and accurately capture patient symptom burden and improvement are needed.

Efficacy of a novel wearable transcutaneous tibial nerve stimulation device on bladder reflex compared to implantable tibial nerve stimulation in cats.

OBJECTIVE: To determine the efficacy of novel wearable transcutaneous tibial nerve stimulation (TTNS) device on bladder reflex in cats compared to implantable tibial nerve stimulation (ITNS). MATERIALS AND METHODS: Two self-adhesive electrodes of the TTNS device were placed at the left leg, and ITNS was applied to stimulate the tibial nerve of the right leg, respectively. The intensity threshold (T) was defined as inducing observable toe movement. Multiple cystometrograms (CMGs) with normal saline (NS) infusion were performed to determine the inhibitory effects of TTNS and ITNS on the micturition reflex. RESULTS: TTNS at 4 times T (4 T), 6 times T (6 T), and the maximum output current intensity 24 mA significantly increased the bladder capacity (BC) compared to the control level (8.70 ± 2.46 ml) (all p < 0.05); however, there was no statistical significance among the three intensities. At the same time, ITNS at 2 times T (2 T), 4 T, 6 T, and the current intension 24 mA could significantly increase the BC compared to the control level (all p < 0.05). Likewise, no significant difference was observed among the four intensities (p > 0.05). The T values of TTNS were higher than those of ITNS (p = 0.02). The inhibitory effects of TTNS and ITNS revealed no significant difference at their respective 2 T, 4 T, 6 T, and 24 mA. Neither TTNS nor ITNS changed the contraction duration and amplitude (all p > 0.05). CONCLUSIONS: TTNS was effective in increasing BC. The non-invasive neuromodulation technique could achieve a similar effect as ITNS.

Tibial nerve electrical stimulation for fecal incontinence: a systematic review and meta-analysis.

Tibial nerve stimulation (TNS) therapy is widely used to treat fecal incontinence (FI), but still, some controversy exists. This study aimed to determine whether TNS could improve FI from different evaluation angles. A systematic review and meta-analysis were conducted to provide indirect evidence of TNS treatment for FI. We searched for the original studies in PubMed, Embase, Web of Science, Ebsco Medline, Ovid Medline, and Cochrane Central Register of Controlled Trials published before November 31, 2021. The standardized mean difference was the efficacy analysis statistic, and the effect was expressed by the 95% confidence interval (CI). For the case series, we calculated the mean difference of the number of patients evaluated at baseline and last follow-up. Four randomized controlled trials (RCTs, four hundred and sixty participants) and eighteen case series (eight hundred and thirty-eight participants) were included in the study. The results of the RCTs showed that the number of weekly episodes of FI significantly reduced in the TNS group compared with the sham stimulation group. The results of the case series showed that TNS reduced the number of patients with FI per week. The Cleveland Clinic Florida FI Score significantly reduced. The post-treatment results of maximum squeeze pressure and maximum resting pressure were significantly different from baseline. This study showed that TNS to some extent reduced the number of patients with FI, reduced clinical symptoms, and improved anal physiological function. Despite the low quality of overall evidence, TNS still shows some potential as a safe treatment for FI.

Posterior Tibial Nerve Stimulation in Children with Lower Urinary Tract Dysfunction: A Mixed-Methods Analysis of Experiences, Quality of Life and Treatment Effect.

BACKGROUND: Posterior tibial nerve stimulation (PTNS) is one of the treatment modalities for children with therapy-refractory lower urinary tract dysfunction (LUTD). This study used a mixed-methods analysis to gain insight into the experiences of children treated with PTNS and their parents, the effect of treatment on quality of life (QOL) and the effect of PTNS on urinary symptoms. METHODS: Quantitative outcomes were assessed through a single-centre retrospective chart analysis of all children treated with PTNS in a group setting between 2016-2021. Voiding parameters and QOL scores before and after treatment were compared. Qualitative outcomes were assessed by an explorative study involving semi-structured interviews transcribed verbatim and inductively analysed using the constant-comparative method. RESULTS: The data of 101 children treated with PTNS were analysed. Overall improvement of LUTD was seen in 42% and complete resolution in 10%. Average and maximum voided volumes significantly increased. QOL improved in both parents and children independent of the actual effect on urinary symptoms. Interviews revealed PTNS to be well-tolerated. Facilitating PTNS in a group setting led to feelings of recognition in both children and parents. CONCLUSIONS: PTNS is a good treatment in children with therapy-refractory LUTD and provides valuable opportunities for peer support if given in a group setting.

Stimulation of the tibial nerve-a randomised trial for urinary problems associated with Parkinson's-the STARTUP trial.

BACKGROUND: non-motor symptoms such as bladder dysfunction are common (80%) in people with Parkinson's increasing the risk for falls with a negative impact on health-related costs and quality of life.We undertook STARTUP to evaluate the clinical and cost-effectiveness of using an adhesive electrode to stimulate the transcutaneous tibial nerve stimulation (TTNS) to treat bladder dysfunction in people with Parkinson's disease (PD).Study design, materials and methods: STARTUP was a parallel two-arm, multi-centre, pragmatic, double-blind, randomised controlled trial. Each participant attended one clinic visit to complete consent, be randomised using a computer-generated system and to be shown how to use the device.The trial had two co-primary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score (IPSS). These were completed at baseline, 6 and 12 weeks. A bladder frequency chart and resource questionnaire were also completed. RESULTS: two hundred forty two participants were randomised. About 59% of participants were male, the mean age was 69 years and mean time since diagnosis was 6 years. Questionnaire return rate was between 79 and 90%.There was a statistically significantly lower score in the active group at 6 weeks in the IPSS questionnaire (mean difference (Standard deviation, SD) 12.5 (6.5) vs 10.9 (5.5), effect size -1.49, 95% CI -2.72, -0.25). There was no statistically significant change in any other outcome. CONCLUSION: TTNS was demonstrated to be safe with a high level of compliance. There was a significant change in one of the co-primary outcome measures at the end of the treatment period (i.e. 6 weeks), which could indicate a benefit. Further fully powered RCTs are required to determine effective treatments.

Does response to percutaneous tibial nerve stimulation predict similar outcome to sacral nerve stimulation?

AIMS: Percutaneous tibial nerve stimulation (PTNS) is a simple neuromodulation technique to treat an overactive bladder. It is unclear whether the response to PTNS would suggest a similar response to sacral nerve stimulation (SNS), and whether PTNS could be utilized as an alternative test phase for an SNS implant. This study assessed whether PTNS response was a reliable indicator for subsequent SNS trials. METHODS: We performed a retrospective review of the hospital databases to collect all patients who had PTNS and who subsequently had an SNS trial in two tertiary hospitals from 2014 to 2020. Response to both interventions was assessed. A 50% reduction in overactive symptoms (frequency-volume charts) was considered a positive response. McNemar's tests using exact binomial probability calculations were used. The statistical significance level was set to 0.05. RESULTS: Twenty-three patients who had PTNS subsequently went on to a trial of SNS. All patients except one had previously poor response to PTNS treatment. Eight of them also failed the SNS trial. However, 15 patients (including the PTNS responder) had a successful SNS trial and proceeded with the second-stage battery implantation. The difference in response rates between the PTNS and SNS trial was statistically significant (p < 0.001). CONCLUSIONS: Poor response to PTNS does not seem to predict the likelihood of patients responding to SNS. A negative PTNS trial should not preclude a trial of a sacral nerve implant. The predictive factors for good and poor responses will be the subject of a larger study.

Urgent PC Versus a Generic Posterior Tibial Neurostimulator for Overactive Bladder: A Retrospective Noninferiority Study.

OBJECTIVE: The aim of the study was to determine whether a generic posterior tibial neurostimulator was noninferior to Urgent PC in the treatment of nonneurogenic OAB, urgency urinary incontinence, and mixed urinary incontinence. Secondary outcomes include rates of starting and completing 3 months of maintenance therapy, treatment success after 3 months, and adverse events. METHODS: We performed a retrospective cohort analysis of women whose nonneurogenic OAB, urgency urinary incontinence, or mixed urinary incontinence was treated with either Urgent PC or a generic posterior tibial neurostimulator. Previous research shows a 55% treatment success rate for posterior tibial nerve stimulation (PTNS). To demonstrate noninferiority with a limit of 14% and 80% power, our analysis required 157 patients per group. RESULTS: We included 267 Urgent PC and 234 generic patients and excluded 51 patients from analysis. A per-protocol analysis demonstrated treatment success in 55.3% (121 of 219) of the Urgent PC and 48.6% (85 of 175) of the generic cohort (P = 0.187). An intention-to-treat analysis showed treatment success in 45.3% (121 of 267) of the Urgent PC and 36.3% (85 of 234) of the generic cohort (P = 0.690). There were no significant differences in rates of starting (82.2% vs 78.2%, P = 0.409) or completing (79.9% vs 70.9%, P = 0.129) 3 months of maintenance therapy, treatment success after 3 months (78.5% vs 73.8%, P = 0.485), and adverse events (0.37% vs 0.85%, P = 1.000) in the Urgent PC versus generic group, respectively. CONCLUSIONS: In this cohort of women undergoing PTNS for nonneurogenic OAB, urgency urinary incontinence, or mixed urinary incontinence, the generic neurostimulator demonstrated noninferior rates of treatment success compared with Urgent PC.

Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial.

INTRODUCTION: To determine whether percutaneous tibial nerve stimulation (PTNS) is superior to sham stimulation for the treatment of fecal incontinence (FI) in women refractory to first-line treatments. METHODS: Women aged 18 years or older with ≥3 months of moderate-to-severe FI that persisted after a 4-week run-in phase were randomized 2:1 (PTNS:sham stimulation) to 12 weekly 30-minute sessions in this multicenter, single-masked, controlled superiority trial. The primary outcome was change from baseline FI severity measured by St. Mark score after 12 weeks of treatment (range 0-24; minimal important difference, 3-5 points). The secondary outcomes included electronic bowel diary events and quality of life. The groups were compared using an adjusted general linear mixed model. RESULTS: Of 199 women who entered the run-in period, 166 (of 170 eligible) were randomized, (111 in PTNS group and 55 in sham group); the mean (SD) age was 63.6 (11.6) years; baseline St. Mark score was 17.4 (2.7); and recording was 6.6 (5.5) FI episodes per week. There was no difference in improvement from baseline in St. Mark scores in the PTNS group when compared with the sham group (-5.3 vs -3.9 points, adjusted difference [95% confidence interval] -1.3 [-2.8 to 0.2]). The groups did not differ in reduction in weekly FI episodes (-2.1 vs -1.9 episodes, adjusted difference [95% confidence interval] -0.26 [-1.85 to 1.33]). Condition-specific quality of life measures did not indicate a benefit of PTNS over sham stimulation. Serious adverse events occurred in 4% of each group. DISCUSSION: Although symptom reduction after 12 weeks of PTNS met a threshold of clinical importance, it did not differ from sham stimulation. These data do not support the use of PTNS as conducted for the treatment of FI in women.

Neuromodulation of the Posterior Tibial Nerve for the Control of Urinary Incontinence.

Urinary incontinence is considered a health problem that both elderly and young people can suffer, most often elderly women. This problem can lead to difficulties in establishing social relationships and dependence, negatively affecting the quality of life of the people who suffer from it. To evaluate and analyze the studies that demonstrate the efficacy of interventions based on the neuromodulation of the posterior tibial nerve as a treatment for the control of urinary incontinence. The search period for articles focused on those published between March 2011 to March 2021, in five databases (Pubmed, Cochrane Library, Scielo, Google Academic and WOS) based on the clinical question, using the keywords derived from the DeCS and MeSH thesauri, combined with the Boolean operators "AND", "NOT" and "OR". The search was limited to publications from the last 10 years, in English and Spanish. After applying the selection criteria and evaluating the quality of the methodology, 5.28% (n = 27) of the 511 results were included with filters: 9 systematic reviews, 10 cohorts and 8 randomized controlled trials. After comparing the different articles, it was found that percutaneous stimulation of the tibial nerve is a suitable technique for treating overactive bladder. It is a promising technique in case of pelvic floor dysfunctions and effective for the control of urinary incontinence.

Percutaneous posterior tibial nerve stimulation (PTNS) for lower urinary tract symptoms (LUTSs) treatment in patients with multiple sclerosis (MS): A systematic review and meta-analysis.

BACKGROUND: Lower urinary tract symptoms (LUTSs) are common in patients with multiple sclerosis (MS). Percutaneous posterior tibial nerve stimulation (PTNS) is a minimally invasive treatment which is considered to be effective for patients who suffer from LUTS symptoms. In previous studies, the endpoints of treatment reported differently. So, we designed this systematic review and meta-analysis to estimate pooled efficacy of PTNS based on different assessment methods. METHODS: We systematically searched PubMed, Scopus, EMBASE, Web of Science, and google scholar. We also searched the gray literature including references of the included studies, and conference abstracts which were published up to May 2021. The search strategy included the MeSH and text words as (((Tibial Nerves) OR Posterior Tibial Nerve) OR (Posterior Tibial Nerves) OR (Medial Plantar Nerves) OR (Medial Plantar Nerve) OR (tibial Nerve Stimulation) OR (Trans-Cutaneous Tibial Nerve Stimulation) OR (Percutaneous Tibial Nerve Stimulation) OR (Cutaneous Tibial Nerve Stimulation) AND ((Multiple Sclerosis OR Sclerosis, Multiple) OR Sclerosis, Disseminated) OR Disseminated Sclerosis) OR MS (Multiple Sclerosis)) OR Multiple Sclerosis, Acute Fulminating).Two independent researchers independently evaluated the articles. RESULTS: We found 2430 articles by literature search, after deleting duplicates 2027 remained. Eight articles remained for meta-analysis The pooled SMD of post voiding residual (PVR) (post-treatment - pre-treatment) was -0.75 (95%CI:-0.93, -0.56)(I2=0, p = 0.67). The pooled SMD of voiding volume (post-treatment - pre-treatment) was 1.21 (95% CI:0.94-1.49) (I2:0%, p = 0.4). The pooled SMD of nocturia (post-treatment - pre-treatment) was -1.10 (95% CI:-1.33, -0.87) (I2:86.4%, p<0.001). The pooled SMD of leakage per day (post-treatment - pre-treatment) was -0.69 (95% CI:-0.93, -0.45) (I2:84.3%, p<0.001). The pooled frequency of responders was 66%(95% CI:59%-73%)(I2:0). CONCLUSION: The results of this systematic review and meta-analysis show that PTNS in effective in treating LUTS in patients with MS.