Tibial Nerve Stimulation In Treatment Research Articles

Efficacy and sex-specific outcomes after six episodes of percutaneous tibial nerve stimulation treatment on overactive bladder syndrome symptoms

ObjectiveThis study aimed to investigate the efficacy of six episodes of percutaneous tibial nerve stimulation (PTNS) treatment for overactive bladder (OAB) symptoms in men and women and to determine the duration of the effects over a 6-month period.MethodsWomen and men with OAB symptoms participated in the study, which was conducted in accordance with an approved ethical protocol (ISRCTN15733799). Patients underwent six 30-min PTNS sessions, twice per week. The symptoms of OAB were assessed using a voiding diary, the short form of the Overactive Bladder Symptom Score questionnaire (OAB-q SF), and the Patient Perception of Bladder Condition (PPBC), which were self-completed by patients before and after treatment (24 h and at 1, 3, and 6 months). The outcome data were compared for sex and time points using two-way ANOVA for repeated measures.ResultsPTNS treatment significantly improved the OAB symptoms and quality of life in men and women. PTNS increased the voided volume (p < 0.05) and decreased the frequency of voiding, nocturia, and urgency at 24 h and up to 6 months (p < 0.001). The OABq-SF and PPBC scores were significantly decreased after PTNS (p < 0.001). Urgency was greater in men than in women. The duration of PTNS clinical success on frequency and the perception of improvement in quality of life were greater in women than in men.ConclusionThe clinical effects of six sessions of PTNS strongly suggest its potential for shortening, from the standard 12 sessions, to effectively alleviate symptoms of OAB. This therapeutic procedure would reduce both the time and economic costs of OAB treatment.

Real-time changes in brain activity during tibial nerve stimulation for overactive bladder: Evidence from functional near-infrared spectroscopy hype scanning.

To use functional near-infrared spectroscopy (fNIRS) to identify changes in brain activity during tibial nerve stimulation (TNS) in patients with overactive bladder (OAB) responsive to therapy. Eighteen patients with refractory idiopathic OAB patients were recruited consecutively for this pilot study. At baseline, all patients completed 3 days voiding diary, Quality-of-Life score, Perception-of-Bladder-Condition, and Overactive-Bladder-Symptom score. Then 4 region-of-interest (ROI) fNIRS scans with 3 blocks were conducted for each patient. The block design was used: 60 s each for the task and rest periods and 3 to 5 repetitions of each period. A total of 360 s of data were collected. During the task period, patients used transcutaneous tibial nerve stimulation (TTNS) of 20-Hz frequency and a 0.2-millisecond pulse width and 30-milliamp stimulatory current to complete the experiment. The initial scan was obtained with a sham stimulation with an empty bladder, and a second was obtained with a verum stimulation with an empty bladder. Patients were given water till strong desire to void, and the third fNIRS scan with a verum stimulation was performed. The patients then needed to urinate since they could not tolerate the SDV condition for a long time. After a period of rest, the patients then were given water until they exhibited SDV state. The fourth scan with sham fNIRS scan in the SDV state was performed. NIRS_KIT software was used to analyze prefrontal activity, corrected by false discovery rate (FDR, p < 0.05). Statistical analyses were performed using GraphPad Prism software; p < 0.05 was considered significant. TTNS treatment was successful in 16 OAB patients and unsuccessful in 2. The 3 days voiding diary, Quality-of-Life score, Perception-of-Bladder-Condition, and Overactive-Bladder-Symptom score were significantly improved after TNS in the successfully treated group but not in the unsuccessfully treated group. The dorsolateral prefrontal cortex (DLPFC) (BA 9, Chapters 25 and 26) and the frontopolar area (FA) (BA 10, Chapters 35, 45, and 46) were significantly activated during TNS treatment with an empty bladder rather than with an SDV. Compared with the successfully treated group, the unsuccessfully treated group did not achieve statistical significance with an empty bladder and an SDV state. fNIRS confirms that TNS influences brain activity in patients with OAB who respond to therapy. That may be the central mechanism of action of TNS.

Long-Term Effects of Percutaneous Tibial Nerve Stimulation Treatment for Neurogenic Overactive Bladder Due to Multiple Sclerosis: 24-Month Results

Long-Term Effects of Percutaneous Tibial Nerve Stimulation Treatment for Neurogenic Overactive Bladder Due to Multiple Sclerosis: 24-Month Results

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.

Efficacy of Tibial Nerve Stimulation on Fecal Incontinence in Patients With Low Anterior Resection Syndrome Following Surgery for Colorectal Cancer.

Objective To systematically review the available literature on the efficacy of tibial nerve stimulation on faecal incontinence and quality of life in adult patients with low anterior resection syndrome following surgery for colorectal cancer.MethodsA primary search of electronic databases was conducted adopting a combination of search terms related to the following areas of interest: “efficacy”, “tibial nerve stimulation” and “low anterior resection syndrome”. A secondary search of the grey literature was performed in addition to checking the reference list of included studies and review papers. The review was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. A descriptive analysis was used to integrate the review findings.ResultsFive distinct studies involving 116 patients met the inclusion criteria for the review. The included studies suggest that tibial nerve stimulation may have a positive effect on faecal incontinence and quality of life in some patients with low anterior resection syndrome and might be considered as an additional treatment option.ConclusionThere were a limited number of studies and a great degree of heterogeneity of evidence due to differences in participants’ baseline characteristics, dropout rates, and follow-up periods. Further research adopting validated, consistent, and complex outcome assessment methods is recommended to determine the efficacy of tibial nerve stimulation for treatment of patients with low anterior resection syndrome.

Persistence in Percutaneous Tibial Nerve Stimulation Treatment for Overactive Bladder Syndrome is Best Predicted by Patient Global Impression of Improvement Rather Than Symptom-Specific Improvement

To evaluate whether progression to maintenance percutaneous tibial nerve stimulation (PTNS) was related to perceived global impression of improvement (PGII) rather than symptom-specific improvement in patient with overactive bladder (OAB). We hypothesize that PGII will predict continuation of PTNS long-term. This prospective observational study included 90 patients with OAB that initiated PTNS. The PGII and OAB short-form questionnaires (OABq-SF) were used to assess bladder symptom severity and improvement. Those that completed the 12-week induction phase were offered to continue PTNS monthly maintenance or pursue other options. The primary outcome was difference in PGII score between those pursuing maintenance therapy versus other options. Descriptive statistics and mixed effect modeling analysis were employed. Seventy patients (78%) completed 12 weeks of PTNS. The majority of completers pursued monthly maintenance (P< .01) and had significantly lower median PGII scores compared with those who sought alternatives (P < .01), while OABq-SF scores did not differ significantly (P=.65). Patients that pursued monthly PTNS maintenance had lower body mass index than those who chose alternative therapies (P < .01). Only 19% continued PTNS therapy for at least 1 year. More patients pursued PTNS monthly maintenance over any other therapy, and this was significantly associated with lower PGII scores. Global improvement, and not symptom-specific response, predicts long-term PTNS maintenance. No symptom-specific predictors were identified in those who pursued maintenance over other options. One-year continuation rates are low.

Efficacy of Percutaneous Tibial Nerve Stimulation for Overactive Bladder in Women and Men at a Safety Net Hospital.

We investigated efficacy and compliance related to percutaneous tibial nerve stimulation in patients treated for overactive bladder at a large, urban safety net hospital. Consecutive patients who underwent percutaneous tibial nerve stimulation at Grady Memorial Hospital from May 2015 through January 2019 were included in our cohort and records were reviewed retrospectively. Primary outcomes of interest included self-reported urinary symptoms and episodes of urinary incontinence. Our secondary outcome of interest was patient compliance, defined as completion of 12 or more treatment sessions. Descriptive analysis and paired t-tests were performed. Of the 50 patients with a mean ± SD age of 59 ± 12 years 80% were black, 52% were male, 34% were uninsured and 54% subscribed to government insurance. Prior treatment included behavioral modification in 100% of cases, anticholinergics in 86% and mirabegron in 4%. Patients completed a mean of 10.7 ± 2.7 of the 12 planned weekly percutaneous tibial nerve stimulation treatments. Of the patients 70% completed all 12 weekly treatments and 77% of those who completed 12 treatments continued to maintenance treatment. After percutaneous tibial nerve stimulation treatment average symptoms improved across all metrics, including mean daytime frequency (from 11.0 to 6.6 episodes per day or -24.5%), nighttime frequency (from 4.8 to 2.5 episodes per night or -47.1%), urgency score (from 3.4 to 1.9 or -42.1%) and incontinence (from 1.6 to 0.4 episodes per day or -79.6%) (each p <0.001). A total of 43 patients (86%) reported symptom improvement. Percutaneous tibial nerve stimulation had favorable efficacy and compliance in a traditionally underserved patient population. This should be considered as a feasible modality to manage overactive bladder symptoms in patients in a similar demographic.

Impact of Posterior Tibial Nerve Stimulation in Treatment of Refractory Overactive Bladder Syndrome [3G

INTRODUCTION: Overactive bladder (OAB) affects approximately 16% of adults in the United States. Posterior tibial nerve stimulation (PTNS) is the least invasive form of neuromodulation to treat OAB after failure of conservative therapies. In this study, we aimed to evaluate the impact of PTNS on OAB syndrome. METHODS: A retrospective study was conducted in Urogynecology Clinic between 2013 and 2016. Inclusion criteria consisted of female gender, documented clinic visit during the year before first PTNS, and completion of 12 weekly treatments. Medications used within the year before PTNS and at last follow up after PTNS were recorded. Symptom severity at first PTNS visit and after completion of PTNS was collected. Episodes of urinary frequency, leakage, and nocturia were recorded in discrete values. Urgency was reported subjectively using a scale from 1-4, with 4 being most extreme. The Wilcoxon Signed Rank Test was used for comparisons of symptom severity. RESULTS: Sixty patients in the clinic were identified with refractory OAB. Of the 46 patients receiving PTNS, 24 met inclusion criteria. Mean age was 70.25 ± 1.11 years. Mean follow up was 9.42 months. 54.17% did not require pharmacotherapy after completion of PTNS. The number of urgency episodes decreased from 3.12 to 1.79 (p=0.001), daytime frequency decreased from 7.29 to 5.58 (p=0.002), nocturia decreased from 3.33 to 2.17 (p=0.01), and leakage decreased from 2.62 to 1.33 (p=0.002). CONCLUSION: In this single center study, refractory OAB bladder responding to PTNS is slightly greater than 50% in selected patients, which agrees with the literature.

Combination of sacral nerve and tibial nerve stimulation for treatment of bladder overactivity in pigs.

Sacral nerve and tibial nerve stimulation have been singly used to treat overactive bladder (OAB). This study evaluated the effects of both combined stimulation on treating bladder overactivity in pigs and explored a novel treatment modality for OAB. An implant-driven stimulator of the S3 spinal nerve was implanted in 5 pigs. The contralateral tibial nerve was stimulated by an external stimulator. Multiple cystometrograms were performed to determine the effects of single nerve stimulation and combination sacral nerve stimulation (SNS) and tibial nerve stimulation (TNS) on the micturition reflex by infusing normal saline (NS) or acetic acid (AA). AA-induced bladder overactivity significantly reduced bladder capacity (BC) to 16.3±2.2% of the NS control level (389.4±27.68ml; P<0.01). When given a single stimulation, both SNS and TNS significantly increased the BC to 39.2±1.6% and 34.9±5.0% of the NS control level (P<0.01), respectively. Combined SNS and TNS significantly increased the BC to 50.2±5.2% of the NS control level (P<0.01) and induced a superior inhibitory effect than SNS or TNS alone (P<0.05). Combination SNS and TNS induced a superior inhibitory effect on bladder overactivity in pigs compared to single stimulation and thus could be a novel treatment modality for OAB.

Percutaneous Tibial Nerve Stimulation for Treatment of Idiopathic Faecal Incontinence: Mid-term Results from a Single Center

Objective: Percutaneous tibial nerve stimulation is a recent and minimally invasive treatment for faecal incontinence (FI). The aim of this study is to evaluate the mid-term results in patients with idiopathic faecal incontinence (IFI). Methods: Fifty one patients (42 female and 9 male) were prospectively recruited. Patients were treated twice a week for 6 weeks as per study protocol. We have assessed the degree of fecal incontinence using the Cleveland Clinic faecal incontinence (CCF-FI) score at baseline, at 6 weeks, at 6 months and at 1 year. Also the anorectal manometric data (mean resting pressure (MRP), squeeze pressure (SP) and, rectal sensation) at baseline, at 6 weeks and at 6 months have been evaluated. Results: The median CCF-FI score was significantly decreased from an initial baseline value from 12 to 7 at 6 weeks, 3 at 6 months and, 3 at 1 year (respectively: 1st interquartile 4.5, 1, 0 vs 10; 3rd interquartile 9, 5, 5 vs 14.5, p = 0.0001). Anorectal manometry showed an improvement of the internal (resting pressure, MRP) and the external sphincters (squeeze pressure, SP) at 6 months compared to the baseline and 6 weeks by PTNS, while, RP and SP at 6 months was greater than at baseline and 6 weeks (p = 0.004 and p = 0.002 respectively). Conclusions: This study demonstrates that stimulation of the posterior tibial nerve could be an excellent procedure for the treatment of IFI. The stimulation of the posterior tibial nerve can improve the fecal continence (CCF-FI score) in the short term and this improvement is maintained after 1 year of follow-up without treatment.

Effect of tibial nerve stimulation on bladder afferent nerve activity in a rat detrusor overactivity model.

To study the post-stimulation effect of tibial nerve stimulation on rat bladder afferent activity, and urodynamic parameters in normal and acetic acid-induced detrusor overactivity conditions. In urethane anesthetized male Wistar rats, the tibial nerve was stimulated for 30 min at 5 Hz, pulse width 200 μs and amplitude approximately threefold the threshold to induce a slight toe movement. The post-stimulation effect was studied by measuring afferent nerve activity of postganglionic pelvic nerve branches and various urodynamic parameters under two different conditions: (i) in physiological saline filling experiments (simulating normal bladder condition); and (ii) in acetic acid irritated bladders (simulating detrusor overactivity). After 30 min of tibial nerve stimulation in saline filling experiments, the bladder capacity, threshold pressure and afferent nerve activity were not significantly different from the prestimulation measurements. The instillation of 0.5% acetic acid significantly reduced the bladder capacity and increased the afferent nerve activity. Tibial nerve stimulation significantly improved the bladder capacity and suppressed the afferent nerve activity compared with prestimulation acetic acid measurements. Tibial nerve stimulation is able to significantly restore the bladder capacity by inhibiting afferent nerve activity in chemically irritated rat bladders. The present study provides important basic electrophysiological evidence to substantiate the clinical use of tibial nerve stimulation for treatment of symptoms related to detrusor overactivity.

Long term sustained therapeutic effects of percutaneous posterior tibial nerve stimulation treatment of neurogenic overactive bladder in multiple sclerosis patients: 12-months results.

The aim of this study is to determine the sustained therapeutic efficacy and treatment intervals for PTNS in NOAB with MS, offering periodic additional treatments during 1 year in patients who completed an initial course of 12 consecutive weekly sessions. A total of 34 patients enrolled to the PTNS treatment and 21 patients completed the 1 year PTNS treatment with a tapering protocol of 6, 9, and 12 months of therapy, respectively. After 12 weeks of therapy, PTNS was applied at 14 day intervals for 3 months, 21 day intervals for 3 months, and 28 day intervals for 3 months. The patients completed a 3-day voiding diary at 3rd, 6th, 9th, and 12th month. The patients requested to complete validated questionnaires (ICIQ-SF, OAB-V8, OAB-q SF) were carried out within 3-month intervals thereafter during their enrolment in the study. A total of 21 patients were enrolled in the study. Of these 5 (23.8%) were men and 16 (76.2%) women. The improvements for all voiding diary parameters were significant in the 6th, 9th, and 12th months when compared with baseline. Mean values between baseline and 12 month parameters suggested that daytime frequency decreased by 5.4 voids daily, urge incontinence decreased by 3.4 episodes daily, urgency episodes decreased by 7.4 episodes daily, nocturia decreased by 2.6 voids, and voided volume improved by a mean of 72.1 cc. These results have demonstrated NOAB symptom improvement in MS patients can be achieved with 12 weekly PTNS treatments which show excellent durability over 12 months. Neurourol. Urodynam. 36:104-110, 2017. © 2015 Wiley Periodicals, Inc.

Randomized clinical trial of transcutaneous electrical posterior tibial nerve stimulation versus lateral internal sphincterotomy for treatment of chronic anal fissure

ObjectivesThe objective of this study was to evaluate the efficacy of transcutaneous electrical posterior tibial nerve stimulation in treatment of patients with chronic anal fissure and to compare it with the conventional lateral internal sphincterotomy. Patients and methodsConsecutive patients with chronic anal fissure were randomly allocated into two treatment groups: transcutaneous electrical posterior tibial nerve stimulation group and lateral internal sphincterotomy group. The primary outcome measures were number of patients with clinical improvement and healed fissure. Secondary outcome measures were complications, VAS pain scores, Wexner's constipation and Peascatori anal incontinence scores, anorectal manometry, and quality of life index. ResultsSeventy-three patients were randomized into two groups of 36 patients who were subjected to transcutaneous electrical nerve stimulation and 37 patients who underwent lateral internal sphincterotomy. All (100%) patients in lateral internal sphincterotomy group had clinical improvement at one month following the procedure in contrast to 27 (75%) patients in transcutaneous electrical nerve stimulation group. Recurrence of anal fissure after one year was reported in one (2.7%) and 11 (40.7%) patients in lateral internal sphincterotomy and transcutaneous electrical nerve stimulation groups respectively. Resting anal pressure and functional anal canal length were significantly reduced after lateral internal sphincterotomy. ConclusionTranscutaneous electrical posterior tibial nerve stimulation for treatment of chronic anal fissure is a novel, non-invasive procedure and has no complications. However, given the higher rate of clinical improvement and fissure healing and the lower rate of fissure recurrence, lateral internal sphincterotomy remains the gold standard for treating chronic anal fissure.

Evaluation of Percutaneous Tibial Nerve Stimulation for Treatment of Refractory Painful Bladder Syndrome

To evaluate the efficacy of intermittent percutaneous tibial nerve stimulation (PTNS) as a treatment modality for patients with refractory interstitial cystitis/bladder pain syndrome (IC/BPS). Twenty female patients with IC/BPS (mean symptom duration of 4.5 ± 2.4 years) each had a 30-minute session of PTNS per week for 12 successive weeks and the symptoms were assessed before, during, and after the treatment sessions by voiding diary, visual analog scale (VAS) for pain, interstitial cystitis symptom and problem indices (ICSI and ICPI), and global response assessment (GRA) scale. The scores of the previous questionnaires were evaluated at weeks 0, 6, and 12. At week 0, the VAS, day time frequency, nocturia, and average voiding volume were 5.6 ± 1.1, 14.5 ± 4.0, 3.0 ± 0.9, and 131.8 ± 35.3 mL, respectively, meanwhile at week 12 these scores were 5.2 ± 1.5, 12.15 ± 3.7, 2.6 ± 0.7, and 141.0 ± 36.2, respectively. There was no statistically significant difference between the scores of the ICPI between weeks 0, 6, and 12 (P = .937). As regards the GRA score after the 12th session, 17 patients (85%) reported having no effect, 1 patient (5%) reported as having worse symptoms, and 2 patients (10%) reported having a mild good response. Intermittent PTNS is not a satisfactory treatment for refractory IC/BPS. However, it is recommended to perform more studies with other treatment protocol (maybe closer sessions) to confirm these results.

Maintenance Percutaneous Posterior Nerve Stimulation for Refractory Lower Urinary Tract Symptoms in Patients with Multiple Sclerosis: An Open Label, Multicenter, Prospective Study

Percutaneous tibial nerve stimulation is an effective second line therapy for lower urinary tract symptoms. Data on percutaneous tibial nerve stimulation maintenance treatment are scarce. In this study we evaluate its effectiveness and propose an algorithm of percutaneous tibial nerve stimulation maintenance treatment in patients with multiple sclerosis. In this prospective, multicenter, open label trial consecutive patients with multiple sclerosis and lower urinary tract symptoms unresponsive to medical therapy were treated with 12 weekly sessions of percutaneous tibial nerve stimulation. Responder patients (50% or greater improvement of lower urinary tract symptoms as measured by the patient perception of bladder condition questionnaire) entered a maintenance phase with individualized treatment frequency based on patient response. Lower urinary tract symptoms were assessed using a 3-day frequency volume chart, urodynamics and patient perception of bladder condition questionnaire. Treatment satisfaction was evaluated using a global response assessment scale and a treatment satisfaction visual analog scale. A total of 83 patients were included in the study and 74 (89%) responded to initial treatment. Persistent efficacy occurred in all initial responders after a mean treatment of 24 months. The greatest frequency of maintenance percutaneous tibial nerve stimulation was every 2 weeks. Lower urinary tract symptoms and patient treatment satisfaction improved with time compared to initial treatment (p <0.05). Bladder diary parameters and voiding parameters improved compared to baseline (p <0.05). Prolonged percutaneous tibial nerve stimulation treatment leads to a persistent improvement of lower urinary tract symptoms in patients with multiple sclerosis.

Percutaneous Tibial Nerve Stimulation for the Long-Term Treatment of Overactive Bladder: 3-Year Results of the STEP Study

We report the long-term efficacy and safety of percutaneous tibial nerve stimulation with the Urgent® PC Neuromodulation System for overactive bladder after 3 years of therapy. Fifty participants in the randomized, double-blind SUmiT (Sham Effectiveness in Treatment of Overactive Bladder Symptoms) Trial who met the primary effectiveness end point after 12 weekly percutaneous tibial nerve stimulation treatments were enrolled in this prospective study to assess long-term outcomes with percutaneous tibial nerve stimulation. STEP (Sustained Therapeutic Effects of Percutaneous Tibial Nerve Stimulation) Study patients were prescribed a fixed schedule 14-week tapering protocol followed by a personal treatment plan aimed at sustaining overactive bladder symptom improvement. Overactive bladder and quality of life questionnaires were completed every 3 months and 3-day voiding diaries were completed every 6 months. A total of 29 patients completed the 36-month protocol and received a median of 1.1 treatments per month after a 14-week treatment tapering protocol. A Bayesian model estimated that 77% (95% CI 64-90) of patients maintained moderate or marked improvement in overactive bladder symptoms at 3 years. Compared to baseline, median voids per day decreased from 12.0 (IQR 10.3-13.7) to 8.7 (IQR 7.3-11.3), nighttime voids per night decreased from 2.7 (IQR 1.7-3.3) to 1.7 (IQR 1.0-2.7) and urge incontinence episodes per day decreased from 3.3 (IQR 0.7-6.0) to 0.3 (IQR 0.0-1.0) (all p <0.0001). All quality of life parameters remained markedly improved from baseline through 3 years (all p <0.0001). One patient experienced 2 mild treatment related adverse events of bleeding at the needle site during followup. Most STEP participants with an initial positive response to 12 weekly percutaneous tibial nerve stimulation treatments safely sustained overactive bladder symptom improvement to 3 years with an average of 1 treatment per month.

Percutaneous Tibial Nerve Stimulation in Treatment of Overactive Bladder: When Should Retreatment Be Started?

To study the response to posterior tibial nerve stimulation in patients with overactive bladder refractory to medical treatment. A cohort of 53 patients were treated by posterior tibial nerve stimulation and followed up for a maximum of 24 months. All patients completed the International Consultation on Incontinence Modular Questionnaire-Short Form quality of life questionnaire and kept a urination diary to record the daytime urination frequency and night-time urination frequency. Urodynamic studies were also conducted. At 6 months of follow-up, a cure/improvement rate of 92.4% (49 of 53 cases) had been achieved. Ten patients were given additional treatment and were excluded from subsequent follow-up analysis. At 12 months of follow-up, a cure/improvement rate of 91.69% had been achieved (39 of 43). At 24 months of follow-up, of the 16 patients initially included during the first year, a cure/improvement rate of 62.5% had been achieved (10 of 16). The first sensation of bladder filling had increased by the end of treatment, with differences observed before and after posterior tibial nerve stimulation (P ≤ .001). The average post-treatment bladder capacity had increased by 72.7 mL compared with the initial value (P ≤ .001). At 24 months of follow-up, the group of 16 patients evaluated recorded a significant worsening of night-time urination frequency (P ≤ .05) and quality of life (P ≤ .01). Posterior tibial nerve stimulation is a good option for the treatment of overactive bladder. In our series, the optimal point to start retreatment would be at 24 months after therapy completion.

Transcutaneous posterior tibial nerve stimulation for treatment of the overactive bladder syndrome in multiple sclerosis: Results of a multicenter prospective study

Electrostimulation is an established therapeutic option for neurogenic urinary disorders. The aim of this study was to investigate the efficacy of the noninvasive technique of transcutaneous posterior tibial nerve stimulation (TPTNS) in patients with multiple sclerosis (MS) and troublesome symptoms of an overactive bladder (OAB). A multicentric study enrolled 70 MS patients, suffering from OAB for a 3-month study period. Daily sessions of 20 min of TPTNS were provided. No change of associated treatments during the study period. The primary outcome measurement was Urgency and Frequency reported by bladder diary and symptom score performed before the treatment (Day 0, D0) and at D30 and D90. The secondary outcomes measurements were continence, symptom score, quality of life, psychosocial burden at DO, D30, and D90 and cystometry at baseline, with and without TPTNS and at D90. Clinical improvement of OAB was shown in 82.6% and 83.3% of the patients on D30 and D90, respectively, with significant improvement of primary and secondary outcomes compared to baseline. The initial acute cystometric response to TPTNS was positive in 51.2% of the patients (increase of >30% of cystometric capacity and/or reflex volume), without correlation with TPTNS clinical efficiency. The procedure was well tolerated. Chronic TPTNS appears to be effective in the management of severe OAB in MS, without compromising bladder emptying or inducing side effect. Treatment may be effective even in the absence of an acute cystometric effect. Additional works are required to demonstrate long-term efficacy of TPTNS.

Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results From the SUmiT Trial

The Study of Urgent PC vs Sham Effectiveness in Treatment of Overactive Bladder Symptoms (SUmiT) was a multicenter, double-blind, randomized, controlled trial comparing the efficacy of percutaneous tibial nerve stimulation to sham through 12 weeks of therapy. The improvement in global response assessment, voiding diary parameters, and overactive bladder and quality of life questionnaires was evaluated. A total of 220 adults with overactive bladder symptoms were randomized 1:1 to 12 weeks of treatment with weekly percutaneous tibial nerve stimulation or sham therapy. Overactive bladder and quality of life questionnaires as well as 3-day voiding diaries were completed at baseline and at 13 weeks. Subject global response assessments were completed at week 13. The 13-week subject global response assessment for overall bladder symptoms demonstrated that percutaneous tibial nerve stimulation subjects achieved statistically significant improvement in bladder symptoms with 54.5% reporting moderately or markedly improved responses compared to 20.9% of sham subjects from baseline (p <0.001). All individual global response assessment subset symptom components demonstrated statistically significant improvement from baseline to 13 weeks for percutaneous tibial nerve stimulation compared to sham. Voiding diary parameters after 12 weeks of therapy showed percutaneous tibial nerve stimulation subjects had statistically significant improvements in frequency, nighttime voids, voids with moderate to severe urgency and urinary urge incontinence episodes compared to sham. No serious device related adverse events or malfunctions were reported. This pivotal multicenter, double-blind, randomized, sham controlled trial provides level I evidence that percutaneous tibial nerve stimulation therapy is safe and effective in treating overactive bladder symptoms. The compelling efficacy of percutaneous tibial nerve stimulation demonstrated in this trial is consistent with other recently published reports and supports the use of peripheral neuromodulation therapy for overactive bladder.

Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Extended-Release Tolterodine: Results From the Overactive Bladder Innovative Therapy Trial

The Overactive Bladder Innovative Therapy trial was a randomized, multicenter, controlled study that compared the effectiveness of percutaneous tibial nerve stimulation to extended-release tolterodine. The reduction in overactive bladder symptoms along with global response assessments was evaluated. A total of 100 adults with urinary frequency were randomized 1:1 to 12 weeks of treatment with weekly percutaneous tibial nerve stimulation or to 4 mg daily extended-release tolterodine. Voiding diaries and an overactive bladder questionnaire were completed at baseline and at the end of therapy to compare 24-hour voiding frequency, urinary urge incontinence episodes, voids causing waking, volume voided, urgency episodes and quality of life indices. Global response assessments were completed by subjects and investigators after 12 weeks of therapy. The global response assessment demonstrated that subject assessment of overactive bladder symptoms compared to baseline was statistically significant in the percutaneous tibial nerve stimulation arm with 79.5% reporting cure or improvement compared to 54.8% of subjects on tolterodine (p = 0.01). Assessments by investigators were similar but did not reach statistical significance (p = 0.05). After 12 weeks of therapy objective measures improved similarly in both groups for reductions in urinary frequency, urge urinary incontinence episodes, urge severity and nighttime voids, as well as for improvement in voided volume. There were no serious adverse events or device malfunctions. This multicenter, randomized trial demonstrates that percutaneous tibial nerve stimulation is safe with statistically significant improvements in patient assessment of overactive bladder symptoms, and with objective effectiveness comparable to that of pharmacotherapy. Percutaneous tibial nerve stimulation may be considered a clinically significant alternative therapy for overactive bladder.