Transcutaneous Tibial Nerve Stimulation Research Articles

Short-term Outcomes of a Randomized Pilot Trial of 2 Treatment Regimens of Transcutaneous Tibial Nerve Stimulation for Fecal Incontinence.

Fecal incontinence is a socially disabling condition that affects ≤15% of adults. Neuromodulatory treatments for fecal incontinence are now well established. Less invasive, cheaper, and more ambulatory forms of neuromodulation are under exploration. The purpose of this study was to assess the acceptability and safety of a new ambulatory tibial nerve stimulation device and to determine clinical effect size for 2 differing regimens of therapy. This was a randomized, investigator-blinded, parallel-arm, 6-week pilot trial. The study was conducted at 7 United Kingdom trial centers. Patients were initially reviewed in the trial center, with subsequent applications of the device performed in the patients home setting. A total of 43 eligible patients (38 women) who failed conservative management of fecal incontinence were included in the study. The study intervention involved twice-weekly, 1- versus 4-hour transcutaneous tibial nerve stimulation for 6 weeks (total of 12 treatments). Standard fecal incontinence outcome tools (bowel diary, symptom severity score, and generic quality-of-life instruments) were used to collect data at baseline and at 2 weeks posttreatment cessation. A total of 22 patients were randomly assigned to the 1-hour group and 21 to the 4-hour group. Improvements in fecal incontinence outcomes were observed for both groups, including median urge incontinence episodes per week at baseline and posttreatment (1-hour group 2.0 to 0.5 versus 4-hour group 4.0 to 1.0) and deferment time (1-hour group 2.0 to 2.0 minutes versus 4-hour group 0.5 to 5.0 minutes). Accompanying changes were observed in physical functioning domains of quality-of-life instruments. There were no adverse events, and the treatment was highly acceptable to patients. Limitations included the pilot design and lack of control arm in the study. Future trials would need to address these limitations. This pilot study provides evidence that transcutaneous tibial nerve stimulation with a new ambulatory device is safe and acceptable for the management of fecal incontinence. Additional study is warranted to investigate clinical effectiveness.

New clinical trials for nonmotor manifestations of Parkinson's disease.

Nonmotor manifestations in Parkinson's disease (PD) encompass a range of clinical features, including neuropsychiatric problems, autonomic dysfunction, sleep disorders, fatigue, and pain. Despite their importance for patients' quality of life, the evidence base for their treatment is relatively sparse. Nevertheless, the last few years have seen a number of new trials starting that specifically address nonmotor features as an outcome measure in clinical trials. Large randomized, controlled trials in the last 3 years reported improvement of psychosis with the new selective serotonin 5-HT2A inverse agonist pimavanserin and of postural hypotension with the oral norepinephrine precursor droxidopa. Smaller new randomized, controlled trials support the effectiveness of Deep Brain Stimulation and opiates for pain, of rivastigmine for apathy and piribedil for apathy post-DBS, group cognitive behavioral therapy for depression and/or anxiety, continuous positive airway pressure for sleep apnea in PD and doxepin for insomnia, and of solifenacin succinate and transcutaneous tibial nerve stimulation for urinary symptoms. A number of new smaller or open trials as well as post-hoc analyses of randomized, controlled trials have suggested usefulness of other treatments, and new randomized, controlled trials are currently ongoing.

Stimulation transcutanée du nerf tibial dans le traitement des hyperactivités vésicales réfractaires de l’enfant et de l’adolescent

The purpose of this study was to evaluate safety and tolerability of transcutaneous tibial nerve stimulation (TENS) in patients under 15years of age with refractory overactive bladder. A retrospective analysis was conducted on outcomes of TENS (1daily 20-minute session, 10Hz) in patients with refractory overactive bladder, excluding patients with neurogenic bladder. Treatment efficacy was evaluated on symptomatic improvement and voiding schedule. Healing was defined as following: no recurrence of urinary tract infection, normal urodynamic voiding parameters, no nighttime continence disorder, normal uroflowmetry. Nineteen consecutive patients with refractory overactive bladder were treated from November 2010 to March 2012 (11girls, 8boys, age 12.1±2.7 years). Three patients reported only daytime voiding disorders, the others reported daytime and nighttime voiding disorders. Ten patients reported febrile urinary tract infection (1 boy, 9 girls). The average length of treatment was 6 months. Two patients were lost to follow-up. Thirteen patients had only tibial TENS; 3 patients had tibial TENS and trospium chloride or desmopressin. At 1-month assessment, 16 patients out of 17 (94%) reported symptomatic improvement. At the end of treatment, 12 patients out of 17 (70%) met healing criteria (5 boys, 7girls), without relapse within 9 months. Three boys (18%) had partial improvement (no daytime wetting, but increased daytime frequency). No patient reported side effects. Tibial TENS is a safe, non invasive and effective treatment in refractory overactive bladder in children. The success rate is 70%, with no side effect and no relapse at the end of the treatment in our study.

Transcutaneous tibial nerve stimulation in the treatment of lower urinary tract symptoms and its impact on health-related quality of life in patients with Parkinson disease: a randomized controlled trial.

A randomized controlled trial study was performed to evaluate the efficacy of transcutaneous tibial nerve stimulation (TTNS) and sham TTNS, in patients with Parkinson disease (PD) with lower urinary tract symptoms (LUTS). Randomized controlled trial. Thirteen patients with a diagnosis of PD and bothersome LUTS were randomly allocated to one of the following groups: Group I: TTNS group (n = 8) and group II: Sham group (n = 5). Both groups attended twice a week during 5 weeks; each session lasted 30 minutes. Eight patients received TTNS treatment and 5 subjects allocated to group II were managed with sham surface electrodes that delivered no electrical stimulation. Assessments were performed before and after the treatment; they included a 3-day bladder diary, Overactive Bladder Questionnaire (OAB-V8), and the International Consultation on Incontinence Quality of Life Questionnaire Short Form (ICIQ-SF), and urodynamic evaluation. Following 5 weeks of treatment, patients allocated to TTNS demonstrated statistically significant reductions in the number of urgency episodes (P = .004) and reductions in nocturia episodes (P < .01). Participants allocated to active treatment also showed better results after treatment in the OAB-V8 and ICIQ-SF scores (P < .01, respectively). Urodynamic testing revealed that patients in the active treatment group showed improvements in intravesical volume at strong desire to void (P < .05) and volume at urgency (P < .01) when compared to subjects in the sham treatment group. These findings suggest that TTNS is effective in the treatment of LUTS in patients with PD, reducing urgency and nocturia episodes and improving urodynamic parameters as well as symptom scores measured by the OAB-V8 and health-related quality-of-life scores measured by the ICIQ-SF.

Transcutaneous tibial nerve stimulation for the treatment of faecal incontinence: results of a prospective study

Background. Transcutaneous tibial nerve stimulation is a simple, non-invasive treatment, which can be used to treat faecal incontinence. Optimal treatment regimen is not known and various stimulation regimens are used in different centers. The aim of this prospective study was to evaluate the efficacy of twice weekly transcutaneous tibial nerve stimulation for faecal incontinence patients, who have failed to respond to maximal conservative treatment. Material and methods. Twenty patients with faecal incontinence resistant to maximal conservative therapy were treated with transcutaneous posterior tibial nerve stimulation twice a week for six weeks. The number of the bowel movements per two weeks and the Cleveland Clinic Florida Feacal Incontinence Score were assessed before and after the treatment. The quality of life was estimated using the Faecal Incontinence Quality of Life questionnaire and the Gastrointestinal Quality of Life Index. Results. Effect was seen in 55% of patients. Two-week faecal incontinence episodes decreased from median 4 (2–84) to 2 (0–56) (p = 0.002). The mean Cleveland Clinic Florida Faecal Incontinence score improved from 10.9 ± 4.34 to 7.8 ± 3.96 (p = 0.002). The quality of life improved significantly after the treatment. The therapy was well tolerated and no participant experienced any adverse event. Conclusions. Transcutaneous tibial nerve stimulation twice a week for 6 weeks may be efficacious in patients with faecal incontinence, who have failed to respond to maximal conservative treatments.

The effect of pelvic floor muscle training alone or in combination with electrostimulation in the treatment of sexual dysfunction in women with multiple sclerosis

Background: Sexual dysfunction (SD) affects up to 80% of multiple sclerosis (MS) patients and pelvic floor muscles (PFMs) play an important role in the sexual function of these patients. Objectives: The objective of this paper is to evaluate the impact of a rehabilitation program to treat lower urinary tract symptoms on SD of women with MS. Methods: Thirty MS women were randomly allocated to one of three groups: pelvic floor muscle training (PFMT) with electromyographic (EMG) biofeedback and sham neuromuscular electrostimulation (NMES) (Group I), PFMT with EMG biofeedback and intravaginal NMES (Group II), and PFMT with EMG biofeedback and transcutaneous tibial nerve stimulation (TTNS) (Group III). Assessments, before and after the treatment, included: PFM function, PFM tone, flexibility of the vaginal opening and ability to relax the PFMs, and the Female Sexual Function Index (FSFI) questionnaire. Results: After treatment, all groups showed improvements in all domains of the PERFECT scheme. PFM tone and flexibility of the vaginal opening was lower after the intervention only for Group II. All groups improved in arousal, lubrication, satisfaction and total score domains of the FSFI questionnaire. Conclusion: This study indicates that PFMT alone or in combination with intravaginal NMES or TTNS contributes to the improvement of SD.

Eficacia de la estimulación percutánea versus transcutánea del nervio tibial posterior en pacientes con vejiga hiperactiva

IntroductionThe estimated prevalence of overactive bladder (OAB) ranges from 3 to 43%. The cause is unknown and diagnosis is clinical. Treatment includes behavioral changes, physical therapy, muscarinic receptor antagonists, neuromodulation and botulinum toxin, and surgical procedures. Because of the adverse effects of pharmacologic treatment and its diminished effectiveness over time, therapeutic alternatives such as tibial nerve stimulation have attracted increasing interest.The aim of this study was to evaluate clinical improvement with percutaneous or transcutaneous tibial nerve stimulation in patients with OAB. Materials and methodsA descriptive study was performed through a retrospective review of the medical records of patients with OAB treated with transcutaneous or percutaneous tibial nerve stimulation. We evaluated a 3-day Bladder Diary, the Sandvik Test and the International Consultation on Incontinence-Short Form (ICIQ-SF). ResultsWe included 34 patients with OAB, with a mean age of 64.5 years. All the patients were treated with tibial nerve stimulation (transcutaneous in 61.8% and percutaneous in 38.2%). Nocturnal urinary frequency, the Sandvik test and the ICIQ-SF all showed improvement (P<.001), with no significant statistical difference between the groups. All the patients completed the treatment and all reported satisfaction. DiscussionTibial nerve stimulation is considered a simple, minimally invasive, easy to apply and well tolerated method that has proved to be effective with no marked adverse effects. This treatment improves the patient's quality of life and treatment adherence is adequate. We were unable to demonstrate that percutaneous tibial nerve stimulation was more effective than transcutaneous stimulation.

Systematic review of tibial nerve stimulation to treat faecal incontinence

Two forms of tibial nerve stimulation are used to treat faecal incontinence (FI): percutaneous (PTNS) and transcutaneous (TTNS) tibial nerve stimulation. This article critically appraises the literature on both procedures. A systematic review was performed adhering to the PRISMA framework. A comprehensive literature search was conducted, with systematic methodological quality assessment and data extraction. Summary measures for individual outcome variables are reported. Twelve articles met eligibility criteria; six related to PTNS, five to TTNS, and one to both procedures. These included ten case series and two randomized clinical trials (RCTs). Case series were evaluated using the National Institute for Health and Care Excellence quality assessment for case series, scoring 3-6 of 8. RCTs were evaluated using the Jadad score, scoring 4 of a possible 5 marks, and the Cochrane Collaboration bias assessment tool. From one RCT and case series reports, the success rate of PTNS, based on the proportion of patients who achieved a reduction in weekly FI episodes of at least 50 per cent, was 63-82 per cent, and that of TTNS was 0-45 per cent. In an RCT of TTNS versus sham, no patient had a reduction in weekly FI episodes of 50 per cent or more, whereas in an RCT of PTNS versus TTNS versus sham, 82 per cent of patients undergoing PTNS, 45 per cent of those having TTNS, and 13 per cent of patients in the sham group had treatment success. PTNS and TTNS result in significant improvements in some outcome measures; however, TTNS was not superior to sham stimulation in a large, adequately powered, RCT. As no adequate RCT of PTNS versus sham has been conducted, conclusions cannot be drawn regarding this treatment.

Effects of transcutaneous tibial nerve stimulation on anorectal physiology in fecal incontinence: a double‐blind placebo‐controlled cross‐over evaluation

Transcutaneous electrical tibial nerve stimulation (TENS) is of growing interest for the treatment of fecal incontinence (FI), but its mechanism of action remains uninvestigated. We aimed to further assess the anorectal response to TENS in a dynamic model. We performed a placebo-controlled, randomized, double-blinded crossover study in 19 patients suffering from FI to assess the effects of TENS on anorectal function. Anorectal physiology and perception were recorded through two sequences of rectal isobaric distension using an electronic barostat device to measure anal and rectal pressures, rectal volumes, and perception scores. Maximal rectal pressure and volume variation were affected by TENS, with higher mean maximal rectal pressure (5.33 and 4.06 mmHg in the active and sham TENS respectively, p < 0.0001) and lower volume variation (11.45 and 14.7 mL in the active and sham stimulation respectively, p < 0.05). Rectal compliance was not modified by active TENS. Pressure of the upper anal canal was significantly lower with raised isobaric distension in sequences assigned to active TENS. Acute TENS modified anorectal physiology by strengthening the myogenic response to distension rather than increasing muscle relaxation and related rectal compliance in patients with FI.

Systematic review of the clinical effectiveness of neuromodulation in the treatment of faecal incontinence

Over the past 18 years neuromodulation therapies have gained support as treatments for faecal incontinence (FI); sacral nerve stimulation (SNS) is the most established of these. A systematic review was performed of current evidence regarding the clinical effectiveness of neuromodulation treatments for FI. The review adhered to the PRISMA framework. A comprehensive search of the literature included PubMed, MEDLINE, Embase and Evidence-Based Medicine Reviews. Methodological quality assessment and data extraction were completed in a systematic fashion. For SNS, 321 citations were identified initially, of which 61 studies were eligible for inclusion. Of studies on other neuromodulation techniques, 11 were eligible for review: seven on percutaneous tibial nerve stimulation (PTNS) and four on transcutaneous tibial nerve stimulation (TTNS). On intention-to-treat, the median (range) success rates for SNS were 63 (33-66), 58 (52-81) and 54 (50-58) per cent in the short, medium and long terms respectively. The success rate for PTNS was 59 per cent at the longest reported follow-up of 12 months. SNS, PTNS and TTNS techniques also resulted in improvements in Cleveland Clinic Incontinence Score and quality-of-life measures. Despite significant use of neuromodulation in treatment of FI, there is still no consensus on outcome reporting in terms of measures used, aetiologies assessed, length of follow-up or assessment standards. Emerging data for SNS suggest maintenance of its initial therapeutic effect into the long term. The clinical effectiveness of PTNS is comparable to that of SNS at 12 months, although there is no evidence to support its continued effectiveness after this period. PTNS may be a useful treatment before SNS. The clinical effectiveness of TTNS is still uncertain owing to the paucity of available evidence. A consensus to standardize the use of outcome measures is recommended in order that further reports can be compared meaningfully.

Stimulation transcutanée chronique du nerf tibial dans l’hyperactivité vésicale des syndromes parkinsoniens

To evaluate the efficacy of chronic transcutaneous tibial nerve stimulation (TNS) on overactive bladder syndrome in female patients with Parkinson's disease (PD) and multiple system atrophy (MSA). A prospective monocentric study enrolled six female patients with PD or MSA suffering from overactive bladder syndrome for a six-week study period. Daily sessions of 20 minutes of TNS were provided. The primary outcome measurement was the Patient Global Impression of Improvement (PGI-I scale). The secondary outcomes measurements were symptom and quality of life scores, bladder diary and urodynamics. The outcomes after 6 weeks of TNS were compared to baseline. TNS was considered as an effective treatment by five patients out of six (83%) who ask to pursue the treatment and were still doing it 6 months after the end of the study. A trend improvement was observed in only two of the secondary evaluation criteria the V8 median score 21/40 to 14/40 (P=0.2) and the maximum cystometric capacity increased from 211 mL ± 106 to 260 mL ± 226 (P=0.6) after SNT. Although urodynamics and symptoms scores did not show significant difference, an efficacy of TNS on overactive bladder in PD and MSA is possible. Additional placebo controlled works enrolling more patients are required to ensure these preliminary results.

What to do if Percutaneous Tibial Nerve Stimulation (PTNS) Works? A Pilot Study on Home-Based Transcutaneous Tibial Nerve Stimulation

Aim of this pilot study was to assess the feasibility of a home-based transcutaneous tibial nerve stimulation (TTNS) protocol in patients responding to percutaneous tibial nerve stimulation (PTNS ). 16 overactive bladder syndrome (OAB) patients, responding to PTNS, were included. Patients performed a flexible home protocol of TTNS. Satisfied patients were considered "subjective responders"; patients not showing a ≥10% increase of urgency/urgency incontinence episodes/day were considered "objective responders". 14/16 patients were followed up for a mean of 19.7 months. All patients were considered subjective responders; 13 were considered objective responders. The mean number of stimulations/week was 1.6 (1-3). After this pilot study, it is possible to conclude that home-based TTNS is feasible. Nevertheless, further randomized trials are needed before drawing any conclusions.

A prospective single blinded placebo controlled study into the role of percutaneous and transcutaneous tibial nerve stimulation for faecal incontinence

IntroductionPosterior tibial nerve stimulation (PTNS) is a safe and effective treatment1 2 for faecal incontinence (FI) but it is not known whether percutaneous or transcutaneous routes of stimulation are better....

Randomized trial of transcutaneous tibial nerve stimulation to treat urge urinary incontinence in older women

The aim of this study was to examine the efficacy of transcutaneous electrical tibial nerve stimulation (TTNS) to treat urge urinary incontinence (UUI) in older women. The study design was a randomized clinical trial conducted on 51 elderly women (>60 years) with UUI. All were treated with 12 weeks of bladder retraining and pelvic floor muscle exercises, and 25 were randomly selected to receive TTNS in addition to the standard therapy. The cases were evaluated at the baseline and after the end of therapy by 3-day bladder diary, quality of life questionnaires (QoL), and subjective response. Of the patients, 68.0% in TTNS group reported cure or improvement vs. 34.6% in the control group (P = 0.017). TTNS showed significant improvement in most areas of QoL and in UUI parameters when compared with the control group. TTNS is efficacious to treat UUI in older women.