Efficacy and safety of tibial nerve stimulation using a wearable device for overactive bladder.

OBJECTIVE: To evaluate the efficacy and safety of a wearable, smartphone-controlled, rechargeable transcutaneous tibial nerve stimulation (TTNS) device in patients with overactive bladder (OAB). PATIENTS AND METHODS: This multicentre, prospective, single-blind, randomised clinical trial included eligible patients with OAB symptoms who were randomly assigned to the stimulation group or sham group. The primary efficacy outcome was change from baseline in voiding frequency/24 h after 4 weeks of treatment. The secondary efficacy outcomes included changes in bladder diary outcomes (urgency score/void, nocturia episodes/day, micturition volume/void, and incontinence episodes/day), questionnaires on Overactive Bladder Symptom Score (OABSS), Patient Perception of Bladder Condition (PPBC), and American Urological Association Symptom Index Quality of Life Score (AUA-SI-QoL) at baseline and after 4 weeks of treatment. Device-related adverse events (AEs) were also evaluated. RESULTS: In the full analysis set (FAS), the mean (sd) change of voiding frequency/24 h in the stimulation group and sham group at 4 weeks were -3.5 (2.9) and -0.6 (2.4), respectively (P < 0.01). Similar results were obtained in the per-protocol set (PPS): -3.5 (2.9) vs -0.4 (2.3) (P < 0.01). In the FAS and PPS, micturition volume/void significantly improved at 4 weeks (P = 0.01 and P = 0.02). PPBC improvement almost reached significance in the FAS (P = 0.05), while it was significant in the PPS (P = 0.02). In the FAS and PPS, AUA-SI-QoL significantly improved at 4 weeks in the two groups (P < 0.01 and P < 0.01), whereas there were no significant differences in urgency score/void, nocturia episodes/day or OABSS between the groups. Also, no device-related serious AEs were reported. CONCLUSIONS: The non-invasive neuromodulation technique using the novel ambulatory TTNS device is effective and safe for treating OAB. Its convenience and easy maintenance make it a new potential home-based treatment modality. Future studies are warranted to confirm its longer-term efficacy.

Is percutaneous tibial nerve stimulation (PTNS) effective for fecal incontinence (FI) in adults compared with sham electrical stimulation? A meta-analysis.

BACKGROUND: Sacral nerve neuromodulation (SNM) has been considered the optimal second-line treatment for fecal incontinence (FI). However, SNM involves high cost and requires highly skilled operators. Percutaneous tibial nerve stimulation (PTNS) has emerged as an alternative treatment modality for FI, yielding varying clinical outcomes. We conducted this meta-analysis to evaluate the effectiveness and safety of PTNS compared to sham electrical stimulation for FI. METHODS: PubMed, Embase, Web of Science, and the Cochrane Library were searched for studies from May 12, 2012 to May 12, 2022. RESULTS: Four randomized controlled studies were included in this review, involving a total of 439 adult patients with FI (300 in the PTNS group and 194 in the sham electrical stimulation group). Our meta-analysis revealed that PTNS demonstrated superior efficacy in reducing weekly episodes of FI compared to the control groups (MD - 1.6, 95% CI - 2.94 to - 0.26, p = 0.02, I2 = 30%). Furthermore, a greater proportion of patients in the PTNS group reported more than a 50% reduction in FI episodes per week (RR 0.73, 95% CI 0.57-0.94, p = 0.02, I2 = 6%). However, no significant differences were observed in any domains of the FI Quality of Life (QoL) and St Mark's incontinence scores (MD - 2.41, 95% CI - 5.1 to 0.27, p = 0.08, I2 = 67%). Importantly, no severe adverse events related to PTNS were reported in any of the participants. CONCLUSIONS: Our meta-analysis revealed that PTNS was more effective than sham stimulation in reducing FI episodes and led to a higher proportion of patients reporting more than a 50% reduction in weekly FI episodes.

Acute transcutaneous electrical stimulation (TES) augments esophageal contractility in patients with weak peristalsis.

BACKGROUND: Lung transplantation (LTx) remains controversial in patients with absent peristalsis (AP) given the increased risk for gastroesophageal reflux (GER), and chronic lung allograft dysfunction. Furthermore, specific treatments to facilitate LTx in those with AP have not been widely described. Transcutaneous Electrical Stimulation (TES) has been reported to improve foregut contractility in LTx patients and therefore we hypothesize that TES may augment the esophageal motility of patients with ineffective esophageal motility (IEM). METHODS: We included 49 patients, 14 with IEM, 5 with AP, and 30 with normal motility. All subjects underwent standard high-resolution manometry and intraluminal impedance (HRIM) with additional swallows as TES was delivered. RESULTS: TES induced a universal impedance change observable in real-time by a characteristic spike activity. TES significantly augmented the contractile vigor of the esophagus measured by the distal contractile integral (DCI) in patients with IEM [median DCI (IQR) 0 (238) mmHg-cm-s off TES vs. 333 (858) mmHg-cm-s on TES; p = .01] and normal peristalsis [median DCI (IQR) 1545 (1840) mmHg-cm-s off TES vs. 2109 (2082) mmHg-cm-s on TES; p = .01]. Interestingly, TES induced measurable contractile activity (DCI > 100 mmHg-cm-s) in three out of five patients with AP [median DCI (IQR) 0 (0) mmHg-cm-s off TES vs. 0 (182) mmHg-cm-s on TES; p < .001]. CONCLUSION: TES acutely augmented contractile vigor in patients with normal and weak/ AP. The use of TES may positively impact LTx candidacy, and outcomes for patients with IEM/AP. Nevertheless, further studies are needed to determine the long-term effects of TES in this patient population.

Development of an implant technique and early experience using a novel implantable pulse generator with a quadripolar electrode array at the tibial nerve for refractory overactive bladder.

OBJECTIVES: Tibial nerve stimulation is an effective treatment for overactive bladder (OAB) and has been utilized as an in-person recurring session treatment option for many years. The primary objective of this study was to evaluate the safety and efficacy of a long-term implantable device and the method of utilizing a retrograde approach to place the device (a percutaneous implantable pulse generator [pIPG] with integrated quadripolar electrodes) at the tibial nerve (Protect PNS; Uro Medical Corp.). METHODS: A novel retrograde implant technique was developed through multiple cadaveric dissections to percutaneously implant a chronic, wireless, minimally invasive pIPG device with integrated quadripolar electrodes (now licensed to Uro Medical) at the tibial nerve. A proof-of-concept pIPG device approved as part of an FDA IDE was designed to gain early experience in subjects with refractory OAB. The pIPG was implanted in the office under local anesthesia using the novel retrograde approach, and stimulation was activated using an external wireless energy source called a transmitter. Initially, a pilot study was designed to compare outcomes in subjects randomized to either percutaneous tibial nerve stimulation (PTNS) or Protect PNS. However, due to the small sample sizes available at this time, it was not possible to compare the two groups. Thus, the purpose of this manuscript is to describe the outcome of subjects who underwent implantation of the Protect PNS system. Twelve-month safety and efficacy were evaluated. RESULTS: Nine subjects were enrolled in the randomized pilot study; 5 to the pIPG group and 4 to PTNS, and all completed the 13-week primary endpoint. Subsequently, two subjects in the PTNS group chose to cross over and have the pIPG implanted after 13 weeks. Outcomes of the seven subjects who underwent implantation of the pIPG are described. No complications related to the office procedure were noted. Two of the older model pIPG devices became nonresponsive at 1 and 4 weeks and were replaced. Six minor adverse events were reported and resolved. Subjects reported improvement in urge urinary incontinence (UUI) episodes, OAB symptoms, and quality of life. Subjects impanted with a pIPG reported a 50% reduction in UUI as early as 1 week. CONCLUSIONS: Results of this pilot study suggest that retrograde percutaneous implantation of a pIPG is a safe, minimally invasive one-stage office procedure for treatment for urge incontinence related OAB symptoms, without significant complications after 12 months follow-up. Future studies will be required to compare outcomes among treatment modalities.

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.

Comparing the effect of transcutaneous electrical nerve stimulation and massage therapy on post laparoscopic shoulder pain: a randomized clinical trial.

BACKGROUND: Shoulder pain is a common clinical problem after laparoscopic surgeries. The use of non-pharmacological massage and transcutaneous electrical nerve stimulation (TENS) as an adjunct to routine treatment is increasing to provide optimal pain relief. Therefore, we aimed to determine the effect of TENS and massage therapy on post laparoscopic shoulder pain (PLSP). METHODS: This study was conducted on 138 patients who underwent laparoscopic cholecystectomy. Patients were randomly divided into three groups: massage plus conventional pharmacological treatment (n = 46), TENS plus conventional pharmacological treatment (n = 46), and conventional pharmacological treatment (n = 46). Massage and TENS were performed three consecutive times after the patients regained consciousness in the inpatient wards. The intensity of Shoulder pain was evaluated using a visual analog scale before and 20 min after each treatment. RESULTS: Both massage therapy and TENS led to a significant reduction in the intensity of PLPS compared to the control group in all three measured times (p < 0.001). However, no significant difference was observed between TENS and massage at any of the three-time points. CONCLUSIONS: This study's findings demonstrated that massage and TENS techniques could reduce PLSP. TRIAL REGISTRATION: Registered in the Iranian registry of clinical trials ( www.irct.ir ) in 05/02/2022 with the following code: IRCT20200206046395N1.

Efficacy and safety of the TENSI+ device for posterior tibial nerve stimulation: A multicenter, retrospective study.

OBJECTIVES: Transcutaneous posterior tibial nerve stimulation (TC-PTNS) is a validated option for lower urinary tract symptoms (LUTS) management, with a short-term success rate of around 60% and few adverse events. Our goal was to report the efficacy and safety results of TC-PTNS using the newly issued device TENSI+ for LUTS management. PATIENTS AND METHODS: A multicenter, retrospective study was conducted in 7 urology departments in France. All patients treated with TC-PTNS for LUTS using the TENSI+ device between September 2021 and February 2022 were included. All patients received supervised at-home training by a specialized nurse. All patients were asked to do daily, 20minutes sessions of TC-PTNS. Patient demographics, history, initial symptoms and previous treatment were collected at inclusion. A follow-up visit was scheduled at 3 months. Efficacy was evaluated through treatment persistence at 3 months and PGI-I (Patient Global Impression of Improvement) score. Adverse events were recorded. RESULTS: One hundred and three patients (86 women and 17 men) were included. All patients had overactive bladder symptoms, 64 suffered from urgency incontinence, and 24 had associated voiding symptoms. Eighteen patients had neurogenic background, and 30 previously received anticholinergics. After a median follow-up of 12 [10-21]weeks, 70 patients were still using the device (68%). PGI-I score reflected an improvement in 70.9% and was 1, 2 and 3 in 28, 26 and 19 patients respectively, while 24 were unchanged and 6 were worse. No clinical baseline parameter was predictive of success. Adverse events included pain at stimulation site (two cases) and pelvic pain (two patients), which rapidly resolved after treatment interruption. CONCLUSIONS: TC-PTNS with TENSI+ device is an effective option for LUTS management, with results that seem similar to other TC-PTNS approaches. Adverse events were mild and reversible after treatment interruption.

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.

Tibial Nerve Stimulation for Fecal Incontinence: The Importance of Sham.

ABSTRACT: Sacral neuromodulation has become an established treatment for fecal incontinence unresponsive to conservative measures. However, it requires surgical implantation and is expensive. Percutaneous tibial nerve stimulation (PTNS) has been suggested as a minimally invasive and less expensive alternative on the basis of uncontrolled studies. The study by Zyczynski et al. compared active PTNS with a sham control group of women with fecal incontinence. Similar to previous studies, active PTNS provided benefits to treated patients but were not different from the sham group. This study highlights the need for rigorously performed controlled studies of neuromodulation for anorectal disorders.

Efficacy of Electroacupuncture Compared With Transcutaneous Electrical Stimulation for Severe Chronic Constipation: A Randomized Controlled Pilot Trial.

BACKGROUND: To treat severe chronic constipation, both electroacupuncture (EA) therapy and transcutaneous electrical stimulation (TES) are safe and effective, but there is a lack of comparison between the 2 treatments. We sought to compare the therapeutic effect of EA relative to TES for the treatment of severe chronic constipation. METHODS: We conducted a pilot randomized controlled trial. Seventy participants with severe chronic constipation were randomly allocated to the EA group or TES group. The acupoints in both groups are bilateral Tianshu (stomach 25), Fujie (spleen 14), and Shangjuxu (stomach 37). Each participant received 24 sessions of EA or TES during the treatment period of 8 weeks. Outcome measures were the proportion of participants with an increase from baseline of 1 or more complete spontaneous bowel movements (CSBMs) at week 8 and changes in the number of CSBMs and spontaneous bowel movements, stool character, difficulty in defecation, Patient Assessment of Constipation Quality of Life (PAC-QOL); the proportion of participants using rescue medicine and adverse reactions. Participants were followed for 24 weeks after the treatment. RESULTS: Sixty of the 70 eligible participants completed the whole trial, 32 participants (91.43%) in the EA group and 28 participants (80.00%) in the TES group. There were 10 participants (14.29%) who dropped out during the whole study, 3 (8.57%) in the EA group, and 7 (20.00%) in the TES group. At weeks 20 and 32, 22 of 32 (68.75%) and 19 of 32 (59.38%) in the EA group met the clinical outcome of an increase of 1 or more CSBMs from the baseline, compared with 10 of 28 (35.71%) and 9 of 28 (32.14%) in the TES group ( P =0.019 and 0.042, respectively). At the same time, the proportions of participants having 3 or more CSBMs per week were 18 of 32 (56.25%) and 15 of 32 (46.88%) in the EA group, respectively, compared with 6 of 28 (21.43%) and 5 of 28 (17.86%) in the TES group ( P =0.008 and 0.027, respectively). Statistical differences between the 2 groups were maintained in the change from baseline in CSBMs during the follow-up period ( P =0.007 and 0.013, at week 20 and 32, respectively) and in the change from baseline in spontaneous bowel movements at week 20 ( P =0.007). Statistical significance was also observed in the decrease of PAC-QOL score after 8 weeks of treatment (mean±SD, EA: 19.06±14.41 vs. TES: 12.48±9.13, P =0.031). No significant difference was noted between the 2 groups in defecation difficulty, stool character, and the use of rescue medicine. CONCLUSIONS: For the treatment of severe chronic constipation, EA performed better than TES in long-term follow-up and improving the quality of life. TES could be a better choice for patients with severe chronic constipation who are afraid of acupuncture because it is noninvasive. Well-designed and more rigorous clinical trials with larger sample sizes are needed.

Efficacy of percutaneous and transcutaneous posterior tibial nerve stimulation on idiopathic overactive bladder and interstitial cystitis/painful bladder syndrome: A systematic review and meta-analysis.

OBJECTIVES: Percutaneous and transcutaneous posterior tibial nerve stimulation (PTNS and TTNS) showed a promising effect on overactive bladder (OAB) and interstitial cystitis/painful bladder syndrome. We aimed to give a systematic review and meta-analysis on the efficacy and safety of these therapeutic methods as well. METHODS: We searched studies available on PubMed, Embase, Cochrane, Scopus, Web of Science, and ProQuest on March 31, 2021, to find both published and unpublished studies. The retrieved articles were screened by two independent researchers and then the selected studies were critically appraised by Cochrane risk-of-bias tool for randomized trials, and Joanna Briggs Institute's checklist for quasi-experimental studies. Finally, the results of studies were synthesized using Review Manager (RevMan) 5.4 statistical software when the data were homogenous. The meta-analysis was performed by calculating the effect size (mean difference) and their 95% confidence intervals (CIs). RESULTS: Of the total 3194 publications, 68 studies were included in our qualitative evaluation and 9 studies (11 trials) in the quantitative stage. When TTNS or PTNS were compared to sham, placebo, no treatment, or conservative management, a decrease in frequency of urination was observed in both TTNS (mean difference [MD]: -3.18, 95% CI: -4.42 to -1.94, and p < 0.00001), and PTNS (MD: -2.84, 95% CI: -4.22 to -1.45, and p < 0.00001), and overall TTNS or PTNS (MD: -2.95, 95% CI: -4.01 to -1.88, and p < 0.00001). Significant improvements in mean voiding volume (MVV) and decreasing nocturia were also observed. CONCLUSIONS: Nerve stimulations either PTNS or TTNS appear to be effective interventions in treating refractory idiopathic OAB in terms of daily voiding frequency, MVV, urgency episodes, and nighttime voiding frequency. However, our result did not show any improvement in terms of urinary incontinence, postvoid residual volume or urge incontinence, and maximum cystometric capacity which emphasized the efficacy of these modalities on dry-OAB rather than wet-OAB.

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.

TENS and EMS Treatment for Diabetic Peripheral Neuropathy.

Context: Diabetic peripheral neuropathy (DPN) is a common complication occurring in both type 1 and type 2 diabetics. DPN may result in foot ulceration or lower-limb amputation. Objective: This case was undertaken to evaluate the efficacy of ReBuilder® therapy in the treatment of diabetic peripheral neuropathy. Methods: The case report is based on 3 selected patients, 2 males and 1 female. Each patient continued being managed by his/her primary care physician. No changes to allopathic medicine or diet were advised by our team. In addition to the allopathic therapy, we added ReBuilder® therapy, low level light therapy, vibration therapy and supplementation. The treatment period ranged from 17 to 20 weeks. Conclusion: The data presented here show promise for future, larger, controlled studies on the use of ReBuilder® devices for the treatment of diabetic peripheral neuropathy pain.

Non-inferior and more feasible transcutaneous tibial nerve stimulation in treating overactive bladder: A systematic review and meta-analysis.

OBJECTIVES: Overactive bladder (OAB) is identified as a urinary urgency accompanied by frequency and nocturia with or without urgency urinary incontinence in the nonexistence of a urinary tract infection or other evident pathologies. This systematic review and meta-analysis aimed to evaluate the efficacy of the transcutaneous tibial nerve stimulation (TTNS) versus percutaneous tibial nerve stimulation (PTNS) or anticholinergic drugs in reducing symptoms and improving the quality of life for OAB patients. METHODS: We performed a systematic search in Medline, Embase, and CENTRAL, in which we included randomized controlled trials that compared TTNS with anticholinergic drugs or PTNS in treating idiopathic OAB. We evaluated the following outcomes: 3-day voiding diary (voiding frequency/day, daytime micturition frequency/day, nighttime micturition frequency/day, number of urgency episodes/day, number of incontinence episodes/day, and mean voiding volume), symptom bother, health related quality of life (HRQoL), and adverse events. We used 95% as a confidence interval (CI) and p < 0.05. Standardized mean difference (SMD) was used for continuous outcomes, and the risk ratio (RR) was used for dichotomous outcomes. RESULTS: There was no significant difference comparing TTNS with anticholinergic drugs or PTNS regarding voiding frequency/day (SMD = -0.01, 95% CI -0.33 to 0.32), nighttime micturition frequency/day (SMD = -0.28, 95% CI -0.94 to 0.37), number of urgency episodes/day (SMD = -0.05, 95% CI -0.36 to 0.26), number of incontinence episodes/day (SMD = -0.04, 95% CI -0.32 to 0.25), symptom bother (SMD = -0.19, 95% CI -0.55 to 0.16), HRQoL (SMD = 0.27, 95% CI -0.32 to 0.85), and adverse events (RR = 0.07, 95% CI 0.01 to 0.54). CONCLUSION: The current meta-analysis reveals that there is no statistically significant difference between TTNS versus PTNS or anticholinergic drugs for the nonsurgical management of OAB patients.

Submental transcutaneous electrical stimulation can impact the timing of laryngeal vestibule closure.

BACKGROUND: Laryngeal vestibule closure (LVC) is one of the critical airway protection mechanisms during swallowing. LVC timing impairments during swallowing are among the common causes of airway invasion in patients with dysphagia. OBJECTIVES: To understand whether using submental transcutaneous electrical stimulation (TES) with varying pulse durations can impact the LVC reaction time (LVCrt) and LVC duration (LVCd) measures in healthy adults. METHODS: Twenty-six healthy adults underwent three TES conditions while receiving three trials of 10 ml pureed: no TES, TES with short pulse duration (300 µs) and TES with long pulse durations(700 µs). Two pairs of electrodes were placed diagonally on the submental area. For each active TES condition, the stimulation was increased up to the participant's self-identified maximum tolerance. Each swallow trial was recorded using videofluoroscopic swallowing study. All data were extracted and analysed offline using VideoPad Video Editor program. RESULTS: Submental TES reduced LVCrt during swallowing [F (2, 46) = 7.234, p < .007, ηp2 = .239] but had no significant impact on LVCd [F (2, 50) = .1.118, p < .335, ηp2 = .043]. Furthermore, pulse duration had no distinguished impact on any LVC timing measures. CONCLUSION: Transcutaneous electrical stimulation may benefit patients with dysphagia who suffer from delayed LVC during swallowing. Future studies should seek whether the same physiologic effect can be observed in patients with dysphagia.

Effects of Transcutaneous Electrical Nerve Stimulation on Mastectomy Pain, Patient Satisfaction, and Patient Outcomes.

PURPOSE: Mastectomy is one of the most painful surgical procedures. Postoperative pain guidelines recommend transcutaneous electrical nerve stimulation (TENS) as a reliable non-pharmacological analgesic method. The aim of this study was to investigate the effects of TENS on postoperative pain and outcomes in patients undergoing modified radical mastectomy (MRM). DESIGN: A single-center, single-blind, prospective, randomized-controlled study. METHODS: This single-center, single-blind, randomized-controlled study included a total of 80 patients who underwent MRM at general surgery clinic of a tertiary center were included. The pain management of the patient outcomes were evaluated using the Turkish Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R-TR). FINDINGS: The pain levels of the intervention group were lower than the control group. There were significant improvements in the patient outcomes such as mobilization, position, sleep, anxiety, and fear in the intervention group. CONCLUSIONS: Our study results suggest that TENS reduces MRM pain. Thus, TENS can be recommended as a useful analgesic method in MRM.

Using TENS for Pain Control: Update on the State of the Evidence.

Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological intervention used in the treatment of acute and chronic pain conditions. The first clinical studies on TENS were published over 50 years ago, when effective parameters of stimulation were unclear and clinical trial design was in its infancy. Over the last two decades, a better understanding of the mechanisms underlying TENS efficacy has led to the development of an adequate dose and has improved outcome measure utilization. The continued uncertainty about the clinical efficacy of TENS to alleviate pain, despite years of research, is related to the quality of the clinical trials included in systematic reviews. This summary of the evidence includes only trials with pain as the primary outcome. The outcomes will be rated as positive (+), negative (-), undecided (U), or equivalent to other effective interventions (=). In comparison with our 2014 review, there appears to be improvement in adverse events and parameter reporting. Importantly, stimulation intensity has been documented as critical to therapeutic success. Examinations of the outcomes beyond resting pain, analgesic tolerance, and identification of TENS responders remain less studied areas of research. This literature review supports the conclusion that TENS may have efficacy for a variety of acute and chronic pain conditions, although the magnitude of the effect remains uncertain due to the low quality of existing literature. In order to provide information to individuals with pain and to clinicians treating those with pain, we suggest that resources for research should target larger, high-quality clinical trials including an adequate TENS dose and adequate timing of the outcome and should monitor risks of bias. Systematic reviews and meta-analyses should focus only on areas with sufficiently strong clinical trials that will result in adequate sample size.

TENS Improves Cisplatin-Induced Neuropathy in Lung Cancer Patients.

Background: Cisplatin-induced peripheral neuropathy is a common complication of cisplatin therapy, which develops in most patients with lung cancer. There are no effective preventive measures and once it occurs there is no effective therapy, except symptomatic. In this study, we aimed to assess the effect of transcutaneous electrical nerve stimulation (TENS) therapy on the pain intensity and the quality of life of patients with cisplatin-induced neuropathy. Material and Methods: A prospective cohort study was performed from 2013 to 2018, at the Clinical Center of Serbia. After the initial evaluation of 106 newly diagnosed patients with lung cancer, 68 patients did not have peripheral neuropathy. These 68 patients continued in the study and started the cisplatin chemotherapy. Forty of these patients developed cisplatin-induced neuropathy, which was manifested by neuropathic symptoms and proven by ENG examination. All patients with cisplatin-induced neuropathy were treated with TENS therapy. Their neuropathic pain and quality of life were evaluated using the following questionnaires at diagnosis, after cisplatin therapy and after four weeks of TENS use: DN4, VAS scale, EORTC QLQ-C30 and FACT-L. Results: Two thirds (68%) of the patients with cisplatin-induced neuropathy were male and the majority were smokers (70%). Adenocarcinoma was the most common (38%), followed by squamous (33%) and small-cell carcinoma (28%). The application of TENS therapy had a positive effect on reducing the neuropathic pain and increasing the quality of life for patients with painful cisplatin-induced neuropathy. The VAS and DN4 scores significantly decreased after TENS therapy, in comparison to its values after cisplatin therapy (p < 0.001). After TENS therapy, patients had significantly higher values in most of the domains of EORTC QLQ-C30 and FACT- L, in comparison with the values after cisplatin therapy (p < 0.001). Conclusion: The application of TENS therapy has a positive effect on reducing neuropathic pain and increasing the quality of life for patients with lung cancer and cisplatin-induced neuropathy.

Transcutaneous Electric Nerve Stimulation Reduces Pathological Sensation of Mesh One Week after Open Inguinal Hernia Surgery: Follow-Up Results from a Randomized, Double Blind and Placebo-Controlled Trial.

Background and Objectives: Quality of life (QoL) and chronic pain are important outcomes following hernia surgery. The long-term effects of Transcutaneous Electric Nerve Stimulation (TENS) on postoperative recovery are not well known. In this trial we investigated the role of TENS on QoL and on the incidence of chronic pain following inguinal hernia repair with mesh. Materials and Methods: A total of 80 male patients with elective primary unilateral hernia Lichtenstein repair were randomly allocated to receive TENS or a placebo-TENS procedure. The TENS group received conventional TENS twice a day on the first and second postoperative days. The intensity was set at 0-0.5 mA in the placebo-TENS group. General and hernia-specific QoL, as well as the incidence of chronic pain were assessed using SF-36v2 and the Carolinas comfort scale. Results: Less sensation of mesh was reported by the TENS group patients one week after surgery. At this time point, the mean sensation score was 6.07 ± 8.88 in the TENS group and 14.08 ± 16.67 in the placebo-TENS group (p = 0.029). Although at two days and one week postoperatively, TENS group patients tended to have less pain, less movement restrictions and better overall hernia-specific QoL, the differences were not statistically significant. At 6 months postoperatively, no incidence of chronic pain was found in either the placebo-TENS or TENS group. Conclusions: Conventional TENS applied in the early postoperative period following inguinal hernia repair with mesh was found to reduce mesh-related foreign body sensation one week after surgery. Promising results were also found for other QoL domains.

Tibial nerve stimulation in the treatment of overactive bladder syndrome: technical features of latest applications.

PURPOSE OF REVIEW: Overactive bladder syndrome (OAB) is a chronic condition, which can be treated by tibial nerve stimulation. The present review will focus on the technical aspects, advantages, drawbacks, and limitations of the latest available applications of posterior tibial nerve stimulation. RECENT FINDINGS: We describe the technical aspects of recent developed implants and techniques of tibial nerve stimulation in a transcutaneous, percutaneous, and minimal invasive way. All different treatment options have advantages and disadvantages based on type of surgery, energy transfer, impedance, treatment setting options, risk of migration, and patient usability, which are described in this review. Only devices with data that are publicly available were included. SUMMARY: New technologies are on their way in the field of tibial nerve stimulation for the treatment of OAB. Technical aspects are important to demonstrate safety and efficacy and user friendliness in order to obtain high acceptance of the various devices.