Transcutaneous tibial nerve stimulation in patients with multiple sclerosis and overactive bladder: a real-life clinical and urodynamic assessment.

AIMS: The aims of the present study were to assess the effectiveness of transcutaneous tibial nerve stimulation (TTNS) on overactive bladder (OAB) symptoms and on urodynamic parameters in patients with multiple sclerosis (PwMS) and to seek predictive factors of satisfaction. METHODS: All PwMS who performed 12-24 weeks of TTNS and who underwent urodynamic assessment before and after treatment between June 2020 and October 2022 were included retrospectively. Data collected were bladder diaries, symptoms assessed with Urinary Symptoms Profile (USP), and urodynamic parameters (bladder sensations, detrusor overactivity, and voiding phase). Patients with improvement rated as very good or good on Patient Global Impression of Improvement (PGI-I) score were considered as responders. RESULTS: Eighty-two patients were included (mean age: 47.1 ± 11.5 years, 67 (82%) were women). The mean USP OAB sub-score decreased from 7.7 ± 3.5 to 6.0 ± 3.4 (p < 0.0001). On bladder diaries, voided volumes, void frequency, and the proportion of micturition done at urgent need to void significantly improved with TTNS (p < 0.05). No significant change was found in urodynamic parameters. According to the PGI-I, 34 (42.5%) patients were good responders. The only parameter associated with higher satisfaction was the percentage of micturition done at urgent need to void before the initiation of the treatment (39.8% ± 30.5 in the responder group vs 25.1% ± 25.6 in the low/no responder group; p = 0.04). CONCLUSION: TTNS improves OAB symptoms in PwMS, without significant changes on urodynamics. A high rate of strong or urgent need to void in daily life was associated with higher satisfaction.

Percutaneous electrical nerve field stimulation for adolescents with irritable bowel syndrome: Cost-benefit and cost-minimization analysis.

Abdominal pain drives significant cost for adolescents with irritable bowel syndrome (IBS). We performed an economic analysis to estimate cost-savings for patients' families and healthcare insurance, and health outcomes, based on abdominal pain improvement with percutaneous electrical nerve field stimulation (PENFS) with IB-Stim® (Neuraxis). We constructed a Markov model with a 1-year time horizon comparing outcomes and costs with PENFS versus usual care without PENFS. Clinical outcomes were derived from a sham-controlled double-blind trial of PENFS for adolescents with IBS. Costs/work-productivity impact for parents were derived from appropriate observational cohorts. PENFS was associated with 18 added healthy days over 1 year of follow-up, increased annual parental wages of $5,802 due to fewer missed work days to care for the child, and $4744 in cost-savings to insurance. Percutaneous electrical field nerve stimulation for adolescents with IBS appears to yield significant cost-savings to patients' families and insurance.

Cost consequence analysis of transcutaneous tibial nerve stimulation (TTNS) for urinary incontinence in care home residents alongside a randomised controlled trial.

BACKGROUND: Urinary incontinence (UI) is prevalent in more than half of residents of nursing and residential care homes and can have a detrimental impact on dignity and quality of life. Care homes predominantly use absorbent pads to contain UI rather than actively treat the condition. Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive, safe, low-cost intervention with demonstrated effectiveness for reducing UI in adults. We examined the costs and consequences of delivering TTNS to care home residents in comparison to sham (inactive) electrical stimulation. METHODS: A cost consequence analysis approach was used to assemble and present the resource use and outcome data for the ELECTRIC trial which randomised 406 residents with UI from 37 care homes in the United Kingdom to receive 12 sessions of 30 min of either TTNS or sham (inactive) TTNS. TTNS was administered by care home staff over 6 weeks. Health state utility was measured using DEMQOL-U and DEMQOL-PROXY-U at baseline, 6 weeks and 18 weeks follow-up. Staff completed a resource use questionnaire at baseline, 6 weeks and 18 weeks follow-up, which also assessed use of absorbent pads. RESULTS: HRQoL did not change significantly in either randomised group. Delivery of TTNS was estimated to cost £81.20 per participant, plus training and support costs of £121.03 per staff member. 85% of participants needed toilet assistance as routine, on average requiring one or two staff members to be involved 4 or 5 times in each 24 h. Daily use of mobility aids and other assistive devices to use the toilet were reported. The value of staff time to assist residents to use the toilet (assuming an average of 5 min per resident per visit) was estimated as £19.17 (SD 13.22) for TTNS and £17.30 (SD 13.33) for sham (per resident in a 24-hour period). CONCLUSIONS: Use of TTNS to treat UI in care home residents did not lead to changes in resource use, particularly any reduction in the use of absorbent pads and no cost benefits for TTNS were shown. Managing continence in care homes is labour intensive, requiring both high levels of staff time and use of equipment aids. TRIAL REGISTRATION: ISRCTN98415244, registered 25/04/2018. NCT03248362 (Clinical trial.gov number), registered 14/08//2017.

An assessment of sensory sensitivity in women suffering from depression using transcutaneous electrical nerve stimulation.

Background: Perception is the process or result of the process arising from the mental interpretation of the phenomena occurring, therefore it depends not only on physiology, but is also psychologically and socially conditioned. The aim of this study was to assess if there is a difference in the sensory sensitivity to an electrical stimulus in women suffering from depression and what the hedonic rating is of the lived experience of transcutaneous electrical nerve stimulation. Methods: The depression group: 44 women, who were inpatients treated for depression at the Psychiatric Ward in the Clinical Hospital, and the control group: 41 women, matched by the age, height and weight, with no mental illness. Measures: threshold for sensing current, type of sensation evoked, hedonic rating. Results: Median sensing threshold of electric current (depression vs. control: 7.75 mA vs. 8.35 mA; no significant), type of sensation evoked (depression vs. control: tingling 90.9% vs. 92.7%, no significant), hedonic rating (depression vs. control: unpleasant 11.4% vs. 2.4%; p = 0.003), hedonic rating (mildly ill vs. moderately ill vs. markedly ill: unpleasant 5.3% vs. 6.3% vs. 33.3%; p = 0.066). Conclusions: Women suffering from depression exhibit a similar threshold of sensitivity to an electrical stimulus as mentally healthy women, however the hedonic rating of the stimulus acting on the skin in the group of clinically depressed women was more negative than in the mentally healthy subjects. The stimulus was described as 'unpleasant' for many of the mentally unhealthy women. The most negative sensations related to the electrical stimulus were experienced by women with the highest severity of mental illness according to The Clinical Global Impression - Severity Scale.

Understanding Mental Health Needs and Gathering Feedback on Transcutaneous Auricular Vagus Nerve Stimulation as a Potential PTSD Treatment among 9/11 Responders Living with PTSD Symptoms 20 Years Later: A Qualitative Approach.

Posttraumatic stress disorder (PTSD) remains one of the most prevalent diagnoses of World Trade Center (WTC) 9/11 responders. Transcutaneous auricular vagus nerve stimulation (taVNS) is a potential treatment for PTSD, as it can downregulate activity in the brain, which is known to be related to stress responses and hyperarousal. To understand barriers and facilitators to engagement in mental health care and the feasibility and acceptability of using the taVNS device as a treatment for PTSD symptoms, a focus group was conducted among patients from the Queens WTC Health Program who had elevated symptoms of PTSD. The focus group discussion was recorded, transcribed, and analyzed. Three themes and subthemes emerged: (1) the continued prevalence of mental health difficulties and systematic challenges to accessing care; (2) positive reception toward the taVNS device as a potential treatment option, including a discussion of how to increase usability; and (3) feedback on increasing the feasibility and acceptance of the research methodology associated with testing the device in a pilot clinical trial. The findings highlight the need for additional treatment options to reduce PTSD symptoms in this population and provide key formative phase input for the pilot clinical trial of taVNS.

It Hurts to Move! Intervention Effects and Assessment Methods for Movement-Evoked Pain in Patients With Musculoskeletal Pain: A Systematic Review with Meta-analysis.

OBJECTIVES: To estimate the effects of musculoskeletal rehabilitation interventions on movementevoked pain and to explore the assessment methods/protocols used to evaluate movement-evoked pain in adults with musculoskeletal pain. DESIGN: Systematic review with meta-analysis. LITERATURE SEARCH: Three electronic databases (PubMed, Web of Science, and Scopus) were searched. STUDY SELECTION CRITERIA: Randomized controlled trials investigating musculoskeletal rehabilitation interventions for movement-evoked pain in adults with musculoskeletal pain were included. DATA SYNTHESIS: Meta-analysis was conducted for outcomes with homogeneous data from at least 2 trials. The mean change in movementevoked pain was the primary outcome measure. Certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation framework. RESULTS: Thirty-eight trials were included, and 60 different interventions were assessed. There was moderate-certainty evidence of a beneficial effect of exercise therapy compared to no treatment (standardized mean difference [SMD], -0.65; 95% confidence interval [CI]: -0.83, -0.47; P<.001) on movement-evoked pain in adults with musculoskeletal pain. There was low-certainty evidence of a beneficial effect of transcutaneous electrical nerve stimulation compared to no treatment (SMD, -0.46; 95% CI: -0.71, -0.21; P = .0004). There was no benefit of transcutaneous electrical nerve stimulation when compared to sham transcutaneous electrical nerve stimulation (SMD, -0.28; 95% CI: -0.60, 0.05; P = .09; moderate-certainty evidence). CONCLUSION: There was moderate-certainty evidence that exercise therapy is effective for reducing movement-evoked pain in patients with musculoskeletal pain compared to no treatment. Consider exercise therapy as the first-choice treatment for movement-evoked pain in clinical practice. J Orthop Sports Phys Ther 2022;52(6):345-374. Epub: 05 Feb 2022. doi:10.2519/jospt.2022.10527.

Comparison of transcutaneous electrical tibial nerve stimulation for the treatment of overactive bladder: a multi-arm randomized controlled trial with blinded assessment.

OBJECTIVE: To compare the effectiveness of tibial nerve transcutaneous electrical nerve stimulation (TENS) for an overactive bladder, considering the sites of application and frequency of attendance. METHODS: This multi-arm randomized controlled trial enrolled 137 adult women (61.0±9.0 years) with overactive bladder from a university hospital. They underwent 12 sessions of 30-min TENS application and were assigned to five groups: one leg, once a week (n=26); one leg, twice a week (n=27); two legs, once a week (n=26); two legs, twice a week (n=28); and placebo (n=30). Symptoms of overactive bladder and its impact on quality of life were evaluated before and after 6 or 12 weeks of treatment using the Overactive Bladder Questionnaire-V8 and voiding diary. ClinicalTrials.gov: NCT01912885. RESULTS: The use of one leg, once a week TENS application reduced the frequency of urgency episodes compared with the placebo (1.0±1.6 vs. 1.4±1.9; p=0.046) and frequency of incontinence episodes compared with the placebo (0.7±1.4 vs.1.4±2.2; p<0.0001). The one-leg, twice a week protocol decreased the urinary frequency compared with the two legs, once a week protocol (8.2±3.5 vs. 9.0±5.1; p=0.026) and placebo (8.2±3.5 vs. 7.9±2.7; p=0.02). Nocturia improved using the two legs, once a week protocol (1.5±1.8) when compared with the one leg, twice a week protocol (1.9±2.0) and placebo (1.7±1.6) (p=0.005 and p=0.027, respectively). Nocturia also improved using the two legs, twice a week protocol when compared with the one leg, twice a week protocol (1.3±1.2 vs.1.9±2.0; p=0.011). CONCLUSION: One-leg stimulation improved the daily urinary frequency, urgency, and incontinence, and the two-leg stimulation once and twice weekly improved nocturia.

Transcutaneous electrical nerve stimulation for women with primary dysmenorrhea: Study protocol for a randomized controlled clinical trial with economic evaluation.

Primary dysmenorrhea (PD) is a common gynecological disorder characterized by cramping pain in the lower abdomen during menstruation, in the absence of identifiable pathology. While Transcutaneous Electrical Nerve Stimulation (TENS) is used to promote PD pain relief, there is still a need to understand the parameters and cost-effectiveness of this intervention. As such, this study aims to disclose a study that will evaluate the effectiveness and cost-effectiveness of TENS on pain intensity in women with PD. This is a protocol for an assessor-blinded randomized controlled trial that includes 174 women with PD, >18 years old, with menstrual pain greater than or equal to four points in the Numerical Rating Scale. Participants will be randomized into three groups (active TENS, placebo TENS, and educational booklet). Participants allocated to the active TENS group will receive electrical stimulation (F = 100 Hz, pulse duration = 200 µs, for 30 min). In contrast, the placebo TENS group will receive placebo stimulation (same parameters, but for only 30 s, and then the current will be ramped off over a 15-s time frame) for three consecutive months during menstruation. Participants allocated to the educational booklet group will receive instructions about health promotion and education actions related to PD. A blinded assessor will evaluate the pain intensity (Numerical Rating Scale), presenteeism (Stanford Presenteeism Scale), Health-Related Quality of Life (Short-Form 6 dimensions and SF-36), and health costs of menstrual pain. This is the first study to propose a health economic evaluation while assessing the benefits of using TENS to treat PD symptoms. It is hypothesized that active TENS will be more effective than placebo TENS or the educational booklet in improving clinical outcomes in the short-, medium- and long-term. The study will also provide information about the cost-effectiveness of TENS, which can be used by policy makers to improve PD care in public and private health systems.

National Trends in Neuromodulation for Urinary Incontinence Among Insured Adult Women and Men, 2004-2013: The Urologic Diseases in America Project.

OBJECTIVE: To examine US trends in neuromodulation for urinary incontinence (UI) treatment from 2004 to 2013. METHODS: This study utilized 2 data sources: the Optum© de-identified Clinformatics® Data Mart Database for privately insured adults aged 18-64 years with a UI diagnosis (N≈40,000 women and men annually) and the Medicare 5% Sample for beneficiaries aged ≥65 years with a UI diagnosis (N≈65,000 women and men annually). We created annual cross-sectional cohorts and assessed prevalence of UI-related neuromodulation procedures among men and women separately from 2004 to 2013. Analyses were conducted overall and stratified by age, race/ethnicity, and geographic region. RESULTS: Nearly all neuromodulation procedures occurred in outpatient settings. Sacral neuromodulation (SNM) procedures for UI in both women and men grew steadily from 2004 to 2013, with more procedures performed in women than men. Among women with UI, SNM prevalence grew from 0.1%-0.2% in 2004 to 0.5%-0.6% in 2013. Posterior tibial nerve stimulation (PTNS) experienced growth from 2011 to 2013. Chemodenervation of the bladder with onabotulinumtoxinA (BTX) combined with other injectable procedures (including urethral bulking) remained stable over time. CONCLUSIONS: From 2004 to 2013, SNM procedures remained relatively uncommon but increased consistently. PTNS experienced growth starting in 2011 when PTNS-specific insurance claims became available. BTX trends remain unclear; future studies should assess it separately from other injectable procedures. Neuromodulation has a growing role in UI treatment, and ongoing trends will be important to examine.

Comparison of transcutaneous electrical tibial nerve stimulation for the treatment of overactive bladder: a multi-arm randomized controlled trial with blinded assessment

OBJECTIVE: To compare the effectiveness of tibial nerve transcutaneous electrical nerve stimulation (TENS) for an overactive bladder, considering the sites of application and frequency of attendance. METHODS: This multi-arm randomized controlled trial enrolled 137 adult women (61.0±9.0 years) with overactive bladder from a university hospital. They underwent 12 sessions of 30-min TENS application and were assigned to five groups: one leg, once a week (n=26); one leg, twice a week (n=27); two legs, once a week (n=26); two legs, twice a week (n=28); and placebo (n=30). Symptoms of overactive bladder and its impact on quality of life were evaluated before and after 6 or 12 weeks of treatment using the Overactive Bladder Questionnaire-V8 and voiding diary. ClinicalTrials.gov: NCT01912885. RESULTS: The use of one leg, once a week TENS application reduced the frequency of urgency episodes compared with the placebo (1.0±1.6 vs. 1.4±1.9; p=0.046) and frequency of incontinence episodes compared with the placebo (0.7±1.4 vs.1.4±2.2; p<0.0001). The one-leg, twice a week protocol decreased the urinary frequency compared with the two legs, once a week protocol (8.2±3.5 vs. 9.0±5.1; p=0.026) and placebo (8.2±3.5 vs. 7.9±2.7; p=0.02). Nocturia improved using the two legs, once a week protocol (1.5±1.8) when compared with the one leg, twice a week protocol (1.9±2.0) and placebo (1.7±1.6) (p=0.005 and p=0.027, respectively). Nocturia also improved using the two legs, twice a week protocol when compared with the one leg, twice a week protocol (1.3±1.2 vs.1.9±2.0; p=0.011). CONCLUSION: One-leg stimulation improved the daily urinary frequency, urgency, and incontinence, and the two-leg stimulation once and twice weekly improved nocturia.

Ultrasound-Guided Peripheral Nerve Stimulation for Shoulder Pain: Anatomic Review and Assessment of the Current Clinical Evidence.

BACKGROUND: The shoulder region is a common area for pain. The shoulder has the largest range of motion and the most complex mechanical anatomy. The shoulder girdle and related tendons allow for numerous painful disorders to occur. Also, given the overall use of the shoulder, arthritic deformities are all too common. Finally, pain from more complex states such as poststroke shoulder pain and status post total shoulder arthroplasty pain have always been a difficult diagnosis to treat with effectiveness. The innervation to the shoulder predominantly comes from the suprascapular and axillary nerves. Both nerves relatively follow an expected anatomic course and whereby they can be targeted with ultrasound or fluoroscopy. Recently, there has been an increase in evidence that suggests peripheral nerve stimulation can make a difference in these patients with shoulder pain. OBJECTIVES: To provide a basic overview of peripheral nerve stimulator placement targeting the axillary and suprascapular nerves. Furthermore, to demonstrate the suggested implantation and current evidence of peripheral nerve stimulation for the treatment of shoulder pain. STUDY DESIGN: Anatomic clinical review. METHODS: A comprehensive review was performed regarding the available literature through targeting articles reporting on the use of peripheral nerve stimulation to treat pain of the shoulder region. RESULTS: We compiled and discuss the current evidence available in treating shoulder pain utilizing peripheral stimulation. The strongest evidence currently is for peripheral nerve stimulation targeting either the axillary or suprascapular nerve, as well as placement targeting the motor points of the deltoid. The most common treated pathology is poststroke shoulder pain. LIMITATIONS: Peripheral nerve stimulation has been trialed and is promising for several shoulder pain pathologies; however, there remains a need for large-scale, randomized, placebo-controlled clinical trials to further evaluate the efficacy of most treatments. Much of the current data relies on case reports without randomization or placebo controls. CONCLUSIONS: Overall there is fair to moderate evidence for peripheral nerve stimulation to treat shoulder pain in hemiplegic poststroke patients. There is limited evidence when treating other shoulder pain etiologies. Utilizing ultrasound or fluoroscopic guidance, the procedure has proven to be safe allowing proper placement of the electrodes near the target nerves. Considering the high prevalence of shoulder pain from degenerative conditions and overuse, future studies are undoubtedly warranted to evaluate whether peripheral nerve stimulation can modify our treatment algorithm for management of these conditions.

Contemporary Patterns of Third-line Treatments for Privately Insured Individuals With Overactive Bladder in the United States.

OBJECTIVE: To evaluate utilization of third-line overactive bladder (OAB) treatments including percutaneous tibial nerve stimulation (PTNS), sacral nerve stimulation (SNS), and intradetrusor botulinum toxin A (BTX) among privately insured patients and examine factors associated with their use. MATERIALS AND METHODS: Using MarketScan claims (2015-2017), we identified patients who underwent third-line OAB treatments based on procedure codes. Factors of interest included location, age, health plan, among others. We fit multivariable logistic regression models to estimate associations between pertinent factors with receipt of PTNS and SNS relative to BTX and associations between provider type and practice location with each treatment modality. RESULTS: We identified 7383 patients (mean age 50.9) in our cohort. SNS was used most frequently (n = 3602, 48.8%), while PTNS was used least frequently (n = 955, 12.9%). PTNS patients were more likely to reside in metropolitan areas (vs BTX: OR 1.6, 95%CI 1.3-2.1; vs SNS: OR 2.2, 95%CI 1.7-2.8), be aged 55 years or older (vs BTX: 54% vs 47%, OR 1.6, 95%CI 1.2-2.1; vs SNS: 54% vs 45%, OR 1.6, 95%CI 1.2-2.0), and be covered under a health maintenance organization (vs BTX: 17% vs 10%; vs SNS: 17% vs 10%, P <.01). Urologists were most likely to perform SNS, and gynecologists were most likely to perform BTX. 91% of PTNS procedures were performed in office settings. CONCLUSION: Among patients receiving third-line OAB treatment, PTNS was used infrequently. PTNS utilization was concentrated within urban areas, and among older patients and those covered by cost-conscious health maintenance organizations.

Racial and Socioeconomic Factors Influence Utilization of Advanced Therapies in Commercially Insured OAB Patients: An Analysis of Over 800,000 OAB Patients.

OBJECTIVE: To determine if racial and/or socioeconomic factors influence advanced therapy utilization for refractory overactive bladder (OAB) among the commercially insured. METHODS: We queried Optum, a national claims database, between 2003 and 2017. Non-neurogenic OAB patients were identified using ICD-9/10 diagnosis codes. Demographic and treatment data were collected, including oral medication therapies (anticholinergic, beta3 agonists), and advanced therapies (OnabotulinumtoxinA [BTX], Sacral Nerve Stimulation [SNS], percutaneous tibial nerve stimulation [PTNS]). Associations between patient sociodemographic factors and advanced therapy utilization were explored. RESULTS: Of 4,229,617 OAB patients, 807,612 (19%) received medical therapies, of which 95% received oral medications only and only 4.7% received advanced therapies. Asians had the lowest use of oral therapy use (14% vs 18%-19% in other races/ethnicities, P <0.05), and advanced therapy use (0.44% vs 0.71%-0.93%, P <0.05). Asians and Hispanics were least likely to utilize SNS therapy and most likely to use PTNS compared to Blacks and Whites. BTX use was similar between races/ethnicities (P <0.05). Female gender (OR 1.65 [CI 1.61,1.69]), younger age (<65) (OR 1.28 [1.25,1.31]), higher annual income ≥$40K (OR 1.09 [1.06,1.12]) and prior use of oral medications (OR 3.30 [3.21,3.38] for 1 medication) were significantly associated with receiving advanced therapies. Non-white race (OR 0.89 [0.87,0.91]), lower education level (less than a bachelor's degree) (OR 0.97 [0.94,0.99]), and Northeast region were associated with a lower likelihood of receiving advanced therapies (P <0.05 for all). CONCLUSION: Among commercially insured, racial and socioeconomic factors predict utilization of advanced OAB therapies, including race/ethnicity, age, gender, education level, and region.

Real World Performance of Sacral Neuromodulation and OnabotulinumtoxinA for Overactive Bladder: Focus on Safety and Cost.

PURPOSE: We aimed to determine the real world safety and cost of third line overactive bladder therapies, including onabotulinumtoxinA and sacral neuromodulation. MATERIALS AND METHODS: We performed an all-inclusive, population based cohort study of third line therapies of overactive bladder (sacral neuromodulation or onabotulinumtoxinA) using the statewide surgical data captured in the New York Statewide Planning and Research Cooperative System. The main outcome measures were 30-day safety events, and 1 and 3-year health care utilization costs. Propensity score matching was done to control for confounding factors and comparative analyses of safety events were also performed. RESULTS: Our cohort included 2,680 patients, of whom 1,328 underwent sacral neuromodulation and 1,352 received onabotulinumtoxinA from January 1, 2013 through December 31, 2016. Average ± SD age was 61.7 ± 16.3 years and 82.7% of the patients were female. Sacral neuromodulation implantation led to re-intervention in 15.8% of cases within 1 year and in 26.1% at 3 years. In this comparative analysis patients who received onabotulinumtoxinA therapy were at higher risk for urinary tract infection, hematuria, urinary retention and an emergency room visit compared to those treated with sacral neuromodulation. The overall cost of onabotulinumtoxinA was lower than the cost of the sacral neuromodulation device (cost at 1 year $2,896 vs $15,343 and at 3 years $3,454 vs $16,189, each p <0.01). CONCLUSIONS: Sacral neuromodulation implantation was more expensive than onabotulinumtoxinA injection. However, patients who underwent sacral neuromodulation had a lower complication rate than patients treated with onabotulinumtoxinA. A quality improvement collective database must be created to track information on onabotulinumtoxinA and sacral neuromodulation treatment. This would help generate better performance and comparative data for patient and physician decision making.

Cost-Effectiveness of Sacral Neuromodulation versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: Results of the ROSETTA Randomized Trial.

PURPOSE: Sacral neuromodulation and intradetrusor onabotulinumtoxinA injection are therapies for refractory urgency urinary incontinence. Sacral neuromodulation involves surgical implantation of a device that can last 4 to 6 years while onabotulinumtoxinA therapy involves serial office injections. We assessed the cost-effectiveness of 2-stage implantation sacral neuromodulation vs 200 units onabotulinumtoxinA for the treatment of urgency urinary incontinence. MATERIALS AND METHODS: Prospective economic evaluation was performed concurrent with the ROSETTA (Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment) randomized trial of 386 women with 6 or more urgency urinary incontinence episodes on a 3-day diary. Analysis is from the health care system perspective with primary within-trial analysis for 2 years and secondary 5-year decision analysis. Costs are in 2018 U.S. dollars. Effectiveness was measured in quality adjusted life-years (QALYs) and reductions in urgency urinary incontinence episodes per day. We generated incremental cost-effectiveness ratios and cost-effectiveness acceptability curves. RESULTS: Two-year costs were higher for sacral neuromodulation than for onabotulinumtoxinA ($35,680 [95% CI 33,920-37,440] vs $7,460 [95% CI 5,780-9,150], p <0.01), persisting through 5 years ($36,550 [95% CI 34,787-38,309] vs $12,020 [95% CI 10,330-13,700], p <0.01). At 2 years there were no differences in mean reduction in urgency urinary incontinence episodes per day (-3.00 [95% CI -3.38 - -2.62] vs -3.12 [95% CI -3.48 - -2.76], p=0.66) or QALYs (1.39 [95% CI 1.34-1.44] vs 1.41 [95% CI 1.36-1.45], p=0.60). The probability that sacral neuromodulation is cost-effective relative to onabotulinumtoxinA is less than 0.025 for all willingness to pay values below $580,000 per QALY at 2 years and $204,000 per QALY at 5 years. CONCLUSIONS: Although both treatments were effective, the high cost of sacral neuromodulation is not good value for treating urgency urinary incontinence compared to 200 units onabotulinumtoxinA.

New Technologies and Applications in Sacral Neuromodulation: An Update.

Recently rechargeable devices have been introduced for sacral neuromodulation (SNM) with conditional safety for full-body magnetic resonance imaging (MRI). Currently a recharge-free SNM device represents the standard implant; however, it is only approved for MRI head scans. As further new technologies with broader MRI capabilities are emerging, the advantages as well as disadvantages of both rechargeable versus recharge-free devices will be briefly discussed in this commentary from the perspective of patients, healthcare professionals, and providers.

ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes: protocol for the ELECTRIC randomised trial.

BACKGROUND: Urinary incontinence (UI) is highly prevalent in nursing and residential care homes (CHs) and profoundly impacts on residents' dignity and quality of life. CHs predominantly use absorbent pads to contain UI rather than actively treat the condition. Transcutaneous posterior tibial nerve stimulation (TPTNS) is a non-invasive, safe and low-cost intervention with demonstrated effectiveness for reducing UI in adults. However, the effectiveness of TPTNS to treat UI in older adults living in CHs is not known. The ELECTRIC trial aims to establish if a programme of TPTNS is a clinically effective treatment for UI in CH residents and investigate the associated costs and consequences. METHODS: This is a pragmatic, multicentre, placebo-controlled, randomised parallel-group trial comparing the effectiveness of TPTNS (target n = 250) with sham stimulation (target n = 250) in reducing volume of UI in CH residents. CH residents (men and women) with self- or staff-reported UI of more than once per week are eligible to take part, including those with cognitive impairment. Outcomes will be measured at 6, 12 and 18 weeks post randomisation using the following measures: 24-h Pad Weight Tests, post void residual urine (bladder scans), Patient Perception of Bladder Condition, Minnesota Toileting Skills Questionnaire and Dementia Quality of Life. Economic evaluation based on a bespoke Resource Use Questionnaire will assess the costs of providing a programme of TPTNS. A concurrent process evaluation will investigate fidelity to the intervention and influencing factors, and qualitative interviews will explore the experiences of TPTNS from the perspective of CH residents, family members, CH staff and managers. DISCUSSION: TPTNS is a non-invasive intervention that has demonstrated effectiveness in reducing UI in adults. The ELECTRIC trial will involve CH staff delivering TPTNS to residents and establish whether TPTNS is more effective than sham stimulation for reducing the volume of UI in CH residents. Should TPTNS be shown to be an effective and acceptable treatment for UI in older adults in CHs, it will provide a safe, low-cost and dignified alternative to the current standard approach of containment and medication. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03248362. Registered on 14 August 2017. ISRCTN, ISRCTN98415244. Registered on 25 April 2018. https://www.isrctn.com/.

Estimulación del nervio tibial posterior en vejiga hiperactiva e incontinencia fecal / Posterior tibial nerve stimulation in overactive bladder and fecal incontinence

CONTEXTO CLÍNICO: Se define al síndrome de vejiga hiperactiva (VH) como la presencia de urgencia urinaria, con o sin incontinencia, frecuentemente acompañada de aumento de la frecuencia miccional y nocturia. En Europa y EE.UU. se reporta una prevalencia de VH de 16% con rangos entre 7% y 27% en hombres y 9% y 43% en mujeres, aumentando su frecuencia con la edad, siendo la urgencia e incontinencia los síntomas más frecuentes.2,3 Mientras que en un estudio realizado en Argentina se observó una prevalencia del 23,4%. La misma puede ser idiopática o neurogénica, esta última secundaria a patologías como Enfermedad Parkinson, injuria medular y accidente cerebrovascular. Los pacientes con VH pueden experimentar disminución marcada de la calidad de vida debido a la alteración de la movilidad y del sueño, aislamiento social, disfunción sexual, requiriéndose tratamiento de por vida. TECNOLOGÍA: El objetivo de la neuromodulación periférica es estimular en forma indirecta las raíces eurológicas responsables del funcionamiento motor y/o sensorial de algún órgano, víscera y/o estructura de soporte. Actualmente en relación con las patologías de piso pélvico se describen la neuromodulación tibial posterior, la neuromodulación sacra y la endovaginal. OBJETIVO: El objetivo del presente informe es evaluar la evidencia disponible acerca de la eficacia, seguridad y aspectos relacionados a las políticas de cobertura del uso de estimulación percutánea y transcutánea del nervio tibial posterior para pacientes adultos con vejiga hiperactiva o incontinencia fecal. MÉTODOS: Se realizó una búsqueda en las principales bases de datos bibliográficas, en buscadores genéricos de internet, y financiadores de salud. Se priorizó la inclusión de revisiones sistemáticas (RS), ensayos clínicos controlados aleatorizados (ECAs), evaluaciones de tecnologías sanitarias (ETS), evaluaciones económicas, guías de práctica clínica (GPC) y políticas de cobertura de diferentes sistemas de salud. RESULTADOS: Se incluyeron un ECA, cuatro RS, seis GPC, dos evaluaciones económicas, y 17 informes de políticas de cobertura de estimulación del nervio tibial posterior para vejiga hiperactiva e incontinencia fecal. CONCLUSIONES: Evidencia de moderada calidad sugiere que la estimulación transcutánea y percutánea del nervio tibial posterior son superiores a la estimulación simulada para el tratamiento de pacientes con vejiga hiperactiva (en el corto plazo) e incontinencia fecal (corto y mediano plazo), refractarias al tratamiento estándar. Asimismo, evidencia de moderada calidad sugiere que la tecnología sería superior a una de las alternativas farmacológicas usadas en el síndrome de vejiga hiperactiva (VH), la tolteridina. Sin embargo, no se identificó evidencia comparativa con otras drogas. Evidencia de moderada calidad sugiere que la estimulación del nervio tibial posterior sería menos eficaz que la estimulación sacra, para el tratamiento de la incontinencia fecal. Para la vejiga hiperactiva, la estimulación del nervio tibial posterior se recomienda en la mayoría de las guías de práctica clínica relevadas, luego de las medidas higiénico dietéticas, ejercicios del piso pelviano y el tratamiento farmacológico, que permanecen como el estándar de cuidado en estos pacientes. Las guías recomiendan débilmente el uso o no mencionan a la estimulación del nervio tibial posterior, en el tratamiento de la incontinencia fecal. Prestadores estatales de salud del Reino Unido y Estados Unidos, y financiadoras privadas de este último país prestan cobertura a la estimulación del nervio tibial posterior para la vejiga hiperactiva, aunque algunos de ellos cubren sólo la estimulación percutánea del nervio. La mayoría de ellos la considera experimental y no presta cobertura en pacientes con incontinencia fecal. No se encontraron estudios económicos locales acerca de la costo efectividad de esta tecnología en las indicaciones evaluadas.

Neuroestimulación/neuromodulación sacra en incontinencia fecal y/o urinaria / Sacral neurostimulation/neuromodulation in fecal and/or urinary incontinence

CONTEXTO: La incontinencia urinaria (IU), o trastorno del vaciado vesical, se define como la incapacidad de mantener un control de la micción. Los trastornos del vaciado vesical se dividen en cuatro tipos generalmente, éstos son: IU de urgencia (generalmente asociado al síndrome de vejiga hiperactiva); IU de esfuerzo (pérdida de orina asociado al ejercicio, al toser o estornudar); IU mixta (combinación de las dos previas) y finalmente la IU por rebosamiento o retención urinaria no obstructiva. Las estimaciones de prevalencia de estas afectaciones varían debido a las diferencias en las definiciones, pero se ha reportado hasta un 55% en mujeres adultas. La IU de urgencia y la de esfuerzo son los tipos más frecuentes de IU crónica, con una prevalencia del 31% en mujeres mayores de 75 años y de 24 a 45% en mujeres mayores de 30 años, respectivamente. Tanto los hombres como las mujeres se ven afectados, siendo las mujeres más propensas a experimentar la incontinencia. TECNOLOGÍA: La neuromodulación sacra consiste en un generador de pulsos implantable que suministra impulsos eléctricos controlados. El dispositivo utilizado para conseguir la estimulación cuenta con un generador el cual está conectado a cables que conectan con los nervios sacros, generalmente a nivel de la raíz de S3. Dos componentes externos del dispositivo ayudan a controlar la estimulación eléctrica: um magneto de control es accionado por el paciente para prender y apagar el dispositivo y una consola programadora puede ser utilizada por el médico para ajustar los pulsos del generador. Los pacientes deben poder operar el dispositivo y llevar un diario de evacuaciones. OBJETIVO: El objetivo del presente informe es evaluar la evidencia disponible acerca de la eficacia, seguridad y aspectos relacionados a las políticas de cobertura del uso de neuroestimulación/ neuromodulador em incontinencia fecal y/o urinaria. MÉTODOS: Se realizó una búsqueda en las principales bases de datos bibliográficas, en buscadores genéricos de internet, y financiadores de salud. Se priorizó la inclusión de revisiones sistemáticas (RS), ensayos clínicos controlados aleatorizados (ECAs), evaluaciones de tecnologías sanitarias (ETS), evaluaciones económicas, guías de práctica clínica (GPC) y políticas de cobertura de diferentes sistemas de salud. RESULTADOS: Se incluyeron cinco RS, tres estudios prospectivos no controlados, cinco GPC, una evaluación económica, y 26 informes de políticas de cobertura neuromodulación sacra en incontinencia fecal y/o urinaria. CONCLUSIÓN: Evidencia de moderada calidad sugiere que la terapia con neuromodulación sacra, en comparación con otras alternativas terapéuticas, podría reducir el número de eventos de incontinencia urinaria y mejorar la calidad de vida de adultos que han fallado a otras líneas de tratamiento conservador, estos resultados fueron observados en el corto y mediano plazo. Evidencia de moderada calidad sugiere que la terapia con neuromodulación sacra, en comparación con la estimulación del tibial posterior, podría reducir el número de eventos de incontinencia fecal en adultos que han fallado a otras líneas de tratamiento conservador, estos resultados fueron observados en el corto y mediano plazo. Evidencia de muy baja calidad no permite evaluar la eficacia y seguridad de neuromodulación sacra en pacientes pediátricos con incontinencia fecal. Evidencia de muy baja calidad, proveniente de dos series de casos, no permiten sacar conclusiones acerca de la eficacia y seguridad de la neuroestimulación sacra en pacientes adultos com coexistencia de incontinencia fecal y urinaria. Las guías de práctica clínica que han sido relevadas sobre incontinencia fecal o incontinência urinaria contemplan a la neuromodulación sacra como una alternativa terapéutica en tercera línea de tratamiento. Las políticas de cobertura que han sido relevadas en América Latina no mencionan la cobertura de esta tecnología. Los financiadores públicos de Francia, Australia, Estados Unidos, Reino Unido y los privados de Estados Unidos que han sido relevados brindan cobertura de esta tecnología para las dos indicaciones evaluadas. No se hallaron estudios económicos realizados en Argentina que permitan conocer la costo-efectividad y/o el impacto presupuestario de esta tecnología.